DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 17 is objected to because of the following informalities: In line 9, ‘configured to be’ should be placed before ‘attached’ to set forth the electrodes relationship to the examinee. 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.
Claims 1 and 3-24 are rejected under 35 U.S.C. 103 as being unpatentable over Braun (“Noninvasive Stroke Volume Monitoring by Electrical Impedance Tomography” -previously cited) in view of Caros et al (US Pub 2013/0123617 -cited by applicant).
Re claims 1, 17: Braun discloses a method of calculating a hemodynamic variable of an examinee on the basis of Electrical Impedance Tomography (EIT), the method comprising:
obtaining, by a controller implemented in hardware of an IC, DSP, programmable logic device, FPGA, microcontroller, or microprocessor, EIT images of a chest of an examinee at a point in time in a cardiac cycle, by obtaining impedance data for the chest from electrodes attached to the chest, and restoring the EIT images from the impedance data (section 9.2.1; see the EIT images restored from impedance data of an electrode belt at discrete time points using a Datex-Ohmeda hemodynamic monitor);
recognizing, by the controller, values of a first pixel in a region corresponding to a heart in the EIT images and values of a second pixel in a region corresponding to lungs - the values of the first pixel are related to the point in time, respectively, and the values of the second pixel are related to the point in time, respectively (9.2.3, figure 3.1; see the min and max pixel values for the heart and lungs, respectively); and
calculating, by the controller, at least one hemodynamic variable on the basis of a first point in time related to a minimum value of the recognized values of the first pixel and a second point in time related to a maximum value of the recognized values of the second pixel (9.3.1, Figure 3.1; see the hemodynamic estimates in step 4).
The method is performed via a storge to store EIT images and a controller to perform the recognizing and calculating (9.2.3; see the computations which requires storage of the images and a processor to perform the calculations).
Braun discloses analyzing a pixel value at a point in time in different cardiac cycles (that are averaged together from gated images) but does not disclose that the values are related to discrete points in time in the same cardiac cycle. However, Caros teaches of a method and apparatus for measurement of PTT wherein pixel values of regions related to discrete points in time of the same cardiac cycle are analyzed [0011; see the sequence of EIT images acquired during a complete cardiac cycle]. It would have been obvious to the skilled artisan to modify Braun, to recognize the pixels at discrete points in time of the same cardiac cycle as taught by Caros, in order to obtain information on the tracking of blood within the chest to facilitate diagnosis.
Re claim 3: Braun discloses the recognizing includes designating the region corresponding to the heart in the EIT images as a first region of interest and selecting the first pixel in the first region of interest, and designating the region corresponding to the lungs in the EIT images as a second region of interest and selecting the second pixel in the second region of interest (Fig 3.1; see the first and second region of interest which is designated by the max/min values).
Re claims 4, 18: Braun discloses the first point in time is ventricular ejection time and the second point in time is pulmonary perfusion time (2.1.2, 9.3.6; see the ventricular ejection and perfusion time).
Re claims 5, 6, 19, 20: Braun discloses the calculating includes calculating pulmonary artery pressure (PAP) on the basis of the first point in time and the second point in time and includes calculating the pulmonary artery pressure on the basis of time difference between the first point in time, the second point in time, the minimum value, and the maximum value. (Fig 3.1; see the PAP estimates as the hemodynamic value which are based on the min/max pixel values from the EIT images).
Re claims 7, 8: Braun discloses the values of the second pixel show two or more peak patterns, and the calculating of pulmonary artery pressure (PAP) on the basis of the first point in time and the second point in time includes calculating the pulmonary artery pressure on the basis of the time difference between the first point in time, the second point in time, the minimum value, the maximum value, peak values of the second pixel at the other peak patterns excluding a peak pattern related to the maximum value of the two or more peak patterns, and points in time related to the peak values and the calculating of pulmonary artery pressure (PAP) on the basis of the first point in time and the second point in time includes calculating the pulmonary artery pressure on the basis of the first point in time, the second point in time, the minimum value, the maximum value, peak values of the first pixel at the other peak patterns excluding a peak pattern related to the minimum value of the two or more peak patterns, and points in time related to the peak values (9.2.3, Fig 3.1; see the peak to peak amplitude determinations from the signals which are based on min-max values at the discrete points in time).
Re claim 9: Braun discloses the calculating of PAP includes calculating the pulmonary artery pressure on the basis of the time difference between the first point in time, the second point in time, electrocardiography (ECG) of the examinee, blood pressure of the examinee, photoplethysmography (PPG) of the examinee, and seismocardiography (SCG) of the examinee (9.2.1; Fig 3.1; see the blood pressure and cardiography measurements).
Re claim 10: Braun discloses the calculating of at least one hemodynamic variable further includes calculating pulmonary vascular resistance (PVR) using the calculated pulmonary artery pressure (page 13 and 46; see the systemic vascular resistance and PVR).
Re claims 11, 21: Braun discloses the calculating of at least one hemodynamic variable includes calculating myocardial contractility on the basis of the minimum value and the first point in time (Fig 2.2; see the contractility calculation).
Re claims 12, 22: Braun discloses a method of calculating a hemodynamic variable of an examinee on the basis of EIT, the method comprising:
obtaining, by a controller implemented in hardware of an IC, DSP, programmable logic device, FPGA, microcontroller, or microprocessor, EIT images of a chest of an examinee at discrete points in time in a cardiac cycle of the examinee, by obtaining impedance data for the chest from electrodes attached to the chest, and restoring the EIT images from the impedance data (section 9.2.1; see the EIT images restored from impedance data of an electrode belt at discrete time points using a Datex-Ohmeda hemodynamic monitor);
recognizing, by the controller, a pixel value corresponding to a first point in time of pixel values in a region corresponding to a heart in EIT images obtained at discrete points in times in a first cardiac cycle of a plurality of cardiac cycles, and a pixel value corresponding a second point in time of pixel values in a region corresponding to the heart of EIT images obtained at discrete points in time in a second cardiac cycle of the plurality of cardiac cycles - the first point in time precedes than the second point in time, by time corresponding to one or more cardiac cycles between the points in time (9.2.3, figure 3.1; see the pixel values determined for the heart, respectively); and
calculating, by the controller, at least one hemodynamic variable on the basis of the pixel value corresponding to the first point in time and the pixel value corresponding to the second point in time (9.3.1, Figure 3.1; see the hemodynamic estimates in step 4).
The method is performed via a storge to store EIT images and a controller to perform the recognizing and calculating (9.2.3; see the computations which requires storage of the images and a processor to perform the calculations).
Braun discloses analyzing a pixel value at a point in time in different cardiac cycles (that are averaged together from gated images) but does not disclose that the value corresponds to discrete points in time in the first or second cardiac cycle. However, Caros teaches of a method and apparatus for measurement of PTT wherein pixel values of regions related to discrete points in time of the same cardiac cycle are analyzed [0011; see the sequence of EIT images acquired during a complete cardiac cycle]. It would have been obvious to the skilled artisan to modify Braun, to recognize the pixels at discrete points in time of the same cardiac cycle as taught by Caros, in order to obtain information on the tracking of blood within the chest to facilitate diagnosis.
Re claims 13-15, 23, 24: Braun discloses the first point in time and the second point in time are end diastole points in time, and the calculating of at least one hemodynamic variable includes calculating a variation of end-diastolic ventricular volume (EDVV) on the basis of the pixel value corresponding to the first point in time and the pixel value corresponding to the second point in time, calculating a variation of end-systolic ventricular volume (ESVV) on the basis of the pixel value corresponding to the first point in time and the pixel value corresponding to the second point in time, and further includes calculating myocardial contractility using the calculated variation of end-diastolic ventricular volume and a variation of a one-time stroke volume (SV) between cardiac cycles (Fig 2.2; see the EDV calculations including SV = EDV - ESV).
Re claim 16: Braun discloses the calculating of at least one hemodynamic variable further includes calculating ejection fraction (EF) using the calculated variation of end-systolic ventricular volume and a variation of a one-time stroke volume between cardiac cycles (2.1.2; see the ejection calculation and SV, stroke volume).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 3-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Applicant argues that Braun uses EIT images from multiple sessions (M1, M2, M3) that are averaged to one representative cardiac cycle and, therefore, the information from discrete points in time in a single cardiac cycle is not taken into account. The rejection is now modified to incorporate the Caros reference.
The prior claim objection, 112 rejections, and 101 rejection are withdrawn due to amendments.
Conclusion
THIS ACTION IS MADE FINAL. 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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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797