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 .
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 1-12, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an Abstract Idea without significantly more.
[STEP 1]
Regarding claim 1, the claim is a system/machine and is one of the four statutory categories.
[STEP 2A, Prong One]
The claims recite the following limitations that recite an abstract idea: receiving ultrasound imaging data of a diaphragm of a patient over a time period encompassing multiple breaths; receiving respiration data of the patient over the time period; calculating a diaphragm thickness metric based on the received ultrasound imaging data of the diaphragm and the received respiration data (judgement or evaluation, which is grouped as mental process under the 2019 PEG). The above limitations are directed to mental processes that can be done by a person simply observing the imaging data, and evaluating the readings using a percentage comparing equation or similar equation that can be expressed in decimals.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 2-12 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
[STEP 2A, Prong Two]
Claims 1 and 4 recite the additional elements of: An electronic processor and a display device and an ultrasound imaging patch.
The above-identified abstract idea in independent Claim 1 (and respective dependent Claims 2-12) is not integrated into a practical application under 2019 PEG because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: An electronic processor and a display device are generically recited computer elements in independent Claim 1 (and respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. The additional element of: An ultrasound imaging patch is amounts to no more than generally linking the use of the abstract idea to a particular technological environment or field of use. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in claim 1 (and respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., the electronic processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in claim 1 (and respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent claim 1 and dependent claims 2-12 are each directed to an abstract idea under 2019 PEG.
[STEP 2B]
The claims do not cite any additional structures that would make it significantly more than the judicial exception. The electronic processor is described as being used to “receiving ultrasound imaging data of a diaphragm of a patient over a time period encompassing multiple breaths; receiving respiration data of the patient over the time period; calculating a diaphragm thickness metric based on the received ultrasound imaging data of the diaphragm and the received respiration data; and displaying, on a display device, a representation of the calculated diaphragm thickness metric” (Specification [0011]) and display device is being used to “show a representation of the calculated diaphragm thickness metric” (Specification [0010]). These elements are conventional and well-known in the art as shown by Souzy (US 20180256075 A1) (Souzy: FIG. 1 Processing circuitry 106 and/or the monitor 110 may provide for control of the measurements being performed as set forth in [0047], and, on a display device, a representation of the diaphragm related parameters, FIG. 1 Monitoring system 100 includes monitor 110 that provides information about the measured motion parameters from the tissue to a human observer as set forth [0047]). The use of a generic processor and/or any other general computer components, such as an artificial neural network (ANN) model (as disclosed in claim 12) to store information and perform basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). Receiving ultrasound imaging data of a diaphragm of a patient over a time period encompassing multiple breaths; receiving respiration data of the patient over the time period; calculating a diaphragm thickness metric based on the received ultrasound imaging data of the diaphragm and the received respiration data; and displaying a representation of the calculated diaphragm thickness metric are merely extra solution activities in that it provides an indication of the result of the abstract determination process. It is well-known analysis technique involving an act of evaluating information can be practically performed in the human mind. Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. See MPEP 2106.05((g). With respect to the data acquisition, Souzy (US 20180256075 A1) and Pirompanich (PIROMPANICH, P. et al., “Use of diaphragm thickening fraction combined with rapid shallow breathing index for predicting success of weaning from mechanical ventilator in medical patients” Journal of Intensive Care, Biomed Central Ltd., vol. 6, no. 1, 2018; DOI: 10.1186/s40560-018-0277-9; Accessed 01/30/2026) mention the data acquisition of ultrasound imaging are well known in the art. The components found in the claim is-well-known to be conventional in the art. Displaying a representation of the calculated diaphragm thickness metric is an insignificant post-solution activity (see MPEP 2106.05(g)). This is conventional and well-known in the art as shown by Souzy (US 20180256075 A1) (Souzy: FIG. 1 Monitoring system 100 includes monitor 110 that provides information about the measured motion parameters from the tissue to a human observer as set forth [0047]).
Further, dependent claims 2-12 include limitations that either further define the abstract idea by further defining the acquisition of data and the diaphragm thickness metric in claims 2-3, 5-7, 9, and 12, and further defining the capabilities of the electronic processor in claim 8 and 11 (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use, like in claim 4 and 11 drawn to an ultrasound imaging patch, or like in claim 10 drawn to the use of a mechanical ventilator, because they’re merely incidental or token additions to the claims that do not alter or affect how the system performs.
[STEP 1]
Regarding claim 15, the claim is a method and is one of the four statutory categories.
[STEP 2A, Prong One]
The claims recite the following limitations that recite an abstract idea: receiving ultrasound imaging data of a diaphragm of a patient over a time period encompassing multiple breaths; receiving respiration data of the patient over the time period; calculating a diaphragm thickness metric based on the received ultrasound imaging data of the diaphragm and the received respiration data (judgement or evaluation, which is grouped as mental process under the 2019 PEG). The above limitations are directed to mental processes that can be done by a person simply observing the imaging data, and evaluating the readings using a percentage comparing equation or similar equation that can be expressed in decimals.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
[STEP 2A, Prong Two]
Claim 1 recites the additional elements of: An electronic processor and a display device.
The above-identified abstract idea in independent claim 15 is not integrated into a practical application under 2019 PEG because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: An electronic processor and a display device are generically recited computer elements in independent Claim 15 which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in claim 1 is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., the electronic processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in claim 1 (and respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent claim 1 is directed to an abstract idea under 2019 PEG.
[STEP 2B]
The claims do not cite any additional structures that would make it significantly more than the judicial exception. The electronic processor is described as being used to “receiving ultrasound imaging data of a diaphragm of a patient over a time period encompassing multiple breaths; receiving respiration data of the patient over the time period; calculating a diaphragm thickness metric based on the received ultrasound imaging data of the diaphragm and the received respiration data; and displaying, on a display device, a representation of the calculated diaphragm thickness metric” (Specification [0011]) and display device is being used to “show a representation of the calculated diaphragm thickness metric” (Specification [0010]). These elements are conventional and well-known in the art as shown by Souzy (US 20180256075 A1) (Souzy: FIG. 1 Processing circuitry 106 and/or the monitor 110 may provide for control of the measurements being performed as set forth in [0047], and, on a display device, a representation of the diaphragm related parameters, FIG. 1 Monitoring system 100 includes monitor 110 that provides information about the measured motion parameters from the tissue to a human observer as set forth [0047]). The use of a generic processor and/or any other general computer components to store information and perform basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). receiving ultrasound imaging data of a diaphragm of a patient over a time period encompassing multiple breaths; receiving respiration data of the patient over the time period; calculating a diaphragm thickness metric based on the received ultrasound imaging data of the diaphragm and the received respiration data; and displaying a representation of the calculated diaphragm thickness metric are merely extra solution activities in that it provides an indication of the result of the abstract determination process. It is well-known analysis technique involving an act of evaluating information can be practically performed in the human mind. Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. See MPEP 2106.05((g). With respect to the data acquisition, Souzy (US 20180256075 A1) and Pirompanich (PIROMPANICH, P. et al., “Use of diaphragm thickening fraction combined with rapid shallow breathing index for predicting success of weaning from mechanical ventilator in medical patients” Journal of Intensive Care, Biomed Central Ltd., vol. 6, no. 1, 2018; DOI: 10.1186/s40560-018-0277-9; Accessed 01/30/2026) mention the data acquisition of ultrasound imaging are well known in the art. The components found in the claim is-well-known to be conventional in the art. Displaying a representation of the calculated diaphragm thickness metric is an insignificant post-solution activity (see MPEP 2106.05(g)). This is conventional and well-known in the art as shown by Souzy (US 20180256075 A1) (Souzy: FIG. 1 Monitoring system 100 includes monitor 110 that provides information about the measured motion parameters from the tissue to a human observer as set forth [0047]).
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 1-5, 9-11, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pirompanich (PIROMPANICH, P. et al., “Use of diaphragm thickening fraction combined with rapid shallow breathing index for predicting success of weaning from mechanical ventilator in medical patients” Journal of Intensive Care, Biomed Central Ltd., vol. 6, no. 1, 2018; DOI: 10.1186/s40560-018-0277-9; Accessed 01/30/2026), in view of Souzy (US 20180256075 A1).
Regarding claim 1, Pirompanich discloses a diaphragm measurement system (A weaning index using point-of-care ultrasound with diaphragmic thickening fraction (DTF) is determined wherein both hemi-diaphragms were visualized in the zone of apposition using a 10-MHz linear probe as set forth on page 1 in the Abstract), comprising: the method including: receiving ultrasound imaging data of a diaphragm of a patient over a time period encompassing multiple breaths (Diaphragm ultrasound scans on both sides were performed as set forth on page 2 in the “Study design” section; The DTF of three breaths on each side were measured and the mean value was used for analysis as set forth on page 3 in the ”Diaphragm ultrasound” section); receiving respiration data of the patient over the time period (The rapid shallow breathing index (RSBI), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP) were recorded after a spontaneous breathing trial (SBT) for 1 min as set forth on page 2 in the “Study design” section); calculating a diaphragm thickness metric (The combined RSBI and DTF ability to predict patients who would succeed at weaning or fail as set forth on page 3 in the “Statistical analysis” section) based on the received ultrasound imaging data of the diaphragm and the received respiration data (Receiver operating characteristic (ROC) curve analysis was performed to assess diaphragm DTF, RSBI, and combined RSBI and DTF ability to predict patients who would succeed at weaning or fail as set forth on page 3 in the “Statistical analysis” section; Diaphragm thickening fraction of the right diaphragm by ultrasound of more than or equal to 26% combined with RSBI of less than or equal to 105 improved the efficacy for prediction of successful weaning compared to RSBI alone. Point-of-care ultrasound to assess diaphragm function has a steep learning curve but is definitely achievable and with excellent reproducibility. This combination could help physicians assess weaning readiness in critically ill patients, relatively easy to manage and cost effective as set forth on page 6 in the “Conclusions” section).
Pirompanich is silent as to the presence of an electronic processor programmed to perform a diaphragm measurement, and fails to explicitly disclose displaying, on a display device, a representation of the calculated diaphragm thickness metric.
However, Souzy teaches an electronic processor programmed to perform a diaphragm measurement (Souzy: FIG. 1 Processing circuitry 106 and/or the monitor 110 may provide for control of the measurements being performed as set forth in [0047]), and, on a display device, a representation of the diaphragm related parameters (Souzy: FIG. 1 Monitoring system 100 includes monitor 110 that provides information about the measured motion parameters from the tissue to a human observer as set forth [0047]).
Pirompanich and Souzy are both considered to be analogous to the claimed invention because they are in the same field of systems involving the use of ultrasound technology for diaphragm measurement. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pirompanich to incorporate the teaching of Souzy and include an electronic processor programmed to perform a diaphragm measurement (Souzy: FIG. 1 Processing circuitry 106 and/or the monitor 110 may provide for control of the measurements being performed as set forth in [0047]), and, on a display device, a representation of the diaphragm related parameters (Souzy: FIG. 1 Monitoring system 100 includes monitor 110 that provides information about the measured motion parameters from the tissue to a human observer as set forth [0047]). Doing so would provide information about the measured parameters from the tissue to a human observer (e.g. a physician or the patient) via the display device and provide for control of the measurements being performed via the processing circuitry and display (Souzy: As set forth in [0047]).
Regarding claim 2, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Pirompanich further discloses, wherein the diaphragm thickness metric includes a diaphragm thickening ratio indicative of a diaphragm thickness during inspiration relative to a diaphragm thickness during expiration (Diaphragm thickness was recorded at the end of inspiration and expiration which supposed the lung volume equal to total lung capacity (TLC) and residual volume (RV), respectively, and the DTF was calculated as a percentage from this formula: thickness at TLC minus thickness at RV divided by thickness at RV as set forth on page 1 in the Abstract).
Regarding claim 3, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Pirompanich further discloses, wherein the diaphragm thickness metric includes a mean diaphragm thickness over multiple respiratory cycles (The DTF of three breaths on each side was measured and the mean value was used for analysis).
Regarding claim 4, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Pirompanich fails to explicitly disclose an ultrasound imaging patch wearable by the patient, wherein the at least one electronic processor controls the ultrasound imaging patch to obtain the ultrasound imaging data of the diaphragm of the patient.
However, Souzy teaches an ultrasound imaging patch wearable by the patient (Souzy: FIG. 2 Probe 102 having at least one ultrasound transducer 202, and being attached to the skin 204 of a patient using contact layer 104 as set forth in [0048]), wherein the at least one electronic processor controls the ultrasound imaging patch to obtain the ultrasound imaging data of the diaphragm of the patient (Souzy: FIG. 1 Processing circuitry 106 and/or the monitor 110 may provide for control of the measurements being performed as set forth in [0047]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pirompanich to incorporate the teaching of Souzy and include an ultrasound imaging patch wearable by the patient (Souzy: FIG. 2 Probe 102 having at least one ultrasound transducer 202, and being attached to the skin 204 of a patient using contact layer 104 as set forth in [0048]), wherein the at least one electronic processor controls the ultrasound imaging patch to obtain the ultrasound imaging data of the diaphragm of the patient (Souzy: FIG. 1 Processing circuitry 106 and/or the monitor 110 may provide for control of the measurements being performed as set forth in [0047]). Doing so would ensure that the device of the system is portable and adapted such that a patient can wear the device during normal life to allow continuous monitoring outside of a hospital environment and with a non-invasive and safe technology (Souzy: As set forth in [0029]).
Regarding claim 5, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Pirompanich further discloses, wherein the ultrasound imaging data comprises M-mode ultrasound imaging data (While sitting in a semi-recumbent position, the diaphragms were evaluated by B-mode and M-mode ultrasound subcostal views to exclude paradoxical movement as set forth on page 2 in the “Study design” section), and the calculating of the diaphragm thickness metric based on the received M-mode ultrasound imaging data of the diaphragm and the received respiration data includes: identifying a component of the M-mode ultrasound imaging data corresponding to the diaphragm of the patient based on the respiration data of the patient; and calculating the diaphragm thickness metric based on the identified component of the M-mode ultrasound imaging data corresponding to the diaphragm of the patient (Reciever operating characteristic (ROC) curve analysis was performed to assess diaphragm DTF, RSBI, and combined RSBI and DTF ability to predict patients who would succeed at weaning or fail as set forth on page 3 in the “Statistical analysis” section; Diaphragm thickening fraction of the right diaphragm by ultrasound of more than or equal to 26% combined with RSBI of less than or equal to 105 improved the efficacy for prediction of successful weaning compared to RSBI alone. Point-of-care ultrasound to assess diaphragm function has a steep learning curve but is definitely achievable and with excellent reproducibility. This combination could help physicians assess weaning readiness in critically ill patients, relatively easy to manage and cost effective as set forth on page 6 in the “Conclusions” section).
Regarding claim 9, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Pirompanich as modified further discloses, wherein the respiration data of the patient comprises airway pressure (The rapid shallow breathing index (RSBI), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP) were recorded after a spontaneous breathing trial (SBT) for 1 min as set forth on page 2 in the “Study design” section).
Regarding claim 10, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Pirompanich as modified fails to explicitly disclose, wherein the patient is receiving mechanical ventilation over the time period, and the electronic processor is programmed to: adjust one or more settings of a mechanical ventilator and repeat the diaphragm measurement method for each adjustment.
However, Souzy teaches, wherein the patient is receiving mechanical ventilation over the time period, and the electronic processor is programmed to: adjust one or more settings of a mechanical ventilator and repeat a diaphragm measurement method for each adjustment (Souzy: The operation of the mechanical ventilator can be synchronized with the breathing efforts of the patient, by adjusting the frequency or phase of the mechanical ventilator's pressure assistance in order to match the patient's needs and to increase the patient's comfort as set forth in [0097]; the data being based on reflections of ultrasound signals from within the body of the patient as set forth in [0045]; The diaphragm is the major muscle of inspiration, and continuous monitoring may support and add information to decision makers in a variety of settings as set forth in [0008]; the invention can function based on data processing devices, computer systems and/or computer architectures to operate with software, hardware, and/or operating system implementations as set forth in [0122]; the synchronization of the patient data and mechanical ventilator indicating the repetition of the parameter acquisition and setting adjustment).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pirompanich to incorporate the teaching of Souzy and include, wherein the patient is receiving mechanical ventilation over the time period, and the electronic processor is programmed to: adjust one or more settings of a mechanical ventilator and repeat a diaphragm measurement method for each adjustment (Souzy: The operation of the mechanical ventilator can be synchronized with the breathing efforts of the patient, by adjusting the frequency or phase of the mechanical ventilator's pressure assistance in order to match the patient's needs and to increase the patient's comfort as set forth in [0097]; the data being based on reflections of ultrasound signals from within the body of the patient as set forth in [0045]; The diaphragm is the major muscle of inspiration, and continuous monitoring may support and add information to decision makers in a variety of settings as set forth in [0008]; the invention can function based on data processing devices, computer systems and/or computer architectures to operate with software, hardware, and/or operating system implementations as set forth in [0122]; the synchronization of the patient data and mechanical ventilator indicating the repetition of the parameter acquisition and setting adjustment). Doing so would allow the mechanical ventilator to address the patient’s needs based on the acquired data (Souzy: As set forth in [0097]).
Regarding claim 11, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Pirompanich as modified fails to explicitly disclose, wherein the electronic processor is programmed to: adjust one or more settings of an ultrasound patch configured to acquire the ultrasound imaging data and repeat the diaphragm measurement method for each adjustment
However, Souzy teaches, wherein the electronic processor is programmed to: adjust one or more settings of an ultrasound patch configured to acquire the ultrasound imaging data and repeat the diaphragm measurement method for each adjustment (Souzy: FIG. 1-2 Communications interface 108 also transmits signals from processing circuitry 106 to probe 102 to cause the transducer within probe 102 to output ultrasound pulses as set forth in [0045] and Processor 610 also controls the timing of the output pulses to be sent to transducer 202 as set forth in [0077]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pirompanich to incorporate the teaching of Souzy and include, wherein the electronic processor is programmed to: adjust one or more settings of an ultrasound patch configured to acquire the ultrasound imaging data and repeat the diaphragm measurement method for each adjustment (Souzy: FIG. 1-2 Communications interface 108 also transmits signals from processing circuitry 106 to probe 102 to cause the transducer within probe 102 to output ultrasound pulses as set forth in [0045] and Processor 610 also controls the timing of the output pulses to be sent to transducer 202 as set forth in [0077]). Doing so would ensure that the device of the system is portable and adapted such that a patient can wear the device to allow for continuous monitoring outside of a hospital environment and with a non-invasive and safe technology (Souzy: As set forth in [0029]) and provide for control of the measurements being performed via the processing circuitry (Souzy: As set forth in [0047]).
Regarding claim 13, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Pirompanich as modified fails to explicitly disclose, wherein the at least one electronic processor is configured to: control an associated mechanical ventilator to adjust one or more parameters of mechanical ventilation therapy delivered to the patient based on acquired data.
However, Souzy teaches, wherein the at least one electronic processor is configured to: control an associated mechanical ventilator to adjust one or more parameters of mechanical ventilation therapy delivered to the patient based on acquired data(Souzy: The operation of the mechanical ventilator can be synchronized with the breathing efforts of the patient, by adjusting the frequency or phase of the mechanical ventilator's pressure assistance in order to match the patient's needs and to increase the patient's comfort as set forth in [0097]; the data being based on reflections of ultrasound signals from within the body of the patient as set forth in [0045]; The diaphragm is the major muscle of inspiration, and continuous monitoring may support and add information to decision makers in a variety of settings as set forth in [0008]; the invention can function based on data processing devices, computer systems and/or computer architectures to operate with software, hardware, and/or operating system implementations as set forth in [0122]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pirompanich to incorporate the teaching of Souzy and include, wherein the at least one electronic processor is configured to: control an associated mechanical ventilator to adjust one or more parameters of mechanical ventilation therapy delivered to the patient (Souzy: The operation of the mechanical ventilator can be synchronized with the breathing efforts of the patient, by adjusting the frequency or phase of the mechanical ventilator's pressure assistance in order to match the patient's needs and to increase the patient's comfort as set forth in [0097]; the data being based on reflections of ultrasound signals from within the body of the patient as set forth in [0045]; The diaphragm is the major muscle of inspiration, and continuous monitoring may support and add information to decision makers in a variety of settings as set forth in [0008]; the invention can function based on data processing devices, computer systems and/or computer architectures to operate with software, hardware, and/or operating system implementations as set forth in [0122]). Doing so would allow the mechanical ventilator to address the patient’s needs based on the acquired data (Souzy: As set forth in [0097]).
Pirompanich as modified fails to explicitly disclose, wherein the acquired data that the ventilation setting is dictated by is the calculated diaphragm thickness metric.
However, Pirompanich does teach wherein diaphragm thickness is used to determine whether a patient can be weaned off of mechanical ventilation (As set forth in the Abstract).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pirompanich as modified to control an associated mechanical ventilator to adjust one or more parameters of mechanical ventilation therapy delivered to the patient based on the calculated diaphragm thickness metric given the means taught by Souzy wherein the at least one electronic processor is configured to: control an associated mechanical ventilator to adjust one or more parameters of mechanical ventilation therapy delivered to the patient (Souzy: The operation of the mechanical ventilator can be synchronized with the breathing efforts of the patient, by adjusting the frequency or phase of the mechanical ventilator's pressure assistance in order to match the patient's needs and to increase the patient's comfort as set forth in [0097]; the data being based on reflections of ultrasound signals from within the body of the patient as set forth in [0045]; The diaphragm is the major muscle of inspiration, and continuous monitoring may support and add information to decision makers in a variety of settings as set forth in [0008]; the invention can function based on data processing devices, computer systems and/or computer architectures to operate with software, hardware, and/or operating system implementations as set forth in [0122]). Doing so would allow the mechanical ventilator to address the patient’s needs based on the acquired data (Souzy: As set forth in [0097]). Additionally, In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) sets forth that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.
Regarding claim 14, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Pirompanich as modified by Souzy further teaches a mechanical ventilator configured to deliver mechanical ventilation therapy to the patient (Souzy: As set forth in [0097]).
Regarding claim 15, Pirompanich discloses, a diaphragm measurement method (A weaning index using point-of-care ultrasound with diaphragmic thickening fraction (DTF) is determined wherein both hemi-diaphragms were visualized in the zone of apposition using a 10-MHz linear probe as set forth on page 1 in the Abstract) comprising: receiving ultrasound imaging data of a diaphragm of a patient over a time period encompassing multiple breaths (Diaphragm ultrasound scans on both sides were performed as set forth on page 2 in the “Study design” section; The DTF of three breaths on each side were measured and the mean value was used for analysis as set forth on page 3 in the ”Diaphragm ultrasound” section); receiving respiration data of the patient over the time period (The rapid shallow breathing index (RSBI), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP) were recorded after a spontaneous breathing trial (SBT) for 1 min as set forth on page 2 in the “Study design” section); calculating a diaphragm thickness metric (The combined RSBI and DTF ability to predict patients who would succeed at weaning or fail as set forth on page 3 in the “Statistical analysis” section) based on the received ultrasound imaging data of the diaphragm and the received respiration data (Receiver operating characteristic (ROC) curve analysis was performed to assess diaphragm DTF, RSBI, and combined RSBI and DTF ability to predict patients who would succeed at weaning or fail as set forth on page 3 in the “Statistical analysis” section; Diaphragm thickening fraction of the right diaphragm by ultrasound of more than or equal to 26% combined with RSBI of less than or equal to 105 improved the efficacy for prediction of successful weaning compared to RSBI alone. Point-of-care ultrasound to assess diaphragm function has a steep learning curve but is definitely achievable and with excellent reproducibility. This combination could help physicians assess weaning readiness in critically ill patients, relatively easy to manage and cost effective as set forth on page 6 in the “Conclusions” section).
Pirompanich is silent as to the presence of an electronic processor programmed to perform a diaphragm measurement, and fails to explicitly disclose displaying, on a display device, a representation of the calculated diaphragm thickness metric.
However, Souzy teaches an electronic processor programmed to perform a diaphragm measurement (Souzy: FIG. 1 Processing circuitry 106 and/or the monitor 110 may provide for control of the measurements being performed as set forth in [0047]), and, on a display device, a representation of the diaphragm related parameters (Souzy: FIG. 1 Monitoring system 100 includes monitor 110 that provides information about the measured motion parameters from the tissue to a human observer as set forth [0047]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pirompanich to incorporate the teaching of Souzy and include an electronic processor programmed to perform a diaphragm measurement (Souzy: FIG. 1 Processing circuitry 106 and/or the monitor 110 may provide for control of the measurements being performed as set forth in [0047]), and, on a display device, a representation of the diaphragm related parameters (Souzy: FIG. 1 Monitoring system 100 includes monitor 110 that provides information about the measured motion parameters from the tissue to a human observer as set forth [0047]). Doing so would provide information about the measured parameters from the tissue to a human observer (e.g. a physician or the patient) via the display device and provide for control of the measurements being performed via the processing circuitry and display (Souzy: As set forth in [0047]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Pirompanich (PIROMPANICH, P. et al., “Use of diaphragm thickening fraction combined with rapid shallow breathing index for predicting success of weaning from mechanical ventilator in medical patients” Journal of Intensive Care, Biomed Central Ltd., vol. 6, no. 1, 2018; DOI: 10.1186/s40560-018-0277-9; Accessed 01/30/2026), in view of Souzy (US 20180256075 A1) as applied to claim 5, in view of Cappellini (Cappellini, I., Picciafuochi, F., Bartolucci, M. et al. Evaluation of diaphragm thickening by diaphragm ultrasonography: a reproducibility and a repeatability study. J Ultrasound 24, 411–416 (2021). https://doi.org/10.1007/s40477-020-00462-x; Accessed 01/30/2026).
Regarding claim 6, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 5 above.
Pirompanich as modified further discloses, wherein the at least one electronic processor is programmed to identify the component of the M-mode ultrasound imaging data corresponding to the diaphragm of the patient (While sitting in a semi-recumbent position, the diaphragms were evaluated by B-mode and M-mode ultrasound subcostal views to exclude paradoxical movement as set forth on page 2 in the “Study design” section; and a receiver operating characteristic (ROC) curve analysis was performed to assess diaphragm DTF, RSBI, and combined RSBI and DTF ability to predict patients who would succeed at weaning or fail as set forth on page 3 in the “Statistical analysis” section; Diaphragm thickening fraction of the right diaphragm by ultrasound of more than or equal to 26% combined with RSBI of less than or equal to 105 improved the efficacy for prediction of successful weaning compared to RSBI alone. Point-of-care ultrasound to assess diaphragm function has a steep learning curve but is definitely achievable and with excellent reproducibility. This combination could help physicians assess weaning readiness in critically ill patients, relatively easy to manage and cost effective as set forth on page 6 in the “Conclusions” section)
Pirompanich, however, is silent as to the exact method the identification is done and fails to explicitly discloses wherein it is done by: identifying hyper-echogenic lines in the M-mode ultrasound imaging data; grouping the hyper-echogenic lines into pairs of hyper-echogenic lines; for each pair of hyper-echogenic lines, determining a distance between the hyper- echogenic lines of the pair as a function of time; for each pair of hyper-echogenic lines, determining a correlation between the determined distance between the hyper-echogenic lines of the pair as a function of time and the respiration data of the patient; and identifying the component of the M-mode ultrasound imaging data corresponding to a diaphragm of the patient as one of the pairs of hyper-echogenic lines based on the determined correlations.
However, Cappellini teaches identifying hyper-echogenic lines in the M-mode ultrasound imaging data; grouping the hyper-echogenic lines into pairs of hyper-echogenic lines; for each pair of hyper-echogenic lines, determining a distance between the hyper- echogenic lines of the pair as a function of time; for each pair of hyper-echogenic lines, determining a correlation between the determined distance between the hyper-echogenic lines of the pair as a function of time and the respiration data of the patient; and identifying the component of the M-mode ultrasound imaging data corresponding to a diaphragm of the patient as one of the pairs of hyper-echogenic lines based on the determined correlations (Cappellini: For every volunteer, each operator acquired three images of the diaphragm for each side, both in B-mode and in M-mode. Then a fourth operator calculated the thickening fraction (TF), by means of the formula TF=(TEI−TEE)/TEE (TEI is the thickness at end inspiration and TEE the thickness at end expiration). Afterwards, intraclass correlation coefficients (ICCs) were computed on TF to establish reproducibility and repeatability both in the B- and M-modes as set forth in the Abstract; An ultrasonographic method that can be used to evaluate diaphragm thickness or excursion, can be M-mode of the thick echogenic line visualized through the liver acoustic window as set forth on page 414 in the “Discussion” section).
Pirompanich and Cappellini are both considered to be analogous to the claimed invention because they are in the same field of systems involving the use of ultrasound technology for diaphragm measurement. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pirompanich to incorporate the teaching of Cappellini and include wherein the at least one electronic processor is programmed to identify the component of the M-mode ultrasound imaging data corresponding to the diaphragm of the patient by: identifying hyper-echogenic lines in the M-mode ultrasound imaging data; grouping the hyper-echogenic lines into pairs of hyper-echogenic lines; for each pair of hyper-echogenic lines, determining a distance between the hyper- echogenic lines of the pair as a function of time; for each pair of hyper-echogenic lines, determining a correlation between the determined distance between the hyper-echogenic lines of the pair as a function of time and the respiration data of the patient; and identifying the component of the M-mode ultrasound imaging data corresponding to a diaphragm of the patient as one of the pairs of hyper-echogenic lines based on the determined correlations (Cappellini: For every volunteer, each operator acquired three images of the diaphragm for each side, both in B-mode and in M-mode. Then a fourth operator calculated the thickening fraction (TF), by means of the formula TF=(TEI−TEE)/TEE (TEI is the thickness at end inspiration and TEE the thickness at end expiration). Afterwards, intraclass correlation coefficients (ICCs) were computed on TF to establish reproducibility and repeatability both in the B- and M-modes as set forth in the Abstract; An ultrasonographic method that can be used to evaluate diaphragm thickness or excursion, can be M-mode of the thick echogenic line visualized through the liver acoustic window as set forth on page 414 in the “Discussion” section). Doing so provides a known method in which diaphragm thickness or excursion can be determined by M-mode ultrasound imaging data.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Pirompanich (PIROMPANICH, P. et al., “Use of diaphragm thickening fraction combined with rapid shallow breathing index for predicting success of weaning from mechanical ventilator in medical patients” Journal of Intensive Care, Biomed Central Ltd., vol. 6, no. 1, 2018; DOI: 10.1186/s40560-018-0277-9; Accessed 01/30/2026), in view of Souzy (US 20180256075 A1) as applied to claim 5, in view of Shahshahani (Shahshahani, A.; Laverdiere, C.; Bhadra, S.; Zilic, Z. Ultrasound Sensors for Diaphragm Motion Tracking: An Application in Non-Invasive Respiratory Monitoring. Sensors 2018, 18, 2617. https://doi.org/10.3390/s18082617; Accessed 01/30/2026).
Regarding claim 7, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 5 above.
Pirompanich as modified fails to explicitly disclose, wherein identifying the component of the M-mode ultrasound imaging data corresponding to the diaphragm of the patient based on the respiration data of the patient includes: identifying a respiration rate of the patient over the time period from the respiration data of the patient; and filtering the M-mode ultrasound imaging data using a bandpass filter with a passband centered at the identified respiration rate to extract the component of the M-mode ultrasound imaging data corresponding to the diaphragm of the patient.
However, Shahshahani teaches identifying a respiration rate of the patient over the time period from the respiration data of the patient; and filtering data using a bandpass filter with a passband centered at the identified respiration rate to extract the component of the M-mode ultrasound imaging data (Shahshahani: A band-pass filter is applied to extract the respiratory frequency from the raw PPG signal and eliminate the extremely low frequency or DC component of the signal. The respiratory signal was a non-stationary signal, and all sensors’ data were processed in the time domain as set forth in the “3.2. Data Analysis and Peak Detection” section) as well as filtering the M-mode ultrasound imaging (Shahshahani: A low-pass FIR filter was used to emit high frequency elements of the raw US signal, which was higher than 1 Hz), wherein it would be obvious to one of ordinary skill in the art that a bandpass filter could be applied to filter the M-mode ultrasound imaging data at the identified respiration rate to extract the component of the M-mode ultrasound imaging data corresponding to the diaphragm of the patient.
Pirompanich and Shahshahani are both considered to be analogous to the claimed invention because they are in the same field of systems involving the use of ultrasound technology for diaphragm measurement. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pirompanich to incorporate the teaching of Shahshahani and include identifying a respiration rate of the patient over the time period from the respiration data of the patient; and filtering data using a bandpass filter with a passband centered at the identified respiration rate to extract the component of the M-mode ultrasound imaging data (Shahshahani: A band-pass filter is applied to extract the respiratory frequency from the raw PPG signal and eliminate the extremely low frequency or DC component of the signal. The respiratory signal was a non-stationary signal, and all sensors’ data were processed in the time domain as set forth in the “3.2. Data Analysis and Peak Detection” section) as well as filtering the M-mode ultrasound imaging (Shahshahani: A low-pass FIR filter was used to emit high frequency elements of the raw US signal, which was higher than 1 Hz), wherein it would be obvious to one of ordinary skill in the art that a bandpass filter could be applied to filter the M-mode ultrasound imaging data at the identified respiration rate to extract the component of the M-mode ultrasound imaging data corresponding to the diaphragm of the patient. Doing so would improve the accuracy of the measurements by eliminating the frequencies that do not represent the ultrasound data (Shahshahani : As set forth in the “3.2. Data Analysis and Peak Detection” section).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pirompanich (PIROMPANICH, P. et al., “Use of diaphragm thickening fraction combined with rapid shallow breathing index for predicting success of weaning from mechanical ventilator in medical patients” Journal of Intensive Care, Biomed Central Ltd., vol. 6, no. 1, 2018; DOI: 10.1186/s40560-018-0277-9; Accessed 01/30/2026), in view of Souzy (US 20180256075 A1), in further view of Shahshahani (Shahshahani, A. et al., “Ultrasound Sensors for Diaphragm Motion Tracking: An Application in Non-Invasive Respiratory Monitoring”, Sensors 2018, 18, 2617. https://doi.org/10.3390/s18082617; Accessed 01/30/2026) as applied to claim 7, in further view of Matamis (Matamis, D. et al., “Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications”, Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24. PMID: 23344830; Accessed 01/30/2026).
Regarding claim 8, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Pirompanich as modified fails to explicitly disclose, wherein the patient is receiving mechanical ventilation over the time period, and the electronic processor is further programmed to: determine a phase shift between the bandpass-filtered M-mode ultrasound imaging data and the respiration data of the patient; determine a patient-ventilator asynchrony based on the phase shift; and display, on the display device, an indication of the determined patient-ventilator asynchrony.
However, Matamis teaches wherein the patient is receiving mechanical ventilation over the time period (Matamis: As set forth in the Abstract), and being able to: determine a phase shift between the bandpass-filtered M-mode ultrasound imaging data and the respiration data of the patient; determine a patient-ventilator asynchrony based on the phase shift; and display, on the display device, an indication of the determined patient-ventilator asynchrony. (Matamis: FIG. 5 and FIG. 6 Show a comparison between the M-mode Imaging data and respiratory data that indicate patient–ventilator asynchrony, in the first assisted breath, ventilator inspiratory time is much longer compared to the second breath, In the first assisted breath, we notice two diaphragmatic contractions shown by the arrows as seen on pages 4 and 5).
Pirompanich and Matamis are both considered to be analogous to the claimed invention because they are in the same field of systems involving the use of ultrasound technology for diaphragm measurement. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pirompanich to incorporate the teaching of Matamis and include wherein the patient is receiving mechanical ventilation over the time period (Matamis: As set forth in the Abstract), and enable the processor to: determine a phase shift between the bandpass-filtered M-mode ultrasound imaging data and the respiration data of the patient; determine a patient-ventilator asynchrony based on the phase shift; and display, on the display device, an indication of the determined patient-ventilator asynchrony. (Matamis: FIG. 5 and FIG. 6 Show a comparison between the M-mode Imaging data and respiratory data that indicate patient–ventilator asynchrony, in the first assisted breath, ventilator inspiratory time is much longer compared to the second breath, In the first assisted breath, we notice two diaphragmatic contractions shown by the arrows as seen on pages 4 and 5). Doing so would allow the system to provide valuable information in the assessment and follow up of patients with diaphragmatic weakness or paralysis, in terms of patient–ventilator interactions during controlled or assisted modalities of mechanical ventilation (Matamis: As set forth in the Abstract) and enable the system to detect cases of patient–ventilator asynchrony and could even allow a proper adjustment of the ventilator settings in order to optimize synchronization of the patient’s inspiratory effort with the assisted mechanical breath (Matamis: As set forth in paragraph 1 on page 7).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pirompanich (PIROMPANICH, P. et al., “Use of diaphragm thickening fraction combined with rapid shallow breathing index for predicting success of weaning from mechanical ventilator in medical patients” Journal of Intensive Care, Biomed Central Ltd., vol. 6, no. 1, 2018; DOI: 10.1186/s40560-018-0277-9; Accessed 01/30/2026), in view of Souzy (US 20180256075 A1) as applied to claim 1, in further view of Panicker (PANICKER, M. et al., “An Approach Towards Physics Informed Lung Ultrasound Image Scoring Neural Network for Diagnostic Assistance in COVID-19”; DOI: 10.48550/arXiv.2106.06980; Accessed 01/30/2026).
Regarding claim 12, Pirompanich as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Pirompanich as modified discloses wherein the calculating of the diaphragm thickness metric based on the received ultrasound imaging data of the diaphragm and the received respiration data ().
Pirompanich as modified fails to explicitly disclose wherein the calculation includes inputting the ultrasound imaging data and the respiration data to an artificial neural network (ANN) model configured to determine the diaphragm thickness metric based on the ultrasound imaging data and the respiration data of the patient.
However, Panicker teaches inputting data to an artificial neural network (ANN) model configured to determine a metric based on the data of the patient (Panicker: As set forth on page 2 column 1 paragraph 3; and the “Conclusion and Discussion” section on page 7).
Pirompanich and Panicker are both considered to be analogous to the claimed invention because they are in the same field of utilizing ultrasound imagining data for patient observation. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pirompanich to incorporate the teaching of Panicker and include inputting the data to an artificial neural network (ANN) model configured to determine a metric based on the data of the patient (Panicker: As set forth on page 2 column 1 paragraph 3; and the “Conclusion and Discussion” section on page 7). In the case of Pirompanich, the ultrasound imaging data and the respiration data would be input to an artificial neural network (ANN) model configured to determine the diaphragm thickness metric. Doing so would aid in the determination the diaphragm thickness metric based on the ultrasound imaging data and the respiration data of the patient when applied to the system of Pirompanich as modified (Panicker: As set forth on page 2 column 1 paragraph 3; and the “Conclusion and Discussion” section on page 7).
Conclusion
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/KEIRA EILEEN CALLISON/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785