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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/13/2026 has been entered.
Response to Arguments
Regarding claim interpretation
Examiner notes that no arguments with respect to the claim interpretations set forth previously are presented in applicant’s remarks. The claim limitations cited in the claim interpretation section therefore remain interpreted as intended use.
Regarding 35 U.S.C. 112
The 112(b) rejections previously set forth are withdrawn in view of the amendments to the claims, however, new 112(b) rejection is necessitated by amendment.
Regarding prior art
Applicant’s arguments with respect to claim 1 have been considered but are moot in view of the new grounds of rejection necessitated by amendment. Specifically, new teachings are relied upon regarding the limitations of detecting motion and selecting a monitoring channel accordingly.
To help promote expedited prosecution of this case, the Applicant is invited to contact the Examiner to set-up an Interview to discuss features of the disclosed invention with respect to the currently applied prior art.
Claim Interpretation
Claim 1 recites the limitation “for monitoring a physiologic parameter” in the preamble and later recites the limitation “to perform the monitoring of the physiological parameter”. Examiner notes that the limitations recited above are directed to an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish from the claimed invention. Thus it is noted that the prior art having the corresponding structure must merely be capable of monitoring a physiologic parameter and must be capable of performing the monitoring of the physiologic parameter to read on the claimed invention.
Claim 10 recites the limitation “for display thereon”. Examiner notes that the limitation is directed to an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish from the claimed invention. Thus it is noted that the prior art having the corresponding structure must merely be capable of being used for displaying on an external computing environment to read on the claimed invention.
Claim 17 recites the limitation “for selecting from among all sensing channels”. Examiner notes that the limitation is directed to an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish from the claimed invention. Thus it is noted that the prior art having the corresponding structure must merely be capable of being used selecting from among all sensing channels to read on the claimed invention.
Claim 37 recites the limitation “for powering the analog front end circuit and the digital circuit”. Examiner notes that the limitation is directed to an intended use A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish from the claimed invention. Thus it is noted that the prior art having the corresponding structure must merely be capable of being used for displaying on an external computing environment to read on the claimed invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7-18, 37-38 and 41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the back-end computing device”. Examiner notes that no back-end computing device is previously recited making it unclear whether the claim intends to refer to the back-end computing environment or if this is a different/distinct back-end computing device. For examination purposes, it has been interpreted that it may be the same or different, however, clarification is required.
Claim 1 recites the limitation “wherein the back-end computing environment is configured to detect motion of tissue relative to the conformal ultrasonic transducer array, and in response to the detected motion, dynamically select in real-time from among the plurality of sensing channels a sensing channel that maintains monitoring of the physiologic parameter”. Examiner notes that the limitation is unclear as to whether this is a different selection of a different channel (e.g. monitoring channel is different from sensing channel) or if the claim is intending to further define the dynamic selection of the monitoring channel previously recited such that it is In response to the detected motion and maintains monitoring, etc. For examination purposes, it has been interpreted that it may be the same or different selection of a same or different channel, however, clarification is required.
Claim 1 recites the limitation “the selected channel being transmitted to the digital circuit”. It is first unclear if the selected channel is the selected monitoring channel or the selected sensing channel previously recited. It is further unclear if the selected channel is the same as or different from the at least the identifier previously recited. In other words, the claim previously recites that the digital circuit receives at least an identifier and is now reciting that the selected channel is transmitted to the digital circuit, thus would appear to constitute an identifier of the selected monitoring channel in a case where the selected sensing channel is the same as the selected monitoring channel or the selected channel is the same selected monitoring channel. For examination purposes, it has been interpreted that the selected channel may be the same as the identifier or different, however, clarification is required.
Claims 3 and 4 recite “through specified tissue”. It is unclear if the specified tissue is the same as the tissue recited in claim 1 or if this is different tissue. For examination purposes, it has been interpreted to mean any specified tissue, however, clarification is required.
Claim 13 recites the limitation “measure a shift, the shift in the time domain, in a detected peak of the received reflected acoustic wave, the shift due to movement of an organ or tissue”. It is unclear if the shift due to movement of an organ or tissue corresponds with the motion of the tissue relative to the conformal array previously recited in claim 13 or if this is a different shift due to a different movement from a different organ/tissue. For examination purposes, it has been interpreted that it may be the same or different, however, clarification is required.
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.
Claims 1-4, 7-8, 10-12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Alford (US 20170007853 A1), hereinafter Alford in view of Furman et al. (US 20130310691 A1), hereinafter Furman.
Regarding claim 1,
Alford teaches a system (at least fig. 1 (10) and corresponding disclosure in at least [0029]) for monitoring a physiologic parameter (abstract which discloses system comprises one or more sensors to sense one or more physiological parameters), comprising:
a. a conformal ultrasonic transducer array (at least fig. 5 (54) and corresponding disclosure in at least [0063] which discloses ultrasound transducers 54 may correspond to any ultrasound transducers e.g. 24, 34, or 44 see figs. 2, 3, and 4 depicting conformal ultrasonic transducer arrays) located on a flexible substrate (at least fig. 2 and 3 (20 or 22) and corresponding disclosure in at least [0050]. See also [0058] and [0059] which discloses wearable ultrasonic device may also include an adhesive layer (i.e. a substrate))
b. an analog front end circuit (at least fig. 5 (56 and 62) and corresponding disclosure in at least [0063] and [0066]) located on the flexible substrate (see fig. 5 depicting the wearable ultrasonic device 50 including the signal generation circuitry (i.e. analog front end circuit) thus located on the wearable ultrasonic device 50 or flexible substrate 20 or adhesive layer thereof) and further coupled to the conformal ultrasonic transducer array (see fig. 5), the analog front end circuit (56 and 62) configured to at least cause the conformal ultrasonic transducer array to generate ultrasonic acoustic waves and receive reflected ultrasonic acoustic waves ([0063] which discloses signal generation circuitry 56 for driving the ultrasound transducers 54 to deliver ultrasound, and one or more power sources 58 that provide power to the signal generation circuitry 56 for driving transducers 54);
c. a digital circuit (at least fig. 5 (52, 64, and 66) and corresponding disclosure in at least located on the flexible substrate (see fig. 5 depicting the wearable ultrasonic device 50 including the elements 52, 66, and 64 located thereon, thus the digital circuit is located on the wearable ultrasonic device 50 or flexible substrate 20 or adhesive layer thereof. See also [0116] which discloses the processing circuitry comprises processing circuity of the flexible ultrasound device coupled to the flexible interconnect element) and further coupled to the analog front end circuit (see at least fig. 5),
d. a back-end computing environment at least fig. 1 (16) and corresponding disclosure in at least [0045])
the digital circuit (52, 66, and 64) being configured to at least:
i. control the analog front end circuit at least in its generation of ultrasonic acoustic waves using a plurality of sensing channels ([0065] which discloses more particularly, processing circuitry 52 controls signal generation circuitry 56 to generate a signal based on power from power source(s) 58 that drives the ultrasound transducers to deliver ultrasound);
ii. transmit data concerning the received reflected ultrasonic acoustic waves to the back-end computing environment ([0045] which discloses Interface device 16 may also receive sensed physiological parameter information from wearable ultrasound device 12, sensors 18, and external sensing devices 19 and [0068] which discloses interface device may also receive diagnostic ultrasound images collected by processing circuitry 52 or any other information generated by processing circuitry 52 via communication circuitry 64, thus is configured to transmit data concerning the received reflected ultrasonic acoustic waves to the back-end computing environment)
iii. receive in real-time control identifiers from the back-end computing environment ([0069] which discloses interface device is configured to control ultrasound device, interface device may be referred to as an external programmer device and [0072] which discloses processing circuitry 70 may be configured to control an ultrasound device to modify the delivery of ultrasound based on changes, or lack thereof)) and cause the analog front-end circuit to generate ultrasonic acoustic waves using the sensing channels to perform the monitoring of the physiological parameter ([0065] which discloses more particularly, processing circuitry 52 controls signal generation circuitry 56 to generate a signal based on power from power source(s) 58 that drives the ultrasound transducers to deliver ultrasound and [0032] which discloses the wearable ultrasound device may deliver ultrasound to patient for diagnostic imaging and [0077] which discloses monitoring a patient during the delivery of the ultrasound. Examiner notes that to perform the monitoring of the physiological parameter is merely an intended use as noted in the claim interpretation section above and it is noted that the system is capable of being used to monitor physiological parameters during delivery of the ultrasound)
Alford fails to explicitly teach the back-end computing device being configured to dynamically select a monitoring channel in real-time from among the plurality of sensing channels, and wherein the backend-computing environment is configured to detect motion of tissue relative to the conformal ultrasonic transducer array, and in response to the detected motion, dynamically select in real-time from among the plurality of sensing channels a sensing channel that maintains monitoring of the physiological parameter based at least in part on detected changes in reflected ultrasonic acoustic waves across the plurality of sensing channels indicative of relative motion between the tissue and the conformal ultrasonic transducer array, the selected channel being transmitted to the digital circuit.
Furman teaches a back-end computing device configured to dynamically select a monitoring channel in real-time from among a plurality of sensing channels ([0027] which discloses several selected steps could be implemented by hardware or by software on any operating system of any firmware or a combination thereof. For example, as hardware, selected steps of the disclosure could be implemented as a chip or a circuit. As software, selected steps of the disclosure could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps of the method and system of the disclosure could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions and [0123] which discloses the system 100 may identify a subset (n-x) of the at least two or more transducer, that provide data in accordance with the vessel criteria, a subset of ultrasound transducers are selected and probe 110 rescans the static scanning area only with the determined subset of ultrasound transducers [0087] which discloses individual ultrasound scan-lines may be selectively and specifically controlled with scan engine 112. Scan engine 112 provides for controlling probe 110 by controlling a plurality of ultrasound transducers and ultrasound elements [0123], [0128]-[0129]),
Wherein the back-end computing environment is configured to detect motion of tissue relative to the conformal ultrasonic transducer array (at least fig. 11 and corresponding disclosure in at least [0181] which discloses the flanking scan lines provide for identifying movement, expansion, deformation and changes of the vessel coordinates, over time and during stages of the cardiac cycle. The vessel ultrasound data, at the boundary 1200b, is determined every 10 milliseconds (10 ms) for about 6 seconds providing data for at least three or more consecutive cardiac cycles. [0184] which discloses next in stages 1105 and 1106 ultrasound and Doppler data provided in earlier stages is then processed to further to track the vessel of interest to account for vessel movement, deformation or the like and [0182] which discloses next in stage 1102 the RHT identified vessel center 1200c, as shown in FIG. 12A-B, is similarly tracked with a Doppler scan line (dsl). In one embodiment, the vessel ultrasound data is determined every 10 ms for about 6 seconds providing data for identifying at least three or more consecutive cardiac cycles)
And in response to the detected motion select in real-time from among the plurality of sensing channels a sensing channel that maintains monitoring of a physiological parameter based at least in part on detected changes in reflected ultrasonic acoustic wave characteristics across the plurality of sensing channels indicative of relative motion between the tissue and the conformal ultrasonic transducer array, the selected channel being transmitted to a probe(See at least fig. 11 which depicts an iterative loop including an ultrasound scan and Doppler scan which use the detected motion from at least 1106, and [0123] which discloses the system 100 may identify a subset (n-x) of the at least two or more transducer, that provide data in accordance with the vessel criteria, a subset of ultrasound transducers are selected and probe 110 rescans the static scanning area only with the determined subset of ultrasound transducers, scan engine 120 activates and/or generates an ultrasound signal utilizing the ultrasound scan-lines in the vicinity of the identified subset of transducers to concentrate the scan area about the vessel borders. See also [0144] which discloses such a Doppler scanning scheme provides for saving resources in particular time as ultrasound transducers and elements are selectively activated, and furthermore provide for real time computational constraints),
Wherein the probe is configured to receive in real-time at least an identifier of the selected monitoring channel from the back-end computing environment and cause the probe to generate ultrasonic acoustic waves on the selected monitoring channel to perform the monitoring of the physiological parameter ([0123] which discloses the system 100 may identify a subset (n-x) of the at least two or more transducer, that provide data in accordance with the vessel criteria, a subset of ultrasound transducers are selected and probe 110 rescans the static scanning area only with the determined subset of ultrasound transducers, scan engine 120 activates and/or generates an ultrasound signal utilizing the ultrasound scan-lines in the vicinity of the identified subset of transducers to concentrate the scan area about the vessel borders)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the back-end computing environment of Alford such that it is configured to detect motion of tissue and dynamically select a monitoring and sensing channel as taught by Furman in order to concentrate the scan area about vessel borders (Furman [0125]). Such a modification would allow for the scan-lines to encompass a vessel of interest and account for movement due to blood flow, stretch, breathing or the like, while optionally, simultaneously saving resources during a subsequent scan and analysis (Furman [0126]).
Examiner notes that in the modified system by transmitting the selected channel to the probe, that the digital circuit of the probe of Alford would receive in real-time said selected channel and thus an identifier of the selected monitoring channel from the back-end computing environment and cause the analog front-end circuit to generate ultrasonic acoustic waves on the selected monitoring channel to perform the monitoring of the physiological parameter accordingly.
Regarding claim 2,
Alford, as modified, teaches the elements of claim 1 as previously stated. Alford, as modified, further teaches wherein the selected monitoring channel received by the digital circuit is dynamically selected in real-time by the back-end computing environment (Furman [0144] which discloses such a Doppler scanning scheme provides for saving resources in particular time as ultrasound transducers and elements are selectively activated, and furthermore provide for real time computational constraints) at least in part using artificial intelligence techniques ([0027] which discloses . As software, selected steps of the disclosure could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps of the method and system of the disclosure could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions. Examiner notes that such use of computer/instructions constitutes artificial intelligence techniques and that the selected monitoring channel is dynamically selected at least in part using such artificial intelligence techniques)
Regarding claim 3,
Alford, as modified, teaches the elements of claim 2 as previously stated.
Furman, as applied to claim 2 above, further teaches wherein the artificial intelligence techniques identifies the selected monitoring channel from among the plurality of sensing channels such that the selected monitoring channel causes reflected acoustic waves to be reflected from specified tissue that is to be monitored ([0123] which discloses the system 100 may identify a subset (n-x) of the at least two or more transducer, that provide data in accordance with the vessel criteria, a subset of ultrasound transducers are selected and probe 110 rescans the static scanning area only with the determined subset of ultrasound transducers, scan engine 120 activates and/or generates an ultrasound signal utilizing the ultrasound scan-lines in the vicinity of the identified subset of transducers to concentrate the scan area about the vessel borders. See also [0144] which discloses such a Doppler scanning scheme provides for saving resources in particular time as ultrasound transducers and elements are selectively activated, and furthermore provide for real time computational constraint).
Regarding claim 4,
Alford, as modified, teaches the elements of claim 2 as previously stated.
Furman, as applied to claim 2 above, further teaches wherein the artificial intelligence techniques identifies that cause ultrasonic acoustic waves to be transmitted through specified tissue that is to be monitored ([0123] which discloses the system 100 may identify a subset (n-x) of the at least two or more transducer, that provide data in accordance with the vessel criteria, a subset of ultrasound transducers are selected and probe 110 rescans the static scanning area only with the determined subset of ultrasound transducers, scan engine 120 activates and/or generates an ultrasound signal utilizing the ultrasound scan-lines in the vicinity of the identified subset of transducers to concentrate the scan area about the vessel borders. See also [0144] which discloses such a Doppler scanning scheme provides for saving resources in particular time as ultrasound transducers and elements are selectively activated, and furthermore provide for real time computational constraints)
Regarding claim 7,
Alford further teaches wherein the physiological parameter being monitored is selected from the group including blood pressure, heart rate, pulse wave velocity, stock volume, cardiac output, augmentation index, and expiratory volume ([0026] which discloses Ultrasound imaging of patient anatomy may be used to non-invasively identify tissue structures and physiological states (e.g., cardiac tissue and blood flow, tissue elasticity) and [0041] which discloses other example physiological parameters of patient 14 that sensors, such as sensors 18 and/or external sensing devices 19, may be configured to detect include blood oxygen level, activity level, heart rate, temperature, respiration rate, or blood pressure and [0062] which discloses sensors 46 (on the substrate 42) may be configured to measure heart rate, blood pressure, respiration rate, blood oxygenation, or temperature)
Additionally/alternatively, Furman, as applied to claim 1 further teaches wherein a physiological parameter being monitored includes blood pressure, heart rate, pulse wave velocity, stock volume, cardiac output, augmentation index, and expiratory volume ([0113]).
Regarding claim 8,
Alford further teaches wherein the digital circuit includes a wireless communication circuit (at least fig. 5 (64) and corresponding disclosure in at least [0068]) for communicating with the back-end computing environment ([0068] which discloses communication circuitry 64 is configured to support wireless communication between the ultrasound device and external sensing devices 19)
Regarding claim 10,
Alford, as modified, teaches the elements of claim 1 as previously stated. Alford, as modified, further teaches wherein the digital circuit is further configured to transmit the data concerning the received reflected ultrasonic acoustic waves to an external computing environment (Alford [0045] which discloses interface device 16 may also receive sensed physiological parameter information from wearable ultrasound device 12, sensors 18, and external sensing devices 19 and [0068] which discloses interface device may also receive diagnostic ultrasound images collected by processing circuitry 52 or any other information generated by processing circuitry 52 via communication circuitry 64, thus is configured to transmit an indication of the reflected ultrasonic acoustic waves to an external computing environment) for display thereon (Examiner notes that the limitation is considered an intended use as noted above, where transmitting ultrasound images collected by the processing circuitry may ultimately be used for display on the external computing environment 16 further more [0071] discloses user interface 76 includes a display which may present any information retrieved from the ultrasound device).
Regarding claim 11,
Alford further teaches wherein the digital circuit is further configured to present an indication of the reflected ultrasonic acoustic waves ([0068] which discloses interface device may also receive diagnostic ultrasound images collected by processing circuitry 52 or any other information generated by processing circuitry 52 via communication circuitry 64. Thus the processing circuitry presents such an indication (i.e. ultrasound images) in order for the interface device to receive it accordingly) arising from use of the selected monitoring channel (i.e. the selected monitoring channel of Furman)
Regarding claim 12,
Alford, as modified, teaches the elements of claim 10 as previously stated.
Alford, as currently modified, further teaches wherein the back-end computing environment is the same as or different from the external computing environment (Examiner notes the back-end computing environment 16 of Alford is the same as an external computing environment 16).
Regarding claim 14,
Alford further teaches wherein the analog front end is further configured to steer or direct the generated ultrasonic acoustic waves toward an organ, tissue, or location of interest ([0065] which discloses Signal generation circuitry 56 may include one or more oscillators configured to generate signals of a desired frequency for the ultrasound, amplification or other circuitry to control the amplitude of the driving signals, as well as switching circuitry to selectively direct the signal to one or more of transducers 54 and/or selectively control the on/off state of individual ones or groups of transducers 54. Some or all of the signal generation circuitry may be respectively associated with certain ones or groups of transducers 54, or shared by all or a subset of transducers 54. Processing circuitry 52 may control ultrasound transducers 54 to deliver ultrasound to a particular depth, region, or point of tissue, with a particular amplitude, by selecting which of transducers 54 is on or driven, and controlling one or more of the amplitude or phase of the driving signal provided to the driven transducers 54 by signal generation circuitry 56. Different active transducers 54 may be driven with different signals, e.g., different amplitudes and/or phases, to target a desired, depth, region, or point of tissue), the steering or directing by beam-forming ([0065] which discloses the phase of the driving signal provided by signal generating unit, where controlling such amplitude or phase necessarily constitutes beam forming (i.e. forming a beam))
Regarding claim 15,
Alford further teaches wherein the steering includes dynamically adjusting a time-delay profile of individual transducer activation in the transducer array ([0065] which discloses different active transducers 54 may be driven with different signals, e.g., different amplitudes and/or phases, to target a desired, depth, region, or point of tissue. Examiner notes that the system would be capable of adjusting such time-delay profiles (i.e. phase) accordingly in order to control the signals to a target dynamically)
Regarding claim 16,
Alford further teaches wherein the transducer array is a piezoelectric array ([0057] which discloses the piezoelectric material of ultrasound transducers 24 may be, as examples, one or more of lead zirconate titanate (PZT) composite, PZT film, polyvinylidene fluoride (PVDF), which is a plastic with piezoelectric properties, thin-film piezoelectric materials (e.g., either lead-containing or non-lead containing materials).
Regarding claim 17,
Alford, as modified, teaches the elements of claim 1 as previously stated. Alford further teaches wherein the analog front end circuit includes switching circuitry for selecting from among all sensing channels that are used to generate the ultrasonic acoustic wave and perform monitoring ([0065] which discloses signal generation circuitry 56 may include one or more oscillators configured to generate signals of a desired frequency for the ultrasound, amplification or other circuitry to control the amplitude of the driving signals, as well as switching circuitry to selectively direct the signal to one or more of transducers 54 and/or selectively control the on/off state of individual ones or groups of transducers 54), however, fails to teach the analog front end circuit includes a multiplexer or that the switching.
Nonetheless, Furman further teaches s a multiplexor (at least fig. 2B (116) and corresponding disclosure in at least [0096]) for selecting from among all sensing channels that are used to generate the ultrasonic acoustic wave and perform monitoring ([0087] which discloses a multiplexor 116 is associated and/or otherwise interfaces or coupled with the scan engine 112 and probe 110 to control the individual ultrasound elements and the scan-lines produced therefrom).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the analog front end circuitry of Alford, as currently modified, to include the multiplexor as taught by Furman in order to allow for selecting of the desired active elements/aperture of the array accordingly. Such a modification amounts to merely one known switching circuitry for another yielding predictable results with respect to ultrasound transmission control thereby rendering the claim obvious (MPEP 2143).
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Alford (US 20170007853 A1), hereinafter Alford and Furman, et al. (US 20130310691 A1), hereinafter Furman as applied to claim 2 above and further in view of Lundberg et al. (US 20200088862 A1), hereinafter Lundberg.
Regarding claim 5,
Alford, as modified, teaches the elements of claim 2 as previously stated. Alford, as modified, fails to explicitly teach wherein the artificial intelligence techniques employ models that are generalizable to allow physiological monitoring to be performed on different subjects.
Lundberg, in a similar field of endeavor involving ultrasound imaging, teaches performing quality assessment of ultrasound transducers using artificial intelligence techniques ([0023] which discloses the processor determines there is a fault in the transducer and [0024] which discloses the neural network analyzes the image data and returns a probability or percentage like .96 and an associated identifier such as #4 transducer element 38 non-functioning and [0037] which discloses the processor receives the output of the neural network and adjusts one or more operating parameters (may not transmit from a transducer element that is found to be defective) that employ models that are generalizable ([0030] which discloses a number of different machine learning models can be employed. For example, variants of freely available models can be used such as VGG5, VGG16, and mobile net. Custom (thus generalizable) models can also be developed and [0032] which discloses neural network models themselves are generally interchangeable. Examiner notes that any of the models disclosed in [0030] or [0032] are considered to be “generalizable” in that they are capable of being generalized).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Alford, as currently modified, to include employing models as taught by Lundberg in order to identify faulty transducers and to better isolate errors in the image data (Lundberg [0027]).
Examiner notes that the limitation “to allow physiological monitoring to be performed on different subjects” is considered an intended use as noted above in the claim interpretation where it is noted that the machine learning models are generalizable as noted above and would be capable of allowing physiological monitoring to be performed on different subjects in the modified system.
Furthermore, Examiner notes that in the modified system the selection of the monitoring channel would thus at least in part use the artificial intelligence techniques which enhance the quality of image data of Lundberg accordingly.
Regarding claim 18,
Alford, as modified, teaches the elements of claim 2 as previously stated. Alford, as modified, fails to explicitly teach wherein the artificial intelligence techniques are machine learning techniques.
Lundberg, in a similar field of endeavor involving ultrasound imaging, teaches performing quality assessment of ultrasound transducers using artificial intelligence techniques ([0023] which discloses the processor determines there is a fault in the transducer and [0024] which discloses the neural network analyzes the image data and returns a probability or percentage like .96 and an associated identifier such as #4 transducer element 38 non-functioning and [0037] which discloses the processor receives the output of the neural network and adjusts one or more operating parameters (may not transmit from a transducer element that is found to be defective), wherein the artificial intelligence techniques are machine learning techniques ([0030] which discloses a number of different machine learning models can be employed. For example, variants of freely available models can be used such as VGG5, VGG16, and mobile net. Custom (thus generalizable) models can also be developed and [0032] which discloses neural network models themselves are generally interchangeable. Examiner notes that any of the models disclosed in [0030] or [0032] are considered to be “generalizable” in that they are capable of being generalized).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Alford, as currently modified, to include employing models as taught by Lundberg in order to identify faulty transducers and to better isolate errors in image data (Lundberg [0027]).
Examiner notes that in the modified system the selection of the monitoring channel would thus at least in part use the artificial intelligence techniques which enhance the quality of image data of Lundberg accordingly.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Alford (US 20170007853 A1), hereinafter Alford and Furman, et al. (US 20130310691 A1), hereinafter Furman as applied to claim 8 above and further in view of Siedenburg et al. (US 20180369065 A1), hereinafter Siedenburg.
Regarding claim 9,
Alford, as modified, teaches the elements of claim 8 as previously stated. Alford, as modified, fails to explicitly teach wherein the wireless communication circuit is a Wi-fi communication circuit.
Siedenburg, in a similar field of endeavor involving ultrasound imaging, teaches wherein a wireless communication circuit is a wi-fi communication circuit ([0023] which discloses the communication module 207 can transmit data… locally such as via Wi-Fi direct).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Alford, as currently modified to include a wi-fi communication circuit as taught by Siedenburg in order to transmit data locally accordingly. Such a modification amounts to merely a simple substitution of one known communication circuit for another yielding predictable results with respect to data transmission thereby rendering the claim obvious (MPEP 2143).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Alford (US 20170007853 A1), hereinafter Alford and Furman, et al. (US 20130310691 A1), hereinafter Furman as applied to claim 10 above and further in view of Foreign Kim (KR 20160087221 A), hereinafter Kim. Examiner notes that citations to Kim are with respect to the translated copy provided herein.
Regarding claim 13,
Alford, as modified, teaches the elements of claim 10 as previously stated. Alford further teaches further comprising the backend computing environment (16).
Alford, as modified, fails to explicitly teach wherein the backend computing environment is configured to measure a shift, the shift in the time domain, in a detected peak of the received reflected acoustic wave, the shift due to movement of an organ or tissue, and wherein the displayed indication of the monitored physiological parameter is based on the measured shift.
Kim, in a similar field of endeavor involving ultrasound imaging, teaches a back-end computing environment configured to measure a shift, the shift in the time domain, in a detected peak of a received reflected acoustic wave, the shift due to movement of an organ or tissue (pg. 7 seventh full paragraph disclosing the blood flow information based on the generated change waveform the period of change of the waveform (i.e. of received reflected acoustic data (i.e. Doppler data as disclosed above), the blood flow information extracting unit 220 (i.e. back-end computing environment) can extract a peak point and calculate the time between (i.e. measure a shift in the time domain) adjacent peak points where the shift is due to movement of an organ or tissue (i.e. a heart)), and wherein a displayed indication of a monitored physiological parameter is based on a measured shift (pg. 8 second full paragraph which discloses the display unit may display the calculated heart rate (i.e. indication of monitored physiological parameter based on the measured shift (i.e. difference in time between peaks)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Alford, as currently modified, to include measuring a shift and displaying an indication of a physiological parameter as taught by Kim in order to provide for additional physiological monitoring using reflected ultrasound. Such a modification would further improve the capabilities of the ultrasound array of Alford by allowing for heart rate/blood flow information to be measured using acquired ultrasound information, thereby eliminating the need for additional sensors to measure such heart rate information.
Claims 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Alford (US 20170007853 A1), hereinafter Alford and Furman, et al. (US 20130310691 A1), hereinafter Furman as applied to claim 1 above and further in view of Rothberg et al. (US 20190069842 A1), hereinafter Rothberg.
Regarding claim 37,
Alford, as modified, teaches the elements of claim 1 as previously stated.
Alford further teaches further comprising a power source (at least fig. 5 (58) and corresponding disclosure in at least [0063]) located on the flexible substrate (see at least fig. 5) for powering the analog front end circuit and the digital circuit ([0063] one or more power sources 58 that provide power to the signal generation circuitry 56 for driving transducers 54, as well as providing power to other components ultrasound device 50).
It is unclear if the power source is or includes a battery.
Rothberg, in a similar field of endeavor involving ultrasound imaging, teaches a battery for powering components of an ultrasound system ([0061] which discloses the battery 130 is configured to provide power to the circuitry on the PCB 120 and supply power to the ultrasound on a chip device 110)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Alford, as currently modified, to include a battery as taught by Rothberg in order to provide an appropriate power supply for the components of the wearable ultrasound system. Such amounts to merely a simple substitution of one known power source for another yielding predictable results with respect to powering circuitry thereby rendering the claim obvious (MPEP 2143).
Regarding claim 38,
Alford, as modified, further teaches wherein the battery is a lithium-polymer battery (Rothberg [0061] which discloses the battery may be a lithium-polymer battery) configured to power the analog front end circuit and the digital circuit (Examiner notes in the modified system the battery is configured to power all components of the wearable device of Alford including the analog front end circuit and digital circuit) up to 12 hours (Rothberg [0042] which discloses the ultrasound-on-a-chip device may be kept bound to the wrist for an extended period of time (e.g., 1 hour, 6 hours, 12 hours, 1 day, 1 week, 1 month, indefinitely, or any suitable length of time), in place for collection of ultrasound data when needed. Instead of a user actively initiating collection of ultrasound data when needed, because the ultrasound-on-a-chip device is kept bound to the wrist for an extended period of time (e.g., 1 hour, 6 hours, 12 hours, 1 day, 1 week, 1 month, indefinitely, or any suitable length of time). Thus examiner notes that the battery is configured to power the components of the wearable system at least up to 12 hours in order to collect ultrasound data as needed for the extended period of time)
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Alford (US 20170007853 A1), hereinafter Alford and Furman, et al. (US 20130310691 A1), hereinafter Furman as applied to claim 16 above and further in view of Perez et al. (US 20200315591 A1), hereinafter Perez.
Regarding claim 41,
Alford, as modified, teaches the elements of claim 1 as previously stated. Alford, as modified, fails to explicitly teach wherein the transducer array has a center frequency between 2 MHz and 6 MHz
Perez, in a similar, field of endeavor involving ultrasound imaging, teaches wherein a transducer array has a center frequency between 2MHz and 6 MHz ([0034] which discloses for diagnosis and/or imaging, the center frequency of components 130 (i.e. transducer array/ultrasound imaging components) can bet between 2 MHz and 75 MHz. Lower frequencies e.g. between 2 MHz and 10 MHz) can advantageously penetrate further into the anatomy 102 where frequencies between 2 MHz and 6 MHz can be found in the range between 2 MHz and 75 MHz and 2 MHz and 10 MHz).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the transducer array of Alford to have a center frequency between 2 MHz and 6 MHz as taught by Perez in order to advantageously allow for ultrasound penetration further in to the anatomy, such that more of the anatomy is visible in the ultrasound images (Perez [0034]). Such a modification would therefore enhance the ultrasound diagnostic imaging of Alford.
Conclusion
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797