DETAILED ACTION
This Office action is responsive to communications filed on 01/02/2026. Claims 1, 6-11 have been amended. Claims 3-5 are canceled. Presently, Claims 1-2, and 6-11 remain pending and are hereinafter examined on the merits.
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 Arguments
Previous rejections under 35 USC § 101 & 35 USC § 112(b) are withdrawn in view of the amendments filed on 01/02/2026
Previous claim objections are withdrawn in view of the amendments filed on 01/02/2026.
The Applicant’s arguments have been fully considered but are not persuasive. The Applicant primarily asserts that Mukumoto and Yashiro “fail to disclose” the claimed features that the claims are “clearly different” form the cited references, without providing substantive analysis explaining why the cited disclosures would not reasonably be understood to teach or suggest the claimed subject matter, or why a person of ordinary skill in the art would not have been motivated to combined the teachings. These assertions without supported analysis are conclusory and unsupported. Mere assertions of differences by stating merely that the cited references don’t teach the claimed subject matter without analysis or support does not establish non-obviousness. The Examiners rejection is set forth in the office action below, under 35 USC § 103 as being unpatentable over Mukumoto et al (US 2009/0060120 A1) in view of Yasuhiro et al (US 2017/0086771 A1) is maintained.
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 1-2, & 6-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 1: line 17, “identify an examination condition”. Line 5 of claim 1 establishes the processing circuitry sets an examination condition, whereas line 17 requires identification of an examination condition. It is unclear if the recitation of “an examination condition” in line 17 is the same or a different examination condition than in line 5. For examination purposes, the Examiner assumes line 17 recitation of “an examination” refers to the examination (i.e., the same examination condition referring to line 5). Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 1: line 23, “an image of the subject by a scan”. Line 5 of claim 1 established the processing circuitry captures “an image of the subject by a scan”, whereas line 23 requires “an image of the subject by a scan”. It is unclear if the recitation of “an image of the subject by a scan” in line 23 refers to or is separate from “an image of the subject by a scan” in line 5. For examination purposes, the Examiner assumes the image of the subject by the scan (i.e., the same image of the subject by the same scan referring to line 5). Consistent claim language is required when referring to the same term. Appropriate correction is required.
The above rejections to claim 1 apply to claim 10 and claim 11 for substantially identical claim
limitations recited in the claim. Accordingly, proper ordinal numbering and/or antecedent basis is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 1:
line 4, “the obtained biological information;”
line 6, “the obtained biological information and the obtained analysis information”
line 11, “the obtained [[the]] analysis information”.
Line 22, “a scan condition [[set]]”.
Line 24, “a reconstruction condition [[set]]”.
Claim 6:
line 3, “the obtained analysis information”.
lines 5-6, “the obtained biological information;”
Claim 7:
line 4, “[[a]]the scan condition and [[a]]the reconstruction condition”.
Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Mukumoto et al (US 2009/0060120 A1) in view of Yasuhiro et al (US 2017/0086771 A1).
Claim 1: Mukumoto discloses, A medical image diagnosis apparatus comprising processing circuitry configured to:
-Mukumoto discloses, (¶Abstract, ‘An X-ray CT apparatus detects a predetermined characteristic wave from each electrocardiographic waveform acquired from an electrocardiograph, predicts intervals with which the characteristic wave appears based on appearance times of the detected predetermined characteristic wave in each electrocardiographic waveform, and determines an X-ray irradiation start time based on the predicted interval time’; ¶0056, ‘The computer 3 includes an input unit 301, a display unit 302, a scanning-condition storage unit 303, the I/F 304, the scan control unit 305, a preprocessing unit 306, an image reconstructing unit 307, a calculating unit 308, a data storage unit 309, a characteristic-wave detecting unit 310, a heartbeat-abnormality determining unit 311, and a data-collection completion determining unit 312’)
obtain biological information about a subject acquired by a biological monitor;
-The apparatus of Mukumoto requires obtaining biological information from the subject acquired by a biological monitor.
-The biological monitor Mukumoto is explicitly an electrocardiograph, Claim 1, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject;’; Claim 8, ‘acquiring an electrocardiographic waveform of the subject by an electrocardiograph;’, ¶0015, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject’, ¶0054, ‘The electrocardiograph 16 is attached to the subject P, and acquires an electrocardiographic waveform of the subject P. The electrocardiographic waveform acquired by the electrocardiograph 16 is sent to the computer 3 via an interface (I/F) 304.’;
-The apparatus of Mukumoto further acquires an electrocardiographic waveform of the subject, ¶0015, ‘an image reconstructing unit that reconstructs a tomographic image of a heart of the subject, based on X-ray detection information detected by the X-ray detecting unit and the electrocardiographic waveform of the subject acquired by the electrocardiograph; a characteristic-wave detecting unit that detects a predetermined characteristic wave from the electrocardiographic waveform acquired from the electrocardiograph; an X-ray irradiation control unit that determines an X-ray detection information collecting period during which the X-ray detection information is collected, based on an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit; an input unit that receives an instruction to start collection of the X-ray detection information; a heartbeat determining unit that performs heartbeat determination whether an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit is a normal heartbeat or an abnormal heartbeat, after a point of time at which the input unit receives the instruction to start the collection; and a control unit that controls the X-ray irradiation control unit such that the X-ray irradiation control unit recalculates and determines the X-ray detection information collecting period, when the heartbeat determining unit determines that an appearance interval is an abnormal heartbeat, during after the input unit receives the instruction to start the collection until reaching a time of starting the collection of the X-ray detection information determined by the X-ray irradiation control unit.’; see also Claim 1, 8, ¶0054.
obtain analysis information resulting from analysis of the biological information; and
-The system of Mukumoto obtains analysis information resulting from analysis of the biological information, which includes measurement information (i.e., characteristics) and diagnosis information (i.e., clinical state), ¶Abstract, ¶0015, ¶0065-0066, Claim 1, Claim 8, Claim 3, Claim 10.
-Mukumoto teaches the measurement information incudes characteristics derived from the electrocardiographic waveform. The system uses the R-wave as the predetermined characteristic wave, ¶0031, ‘the X-ray CT apparatus detects an R-wave as a characteristic wave in an electrocardiographic waveform, and acquires the time of the detection (for example, a time distance from the start of acquisition of the electrocardiographic waveform to the detection).’. Said system uses the R-R average interval, ¶0032, ‘calculates an R-R average interval, which is an average of R-wave intervals observed in the subject, by using appearance times of R-waves in each electrocardiographic waveform detected from the electrocardiograph attached to the subject through a first monitoring executed before the start of tomographic scanning. For example, an R-R average interval can be calculated as one second.’. In addition, the system uses an appearance interval (i.e., R-wave interval) to predict when the next characteristic wave will appear, ¶Abstract, Claim 9. In other words, the system predicts interval timing with which a characteristic wave appears based on predetermine characteristic waves, Claim 9.
-The analysis of Mukumoto further discloses diagnosis information representing a clinical state of the subject. Specifically, a heartbeat determination unit for clinical assessment of rhythm, ¶0015, ¶0065-0067. The heartbeat determining unit determines whether an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit is normal heartbeat or an abnormal heartbeat, ¶0015-0016, ¶0034, ¶0066. An abnormal heartbeat can be caused by a heartbeat abnormality such as arrhythmia caused by extrasystole or a heartbeat fluctuation, ¶0010. This determination functions as diagnosis information of the rhythm state (i.e., a clinical state) of the subject, ¶0010, ¶0066, ¶0091-0094.
set an examination condition for capturing an image of the subject by a scan, based on the biological information and the analysis information,
-Mukumoto teaches setting the examination condition (i.e., scanning schedule) for capturing an image of the subject by a scan, based on the biological information and the analysis information. The examination condition involves determining the X-ray irradiation start time, ¶Abstract, ¶0015-0016, ¶0035, ¶0065-0066, or the X-ray detection information collection period, ¶0097, ¶0099, ¶0104-0115. If the heartbeat determining unit determines that an interval is an abnormal heartbeat (i.e., diagnosis information) during the preparatory period, the control unit ensures the examination condition (i.e., X-ray irradiation start time or collection period) is recalculated and determined (i.e., re-set). Hence, the examination condition for capturing an image of the subject is dynamically set based on the biological information and the analysis information, ¶Abstract, ¶0015-0016, ¶0036, ¶0067.
wherein
the biological monitor includes an electrocardiograph, and
-Mukumoto teaches the biological monitor is explicitly an electrocardiograph, Claim 1, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject;’; Claim 8, ‘acquiring an electrocardiographic waveform of the subject by an electrocardiograph;’, ¶0015, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject’, ¶0054, ‘The electrocardiograph 16 is attached to the subject P, and acquires an electrocardiographic waveform of the subject P. The electrocardiographic waveform acquired by the electrocardiograph 16 is sent to the computer 3 via an interface (I/F) 304.’;
the processing circuitry is configured to obtain an electrocardiogram waveform of the subject in real time as transmitted from the electrocardiograph;
-Mukumoto teaches the processing circuitry is configured to obtained electrocardiogram waveform continuously or simultaneously with the scanning process, ¶0007, ¶0015, ¶0036, ¶0042.
obtain the analysis information including diagnosis information representing a clinical state of the subject,
-The analysis of Mukumoto further discloses diagnosis information representing a clinical state of the subject. Specifically, a heartbeat determination unit for clinical assessment of rhythm, ¶0015, ¶0065-0067. The heartbeat determining unit determines whether an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit is normal heartbeat or an abnormal heartbeat, ¶0015-0016, ¶0034, ¶0066. An abnormal heartbeat can be caused by a heartbeat abnormality such as arrhythmia caused by extrasystole or a heartbeat fluctuation, ¶0010. This determination functions as diagnosis information of the rhythm (i.e., a clinical state – normal vs abnormal) of the subject, ¶0010, ¶0066, ¶0091-0094.
the diagnosis information including an electrocardiographic finding representing a finding of the electrocardiogram waveform of the subject,
-Mukumoto teaches this determination of an electrocardiographic finding representing a finding of the electrocardiogram waveform of the subject derived from the waveform. The detection of a predetermined characteristic wave, ¶Abstract, ¶0031-0034. The calculation of the interval of these waves, ¶Abstract, ¶0031-0034. And finding that an interval falls inside or outside an acceptable normal-heart beat range, ¶Abstract, ¶0031-0034. If the detected finding (i.e., R-wave interval) is outside the acceptable range, the system diagnosis the state as an abnormal heart beat and adjust the scans accordingly, ¶Abstract, ¶0031-0034.
identify an examination condition corresponding to the diagnosis information included in the obtained analysis information from the diagnosis information included in the obtained analysis information and an examination-condition database (DB) including a plurality of sets of pieces of diagnosis information and examination conditions, and set the identified examination condition as the examination condition,
-Mukumoto teaches that the system where diagnosis information, specifically determination of normal vs abnormal is derived from biological information used to retrieve specific examination conditions such as expanding the scanning phase stored in a scanning condition storage unit. Mukumoto teaches a scanning storage unit 303. This scanning storage unit 303 stores various conditions and parameters including a set phase and specific expansion conditions, ¶0060, ¶0119-0120.
-Mukumoto teaches obtaining the analysis information in the form of a heat beat determination. This determination diagnosis the current clinical state of the subject as either normal heat beat or an abnormal heart beat based on whether the detected R-wave interval falls within an acceptable range, ¶0015, ¶0101-0102, Claim 1.
-Mukumoto teaches that the processing circuitry, specifically the scan control unit 305 and calculating unit 308 identifies the appropriate condition based on the heartbeat determination (i.e., diagnosis information, ¶0067, ¶0120. If the diagnosis is normal the system sets the examination condition based on the standard “set phase” stored in the storage unit, ¶0119. If the diagnosis is abnormal the system identifies and applies the expansion condition stored in the scanning condition storage unit 303, ¶0119. Specifically, Mukumoto teaches ¶0120, “re-sets and calculates the collection period [...] by expanding the range of the set phase [...] in accordance with the expansion condition stored in the scanning-condition storage unit 303”. The system of Mukumoto then uses the heartbeat determining unit to diagnosis the subject state as normal or abnormal, ¶0015. It then accesses the scanning-condition storage unit (DB), ¶0119, to identify the corresponding condition as either the standard collection period or the expanded collection period defined by the stored expansion condition, ¶0119-0120. It then sets this identified condition, as the “X-ray detection information collecting period”, ¶0015, ¶0120.
control, based on a scan condition set. the medical image diagnosis apparatus to execute capturing an image of the subject by a scan, and
-Mukumoto teaches a scan control unit 305 part of the processing circuitry that controls the tomographic scanning performed by the apparatus, ¶0061. The apparatus of Mukumoto includes a scanning-condition storage unit 303 that stores scanning conditions received from an operator such as retrospective gating or prospective gating, and specific parameters like set phases, ¶0060-0061, ¶0084, ¶0119, ¶0131, ¶0134-0135.
control, based on a reconstruction condition set, the medical image diagnosis apparatus to perform an image generation process.
-Mukumoto describes an image reconstructing unit that performs the image generation process, ¶0058, ¶0117. The scanning condition storage unit stores reconstruction conditions, specifically determining whether to use retrospective gating or prospective gating as the gated reconstruction method, ¶0060, ¶0119. The image reconstruction unit reconstructs the tomographic image of the heart using the collected X-ray distribution data and the electrocardiogram waveform according to retrospective gating or prospective gating stored conditions, ¶0058, ¶0119.
Mukumoto fails to disclose: the electrocardiographic finding including at least one of ventricular premature contraction, atrioventricular block, short P interval, pacemaker in operation, bigeminy, or atrial fibrillation,
However, Yasushiro in the context of medical imaging processing discloses, an electrocardiographic finding includes ventricular premature contraction, ¶0154, ‘In the medical image processing device according to the embodiment of the present disclosure, the port may acquire electrocardiographic information from an electrocardiograph. The processor may acquire information of a ventricular contraction time at which ventricular contraction appears from the electrocardiographic information and may set the ventricular contraction time as a reference point of the second time component. The ventricular contraction time may be a time at which an R wave is located.’
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processing of the electrocardiographic finding of Mukumoto to include teach teachings of Yasuhiro. The motivation to do this yields predictable results such as improving reading accuracy of a heart disease, as suggested by Yashuiro ¶0108.
Claim 2: Modified Mukumoto discloses all the elements above in claim 1, Mukumoto discloses, wherein the processing circuitry is configured to obtain the analysis information with a delay from obtaining the biological information.
-The electrocardiograph 16 acquires the electrocardiographic waveform (i.e., the biological information) of the subject, ¶0054, ‘The electrocardiograph 16 is attached to the subject P, and acquires an electrocardiographic waveform of the subject P.’. This waveform is sent to computer 3 and stored in the data storage unit 309, ¶0054, ‘The electrocardiographic waveform acquired by the electrocardiograph 16 is sent to the computer 3 via an interface (I/F) 304.’, ¶0063, ‘The characteristic-wave detecting unit 310 detects an R-wave from each electrocardiographic waveform acquired by the electrocardiograph 16 stored in the data storage unit 309, and acquires the time of the detection (for example, a time distance from the start of acquisition of the electrocardiographic waveform to the detection).’.
-The characteristic wave detecting unit 310 detects a predetermined characteristic wave (i.e., R-wave) from the acquired electrographic waveform, ¶0063, ‘The characteristic-wave detecting unit 310 detects an R-wave from each electrocardiographic waveform acquired by the electrocardiograph 16 stored in the data storage unit 309, and acquires the time of the detection (for example, a time distance from the start of acquisition of the electrocardiographic waveform to the detection).’.
-The sequencing from the waveform to the characteristics are functionally different, which demonstrate that analysis information is a result of the biological information, which occurs after the biological information has been obtained and detected and thus would imply a processing delay from the obtained biological information.
Claim 6: Modified Mukumoto discloses all the elements above in claim 1, Mukumoto discloses,
wherein
the analysis information includes at least either of:
the diagnosis information, and
-The analysis of Mukumoto further discloses diagnosis information representing a clinical state of the subject. Specifically, a heartbeat determination unit for clinical assessment of rhythm, ¶0015, ¶0065-0067. The heartbeat determining unit determines whether an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit is normal heartbeat or an abnormal heartbeat, ¶0015-0016, ¶0034, ¶0066. An abnormal heartbeat can be caused by a heartbeat abnormality such as arrhythmia caused by extrasystole or a heartbeat fluctuation, ¶0010. This determination functions as diagnosis information of the rhythm state (i.e., a clinical state) of the subject, ¶0010, ¶0066, ¶0091-0094.
measurement information representing a characteristic of the biological information,
-The measurement information incudes characteristics derived from the electrocardiographic waveform. The system uses the R-wave as the predetermined characteristic wave, ¶0031, ‘the X-ray CT apparatus detects an R-wave as a characteristic wave in an electrocardiographic waveform, and acquires the time of the detection (for example, a time distance from the start of acquisition of the electrocardiographic waveform to the detection).’. Said system uses the R-R average interval, ¶0032, ‘calculates an R-R average interval, which is an average of R-wave intervals observed in the subject, by using appearance times of R-waves in each electrocardiographic waveform detected from the electrocardiograph attached to the subject through a first monitoring executed before the start of tomographic scanning. For example, an R-R average interval can be calculated as one second.’. In addition, the system uses an appearance interval (i.e., R-wave interval) to predict when the next characteristic wave will appear, ¶Abstract, Claim 9. In other words, the system predicts interval timing with which a characteristic wave appears based on predetermine characteristic waves, Claim 9.
the measurement information includes at least one of PR interval, PQ interval, RR interval, heart-rate variation, or frequency of irregular pulse, and
-Mukumoto discloses the time measured between successive R-waves, ¶0032, ‘the X-ray CT apparatus according to the first embodiment calculates an R-R average interval, which is an average of R-wave intervals observed in the subject, by using appearance times of R-waves in each electrocardiographic waveform detected from the electrocardiograph attached to the subject through a first monitoring executed before the start of tomographic scanning. For example, an R-R average interval can be calculated as one second.’
-Mukumoto implicitly teaches heart-rate variation, detecting and calculating the R-R interval is a directed result of heart-rate variation.
the processing circuitry is configured to set the examination condition based on the measurement information.
-Mukumoto teaches setting the examination condition (i.e., scanning schedule) for capturing an image of the subject by a scan, based on the biological information and the analysis information. The examination condition involves determining the X-ray irradiation start time, ¶Abstract, ¶0015-0016, ¶0035, ¶0065-0066, or the X-ray detection information collection period, ¶0097, ¶0099, ¶0104-0115. If the heartbeat determining unit determines that an interval is an abnormal heartbeat (i.e., diagnosis information) during the preparatory period, the control unit ensures the examination condition (i.e., X-ray irradiation start time or collection period) is recalculated and determined (i.e., re-set). Hence, the examination condition for capturing an image of the subject is dynamically set based on the biological information and the analysis information, ¶Abstract, ¶0015-0016, ¶0036, ¶0067; wherein the analysis information includes both diagnosis information that includes an electrocardiographic finding of the subject and measurement information includes at least RR interval
Claim 7: Modified Mukumoto discloses all the elements above in claim 1, Mukumoto discloses, wherein the processing circuitry is configured to set the examination condition including at least either of a scan condition and a reconstruction condition.
-Mukumoto discloses a scan condition that includes a temporal condition for scanning the subject. The temporal condition determined is the X-ray irradiation start time, ¶Abstract, ¶0030, ¶0035-0036, ¶0065-0066. This time is calculated from the R-R average interval, ¶0035-0036. The system also determined an X-ray irradiation end time, ¶0030.
-Mukumoto further discloses that the scan condition includes an operation condition for elements of the medical image diagnosis apparatus to scan the subject at the scan time. The apparatus of Mukumoto contains an X-ray tube 11 which irradiates a subject with X-rays, ¶0048-0050. The scan control unit 305 controls the high-voltage generating unit to control the on and off of X-ray irradiation, ¶0048-0050, ¶0061. Specifically, the control unit controls the high-voltage generating unit 14 so as to start X-ray irradiation from the X-ray tube, ¶0048-0050, ¶0061.
-Mukumoto discloses the reconstruction condition includes a reconstruction timing representing a temporal condition for reconstructing medical image data of the subject. Specifically, Mukumoto defines a temporal constraint placed on the image reconstruction unit 307 for reconstructing medical image data. This reconstruction of the heart image is governed by the principle of electrocardiogram-gated reconstruction, ¶0006-0007, ¶0057-0058. The image reconstructing unit achieves this by extracting X-ray distribution data in a specific phase from the continuously collected data, based on the subject’s electrocardiographic waveform, ¶0007, ¶0029-0030, ¶0057-0058. The extraction process represents the temporal condition for reconstructing the image data. While the final image reconstruction process is after the scan termination, the reconstruction condition/parameters would be set prior to the scanning; the parameters of the reconstruction are based on operator input which occurs before scanning, ¶0059-0060.
-Mukumoto teaches setting the examination condition (i.e., scanning schedule) for capturing an image of the subject by a scan, based on the biological information and the analysis information. The examination condition involves determining the X-ray irradiation start time, ¶Abstract, ¶0015-0016, ¶0035, ¶0065-0066, or the X-ray detection information collection period, ¶0097, ¶0099, ¶0104-0115. If the heartbeat determining unit determines that an interval is an abnormal heartbeat (i.e., diagnosis information) during the preparatory period, the control unit ensures the examination condition (i.e., X-ray irradiation start time or collection period) is recalculated and determined (i.e., re-set). Hence, the examination condition for capturing an image of the subject is dynamically set based on the biological information and the analysis information, ¶Abstract, ¶0015-0016, ¶0036, ¶0067; including the scan condition, ¶0035-0036, ¶0048-0050, ¶0065-0066 and the reconstruction condition, ¶0057-0060.
the scan condition includes
a scan timing representing a temporal condition for scanning the subject, and
-Mukumoto discloses a scan condition that includes a temporal condition for scanning the subject. The temporal condition determined is the X-ray irradiation start time, ¶Abstract, ¶0030, ¶0035-0036, ¶0065-0066. This time is calculated from the R-R average interval, ¶0035-0036. The system also determined an X-ray irradiation end time, ¶0030.
an operation condition for elements of the medical image diagnosis apparatus to scan the subject at the scan timing, and
-Mukumoto further discloses that the scan condition includes an operation condition for elements of the medical image diagnosis apparatus to scan the subject at the scan time. The apparatus of Mukumoto contains an X-ray tube 11 which irradiates a subject with X-rays, ¶0048-0050. The scan control unit 305 controls the high-voltage generating unit to control the on and off of X-ray irradiation, ¶0048-0050, ¶0061. Specifically, the control unit controls the high-voltage generating unit 14 so as to start X-ray irradiation from the X-ray tube, ¶0048-0050, ¶0061.
the reconstruction condition includes a reconstruction timing representing a temporal condition for reconstructing medical image data of the subject that is obtained by scanning the subject.
-Mukumoto discloses the reconstruction condition includes a reconstruction timing representing a temporal condition for reconstructing medical image data of the subject. Specifically, Mukumoto defines a temporal constraint placed on the image reconstruction unit 307 for reconstructing medical image data. This reconstruction of the heart image is governed by the principle of electrocardiogram-gated reconstruction, ¶0006-0007, ¶0057-0058. The image reconstructing unit achieves this by extracting X-ray distribution data in a specific phase from the continuously collected data, based on the subject’s electrocardiographic waveform, ¶0007, ¶0029-0030, ¶0057-0058. The extraction process represents the temporal condition for reconstructing the image data. While the final image reconstruction process is after the scan termination, the reconstruction condition/parameters would be set prior to the scanning; the parameters of the reconstruction are based on operator input which occurs before scanning, ¶0059-0060.
Claim 8: Modified Mukumoto discloses all the elements above in claim 7, Mukumoto discloses, wherein the processing circuitry is configured to set the examination condition including the scan condition.
-Mukumoto teaches setting the examination condition (i.e., scanning schedule) for capturing an image of the subject by a scan, based on the biological information and the analysis information. The examination condition involves determining the X-ray irradiation start time, ¶Abstract, ¶0015-0016, ¶0035, ¶0065-0066, or the X-ray detection information collection period, ¶0097, ¶0099, ¶0104-0115. If the heartbeat determining unit determines that an interval is an abnormal heartbeat (i.e., diagnosis information) during the preparatory period, the control unit ensures the examination condition (i.e., X-ray irradiation start time or collection period) is recalculated and determined (i.e., re-set). Hence, the examination condition for capturing an image of the subject is dynamically set based on the biological information and the analysis information, ¶Abstract, ¶0015-0016, ¶0036, ¶0067; including the scan condition, ¶0035-0036, ¶0048-0050, ¶0065-0066.
Claim 9: Modified Mukumoto discloses all the elements above in claim 7, Mukumoto discloses, wherein the processing circuitry is configured to set the examination condition including the reconstruction condition.
-Mukumoto teaches setting the examination condition (i.e., scanning schedule) for capturing an image of the subject by a scan, based on the biological information and the analysis information. The examination condition involves determining the X-ray irradiation start time, ¶Abstract, ¶0015-0016, ¶0035, ¶0065-0066, or the X-ray detection information collection period, ¶0097, ¶0099, ¶0104-0115. If the heartbeat determining unit determines that an interval is an abnormal heartbeat (i.e., diagnosis information) during the preparatory period, the control unit ensures the examination condition (i.e., X-ray irradiation start time or collection period) is recalculated and determined (i.e., re-set). Hence, the examination condition for capturing an image of the subject is dynamically set based on the biological information and the analysis information, ¶Abstract, ¶0015-0016, ¶0036, ¶0067; including the reconstruction condition, ¶0057-0060.
Claim 10: Mukumoto discloses, An X-ray computed tomography apparatus, (FIG. 3) comprising:
a gantry (gantry 1) that rotationally moves an X-ray tube (X-ray tube 11); (¶0047, ‘As shown in FIG. 3, the X-ray CT apparatus according to the first embodiment includes a gantry 1 and a computer 3. The gantry 1 irradiates a subject with X-rays, and collects X-ray intensity distribution data of the X-rays passed through the subject. The computer 3 performs control processing of tomographic scanning to be performed by the gantry 1, and reconstruction processing of a tomographic image using the X-ray intensity distribution data collected by the gantry 1.’; ¶0048, ‘The gantry 1 includes an X-ray tube 11, a rotating frame 12, an X-ray detector 13, a high-voltage generating unit 14, a gantry driving unit 15, an electrocardiograph 16, a data collecting unit 17, and a patient couch 2 shown below the gantry 1 in FIG. 2.’; ¶0061, ‘The scan control unit 305 controls tomographic scanning (according to the embodiment, heart tomographic scanning) performed by the X-ray CT apparatus. Specifically, the scan control unit 305 controls movement of the patient couch 2 carried out by the bed driving unit 21 in accordance with an instruction received by the input unit 301 from an operator of the X-ray CT apparatus. Moreover, the scan control unit 305 modulates the intensity, including ON and OFF, of X-rays irradiated from the X-ray tube 11 by controlling the high-voltage generating unit 14, and drives and rotates the rotating frame 12 by controlling the gantry driving unit 15.’)
a couch (patient couch 2) having a couch top (tabletop 22) on which a subject is to be laid; (¶0053, ‘A tabletop 22 arranged on the patient couch 2 is a bed on which a subject P is to be laid, and the patient couch 2 is driven by a bed driving unit 21, and moves the tabletop 22 in the longitudinal direction of the tabletop 22 (leftward and rightward in FIG. 3). Generally, the patient couch 2 is arranged such that the longitudinal direction of the tabletop 22 along which the tabletop 22 moves is to be parallel with a slice direction (z-axis direction) in which tomographic scanning is performed, and the subject P is laid on the tabletop 22 such that the body axis of the subject P is to be placed along the z axis, and inserted into the scanning space in the gantry 1 as the tabletop 22 moves.’) and processing circuitry configured to (¶Abstract, ‘An X-ray CT apparatus detects a predetermined characteristic wave from each electrocardiographic waveform acquired from an electrocardiograph, predicts intervals with which the characteristic wave appears based on appearance times of the detected predetermined characteristic wave in each electrocardiographic waveform, and determines an X-ray irradiation start time based on the predicted interval time’; ¶0056, ‘The computer 3 includes an input unit 301, a display unit 302, a scanning-condition storage unit 303, the I/F 304, the scan control unit 305, a preprocessing unit 306, an image reconstructing unit 307, a calculating unit 308, a data storage unit 309, a characteristic-wave detecting unit 310, a heartbeat-abnormality determining unit 311, and a data-collection completion determining unit 312’)
obtain biological information about the subject acquired by a biological monitor,
-The apparatus of Mukumoto requires obtaining biological information from the subject acquired by a biological monitor.
-The biological monitor is explicitly an electrocardiograph, Claim 1, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject;’; Claim 8, ‘acquiring an electrocardiographic waveform of the subject by an electrocardiograph;’, ¶0015, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject’, ¶0054, ‘The electrocardiograph 16 is attached to the subject P, and acquires an electrocardiographic waveform of the subject P. The electrocardiographic waveform acquired by the electrocardiograph 16 is sent to the computer 3 via an interface (I/F) 304.’;
-The apparatus further acquires an electrocardiographic waveform of the subject, ¶0015, ‘an image reconstructing unit that reconstructs a tomographic image of a heart of the subject, based on X-ray detection information detected by the X-ray detecting unit and the electrocardiographic waveform of the subject acquired by the electrocardiograph; a characteristic-wave detecting unit that detects a predetermined characteristic wave from the electrocardiographic waveform acquired from the electrocardiograph; an X-ray irradiation control unit that determines an X-ray detection information collecting period during which the X-ray detection information is collected, based on an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit; an input unit that receives an instruction to start collection of the X-ray detection information; a heartbeat determining unit that performs heartbeat determination whether an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit is a normal heartbeat or an abnormal heartbeat, after a point of time at which the input unit receives the instruction to start the collection; and a control unit that controls the X-ray irradiation control unit such that the X-ray irradiation control unit recalculates and determines the X-ray detection information collecting period, when the heartbeat determining unit determines that an appearance interval is an abnormal heartbeat, during after the input unit receives the instruction to start the collection until reaching a time of starting the collection of the X-ray detection information determined by the X-ray irradiation control unit.’; see also Claim 1, 8, ¶0054.
obtain analysis information resulting from analysis of the biological information,
-The system of Mukumoto obtains analysis information resulting from analysis of the biological information, which includes measurement information (i.e., characteristics) and diagnosis information (i.e., clinical state), ¶Abstract, ¶0015, ¶0065-0066, Claim 1, Claim 8, Claim 3, Claim 10.
-The measurement information incudes characteristics derived from the electrocardiographic waveform. The system uses the R-wave as the predetermined characteristic wave, ¶0031, ‘the X-ray CT apparatus detects an R-wave as a characteristic wave in an electrocardiographic waveform, and acquires the time of the detection (for example, a time distance from the start of acquisition of the electrocardiographic waveform to the detection).’. Said system uses the R-R average interval, ¶0032, ‘calculates an R-R average interval, which is an average of R-wave intervals observed in the subject, by using appearance times of R-waves in each electrocardiographic waveform detected from the electrocardiograph attached to the subject through a first monitoring executed before the start of tomographic scanning. For example, an R-R average interval can be calculated as one second.’. In addition, the system uses an appearance interval (i.e., R-wave interval) to predict when the next characteristic wave will appear, ¶Abstract, Claim 9. In other words, the system predicts interval timing with which a characteristic wave appears based on predetermine characteristic waves, Claim 9.
-The analysis of Mukumoto further discloses diagnosis information representing a clinical state of the subject. Specifically, a heartbeat determination unit for clinical assessment of rhythm, ¶0015, ¶0065-0067. The heartbeat determining unit determines whether an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit is normal heartbeat or an abnormal heartbeat, ¶0015-0016, ¶0034, ¶0066. An abnormal heartbeat can be caused by a heartbeat abnormality such as arrhythmia caused by extrasystole or a heartbeat fluctuation, ¶0010. This determination functions as diagnosis information of the rhythm state (i.e., a clinical state) of the subject, ¶0010, ¶0066, ¶0091-0094.
set an examination condition for capturing an image of the subject by a scan, based on the biological information and the analysis information, and
-Mukumoto teaches setting the examination condition (i.e., scanning schedule) for capturing an image of the subject by a scan, based on the biological information and the analysis information. The examination condition involves determining the X-ray irradiation start time, ¶Abstract, ¶0015-0016, ¶0035, ¶0065-0066, or the X-ray detection information collection period, ¶0097, ¶0099, ¶0104-0115. If the heartbeat determining unit determines that an interval is an abnormal heartbeat (i.e., diagnosis information) during the preparatory period, the control unit ensures the examination condition (i.e., X-ray irradiation start time or collection period) is recalculated and determined (i.e., re-set). Hence, the examination condition for capturing an image of the subject is dynamically set based on the biological information and the analysis information, ¶Abstract, ¶0015-0016, ¶0036, ¶0067.
control operations of the gantry and the couch to irradiate the subject with an X-ray under the set examination condition, (¶0061, ‘The scan control unit 305 controls tomographic scanning (according to the embodiment, heart tomographic scanning) performed by the X-ray CT apparatus. Specifically, the scan control unit 305 controls movement of the patient couch 2 carried out by the bed driving unit 21 in accordance with an instruction received by the input unit 301 from an operator of the X-ray CT apparatus. Moreover, the scan control unit 305 modulates the intensity, including ON and OFF, of X-rays irradiated from the X-ray tube 11 by controlling the high-voltage generating unit 14, and drives and rotates the rotating frame 12 by controlling the gantry driving unit 15.’)
-Mukumoto discloses the scan condition includes a temporal condition for scanning the subject. The temporal condition determined is the X-ray irradiation start time, ¶Abstract, ¶0030, ¶0035-0036, ¶0065-0066. This time is calculated from the R-R average interval, ¶0035-0036. The system also determined an X-ray irradiation end time, ¶0030. Hence the control operations of the gantry and the couch to irradiate the subject with an X-ray are under the set examination conditions.
wherein
the biological monitor includes an electrocardiograph, and
-Mukumoto teaches the biological monitor is explicitly an electrocardiograph, Claim 1, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject;’; Claim 8, ‘acquiring an electrocardiographic waveform of the subject by an electrocardiograph;’, ¶0015, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject’, ¶0054, ‘The electrocardiograph 16 is attached to the subject P, and acquires an electrocardiographic waveform of the subject P. The electrocardiographic waveform acquired by the electrocardiograph 16 is sent to the computer 3 via an interface (I/F) 304.’;
the processing circuitry is configured to obtain an electrocardiogram waveform of the subject in real time as transmitted from the electrocardiograph;
-Mukumoto teaches the processing circuitry is configured to obtained electrocardiogram waveform continuously or simultaneously with the scanning process, ¶0007, ¶0015, ¶0036, ¶0042.
obtain the analysis information including diagnosis information representing a clinical state of the subject,
-The analysis of Mukumoto further discloses diagnosis information representing a clinical state of the subject. Specifically, a heartbeat determination unit for clinical assessment of rhythm, ¶0015, ¶0065-0067. The heartbeat determining unit determines whether an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit is normal heartbeat or an abnormal heartbeat, ¶0015-0016, ¶0034, ¶0066. An abnormal heartbeat can be caused by a heartbeat abnormality such as arrhythmia caused by extrasystole or a heartbeat fluctuation, ¶0010. This determination functions as diagnosis information of the rhythm (i.e., a clinical state – normal vs abnormal) of the subject, ¶0010, ¶0066, ¶0091-0094.
the diagnosis information including an electrocardiographic finding representing a finding of the electrocardiogram waveform of the subject,
-Mukumoto teaches this determination of an electrocardiographic finding representing a finding of the electrocardiogram waveform of the subject derived from the waveform. The detection of a predetermined characteristic wave, ¶Abstract, ¶0031-0034. The calculation of the interval of these waves, ¶Abstract, ¶0031-0034. And finding that an interval falls inside or outside an acceptable normal-heart beat range, ¶Abstract, ¶0031-0034. If the detected finding (i.e., R-wave interval) is outside the acceptable range, the system diagnosis the state as an abnormal heart beat and adjust the scans accordingly, ¶Abstract, ¶0031-0034.
identify an examination condition corresponding to the diagnosis information included in the obtained analysis information from the diagnosis information included in the obtained analysis information and an examination-condition database (DB) including a plurality of sets of pieces of diagnosis information and examination conditions, and set the identified examination condition as the examination condition,
-Mukumoto teaches that the system where diagnosis information, specifically determination of normal vs abnormal is derived from biological information used to retrieve specific examination conditions such as expanding the scanning phase stored in a scanning condition storage unit. Mukumoto teaches a scanning storage unit 303. This scanning storage unit 303 stores various conditions and parameters including a set phase and specific expansion conditions, ¶0060, ¶0119-0120.
-Mukumoto teaches obtaining the analysis information in the form of a heat beat determination. This determination diagnosis the current clinical state of the subject as either normal heat beat or an abnormal heart beat based on whether the detected R-wave interval falls within an acceptable range, ¶0015, ¶0101-0102, Claim 1.
-Mukumoto teaches that the processing circuitry, specifically the scan control unit 305 and calculating unit 308 identifies the appropriate condition based on the heartbeat determination (i.e., diagnosis information, ¶0067, ¶0120. If the diagnosis is normal the system sets the examination condition based on the standard “set phase” stored in the storage unit, ¶0119. If the diagnosis is abnormal the system identifies and applies the expansion condition stored in the scanning condition storage unit 303, ¶0119. Specifically, Mukumoto teaches ¶0120, “re-sets and calculates the collection period [...] by expanding the range of the set phase [...] in accordance with the expansion condition stored in the scanning-condition storage unit 303”. The system of Mukumoto then uses the heartbeat determining unit to diagnosis the subject state as normal or abnormal, ¶0015. It then accesses the scanning-condition storage unit (DB), ¶0119, to identify the corresponding condition as either the standard collection period or the expanded collection period defined by the stored expansion condition, ¶0119-0120. It then sets this identified condition, as the “X-ray detection information collecting period”, ¶0015, ¶0120.
control, based on a scan condition set. the medical image diagnosis apparatus to execute capturing an image of the subject by a scan, and
-Mukumoto teaches a scan control unit 305 part of the processing circuitry that controls the tomographic scanning performed by the apparatus, ¶0061. The apparatus of Mukumoto includes a scanning-condition storage unit 303 that stores scanning conditions received from an operator such as retrospective gating or prospective gating, and specific parameters like set phases, ¶0060-0061, ¶0084, ¶0119, ¶0131, ¶0134-0135.
control, based on a reconstruction condition set, the medical image diagnosis apparatus to perform an image generation process.
-Mukumoto describes an image reconstructing unit that performs the image generation process, ¶0058, ¶0117. The scanning condition storage unit stores reconstruction conditions, specifically determining whether to use retrospective gating or prospective gating as the gated reconstruction method, ¶0060, ¶0119. The image reconstruction unit reconstructs the tomographic image of the heart using the collected X-ray distribution data and the electrocardiogram waveform according to retrospective gating or prospective gating stored conditions, ¶0058, ¶0119.
Mukumoto fails to disclose: the electrocardiographic finding including at least one of ventricular premature contraction, atrioventricular block, short P interval, pacemaker in operation, bigeminy, or atrial fibrillation,
However, Yasushiro in the context of medical imaging processing discloses, an electrocardiographic finding includes ventricular premature contraction, ¶0154, ‘In the medical image processing device according to the embodiment of the present disclosure, the port may acquire electrocardiographic information from an electrocardiograph. The processor may acquire information of a ventricular contraction time at which ventricular contraction appears from the electrocardiographic information and may set the ventricular contraction time as a reference point of the second time component. The ventricular contraction time may be a time at which an R wave is located.’
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processing of the electrocardiographic finding of Mukumoto to include teach teachings of Yasuhiro. The motivation to do this yields predictable results such as improving reading accuracy of a heat disease, as suggested by Yashuiro ¶0108.
Claim 11: Mukumoto discloses, A medical image diagnosis system comprising:
a biological monitor including processing circuitry configured to acquire biological information about a subject, and output the biological information; and
-The apparatus of Mukumoto requires obtaining biological information from the subject acquired by a biological monitor.
-The biological monitor is explicitly an electrocardiograph, Claim 1, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject;’; Claim 8, ‘acquiring an electrocardiographic waveform of the subject by an electrocardiograph;’, ¶0015, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject’, ¶0054, ‘The electrocardiograph 16 is attached to the subject P, and acquires an electrocardiographic waveform of the subject P. The electrocardiographic waveform acquired by the electrocardiograph 16 is sent to the computer 3 via an interface (I/F) 304.’;
-The apparatus further acquires an electrocardiographic waveform of the subject, ¶0015, ‘an image reconstructing unit that reconstructs a tomographic image of a heart of the subject, based on X-ray detection information detected by the X-ray detecting unit and the electrocardiographic waveform of the subject acquired by the electrocardiograph; a characteristic-wave detecting unit that detects a predetermined characteristic wave from the electrocardiographic waveform acquired from the electrocardiograph; an X-ray irradiation control unit that determines an X-ray detection information collecting period during which the X-ray detection information is collected, based on an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit; an input unit that receives an instruction to start collection of the X-ray detection information; a heartbeat determining unit that performs heartbeat determination whether an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit is a normal heartbeat or an abnormal heartbeat, after a point of time at which the input unit receives the instruction to start the collection; and a control unit that controls the X-ray irradiation control unit such that the X-ray irradiation control unit recalculates and determines the X-ray detection information collecting period, when the heartbeat determining unit determines that an appearance interval is an abnormal heartbeat, during after the input unit receives the instruction to start the collection until reaching a time of starting the collection of the X-ray detection information determined by the X-ray irradiation control unit.’; see also Claim 1, 8, ¶0054.
a medical image diagnosis apparatus including processing circuitry configured to (¶Abstract, ‘An X-ray CT apparatus detects a predetermined characteristic wave from each electrocardiographic waveform acquired from an electrocardiograph, predicts intervals with which the characteristic wave appears based on appearance times of the detected predetermined characteristic wave in each electrocardiographic waveform, and determines an X-ray irradiation start time based on the predicted interval time’; ¶0056, ‘The computer 3 includes an input unit 301, a display unit 302, a scanning-condition storage unit 303, the I/F 304, the scan control unit 305, a preprocessing unit 306, an image reconstructing unit 307, a calculating unit 308, a data storage unit 309, a characteristic-wave detecting unit 310, a heartbeat-abnormality determining unit 311, and a data-collection completion determining unit 312’)
obtain the biological information from the biological monitor,
-The biological monitor is explicitly an electrocardiograph, Claim 1, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject;’; Claim 8, ‘acquiring an electrocardiographic waveform of the subject by an electrocardiograph;’, ¶0015, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject’, ¶0054, ‘The electrocardiograph 16 is attached to the subject P, and acquires an electrocardiographic waveform of the subject P. The electrocardiographic waveform acquired by the electrocardiograph 16 is sent to the computer 3 via an interface (I/F) 304.’;
-The apparatus further acquires an electrocardiographic waveform of the subject, ¶0015, ‘an image reconstructing unit that reconstructs a tomographic image of a heart of the subject, based on X-ray detection information detected by the X-ray detecting unit and the electrocardiographic waveform of the subject acquired by the electrocardiograph; a characteristic-wave detecting unit that detects a predetermined characteristic wave from the electrocardiographic waveform acquired from the electrocardiograph; an X-ray irradiation control unit that determines an X-ray detection information collecting period during which the X-ray detection information is collected, based on an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit; an input unit that receives an instruction to start collection of the X-ray detection information; a heartbeat determining unit that performs heartbeat determination whether an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit is a normal heartbeat or an abnormal heartbeat, after a point of time at which the input unit receives the instruction to start the collection; and a control unit that controls the X-ray irradiation control unit such that the X-ray irradiation control unit recalculates and determines the X-ray detection information collecting period, when the heartbeat determining unit determines that an appearance interval is an abnormal heartbeat, during after the input unit receives the instruction to start the collection until reaching a time of starting the collection of the X-ray detection information determined by the X-ray irradiation control unit.’; see also Claim 1, 8, ¶0054.
obtain analysis information resulting from analysis of the biological information,
-The system of Mukumoto obtains analysis information resulting from analysis of the biological information, which includes measurement information (i.e., characteristics) and diagnosis information (i.e., clinical state), ¶Abstract, ¶0015, ¶0065-0066, Claim 1, Claim 8, Claim 3, Claim 10.
-The measurement information incudes characteristics derived from the electrocardiographic waveform. The system uses the R-wave as the predetermined characteristic wave, ¶0031, ‘the X-ray CT apparatus detects an R-wave as a characteristic wave in an electrocardiographic waveform, and acquires the time of the detection (for example, a time distance from the start of acquisition of the electrocardiographic waveform to the detection).’. Said system uses the R-R average interval, ¶0032, ‘calculates an R-R average interval, which is an average of R-wave intervals observed in the subject, by using appearance times of R-waves in each electrocardiographic waveform detected from the electrocardiograph attached to the subject through a first monitoring executed before the start of tomographic scanning. For example, an R-R average interval can be calculated as one second.’. In addition, the system uses an appearance interval (i.e., R-wave interval) to predict when the next characteristic wave will appear, ¶Abstract, Claim 9. In other words, the system predicts interval timing with which a characteristic wave appears based on predetermine characteristic waves, Claim 9.
-The analysis of Mukumoto further discloses diagnosis information representing a clinical state of the subject. Specifically, a heartbeat determination unit for clinical assessment of rhythm, ¶0015, ¶0065-0067. The heartbeat determining unit determines whether an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit is normal heartbeat or an abnormal heartbeat, ¶0015-0016, ¶0034, ¶0066. An abnormal heartbeat can be caused by a heartbeat abnormality such as arrhythmia caused by extrasystole or a heartbeat fluctuation, ¶0010. This determination functions as diagnosis information of the rhythm state (i.e., a clinical state) of the subject, ¶0010, ¶0066, ¶0091-0094.
set an examination condition for capturing an image of the subject by a scan, based on the biological information and the analysis information.
-Mukumoto teaches setting the examination condition (i.e., scanning schedule) for capturing an image of the subject by a scan, based on the biological information and the analysis information. The examination condition involves determining the X-ray irradiation start time, ¶Abstract, ¶0015-0016, ¶0035, ¶0065-0066, or the X-ray detection information collection period, ¶0097, ¶0099, ¶0104-0115. If the heartbeat determining unit determines that an interval is an abnormal heartbeat (i.e., diagnosis information) during the preparatory period, the control unit ensures the examination condition (i.e., X-ray irradiation start time or collection period) is recalculated and determined (i.e., re-set). Hence, the examination condition for capturing an image of the subject is dynamically set based on the biological information and the analysis information, ¶Abstract, ¶0015-0016, ¶0036, ¶0067.
wherein the biological monitor includes an electrocardiograph, and
-Mukumoto teaches the biological monitor is explicitly an electrocardiograph, Claim 1, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject;’; Claim 8, ‘acquiring an electrocardiographic waveform of the subject by an electrocardiograph;’, ¶0015, ‘an electrocardiograph that acquires an electrocardiographic waveform of the subject’, ¶0054, ‘The electrocardiograph 16 is attached to the subject P, and acquires an electrocardiographic waveform of the subject P. The electrocardiographic waveform acquired by the electrocardiograph 16 is sent to the computer 3 via an interface (I/F) 304.’;
the processing circuitry of the medical image diagnosis is configured to obtain an electrocardiogram waveform of the subject in real time as transmitted from the electrocardiograph;
-Mukumoto teaches the processing circuitry is configured to obtained electrocardiogram waveform continuously or simultaneously with the scanning process, ¶0007, ¶0015, ¶0036, ¶0042.
obtain the analysis information including diagnosis information representing a clinical state of the subject,
-The analysis of Mukumoto further discloses diagnosis information representing a clinical state of the subject. Specifically, a heartbeat determination unit for clinical assessment of rhythm, ¶0015, ¶0065-0067. The heartbeat determining unit determines whether an appearance interval of the predetermined characteristic wave detected by the characteristic-wave detecting unit is normal heartbeat or an abnormal heartbeat, ¶0015-0016, ¶0034, ¶0066. An abnormal heartbeat can be caused by a heartbeat abnormality such as arrhythmia caused by extrasystole or a heartbeat fluctuation, ¶0010. This determination functions as diagnosis information of the rhythm (i.e., a clinical state – normal vs abnormal) of the subject, ¶0010, ¶0066, ¶0091-0094.
the diagnosis information including an electrocardiographic finding representing a finding of the electrocardiogram waveform of the subject,
-Mukumoto teaches this determination of an electrocardiographic finding representing a finding of the electrocardiogram waveform of the subject derived from the waveform. The detection of a predetermined characteristic wave, ¶Abstract, ¶0031-0034. The calculation of the interval of these waves, ¶Abstract, ¶0031-0034. And finding that an interval falls inside or outside an acceptable normal-heart beat range, ¶Abstract, ¶0031-0034. If the detected finding (i.e., R-wave interval) is outside the acceptable range, the system diagnosis the state as an abnormal heart beat and adjust the scans accordingly, ¶Abstract, ¶0031-0034.
identify an examination condition corresponding to the diagnosis information included in the obtained analysis information from the diagnosis information included in the obtained analysis information and an examination-condition database (DB) including a plurality of sets of pieces of diagnosis information and examination conditions, and set the identified examination condition as the examination condition,
-Mukumoto teaches that the system where diagnosis information, specifically determination of normal vs abnormal is derived from biological information used to retrieve specific examination conditions such as expanding the scanning phase stored in a scanning condition storage unit. Mukumoto teaches a scanning storage unit 303. This scanning storage unit 303 stores various conditions and parameters including a set phase and specific expansion conditions, ¶0060, ¶0119-0120.
-Mukumoto teaches obtaining the analysis information in the form of a heat beat determination. This determination diagnosis the current clinical state of the subject as either normal heat beat or an abnormal heart beat based on whether the detected R-wave interval falls within an acceptable range, ¶0015, ¶0101-0102, Claim 1.
-Mukumoto teaches that the processing circuitry, specifically the scan control unit 305 and calculating unit 308 identifies the appropriate condition based on the heartbeat determination (i.e., diagnosis information, ¶0067, ¶0120. If the diagnosis is normal the system sets the examination condition based on the standard “set phase” stored in the storage unit, ¶0119. If the diagnosis is abnormal the system identifies and applies the expansion condition stored in the scanning condition storage unit 303, ¶0119. Specifically, Mukumoto teaches ¶0120, “re-sets and calculates the collection period [...] by expanding the range of the set phase [...] in accordance with the expansion condition stored in the scanning-condition storage unit 303”. The system of Mukumoto then uses the heartbeat determining unit to diagnosis the subject state as normal or abnormal, ¶0015. It then accesses the scanning-condition storage unit (DB), ¶0119, to identify the corresponding condition as either the standard collection period or the expanded collection period defined by the stored expansion condition, ¶0119-0120. It then sets this identified condition, as the “X-ray detection information collecting period”, ¶0015, ¶0120.
control, based on a scan condition set. the medical image diagnosis apparatus to execute capturing an image of the subject by a scan, and
-Mukumoto teaches a scan control unit 305 part of the processing circuitry that controls the tomographic scanning performed by the apparatus, ¶0061. The apparatus of Mukumoto includes a scanning-condition storage unit 303 that stores scanning conditions received from an operator such as retrospective gating or prospective gating, and specific parameters like set phases, ¶0060-0061, ¶0084, ¶0119, ¶0131, ¶0134-0135.
control, based on a reconstruction condition set, the medical image diagnosis apparatus to perform an image generation process.
-Mukumoto describes an image reconstructing unit that performs the image generation process, ¶0058, ¶0117. The scanning condition storage unit stores reconstruction conditions, specifically determining whether to use retrospective gating or prospective gating as the gated reconstruction method, ¶0060, ¶0119. The image reconstruction unit reconstructs the tomographic image of the heart using the collected X-ray distribution data and the electrocardiogram waveform according to retrospective gating or prospective gating stored conditions, ¶0058, ¶0119.
Mukumoto fails to teach: the electrocardiographic finding including at least one of ventricular premature contraction, atrioventricular block, short PO interval, pacemaker in operation, bigeminy, or atrial fibrillation,
However, Yasushiro in the context of medical imaging processing discloses, an electrocardiographic finding includes ventricular premature contraction, ¶0154, ‘In the medical image processing device according to the embodiment of the present disclosure, the port may acquire electrocardiographic information from an electrocardiograph. The processor may acquire information of a ventricular contraction time at which ventricular contraction appears from the electrocardiographic information and may set the ventricular contraction time as a reference point of the second time component. The ventricular contraction time may be a time at which an R wave is located.’
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processing of the electrocardiographic finding of Mukumoto to include teach teachings of Yasuhiro. The motivation to do this yields predictable results such as improving reading accuracy of a heat disease, as suggested by Yashuiro ¶0108.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798