Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 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 1-8, 10-12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd et al. (2005/0080336) in view of Ibanez Catala et al. (2018/0368723)(hereinafter Ibanez).
Regarding claim 1, Byrd teaches a medical image diagnostic apparatus comprising processing circuitry configured to: acquire electrocardiographic waveform data of a subject; and set one imaging condition to be applied to electrocardiogram-gated imaging of the subject among a plurality of preset imaging conditions for electrocardiogram-gated imaging on the basis of the acquired electrocardiogram waveform data. (Byrd, [0034]-[0036])
While Byrd discloses identifying a complex or intermittently occurring ECG signal for trigger generation purposes, it does not explicitly classify that signal among a set of identified patterns.
Ibanez teaches the identification and classification of irregular ECG signals. (Ibanez, throughout, see abstract and [0017]-[0018])
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the arrhythmia identification system of Ibanez in the detector system of Byrd in order to accurately identify heartbeats for accurate trigger generation and subsequent resulting improved picture clarity.
Regarding claim 2, the combination of Byrd and Ibanez further teaches the imaging condition includes waveform information serving as a reference for imaging timing in the electrocardiogram-gated imaging, imaging timing in the electrocardiogram-gated imaging, and an imaging method. (Byrd, [0034]-[0036])
Regarding claim 3, the combination of Byrd and Ibanez further teaches the plurality of imaging conditions include at least a first condition for a subject with a normal heartbeat, a second condition for a subject with an abnormal heartbeat, and a third condition for a subject with heart disease. (Ibanez, [0018], [0022], [0030], [0031])
Regarding claim 4, the combination of Byrd and Ibanez further teaches the processing circuitry is configured to: acquire electrocardiographic waveform data of the subject measured at a first timing before the electrocardiogram-gated imaging is performed; and set the one imaging condition to be applied to the electrocardiogram-gated imaging to be performed thereafter on the basis of the electrocardiographic waveform data measured at the first timing. (Byrd, [0034]-[0036])
Regarding claim 5, the combination of Byrd and Ibanez further teaches the processing circuitry is further configured to: acquire electrocardiographic waveform data of the subject measured at a second timing after the first timing before the electrocardiogram-gated imaging is performed; and change the one imaging condition on the basis of the electrocardiographic waveform data measured at the second timing. (Byrd, [0035])
Regarding claim 6, the limitation requiring the first timing is during breathing exercise, and the second timing is during a contrast agent monitoring scan is not a structural feature by which the apparatus claimed may be distinguished from the prior art of record.
Regarding claim 7, the combination of Byrd and Ibanez further teaches the processing circuitry is configured to automatically set the one imaging condition, or set the one imaging condition on the basis of an instruction from an operator. (Byrd, [0034])
Regarding claim 8, the combination of Byrd and Ibanez further teaches the medical image diagnostic apparatus is an X-ray CT apparatus (Byrd, [0005]), the plurality of imaging conditions include a plurality of modes for defining a specific period regarding X-ray radiation, and the processing circuitry is configured to: set the specific period on the basis of an R wave in the electrocardiographic waveform data in a first mode among the plurality of modes; and set the specific period on the basis of a P wave in the electrocardiographic waveform data in a second mode among the plurality of modes. (Byrd, [0034], P-waves and R-waves being common and well-known characteristics of ECG signals, [0038])
Regarding claim 10, the combination of Byrd and Ibanez further teaches the specified period is a period in which X-rays are radiated or a period in which a higher dose of X-rays is radiated than in periods other than the specified period. (Byrd, [0038])
Regarding claim 11, the combination of Byrd and Ibanez further teaches the medical image diagnostic apparatus is an X-ray CT apparatus (Byrd, [0005]), and the imaging condition includes at least an exposure phase of X-rays, an exposure method, and a trigger signal indicating a waveform serving as a reference for the exposure phase in the electrocardiogram-gated imaging. (Byrd, [0034])
Regarding claim 12, the combination of Byrd and Ibanez further teaches the plurality of imaging conditions include at least a first condition for a subject with a normal heartbeat, a second condition for a subject with an abnormal heartbeat, and a third condition for a subject with heart disease, and the trigger signal in the first condition and the trigger signal in the third condition are different from each other. (Byrd, [0034], Ibanez, throughout)
Regarding claim 14, the combination of Byrd and Ibanez further teaches the processing circuitry is further configured to cause a display to display the electrocardiographic waveform data (Byrd, [0025]) and diagnostic information measured by an apparatus different from the medical image diagnostic apparatus (id.).
Regarding claim 15, the combination of Byrd and Ibanez further teaches the processing circuitry is configured to: set an imaging condition for a subject with heart disease as an initial condition of the one imaging condition in a case where diagnostic information of the subject obtained in advance indicates that the subject has heart disease; and change the imaging condition to an imaging condition for a subject with a normal heartbeat in a case where the electrocardiographic waveform data of the subject indicates a normal heartbeat during a contrast agent monitoring scan of the subject. (Byrd, [0034]; Ibanez throughout)
Regarding claim 16, the combination of Byrd and Ibanez lacks explicit teaching of the processing circuitry is further configured to cause the display to display a notification that a change has occurred in the electrocardiographic waveform data during a contrast agent monitoring scan of the subject. However, Byrd does disclose real-time ECG trace display, which necessarily displays changes when they occur for whatever reason, including during a contrast agent monitoring scan.
Regarding claims 17 and 18, claims 17 and 18 are rejected on the same grounds as claim 1 above.
Claims 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd in view of Ibanez and Brodnick et al. (2013/0245477)
Regarding claims 9 and 13, the combination of Byrd and Ibanez lacks explicit teaching of the particular waveform features used to trigger the gating thresholds.
Brodnick teaches the various waveform features and their functions, allowing one of ordinary skill in the art to arbitrarily select characteristic features for a given ECG pattern. (Brodnick, [0114])
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the characteristic selection knowledge of Brodnick to identify useful features in the waveform catalogues of Ibanez in order to more accurately gate the timing signals for x-ray irradiation and detection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C GUNBERG whose telephone number is (571)270-3107. The examiner can normally be reached Monday-Friday, 8:30AM-5:00PM.
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/EDWIN C GUNBERG/ Primary Examiner, Art Unit 2884