DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 04/08/2026 has been entered. Claims 1-2, 4, 6-7, 10-13, and 15-20 remain pending in the application.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1-2, 4, 6-7, 13, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Zeller (US 20180031665), hereinafter Zeller, in view of Carinci et al (US 20170251949), hereinafter, Carinci.
Regarding claim 1, Zeller teaches a method for monitoring and/or adapting breath-holding magnetic resonance (MR) examinations (Abstract. “Based on the acquired MR measurement data and depending on the detected next-breath time, a final MR measurement data set DSf is created (block 209) from which image data BD can be reconstructed (block 213). If the acquisition of the MR measurement data was cancelled as soon as a next-breath time was detected (Cancel? 207 “y”), the final MR measurement data set comprises the MR measurement data acquired before detection of the next-breath time, i.e. the MR measurement data of the first data set DS1.” [0041]; Fig. 2. “The MR measurement data in the first data set DS1 acquired before detection of the next-breath time WAZ contain no interfering influences due to the resuming respiratory movement and are thus suitable as a basis for a reconstruction kernel used.” [0044]; Figs. 1 and 4), the method comprising:
acquiring, by at least one processor (40) of a MR system (1) ("FIG. 3 shows schematically a breathing analysis processor 40." [0061]. "The central control computer 13 can be operated via a terminal with an input unit 10 and a display unit 9, via which the entire MR system 1 can thus also be operated by an operator." [0066]; Fig. 4), a respiratory signal (AK) from a patient during a breath-holding MR scan (“detection of the next-breath time WAZ” [0054]. “The respiratory movement determination unit 43 has a breathing curve recording unit 43a, which is configured to record, based on the received phase values PHW, in real time a breathing curve AK of a patient to be examined.” [0061]; Fig. 1);
determining, by the at least one processor, a respiratory behavior of the patient for the breath-holding MR scan from the respiratory signal (“the determined breath-holding capacity of the patient” [0057]); and
outputting, by the at least one processor, information about the respiratory behavior and/or outputting control commands (AAH) based on the respiratory behavior (“If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data. Depending on the sequence to be performed, parameters to be adapted here may be: a repetition time TR, a number of breath-holding states needed in total, a number of required averagings, a recording matrix size, or a parallel acceleration factor.” [0057]; Fig. 2).
Zeller dos not explicitly teach that the determining of the respiratory behavior comprises a determination of a starting time of suspension of breathing, a breath-holding duration, a gradient of a respiratory curve, variations in a case of multiple respiratory curves, or a combination thereof; determining, by the at least one processor, a time of a respiratory command on the patient and a period of time between the time of the respiratory command and a reaction by the patient, wherein the reaction by the patient is the starting time of the suspension of breathing; and when the period of time is longer than a predefined comparison period, the information being output comprises that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time; and/or outputting, by the at least one processor, information with respect of a switch to a different scan strategy or automatically performing the different scan strategy when it is established that the patient cannot follow the respiratory command because the period of time between the time of the respiratory command and the time of suspension is too long, or the breath-holding duration is too short.
However, in the MR imaging field of endeavor, Carinci discloses synchronizing an MR imaging process with attainment of the breath-hold state, which is the same art. Carinci teaches the determining of the respiratory behavior comprises a determination of a starting time of suspension of breathing (1500), a breath-holding duration, a gradient of a respiratory curve, variations in a case of multiple respiratory curves, or a combination thereof (“The start time of the actual MR image acquisition may thus be set very precisely using the recorded respiratory curve AK." [0037]; Fig. 3);
determining, by the at least one processor, a time of a respiratory command on the patient (AAH) and a period of time between the time of the respiratory command and a reaction by the patient (“a reaction time T.sub.AAH of about 2.5 s” [0037]; Fig. 3), wherein the reaction by the patient is the starting time of the suspension of breathing ("With regard to the respiratory curve AK in the right-hand graph of FIG. 3, the patient was given a breath-hold instruction AAH approximately after 1000 repetition cycles. As is evident from the right-hand graph, the respiratory curve AK plateaus at around 1500 repetition cycles, and therefore a reaction time T.sub.AAH of about 2.5 s may be identified from the graph given a repetition time TR=5 ms. The start time of the actual MR image acquisition may thus be set very precisely using the recorded respiratory curve AK." [0037]; Fig. 3); and when the period of time is longer than a predefined comparison period (“a preset time interval” [0018]), the information being output comprises that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time ("the MR imaging process is interrupted and the operating personnel are automatically given notification of the interruption." [0019]. “5. The method of claim 2, wherein when a start time (T.sub.AAH) for a breath-hold state of the patient has not been identified within a preset time interval: the MR imaging process is started automatically; or the MR imaging process is interrupted, and the operating personnel are automatically given notification of the interruption;”).
Therefore, based on Carinci’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller to employ the determining of the respiratory behavior that comprises a determination of a starting time of suspension of breathing, a breath-holding duration, a gradient of a respiratory curve, variations in a case of multiple respiratory curves, or a combination thereof; determining, by the at least one processor, a time of a respiratory command on the patient and a period of time between the time of the respiratory command and a reaction by the patient, wherein the reaction by the patient is the starting time of the suspension of breathing; and when the period of time is longer than a predefined comparison period, the information being output that comprises that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time; as taught by Carinci, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Regarding claim 2, Zeller modified by Carinci teaches the method of claim 1, and Zeller teaches further comprising: establishing a scanning protocol of an MR scan based on the information about the respiratory behavior of the patient (“At least one final MR measurement data set is created based on the acquired MR measurement data, depending on the detected next-breath time.” Abstract; “An instruction is given to the patient to hold his/her breath, and the acquisition of MR measurement data is then started. A breathing curve is recorded at least after the instruction to the patient. A next-breath time is detected based on the recorded breathing curve. At least one final MR measurement data set is created in a processor based on the acquired MR measurement data, depending on the detected next-breath time.” [0005]; “If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data.” [0057]; Fig. 2).
Regarding claim 4, Zeller modified by Carinci teaches the method of claim 1, wherein the determining of the respiratory behavior comprises creating the respiratory curve (AK) from a strength of the respiratory signal against time (“FIG. 1 is a diagram that illustrates a breathing curve depending on a scan time.” [0016] “The breathing curve is recorded preferably by capturing MR signals in the center of k-space at a number of points in time and extracting the phase portion of the captured MR signal.” [0028]; “If a determination is made in the spatial domain, a weighted averaging can be carried out. For example, points outside the body (associated with high level of noise) can be excluded and a weighting can be carried out, for example according to signal intensity.” [0030]; “the value of the breathing curve AK over time” [0032]; Fig. 1) and determining the respiratory behavior from the respiratory curve (“The respiratory movement determination unit 43 has a breathing curve recording unit 43a, which is configured to record, based on the received phase values PHW, in real time a breathing curve AK of a patient to be examined.” [0061]; Fig. 1).
Regarding claim 6, Zeller modified by Carinci teaches the method of claim 1, wherein Zeller teaches that, in an event that the breath-holding duration is below a predefined limit value, information is output that the patient has not held his or her breath for long enough (“However, patients cannot always follow the given instructions to the extent desired. Normally, a patient is asked to hold his/her breath for a period of approximately 15 to 20 seconds. Many patients are unable to hold their breath for sufficiently long.” [0003]; “If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient,” [0057]).
Regarding claim 7, Zeller modified by Carinci teaches the method of claim 1, wherein Zeller teaches that the multiple respiratory curves are compared with a reference respiratory profile (“the respiratory cycle of the patient can be used before the time of the intended breath-hold period of the patient, optionally as reference data and/or calibration data for the following detection step” [0007]. “Comparison of the absolute values of the phase values of the captured MR signals with a reference value.” [0037]; “threshold values or reference values can be determined for example through a learning phase upstream of the imaging process, wherein the breathing pattern of the patient concerned is examined by a prerecording of a breathing curve.” [0038]; “The breathing analysis processor 40 can be, for example, part of a control computer of a magnetic resonance imaging system (see FIG. 4). The breathing analysis processor 40 has a raw-data-capture unit 41, which receives raw data, in this exemplary embodiment navigator-k-space data NKRD that have been recorded in the course of a navigator acquisition. The raw data NKRD are transmitted to a phase-value determination unit 42, which extracts phase values PHW from the raw data NKRD. The phase values PHW are then transferred to a respiratory movement determination unit 43. The respiratory movement determination unit 43 has a breathing curve recording unit 43a, which is configured to record, based on the received phase values PHW, in real time a breathing curve AK of a patient to be examined.” [0061] Fig. 3. It is implied that the “reference values” are for multiple respiratory curves).
Regarding claim 13, Zeller modified by Carinci teaches the method of claim 1, and Zeller teaches further comprising:
checking scanning protocols of subsequent MR scans (203) of the examination (“In the renewed acquisition of MR measurement data 203 that now follows, the missing MR measurement data can now be acquired.” [0054]) for respective lengths in time (“a breath-holding duration with which the process of acquisition of MR measurement data was planned” [0057]) when the breath-holding duration lies below a predefined limit value (below a value of the “breath-holding duration with which the process of acquisition of MR measurement data was planned” [0057]); and
identifying a restriction of breathing of the patient when multiple breath-holding durations lie below the predefined limit value in the scanning protocols of the subsequent MR scans (“If the data are not complete (query 211 “n”), an instruction AAH can be given to the patient again to hold his/her breath. In the renewed acquisition of MR measurement data 203 that now follows, the missing MR measurement data can now be acquired. Advantageously, only the missing MR measurement data are acquired in the renewed acquisition of MR measurement data. The MR measurement data recorded little by little in this way, in each case during a breath-holding phase of the patient" [0054]; “deviates from a breath-holding duration” [0057]); and automatically shortening a length in time of a scanning protocol of an MR scan or dividing a scanning protocol into multiple parts following the identifying of the restriction of breathing of the patient (“In addition, or as an alternative, to the measures already mentioned, the breath-holding capacity of the patient can be determined, e.g. as part of the creation of the final MR measurement data set in block 209, after detection of the next-breath time. This can be done, for example, simply by determining the time that has elapsed between the output of the instruction AAH to the patient to hold his/her breath and the detection of the next-breath time WAZ. If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data.” [0057]).
Regarding claim 17, Zeller teaches a device for monitoring and/or adapting breath-holding magnetic resonance (MR) examinations (Fig. 4), the device comprising:
at least one processor (43) configured to acquire a respiratory signal from a patient (“O”) during a breath-holding MR scan (“detection of the next-breath time WAZ” [0054]. “The respiratory movement determination unit 43 has a breathing curve recording unit 43a, which is configured to record, based on the received phase values PHW, in real time a breathing curve AK of a patient to be examined.” [0061]; Figs. 1, 4);
determine a respiratory behavior of the patient from the respiratory signal (“the determined breath-holding capacity of the patient” [0057]; “The respiratory movement determination unit 43 furthermore has a detection device 43b, which determines, on the basis of the captured breathing curve AK, the next-breath time WAZ, at which the patient starts to continue breathing again after a breath-holding phase” [0061]; Fig. 2); and
and output information about the respiratory behavior and/or to output control commands (AAH) based on the respiratory behavior (“The breathing analysis processor 40 furthermore has a command output unit 45 for automatically emitting an instruction AAH as an output to the patient O to hold his/her breath.” [0061]; Fig. 4) (“If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data. Depending on the sequence to be performed, parameters to be adapted here may be: a repetition time TR, a number of breath-holding states needed in total, a number of required averagings, a recording matrix size, or a parallel acceleration factor.” [0057]; “The central control computer 13 can be operated via a terminal with an input unit 10 and a display unit 9, via which the entire MR system 1 can thus also be operated by an operator. MR images can also be displayed on the display unit 9, and with the input unit 10, optionally in combination with the display unit 9, measurements can be planned and started, and suitable control protocols with suitable measurement sequences, as explained above, are selected and optionally modified.” [0066]; Fig. 4).
Zeller dos not explicitly teach that the determining of the respiratory behavior comprises a determination of a starting time of suspension of breathing, a breath-holding duration, a gradient of a respiratory curve, variations in a case of multiple respiratory curves, or a combination thereof; determining, by the at least one processor, a time of a respiratory command on the patient and a period of time between the time of the respiratory command and a reaction by the patient, wherein the reaction by the patient is the starting time of the suspension of breathing; and when the period of time is longer than a predefined comparison period, the information being output comprises that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time; and/or outputting, by the at least one processor, information with respect of a switch to a different scan strategy or automatically performing the different scan strategy when it is established that the patient cannot follow the respiratory command because the period of time between the time of the respiratory command and the time of suspension is too long, or the breath-holding duration is too short.
However, in the MR imaging field of endeavor, Carinci discloses synchronizing an MR imaging process with attainment of the breath-hold state, which is the same art. Carinci teaches the determining of the respiratory behavior comprises a determination of a starting time of suspension of breathing (1500), a breath-holding duration, a gradient of a respiratory curve, variations in a case of multiple respiratory curves, or a combination thereof (“The start time of the actual MR image acquisition may thus be set very precisely using the recorded respiratory curve AK." [0037]; Fig. 3);
determining, by the at least one processor, a time of a respiratory command on the patient (AAH) and a period of time between the time of the respiratory command and a reaction by the patient (“a reaction time T.sub.AAH of about 2.5 s” [0037]; Fig. 3), wherein the reaction by the patient is the starting time of the suspension of breathing ("With regard to the respiratory curve AK in the right-hand graph of FIG. 3, the patient was given a breath-hold instruction AAH approximately after 1000 repetition cycles. As is evident from the right-hand graph, the respiratory curve AK plateaus at around 1500 repetition cycles, and therefore a reaction time T.sub.AAH of about 2.5 s may be identified from the graph given a repetition time TR=5 ms. The start time of the actual MR image acquisition may thus be set very precisely using the recorded respiratory curve AK." [0037]; Fig. 3); and when the period of time is longer than a predefined comparison period (“a preset time interval” [0018]), the information being output comprises that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time ("the MR imaging process is interrupted and the operating personnel are automatically given notification of the interruption." [0019]. “5. The method of claim 2, wherein when a start time (T.sub.AAH) for a breath-hold state of the patient has not been identified within a preset time interval: the MR imaging process is started automatically; or the MR imaging process is interrupted, and the operating personnel are automatically given notification of the interruption;”).
Therefore, based on Carinci’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller to employ the determining of the respiratory behavior that comprises a determination of a starting time of suspension of breathing, a breath-holding duration, a gradient of a respiratory curve, variations in a case of multiple respiratory curves, or a combination thereof; determining, by the at least one processor, a time of a respiratory command on the patient and a period of time between the time of the respiratory command and a reaction by the patient, wherein the reaction by the patient is the starting time of the suspension of breathing; and when the period of time is longer than a predefined comparison period, the information being output that comprises that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time; as taught by Carinci, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Regarding claim 18, Zeller modified by Carinci teaches the device of claim 17, wherein Zeller teaches that the at least one processor is further configured to:
adapt a scanning protocol for an MR scan based on the respiratory behavior from one or more previous MR scans (“If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data. Depending on the sequence to be performed, parameters to be adapted here may be: a repetition time TR, a number of breath-holding states needed in total, a number of required averagings, a recording matrix size, or a parallel acceleration factor.” [0057]; “The central control computer 13 can be operated via a terminal with an input unit 10 and a display unit 9, via which the entire MR system 1 can thus also be operated by an operator. MR images can also be displayed on the display unit 9, and with the input unit 10, optionally in combination with the display unit 9, measurements can be planned and started, and suitable control protocols with suitable measurement sequences, as explained above, are selected and optionally modified.” [0066]; Fig. 4).
Regarding claim 19, Zeller teaches a magnetic resonance tomography (MRT) system (1) (Fig. 4) comprising:
at least one processor (13) (“The central control computer 13 can be operated via a terminal with an input unit 10 and a display unit 9, via which the entire MR system 1 can thus also be operated by an operator. MR images can also be displayed on the display unit 9, and with the input unit 10, optionally in combination with the display unit 9, measurements can be planned and started, and suitable control protocols with suitable measurement sequences, as explained above, are selected and optionally modified.” [0066]; Fig. 4) configured to:
acquire a respiratory signal (AK) from a patient (“O”) during a breath-holding magnetic resonance (MR) scan (“detection of the next-breath time WAZ” [0054]. “The respiratory movement determination unit 43 has a breathing curve recording unit 43a, which is configured to record, based on the received phase values PHW, in real time a breathing curve AK of a patient to be examined.” [0061]; Figs. 1 and 4);
determine a respiratory behavior of the patient from the respiratory signal (“the determined breath-holding capacity of the patient” [0057]); and
output information about the respiratory behavior and/or output control commands (AAH) based on the respiratory behavior (“If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data. Depending on the sequence to be performed, parameters to be adapted here may be: a repetition time TR, a number of breath-holding states needed in total, a number of required averagings, a recording matrix size, or a parallel acceleration factor.” [0057]; Fig. 2).
Zeller dos not explicitly teach that the determining of the respiratory behavior comprises a determination of a starting time of suspension of breathing, a breath-holding duration, a gradient of a respiratory curve, variations in a case of multiple respiratory curves, or a combination thereof; determining, by the at least one processor, a time of a respiratory command on the patient and a period of time between the time of the respiratory command and a reaction by the patient, wherein the reaction by the patient is the starting time of the suspension of breathing; and when the period of time is longer than a predefined comparison period, the information being output comprises that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time; and/or outputting, by the at least one processor, information with respect of a switch to a different scan strategy or automatically performing the different scan strategy when it is established that the patient cannot follow the respiratory command because the period of time between the time of the respiratory command and the time of suspension is too long, or the breath-holding duration is too short.
However, in the MR imaging field of endeavor, Carinci discloses synchronizing an MR imaging process with attainment of the breath-hold state, which is the same art. Carinci teaches the determining of the respiratory behavior comprises a determination of a starting time of suspension of breathing (1500), a breath-holding duration, a gradient of a respiratory curve, variations in a case of multiple respiratory curves, or a combination thereof (“The start time of the actual MR image acquisition may thus be set very precisely using the recorded respiratory curve AK." [0037]; Fig. 3);
determining, by the at least one processor, a time of a respiratory command on the patient (AAH) and a period of time between the time of the respiratory command and a reaction by the patient (“a reaction time T.sub.AAH of about 2.5 s” [0037]; Fig. 3), wherein the reaction by the patient is the starting time of the suspension of breathing ("With regard to the respiratory curve AK in the right-hand graph of FIG. 3, the patient was given a breath-hold instruction AAH approximately after 1000 repetition cycles. As is evident from the right-hand graph, the respiratory curve AK plateaus at around 1500 repetition cycles, and therefore a reaction time T.sub.AAH of about 2.5 s may be identified from the graph given a repetition time TR=5 ms. The start time of the actual MR image acquisition may thus be set very precisely using the recorded respiratory curve AK." [0037]; Fig. 3); and when the period of time is longer than a predefined comparison period (“a preset time interval” [0018]), the information being output comprises that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time ("the MR imaging process is interrupted and the operating personnel are automatically given notification of the interruption." [0019]. “5. The method of claim 2, wherein when a start time (T.sub.AAH) for a breath-hold state of the patient has not been identified within a preset time interval: the MR imaging process is started automatically; or the MR imaging process is interrupted, and the operating personnel are automatically given notification of the interruption;”).
Therefore, based on Carinci’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller to employ the determining of the respiratory behavior that comprises a determination of a starting time of suspension of breathing, a breath-holding duration, a gradient of a respiratory curve, variations in a case of multiple respiratory curves, or a combination thereof; determining, by the at least one processor, a time of a respiratory command on the patient and a period of time between the time of the respiratory command and a reaction by the patient, wherein the reaction by the patient is the starting time of the suspension of breathing; and when the period of time is longer than a predefined comparison period, the information being output that comprises that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time; as taught by Carinci, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Claims 10-11, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zeller and Carinci as applied to claim 1, and further in view of Beck (US 20130211236), hereinafter, Beck.
Regarding claim 10, Zeller modified by Carinci teaches the method of claim 1.
Zeller modified by Carinci does not teach that the information being output comprises the information with respect of the switch to the different scan strategy.
However, in the MR imaging field of endeavor, Beck discloses MR data acquisition using physiological monitoring, which is analogous art. Beck teaches that the information being output comprises the information with respect of the switch to the different scan strategy (“the imaging protocol optimization… the actually selected imaging protocol can be changed to a new imaging protocol” [0061]) (“It has to be noted that in case the motion control detects that a patient cannot follow the breath hold instructions and also cannot hold the breath for a specified time not fulfilling a specified breath capability criteria, the imaging protocols can be set up to be automatically changed within the exam to a specified free breathing or a short breath hold protocol with a lower quality (lower resolution, 2D etc).” [0040] "Step 214 comprising the imaging protocol optimization … should be applied in case the motion control detects that a patient cannot follow the breath hold instructions or cannot follow the breath hold for a specified time not fulfilling a specified breath hold capability criteria. In this case, the actually selected imaging protocol can be changed to a new imaging protocol which requires a shorter data acquisition time for completing a respective magnetic resonance imaging scan.” [0061]).
Therefore, based on Beck’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller and Carinci to employ the information being output that comprises the information with respect of the switch to the different scan strategy, as taught by Beck, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Regarding claim 11, Zeller modified by Carinci and Beck teaches the method of claim 10.
Zeller modified by Carinci does not teach that the different scan strategy is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing.
However, in the MR imaging field of endeavor, Beck discloses MR data acquisition using physiological monitoring, which is analogous art. Beck teaches that the different scan strategy is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing (“It has to be noted that in case the motion control detects that a patient cannot follow the breath hold instructions and also cannot hold the breath for a specified time not fulfilling a specified breath capability criteria, the imaging protocols can be set up to be automatically changed within the exam to a specified free breathing or a short breath hold protocol with a lower quality (lower resolution, 2D etc). The consequence is that the `recovery` period of the patient is extended.” [0040]).
Therefore, based on Beck’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller and Carinci to employ the different scan strategy that is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing, or the breath-holding duration is too short, as taught by Beck, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Regarding claim 15, Zeller modified by Carinci teaches the method of claim 1.
Zeller modified by Carinci does not teach that the different scan strategy is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing.
However, in the MR imaging field of endeavor, Beck discloses MR data acquisition using physiological monitoring, which is analogous art. Beck teaches that the different scan strategy is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing (“It has to be noted that in case the motion control detects that a patient cannot follow the breath hold instructions and also cannot hold the breath for a specified time not fulfilling a specified breath capability criteria, the imaging protocols can be set up to be automatically changed within the exam to a specified free breathing or a short breath hold protocol with a lower quality (lower resolution, 2D etc). The consequence is that the `recovery` period of the patient is extended.” [0040]).
Therefore, based on Beck’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller and Carinci to employ the different scan strategy that is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing, or the breath-holding duration is too short, as taught by Beck, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Regarding claim 20, Zeller modified by Carinci teaches the method of claim 1.
Zeller modified by Carinci does not teach that the different scan strategy is automatically performed when the patient cannot follow the respiratory command or the breath-holding duration is too short.
However, in the MR imaging field of endeavor, Beck discloses MR data acquisition using physiological monitoring, which is analogous art. Beck teaches that the different scan strategy is automatically performed when the patient cannot follow the respiratory command or the breath-holding duration is too short ("It has to be noted that in case the motion control detects that a patient cannot follow the breath hold instructions and also cannot hold the breath for a specified time not fulfilling a specified breath capability criteria, the imaging protocols can be set up to be automatically changed within the exam to a specified free breathing or a short breath hold protocol with a lower quality (lower resolution, 2D etc)." [0040]).
Therefore, based on Beck’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller and Carinci to employ the different scan strategy that is automatically performed when the patient cannot follow the respiratory command or the breath-holding duration is too short, as taught by Beck, in order to improve the image quality of MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Claims 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zeller and Carinci as applied to claim 1, and further in view of Hwang et al (KR 20180048502), hereinafter, Hwang.
Regarding claim 12, Zeller modified by Carinci teaches the method of claim 1.
Zeller modified by Carinci does not teach determining a gradient of the respiratory signal during the breath-holding duration; and outputting information or stopping the breath-holding MR scan when an absolute value of the gradient falls below a predefined limit value.
However, in the MR imaging field of endeavor, Hwang discloses a medical imaging apparatus, and method for controlling thereof, which is analogous art. Hwang teaches determining a gradient of the respiratory signal during the breath-holding duration (“the breathing gradient” p. 8, 5th para.); and
outputting information or stopping the breath-holding MR scan when an absolute value of the gradient (“the breathing gradient of the breathing curve” p. 14, 3rd complete para.) falls below a predefined limit value (below the “predetermined range” p. 14, 3rd complete para.; “the slope” p. 14, 4th and 5th complete para.) (“the controller 30 may obtain respiration information using the navigator image data restored based on the navigator MR data. Here, the respiration information includes various information indicating the respiration state of the object. For example, the respiration information may include at least one of the respiration curve of the subject, … the breathing gradient” p. 8, 5th para.; “the control unit 30 may determine the acquisition interval when the breathing gradient of the breathing curve is within a preset range. Referring to FIG. 5, in general, the breathing gradient of the breathing curve when exhaled corresponds to a certain range based on the time axis. Accordingly, the control unit 30 can determine the acquisition period for the region having the breathing gradient of the breathing curve corresponding to the predetermined range. As a specific example, the control unit 30 may determine an acquisition interval in which the breathing gradient is -N? Breathing gradient? + M (N, M? 0) based on the time axis.” p. 14, 3rd complete para.).
Therefore, based on Hwang’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller and Carinci to have the steps of determining a gradient of the respiratory signal during the breath-holding duration; and outputting information or stopping the breath-holding MR scan when an absolute value of the gradient falls below a predefined limit value, as taught by Hwang, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Regarding claim 16, Zeller modified by Carinci teaches the method of claim 1.
Zeller modified by Carinci does not teach that respiratory signals are acquired for multiple breath-holding MR scans on the patient including the breath-holding MR scan and the respiratory behavior of the patient is determined from the multiple respiratory signals, wherein a mean value, a maximum value, a minimum value, or a combination thereof is determined for a breath-holding duration and/or a maximum value for a period of time between the time of the respiratory command and the time of suspension and/or a mean value for a gradient.
However, in the MR imaging field of endeavor, Hwang discloses a medical imaging apparatus, and method for controlling thereof, which is analogous art. Hwang teaches that
respiratory signals are acquired for multiple MR scans on a patient (multiple MR scans corresponding to the “respiration curve for each breathing cycle”; p. 14, 1st complete para.) and the respiratory behavior of the patient is determined from the multiple respiratory signals (“The MRI system can acquire the MR signal only in specific respiratory state while monitoring the respiratory state of the patient in real time while scanning. To this end, the MRI system can acquire breathing information (1900). For example, an MRI system can acquire respiration information of an object using a breathing detection navigator. At this time, the respiration information is various information that can grasp the respiration of the object, and it can include various information such as the breathing curve, the respiratory cycle, and the breathing gradient”; p. 15, the last para.),
wherein a mean value, a maximum value, a minimum value, or a combination thereof is determined for a breath-holding duration and/or a maximum value for a period of time between the time of the respiratory command and the time of suspension and/or a mean value for a gradient (“the breathing gradient at the same point in the mean breathing curve”; p. 14, 3rd para. from the end) (“when it is determined that the breathing gradient at a specific point in the breathing curve of the object is stronger than the breathing gradient at the same point in the mean breathing curve, the control unit 30 can determine the specific point as the acquisition start time have.” p. 14, 3rd para. from the end).
Therefore, based on Hwang’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller and Carinci to have respiratory signals that are acquired for multiple breath-holding MR scans on a patient and the respiratory behavior of the patient is determined from the multiple respiratory signals, and a mean value, a maximum value, a minimum value, or a combination thereof that is determined for a breath-holding duration and/or a maximum value for a period of time between the time of the respiratory command and the time of suspension and/or a mean value for a gradient, as taught by Hwang, in order to improve MRI scanning of the patient by adjusting MR examination protocols based on obtained patient’s data. In the invention of Zeller and Hwang, MR scans are breath-holding MR scans.
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Zeller in view of Carinci.
Response to the 35 U.S.C. §101 rejection arguments on pages 12-15 of the REMARKS.
Claims 1-2, 4, 6-7, 10-13, and 15-20
The 101 rejection has been withdrawn based on the claim amendments and the Applicant’s arguments.
Response to the 35 U.S.C. §103 rejection arguments on pages 12-14 of the REMARKS.
Claims 1-2, 4, 6-7, 10-13, and 15-20
The Applicant argues that “The cited art does not teach or suggest such a method. Specifically, Zeller does not teach or suggest determining a time of a respiratory command on the patient and a period of time between the time of the respiratory command and a reaction by the patient, wherein the reaction by the patient is the starting time of the suspension of breathing.” (Page 13). The Examiner agrees and therefore the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Zeller in view of Carinci. The dependent claims are not allowable because the independent claims are not allowable and because additional secondary references meet additional limitations of the dependent claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798
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