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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 08/15/2023. It is noted, however, that applicant has not filed a certified copy of the JP2023-132294 application as required by 37 CFR 1.55.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The limitation “reconstruction unit” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“reconstructs a plurality of images”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a processor ([0032]) configured to perform at least functions disclosed in [0040] of applicant’s specification appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “time-phase detection unit” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“detects one or more cardiac rest phases”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a processor ([0032]) configured to perform at least functions disclosed in [0043]-[0050] of applicant’s specification appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “display control unit” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“displays the cardiac rest phase”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a processor ([0032]) configured to perform at least functions disclosed in at least [0062]-[0063] of applicant’s specification appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “operation unit” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“accepts an input of a correction operation”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a keyboard and mouse ([0031]) or the like appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “time-phase correction unit” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“unit”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a processor ([0032]) configured to perform at least functions disclosed in [0067]-[0068] of applicant’s specification appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “parameter setting unit” in claims 2, 5, and 6 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“sets a scan parameter”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a processor ([0032]) configured to perform at least the functions disclosed in [0070]-[0082] of applicant’s specification appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “standard value decision unit” in claim 10 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“decides on a standard value”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a processor ([0032]) configured to perform at least the functions disclosed in [0105] of applicant’s specification appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “accuracy calculation unit” in claim 10 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“calculates accuracy”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a processor ([0032]) configured to perform at least the functions disclosed in [0106] of applicant’s specification appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “measurement control unit” in claim 13 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“acquires nuclear magnetic resonance signals”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that an MRI machine/apparatus ([0024]-[0028]) appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 14 recites the limitation “the cardiac rest phase” in three instances. There is insufficient antecedent basis for the limitation in the claim. In this case, the limitations are unclear as the claim previously recites “one or more cardiac rest phases”. In other words, by reciting the cardiac rest phase, it is unclear which of the one or more cardiac rest phases the claim is referring to. For examination purposes, it has been interpreted to mean any of the one or more cardiac rest phases, however, clarification is required. Examiner notes that claims 2-3, 5-8, 10, and 12 also recite “the cardiac rest phase” and inherit the same issue as claim 1.
Claim 4 recites the limitation “detects a first cardiac rest phase… and a second cardiac rest phase”. Examiner notes that it is unclear if the first cardiac rest and/or second cardiac rest phase are the same as or included in the one or more cardiac rest phases or the cardiac rest phase of claim 1 or if these are different cardiac rest phases. In other words, while the limitation makes it clear that these are rest phases, it does not explicitly tie the rest phases to the one or more rest phases to make clear if the rest phases are detected based on the plurality of images as recited in claim 1 or if these are different rest phases detected based on other information. For examination purposes, it has been interpreted to mean any rest phases, however, clarification is required.
Claim 10 recites the limitation “decides on… a standard value of the cardiac rest phase corresponding to the heart rate”. It is unclear what constitutes a standard value of the cardiac rest phase. In other words, it is unclear what a value of the cardiac rest phase is and what makes it “standard” (e.g. a time value, a volume value, or other parameter value?). For examination purposes, it has been interpreted to mean any value which corresponds to the rest phase, however, clarification is required.
Claim 13 incorporates the elements of claim 1 which recite a magnetic resonance imaging apparatus that acquires nuclear magnetic resonance signals of a heart in synchronization with an electrocardiogram waveform for a period of one or more heartbeats, it is therefore unclear if the nuclear magnetic resonance signals of the data processing unit are the same as the magnetic resonance signals of the measurement control unit and if the electrocardiogram wave are the same. For examination purposes, it has been interpreted to be the same, however, clarification is required. Examiner recommends amending claim 13 to specifically recite the limitations of claim 1 excluding the recitation of “a magnetic resonance imaging apparatus….” Or similar.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7-9, and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayes et al. (US 20090208083 A1), hereinafter Hayes.
Regarding claims 1, 13, and 14,
Hayes discloses a magnetic resonance imaging apparatus (at least fig. 1 (10) and corresponding disclosure in at least [0021]) comprising:
a measurement control unit (at least fig. 1 (Control device and/or 15) and corresponding disclosure in at least [0021]) that acquires nuclear magnetic resonance signals of a heart in synchronization with an electrocardiogram waveform for a period of one or more heartbeats ([0025] which discloses the acquisition window which typically defines the time spans in the EKG signal during which the signal acquisition ensues. A trigger delay can likewise be automatically set which initiates the start of the image acquisition after the R-spike in the EKG signal); and
a data processing device (at least fig. 1 (14) and corresponding disclosure in at least [0021]) of a magnetic resonance imaging apparatus that acquires nuclear magnetic resonance signals of a heart in synchronization with an electrocardiogram waveform for a period of one or more heartbeats, the data processing device (14) comprising:
a reconstruction unit that reconstructs a plurality of images of the heart along a time series based on the nuclear magnetic resonance signals acquired by the magnetic resonance imaging apparatus ([0021] which discloses measurement signals are converted into an MR image via post-processing in a control device 14);
a time-phase detection unit (at least fig. 1 (17) and corresponding disclosure in at least [0021]) that detects one or more cardiac rest phases based on the plurality of images reconstructed by the reconstruction unit ([0022] which discloses the calculation unit 17 can be fashioned such that it identifies an endocardial volume as a rest phase whose area does not change more than, for example, 5%, and that follow one another in the images over time);
a display control unit that displays the cardiac rest phase on a display unit (see at least figs. 2-4 and [0022]-[0023] which discloses the calculated time points for the rest phase can be presented to the operator on the display unit 16 and the markings 30 and 31 can be presented to the displayed to the operator);
an operation unit that accepts an input of a correction operation of the cardiac rest phase ([0022]-[0023] which discloses the operator can check the starting point in time and the end point in time and change them as necessary for example, by selection of an earlier or later point in time by shifting the marking in the curve or by selecting a different image and The images that belong to the markings 30, 31 can then be displayed to the operator, wherein the operator gain checks the starting and end points in time of the rest phase and can modify them as needed by displacing the markings 30, 31 via selection of an earlier or later image. Examiner notes that such shifting/changing of the starting point/ending point necessarily requires an operation unit (e.g. input unit));
and a time-phase correction unit that corrects the cardiac rest phase based on the correction operation input to the operation unit ([0022]-[0023] which discloses the operator can check the starting point in time and the end point in time and change them as necessary for example, by selection of an earlier or later point in time by shifting the marking in the curve or by selecting a different image and The images that belong to the markings 30, 31 can then be displayed to the operator, wherein the operator gain checks the starting and end points in time of the rest phase and can modify them as needed by displacing the markings 30, 31 via selection of an earlier or later image. Examiner notes that such displacing of markings necessarily corrects the cardiac rest phase based on the correction operation input to the operation unit).
Examiner notes that the system of Hayes comprises the data processing device of claim 1 and would perform the data processing method of claim 14 having corresponding method steps.
Regarding claim 2,
Hayes further discloses further comprising:
A parameter setting unit that sets a scan parameter of the magnetic resonance imaging apparatus based on the cardiac rest phase ([0014] which discloses According to one embodiment, the starting points in time and the end points in time of the rest phase are respectively automatically determined and are used immediately as a basis for the calculation of imaging parameters of the additional heart imaging sequences, without review by the operator. In another embodiment, it is likewise possible to present the calculated starting and end points in time to the operator so that he can review the calculation and can change the points in time as necessary. see also [0025])
Wherein the parameter setting unit sets, in a case where the correction operation is input to the operation unit, the scan parameter based on the cardiac rest phase corrected by the time-phase correction unit ([0025] which discloses the established time spans of the rest phase of the heart can then be automatically integrated into the subsequent measurement. For this it is necessary to adapt some parameters to the duration of the rest phase. These parameters can be provided in the follow-up measurement with start values that are then automatically adapted by the system. Possible values that can be adapted are, for example, the acquisition window which typically defines the time spans in the EKG signal during which the signal acquisition ensues. A trigger delay can likewise be automatically set which initiates the start of the image acquisition after the R-spike in the EKG signal. In segmented measurement techniques, the number of the segments can likewise be adapted under consideration of the duration of the rest phase of the heart so that this time span can be optimally used for data acquisition. In procedures known as single shot measurement techniques in which the entire raw data space is measured during a rest phase, it can occur that the rest phase of the heart is shorter than the acquisition duration necessary in order to fill the entire raw data space in one heartbeat. If this should be the case, the operator can be informed of this fact and receives the possibility to use other measurement parameters (for example by reducing the spatial resolution, limiting the field of view, etc.) so that the entire MR image can be acquired in one rest phase)
Regarding claim 3,
Hayes further discloses wherein the operation unit is configured to accept an input of a re-correction operation of the cardiac rest phase that has been corrected in the correction operation, the time-phase correction unit re-corrects, in a case where the re-correction operation is input to the operation unit, the cardiac rest phase based on the re-correction operation ([0014] which discloses it is likewise possible to present the calculated starting and end points in time to the operator so that he can review the calculation and can change the points in time as necessary and [0022] which discloses The automatically calculated points in time for the rest phase can be presented to the operator on the display unit 16, wherein the operator can check the starting point in time and the end point in time and change them as necessary, for example by selection of an earlier or later point in time by shifting the marking in the curve or by selecting a different image and [0023] which discloses The images that belong to the markings 30, 31 can then be displayed to the operator, wherein the operator gain checks the starting and end points in time of the rest phase and can modify them as needed by displacing the markings 30, 31 via selection of an earlier or later image. Examiner notes that a person having ordinary skill recognizes that a user’s ability to change the starting/end times as necessary means that a person could re-correct (i.e. change the starting/end points again) as necessary and the system functions to accept such an input of recorrection), and the parameter setting unit sets, in a case where the re-correction operation is input to the operation unit, the scan parameter based on the cardiac rest phase re-corrected by the time-phase correction unit ([0025] which discloses the established time spans of the rest phase of the heart can then be automatically integrated into the subsequent measurement. For this it is necessary to adapt some parameters to the duration of the rest phase. These parameters can be provided in the follow-up measurement with start values that are then automatically adapted by the system. Possible values that can be adapted are, for example, the acquisition window which typically defines the time spans in the EKG signal during which the signal acquisition ensues. A trigger delay can likewise be automatically set which initiates the start of the image acquisition after the R-spike in the EKG signal. In segmented measurement techniques, the number of the segments can likewise be adapted under consideration of the duration of the rest phase of the heart so that this time span can be optimally used for data acquisition. In procedures known as single shot measurement techniques in which the entire raw data space is measured during a rest phase, it can occur that the rest phase of the heart is shorter than the acquisition duration necessary in order to fill the entire raw data space in one heartbeat. If this should be the case, the operator can be informed of this fact and receives the possibility to use other measurement parameters (for example by reducing the spatial resolution, limiting the field of view, etc.) so that the entire MR image can be acquired in one rest phase).
Regarding claim 7,
Hayes further discloses wherein herein the display control unit displays the cardiac rest phase on the display unit in accordance with a time axis (see at least figs. 2 and 4 depicting markings 30 and 31 or times t1 and t2 displayed in accordance with a time axis (i.e. x-axis)).
Regarding claim 8,
Hayes further discloses wherein the display control unit displays, on the display unit, a time-phase display region including the cardiac rest phase and the time axis (see at least figs. 2 and 4), and an image display region for selectively displaying any of the plurality of images reconstructed by the reconstruction unit, the operation unit is configured to accept an input of a time designation operation of designating a certain time of the time axis, and the display control unit displays, in a case where the time designation operation is input to the operation unit, an image corresponding to the time designated in the time designation operation among the plurality of images reconstructed by the reconstruction unit, in the image display region (.
Regarding claim 9,
Hayes further discloses wherein the display control unit displays, on the display unit, a time-phase display region including the cardiac rest phase and the time axis (see at least figs. 2 and 4), and an image display region for selectively displaying any of the plurality of images reconstructed by the reconstruction unit ([0023] which discloses the images that belong to the markings 30, 31 can then be displayed to the operator, wherein the operator gain checks the starting and end points in time of the rest phase and can modify them as needed by displacing the markings 30, 31 via selection of an earlier or later image), the operation unit is configured to accept an input of an image selection operation of selecting the image to be displayed in the image display region ([0023] which discloses the images that belong to the markings 30, 31 can then be displayed to the operator, wherein the operator gain checks the starting and end points in time of the rest phase and can modify them as needed by displacing the markings 30, 31 via selection of an earlier or later image [0022] which discloses the automatically calculated points in time for the rest phase can be presented to the operator on the display unit 16, wherein the operator can check the starting point in time and the end point in time and change them as necessary, for example by selection of an earlier or later point in time by shifting the marking in the curve or by selecting a different image))., and the display control unit displays, in a case where the image selection operation is input to the operation unit, the image selected in the image selection operation in the image display region and displays a time phase corresponding to the image selected in the image selection operation on the time axis in the time-phase display region ([0023] which discloses the images that belong to the markings 30, 31 can then be displayed to the operator, wherein the operator gain checks the starting and end points in time of the rest phase and can modify them as needed by displacing the markings 30, 31 via selection of an earlier or later image and [0022] which discloses the automatically calculated points in time for the rest phase can be presented to the operator on the display unit 16, wherein the operator can check the starting point in time and the end point in time and change them as necessary, for example by selection of an earlier or later point in time by shifting the marking in the curve or by selecting a different image).
Regarding claim 11,
Hayes further discloses wherein the reconstruction unit reconstructs the plurality of images at regular time intervals (see at least fig. 2 depicting data from images acquired/reconstructed at regular time intervals across the time axis and see also fig. 4).
Regarding claim 12,
Hayes further discloses wherein the time-phase detection unit calculates a representative value of signal values of the image for each of the plurality of images reconstructed by the reconstruction unit to detect the cardiac rest phase based on the representative value for each image along the time series ([0023] which discloses the intensity cross-section through the center point can be formed in various MR images. This intensity cross-section can now be presented shown over time as in FIG. 4, wherein in FIG. 4 the intensity cross-section in the image 27 is representative of the intensity curve over time for a specific radius starting from the center point 25 and In the y-direction, the intensity cross-section is presented in FIG. 4 at a point in time; the x-axis represents this intensity cross-section at various points in time. The movement of the left ventricle 28 is well recognizable in the y-direction. In the method presented in FIG. 4, the position of the left ventricle is now examined. In the event that the position of the ventricle is constant over a longer time period, the rest phase in the cardiac cycle can be concluded)
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 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Hayes in view of Jo et al. (US 20160125596 A1), hereinafter Jo.
Regarding claim 4,
Hayes teaches the elements of claim 1 as previously stated. Hayes further teaches wherein the time-phase detection unit detects a second cardiac rest phase indicating an end-diastolic cardiac rest phase of the heart, the display control unit displays the second cardiac rest phase on the display unit in an identifiable manner, the operation unit accepts input of the correction operation of the second cardiac rest phase, and the time-phase correction unit corrects the second cardiac rest phase in a case where the correction operation of the second cardiac rest phase is input to the operation unit.
Hayes fails to explicitly teach wherein the time-phase detection unit detects a first cardiac rest phase indicating an end-systolic cardiac rest phase of the heart, the display control unit displays the first cardiac rest phase in an identifiable manner, the operation unit accepts inputs of the correction operation of the first cardiac rest phase, and the time-phase correction unit corrects the first cardiac rest phase in a case where the correction operation of the first cardiac rest phase is input to the operation unit.
Jo teaches wherein a time-phase detection unit that detects a first cardiac rest phase indicating an end-systolic cardiac rest phase of the heart and a second cardiac rest phase indicating an end diastolic cardiac rest phase of the heart ([0115] which discloses the image processor 320 is configured to indicate images representing end diastole, end systole, an apex, and a base of the heart in an MR image matrix by, for example, using marks, thus detects the first cardiac phase (end systole) indicating an end-systole cardiac rest phase and a second cardiac rest phase (end diastole) indicating an end-diastolic cardiac rest phase of the heart in order to indicate the images accordingly),
a display control unit displays the first cardiac rest phase and the second cardiac rest phase on the display unit in an identifiable manner (see at least fig. 5 and 7) ,
an operation unit accepts inputs of the correction operation of the first cardiac rest phase and the correction operation of the second cardiac rest phase (see at least fig. 7 and [0014] which discloses [0014] The apparatus may further include an input unit configured to receive a user input for repositioning the at least one first indicator which indicates the column of the MR image matrix corresponding to at least one of end diastole and end systole, wherein the output unit is configured to reposition, based on the user input, the at least one first indicator) and
the time-phase correction unit corrects the first cardiac rest phase in a case where the correction operation of the first cardiac rest phase is input to the operation unit, and corrects the second cardiac rest phase in a case where the correction operation of the second cardiac rest phase is input to the operation unit ([0014] which discloses the apparatus may further include an input unit configured to receive a user input for repositioning the at least one first indicator which indicates the column of the MR image matrix corresponding to at least one of end diastole and end systole, wherein the output unit is configured to reposition, based on the user input, the at least one first indicator).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Hayes to include detecting a first cardiac rest phase, accepting input to correct operation of the first cardiac rest phase and correcting the first cardiac rest phase as taught by Jo in order to provide additional diagnostic data to a user regarding other portions of the heart cycle. Such a modification would be beneficial for diagnosing by facilitating identification of images indicating end-diastole and end-systole such that partial volumes at both end diastole and end systole in the cardiac cycle to be used to calculate important clinical parameters cu has ejection fraction, end-diastolic volume, and end-systole volume and the like (Jo [0017]-[0019]).
Regarding claim 5,
Hayes, as modified, teaches the elements of claim 4 as previously stated. Hayes further teaches a parameter setting unit that sets a scan parameter of the magnetic resonance imaging apparatus based on the cardiac rest phase, the parameter setting unit sets the scan parameter based on selected input ([0025] which discloses the established time spans of the rest phase of the heart can then be automatically integrated into the subsequent measurement. For this it is necessary to adapt some parameters to the duration of the rest phase. These parameters can be provided in the follow-up measurement with start values that are then automatically adapted by the system. Possible values that can be adapted are, for example, the acquisition window which typically defines the time spans in the EKG signal during which the signal acquisition ensues. A trigger delay can likewise be automatically set which initiates the start of the image acquisition after the R-spike in the EKG signal. In segmented measurement techniques, the number of the segments can likewise be adapted under consideration of the duration of the rest phase of the heart so that this time span can be optimally used for data acquisition. In procedures known as single shot measurement techniques in which the entire raw data space is measured during a rest phase, it can occur that the rest phase of the heart is shorter than the acquisition duration necessary in order to fill the entire raw data space in one heartbeat. If this should be the case, the operator can be informed of this fact and receives the possibility to use other measurement parameters (for example by reducing the spatial resolution, limiting the field of view, etc.) so that the entire MR image can be acquired in one rest phase).
Jo, as applied to claim 4 above, further teaches the operation unit is configured to accept an input of a time-phase selection operation of selecting any one of the first cardiac rest phase or the second cardiac rest phase ([0016] which discloses and the user input for repositioning the at least one first indicator may include dragging the index for identifying the at least one of the end-diastole column and the end-systole column. Examiner notes that such dragging/selection of the column is considered to be a selection of any one of the first cardiac rest phase (i.e. end-systole) or second cardiac rest phase (i.e. end-diastole)),
Examiner notes that in the modified system, the parameter setting unit of Hayes, sets the scan parameter based on the selected data in the time-phase selection operation and thus would set the scan parameter based on the one selected in the time-phase selection operation due to the breadth of based on where the subsequent imaging parameters are necessarily based on any actions which come before hand including the selection of the one and would occur in a case where the time-phase selection operation is input to the operation unit.
Regarding claim 6,
Hayes, as modified, teaches the elements of claim 4. Hayes further teaches a parameter setting unit that sets a scan parameter of the magnetic resonance imaging apparatus based on the cardiac rest phase ([0025] which discloses the established time spans of the rest phase of the heart can then be automatically integrated into the subsequent measurement. For this it is necessary to adapt some parameters to the duration of the rest phase. These parameters can be provided in the follow-up measurement with start values that are then automatically adapted by the system. Possible values that can be adapted are, for example, the acquisition window which typically defines the time spans in the EKG signal during which the signal acquisition ensues. A trigger delay can likewise be automatically set which initiates the start of the image acquisition after the R-spike in the EKG signal. In segmented measurement techniques, the number of the segments can likewise be adapted under consideration of the duration of the rest phase of the heart so that this time span can be optimally used for data acquisition. In procedures known as single shot measurement techniques in which the entire raw data space is measured during a rest phase, it can occur that the rest phase of the heart is shorter than the acquisition duration necessary in order to fill the entire raw data space in one heartbeat. If this should be the case, the operator can be informed of this fact and receives the possibility to use other measurement parameters (for example by reducing the spatial resolution, limiting the field of view, etc.) so that the entire MR image can be acquired in one rest phase),
Jo, as applied to claim 4 above, further teaches wherein the a processor selects any one of the first cardiac rest phase or the second cardiac rest phase in accordance with a predetermined recommendation condition ([0016] which discloses and the user input for repositioning the at least one first indicator may include dragging the index for identifying the at least one of the end-diastole column and the end-systole column, where the user input is considered a predetermined recommendation condition and the processor selects the first/second rest phase in accordance with the dragging/selection by the user)
Examiner notes that the parameter setting of Hayes would necessarily be based on the selected one due to the breadth of based on and subsequent imaging parameters are necessarily based on any actions which come beforehand.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hayes in view of Turcea et al. (US 20200085394 A1), hereinafter Turcea.
Regarding claim 10,
Hayes teaches the elements of claim 1 as previously stated. Hayes fails to explicitly teach a standard value decision unit that decides, based on a heart rate obtained from the electrocardiogram waveform, a standard value of the cardiac rest phase corresponding to the heart rate; and an accuracy calculation unit that calculates accuracy of the cardiac rest phase detected by the time-phase detection unit based on the standard value decided by the standard value decision unit, wherein the display control unit displays a calculation result of the accuracy calculation unit on the display unit.
Turcea, in a similar field of endeavor involving MRI imaging, teaches a standard value decision unit, that decides based on a heart rate obtained from an electrocardiogram waveform, a standard value of a cardiac rest phase corresponding to the heart rate ([0053] which discloses corresponding secondary data (e.g. ECG traces) is first assembled and ground truth information regarding the cardiac phase and/or time points of interest of each heart cycle is determined from the corresponding secondary data) and an accuracy calculation unit that calculates accuracy of the cardiac rest phase detected by a time-phase detection unit based on the standard value decided by the standard value decision unit ([0082] which discloses the difference between each of the two or more probability values and the values representing the cardiac phases (e.g. the indices ‘0’ or ‘1’ described with reference to FIG. 3) is determined i.e. ground truth values of systolic and diastolic phase as disclosed in [0085]), which generates two or more confidence values for each frame. The probability value for a given frame that has the least difference (i.e. the highest confidence value) is determined to be the probability value having the highest confidence. Accordingly, it is that probability value that is used by the classifier 512 to determine the cardiac phase. [0083] The classifier 512 provides an output indicating a cardiac phase associated with each image frame based on the probability value having the highest confidence value associated with that frame and [0088] which discloses a difference between a predicted phase and a ground truth phase).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Hayes to include a standard value decision unit and accuracy calculation unit as taught by Turcea in order to provide a neural network system which determines the cardiac phase associated with the images (Turcea Abstract). Such a modification would enhance the detection of the cardiac rest phase of Hayes accordingly.
Hayes further teaches wherein the display control unit displays a result of the detection of the cardiac rest phase (See at least figs. 2-4) on the display unit. Examiner notes that in the modified system the displayed cardiac rest phase (or images associated therewith) are considered a calculation result of the accuracy calculation unit, therefore, examiner notes that the modified system displays a calculation result of the accuracy calculation unit on the display unit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 5712700552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797