DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03 February 2026 has been entered.
Status of Claims
Claim(s) 1-14 and 16 is/are currently amended. Claim(s) 15 has/have been canceled. Claim(s) 1-14 and 16-18 is/are pending.
Objections and/or Rejections Withdrawn
Objections to the claims, rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Drawings
As discussed in the prior Office actions, color photographs and color drawings are not accepted in utility applications unless a petition filed under 3 7 CPR 1.84(a)(2) is granted.
Claim Interpretation
None of the pending claims have been interpreted to invoke 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph) in view of Applicant's amendments to the claims.
Claim Objections
Claim(s) 1, 8 and 14 objected to because of the following informalities: abbreviations, e.g., "EIT," should be defined at their first occurrence in each independent claim for clarity. For example, by amending the preambles of each of claims 1, 8 and 14 to, e.g., "[…] using electrical impedance tomography (EIT), […]."
Appropriate correction is required.
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 2, 5, 9 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 2, claim 5 and claims dependent thereon, the limitation "the blood flow change signal being expressed as a sum of pixel values within the region of interest of the restored blood flow EIT image" of claim 2 and the limitation "the blood flow change signal being expressed as a sum of pixel values in a selected region of interest in a lung region" are indefinite. Firstly, with respect to claim 2, it is unclear to which of the restored blood flow EIT image of the previously-recited time-series of restored blood flow EIT images the limitation refers. Additionally, the blood flow change signal "being expressed as a sum…" is indefinite. Specifically, it is unclear if the blood flow change signal is "extracted" by summing impedance values of the ROI pixels for each EIT image in the time-series, or if the change signal "being expressed as a sum…" requires some manipulation of the blood flow change signal for use in calculating stroke volume or lung perfusion. For the purpose of this Office action, claim 2 will be further discussed with the understanding that the blood flow change signal is extracted by summing/adding the impedance values of all ROI pixels for each blood flow EIT image in the time series.
Regarding claim 9 and claims dependent thereon, similar to claim 2 discussed above, the limitation "the air flow change signal being expressed as a sum of pixel values inside the region of interest of the restored air flow EIT image" is indefinite. It is unclear to which of the previously-recited restored air flow EIT image of the time series the limitation refers. Additionally, the air flow change signal "being expressed as a sum…" is indefinite. Specifically, it is unclear if the air flow change signal is "extracted" by summing impedance values of the ROI pixels for each air flow EIT image in the time series, or if the change signal "being expressed as a sum…" requires some manipulation of the air flow change signal for use in calculating tidal volume. For the purpose of this Office action, similar to claim 2, claim 9 will be further discussed with the understanding that the air flow change signal is extracted by summing/adding impedance values of all ROI pixels for each air flow EIT image in the time series.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/093136 A1 (previously cited, Woo) in view of "Determination of Stroke Volume by Means of Electrical Impedance Tomography" (previously cited, Vonk-Noordegraaf).
Regarding claims 1 and 7, Woo discloses and/or suggests a system for monitoring cardio-pulmonary function using electrical impedance tomography (EIT), comprising:
an electrode unit configured to measure impedance data by attaching a plurality of electrodes to at least one region with blood vessels of a chest, neck, arms, legs, or wrists of a subject (chest electrode unit 621, or unit chest electrode 621 and impedance data acquirer 623, for measuring impedance data);
an EIT reconstruction unit (EIT control unit 625 (or control module 6253, algorithm function unit 624, etc., thereof) and/or image monitoring device 630, or image processor (e.g., pg. 11) thereof; etc.) comprising at least one processor and a memory storing instructions (e.g., pg. 20) that, when executed by the at least one processor of the EIT reconstruction unit, cause the at least one processor of the EIT reconstruction unit to:
extract a blood flow impedance data component from the measured impedance data (pg. 13, EIT device 620 receives impedance data including a complex signal in which different independent signals are mixed at the chest of the subject 610 and algorithm function unit 624 separates the independent lung ventilation impedance data, lung perfusion impedance data, and blood flow of the heart and main blood vessels impedance data from the received impedance data), and
restore a blood flow EIT image from the extracted blood flow impedance data component (pg. 7, image processor 120 reconstructs a lung ventilation impedance image, a lung perfusion impedance image and a blood flow impedance image based on the lung ventilation impedance data, the lung perfusion impedance data and the blood flow impedance data, respectively);
an EIT control module (image monitoring device 630, or image processor (e.g., pg. 11) thereof) comprising at least one processor and a memory storing instructions (e.g., pg. 20) that, when executed by the at least one processor of the EIT control module, cause the at least one processor of the EIT control module to:
calculate hemodynamic diagnostic parameters based on the blood flow EIT image (pg. 7, image processor 120 may quantify change of internal perfusion of the lung over time based on the lung perfusion impedance image; image processor 120 may quantify at least one of hemodynamic changes, degrees, and shapes of the heart and blood vessels over time based on blood flow impedance images of the heart and main blood vessels; etc.); and
a display unit (image and waveform output control module 131) configured to display the blood flow EIT image, a blood flow change signal, and graphs and numerical values of hemo-dynamic diagnostic parameters over time (pg. 6, displaying one or more of the lung perfusion impedance image and the blood flow impedance image; pg. 7, displaying measurement data as an image, a waveform and a numerical value; etc.).
Woo does not expressly disclose calculating the hemodynamic diagnostic parameters includes setting a region of interest (ROI) from a time-series of the restored blood flow EIT image, extracting a blood flow change signal based on changes in pixel values inside the ROI from a time-series of the restored blood flow EIT images, and calculating hemodynamic diagnostic parameters by using the extracted blood flow change signal.
Vonk-Noordegraaf discloses/suggests a system for monitoring cardiopulmonary function using electrical impedance tomography (EIT), comprising, inter alia: an electrode unit configured to measure impedance data by attaching a plurality of electrodes to at least one region of a subject with blood vessels, such as a chest (pg. 287, measurements made using an array of 16 equidistantly spaced electrodes around the chest); and an EIT control module comprising at least one processor and a memory storing instructions (e.g., pg. 291, computer), wherein the system is utilized to set a region of interested from a time-series of blood flow EIT images (pg. 287, defining a region of interest), extract a blood flow change signal based on changes in pixel values indies the region of interest from a time-series of blood flow EIT images (pg. 287, impedance in the region was calculated and plotted as a function of time), and calculate hemodynamic diagnostic parameters, including at least stroke volume and cardiac output, using the extracted blood flow change signal (pg. 290, SVEIT equation; pg. 292, assessing stroke volume and cardiac output; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woo with the EIT control module being configured to set a region of interest from a time-series of the restored blood flow EIT image, extract a blood flow change signal based on changes in pixel values inside the region of interest from a time-series of the restored blood flow EIT image, and calculating hemodynamic diagnostic parameters, e.g., stroke volume over time, stroke volume and cardiac output, etc., by using the extracted blood flow change signal, as taught/suggested by Vonk-Noordegraaf in order to enable easily, non-invasively, and inexpensively assessing said hemodynamic diagnostic parameters at bedside (Vonk-Noordegraaf, pg. 292) in a manner that is accurate and/or reliable as interference by different bio-signals in the restored blood flow image is suppressed (Woo, pg. 4).
Regarding claim 2, Vonk-Noordegraaf (or Woo as modified thereby) discloses/suggests stroke volume is calculated from the extracted blood flow change signal, the blood flow change signal being expressed as a sum of pixel values within the region of interest of the restored blood flow EIT image (pg. 287, impedance in the region, relative to the reference, was calculated for each dynamic image and plotted as a function of time; pg. 290, from this curve, two parameters were obtained from which stroke volume was calculated, e.g., SVEIT equation).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woo in view of Vonk-Noordegraaf as applied to claim(s) 2 above, and further in view of US 2008/0294057 A1 (previously cited, Parlikar).
Regarding claims 3-4, Woo as modified discloses/suggests the limitations of claim 2, as discussed above, and discloses the hemodynamic diagnostic parameters comprise (and/or the EIT control module is configured to calculate) a cardiac output based on the calculated stroke volume (Vonk-Noordegraaf, pg. 292), but neither expressly discloses said cardiac output is calculated by multiplying a heart rate measured from the subject by the calculated stroke volume, nor discloses the hemodynamic diagnostic parameters comprise (and/or the EIT control module is configured to calculate) a peripheral vascular impedance by dividing a blood pressure measured from the subject by the calculated cardiac output.
Parlikar discloses a plurality of hemodynamic diagnostic parameters including cardiac output (CO) and a peripheral vascular impedance (total peripheral resistance, TPR), wherein cardiac output may be calculated by multiplying a heart rate measured from the subject by stroke volume, and peripheral vascular impedance may be calculated by dividing a blood pressure measured from the subject by the calculated cardiac output (¶ [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woo with the EIT module being configured to calculate cardiac output by multiplying a heart rate measured from the subject by the calculated stroke volume as disclosed/suggested by Parlikar as a simple substitution of one suitable means or method (e.g., equation) for calculating cardiac output from stroke volume for another to yield no more than predictable results. See MPEP 2143(I)(B). Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woo with the EIT module being configured to calculate a peripheral vascular impedance by dividing a blood pressure measured from the subject by the calculated cardiac output as disclosed and/or suggested by Parlikar in order to provide a more comprehensive assessment of a patient by calculating additional hemodynamic parameters thereof, e.g., calculating parameters indicative of heart performance/effectiveness (Parlikar, ¶ [0004]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woo in view of Vonk-Noordegraaf as applied to claim(s) 1 above, and further in view of "Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group" (Frerichs).
Regarding claim 5, Woo as modified discloses/suggests the limitations of claim 1, as discussed above. Woo as modified further discloses calculating lung perfusion based on a time-series of restored lung perfusion impedance images (e.g., pg. 7, quantifying change of the internal perfusion of the lung over time based on the lung perfusion impedance image), but does not expressly disclose said calculating comprises using a blood flow change signal indicative of a sum of pixel values in a selected region of interest in a lung region.
Frerichs discloses/suggests extracting a change signal indicative of a sum of pixel values in a selected region of interest for use in providing functional EIT images and/or EIT measures (pgs. 85-86; Supplement 3, pgs. 3-4, the EIT waveform in a ROI is the sum or average of the pixel waveforms for all pixels in the ROI).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woo with calculating lung perfusion by a blood flow change signal indicative of a sum of pixel values in a selected region (e.g., a lung or region thereof) in order to facilitate quantifying the change or degree of perfusion over time (Woo, pg. 7; Frerichs, pg. 85; Supplement 3; etc.).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woo in view of Vonk-Noordegraaf as applied to claim(s) 2 above, and further in view of US 2008/0009759 A1 (previously cited, Chetham).
Regarding claim 6, Woo as modified discloses/suggests the limitations of claim 2, as discussed above, but does not disclose the EIT control module is configured by the instructions to preset a scale factor according to gender, age, height, and weight of the subject and apply the preset scale factor in calculating the stroke volume.
Chetham discloses calculating a stroke volume based on a measured impedance value and preset weights according to gender, age, height, and weight of the subject (e.g., ¶ [0020] stroke volume may be determined by multiplying the maximum change in impedance during a cardiac cycle by one or more constants including constants based on the subject's physical characteristics; ¶ [0025] physical characteristics may include height, gender, weight, pulse rate, age, ethnicity, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woo with the EIT control module being configured to preset a scale factor according to gender, age, height, and weight of the subject and apply the preset scale factor in calculating the stroke volume as taught/suggested by Chetham in order to produce a more accurate/reliable stroke volume value by accounting for patient-specific factors (Chetham, ¶ [0113]).
Claim(s) 8-9, 14 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woo in view of Frerichs.
Regarding claims 8-9, Woo discloses/suggests a system for monitoring cardiopulmonary function using electrical impedance tomography (EIT), comprising:
an electrode unit configured to measure impedance data by attaching a plurality of electrodes to a chest of a subject (chest electrode unit 621, or unit chest electrode 621 and impedance data acquirer 623, for measuring impedance data) for monitoring collapse and hyperinflation of lungs during mechanical ventilation (an intended use of which the electrode unit is capable) in real-time (throughout document, e.g., pg. 2, information is extracted from the subject in real time);
an EIT reconstruction unit (EIT control unit 625 (or control module 6253, algorithm function unit 624, etc., thereof) and/or image monitoring device 630, or image processor (e.g., pg. 11) thereof; etc.) comprising at least one processor and a memory storing instructions (e.g., pg. 20) that, when executed by the at least one processor of the EIT reconstruction unit, cause the at least one processor of the EIT reconstruction unit to:
extract an air flow impedance data component from the measured impedance data (pg. 13, EIT device 620 receives impedance data including a complex signal in which different independent signals are mixed at the chest of the subject 610 and algorithm function unit 624 separates the independent lung ventilation impedance data, lung perfusion impedance data, and blood flow of the heart and main blood vessels impedance data from the received impedance data), and
restore an air flow EIT image from the extracted air flow impedance data component (pg. 7, image processor 120 reconstructs a lung ventilation impedance image, a lung perfusion impedance image and a blood flow impedance image based on the lung ventilation impedance data, the lung perfusion impedance data and the blood flow impedance data, respectively);
an EIT control module (image monitoring device 630, or image processor (e.g., pg. 11) thereof) comprising at least one processor and a memory storing instructions (e.g., pg. 20) that, when executed by the at least one processor of the EIT control module, cause the at least one processor of the EIT control module to:
calculate respiratory dynamics diagnostic parameters from a time-series of the restored air flow EIT image (pg. 7, image processor 120 may quantify at least one of change, degree and shape/pattern of ventilation inside a lung over time based on the lung ventilation impedance image); and
a display unit (image and waveform output control module 131) configured to display an image of the respiratory dynamics diagnostic parameters (pg. 7, displaying measurement data as an image, a waveform and a numerical value; etc.).
Woo neither discloses the system comprises a sensing unit configured to measure airway pressure applied to the subject during the mechanical ventilation. nor expressly discloses calculating the diagnostic parameters comprises setting a region of interest from a time-series of the restored air flow EIT image, and extracting an air flow change signal based on changes in pixel value inside the region of interest from a time-series of the restored air flow EIT image.
Frerichs discloses/suggests a method of using electrical impedance tomography (EIT), comprising, inter alia:
measuring impedance data by attaching a plurality of electrodes to a chest of a subject for monitoring collapse and hyperinflation of lungs in real-time during mechanical ventilation (pg. 84, Execution of EIT Chest Measurements, electrodes on the chest circumference; pg. 86, Monitoring of Mechanical Ventilation; Supplement 4, pg. 22, identification of hyper-distended and atelectatic lung regions; etc.);
sensing airway pressure applied to the subject during the mechanical ventilation (pg. 86, Functional EIT images, means for registering airway pressure);
extracting an air flow impedance data component from the measured impedance data and restoring an air flow EIT image from the extracted air flow impedance data component (pg. 85, EIT Waveforms and ROI, digital frequency filtering to isolate ventilation phenomena; Supplement 3, pgs. 3-4, it is necessary to isolate the different components of EIT signals; pgs. 10-11, digital filtering can be performed by filtering raw EIT data and then reconstructing images therefrom; etc.);
setting a region of interest from a time-series of the restored air flow EIT image (pg. 85, EIT Waveforms and ROI, defining a ROI in a reconstructed image);
extracting an air flow change signal based on changes in pixel value inside the region of interest from a time-series of the restored air flow EIT image (pg. 85, EIT Waveforms and ROI, pixel(s) waveform over time), wherein the air flow change signal is expressed as a sum of pixel values inside the region of interest of the restored air flow EIT image (Supplement 3, pgs. 2-3, EIT waveforms in an ROI is the sum or average of the pixel waveforms for all pixels in the ROI; etc.); and
calculating respiratory dynamics diagnostic parameters, such as tidal volume, lung compliance, etc. by using the extracted air flow change signal (pg. 86, Functional EIT Images and EIT Measures, local or regional tidal volume; regional lung opening and closing; regional respiratory system compliance; etc.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woo to comprise a sensing unit configured to measure airway pressure applied to the subject during the mechanical ventilation; and the EIT control module being configured to set a region of interest from a time-series of the restored air EIT image, extract an air flow signal based on changes in at least one pixel value inside the region of interest from a time-series of the restored air EIT image, wherein the air flow change signal is expressed as a sum of pixel values inside the region of interest of the restored air flow EIT image, and calculate respiratory dynamics diagnostic parameters, such as tidal volume, lung compliance, etc., using the extracted air flow change signal as taught/suggested by Frerichs, and the display unit being configured to display said respiratory dynamics diagnostic parameters, such as an image thereof (Woo, pg. 7), in order to provide real-time monitoring (Woo, pg. 2) of clinically useful diagnostic parameters characterizing overall ventilation and aeration (Frerichs, Supplement 5, pg. 4) and characterizing regional respiratory system mechanics (Frerichs, Supplement 5, pg. 10), tissue state (Frerichs, Supplement 4, pg. 22), etc.
Regarding claims 14 and 16-18, Woo discloses and/or suggests a method for monitoring cardiopulmonary function using electrical impedance tomography (EIT), comprising:
measuring impedance data by attaching a plurality of electrodes a body part where there is air flow due to due to respiration, such as the chest (chest electrode unit 621, or unit chest electrode 621 and impedance data acquirer 623, for measuring impedance data) for blood flow and air flow monitoring (throughout document);
extracting a blood flow impedance data component and an air flow impedance data component from the measured impedance data (pg. 13, EIT device 620 receives impedance data including a complex signal in which different independent signals are mixed at the chest of the subject 610 and algorithm function unit 624 separates the independent lung ventilation impedance data, lung perfusion impedance data, and blood flow of the heart and main blood vessels impedance data from the received impedance data);
restoring a blood flow EIT image and an air flow EIT image from the extracted blood flow impedance data component and the extracted air flow impedance data component, respectively (pg. 7, image processor 120 reconstructs a lung ventilation impedance image, a lung perfusion impedance image and a blood flow impedance image based on the lung ventilation impedance data, the lung perfusion impedance data and the blood flow impedance data, respectively);
calculating hemodynamic diagnostic parameters by using a time-series of the restored blood flow EIT image (pg. 7, image processor 120 may quantify change of internal perfusion of the lung over time based on the lung perfusion impedance image; image processor 120 may quantify at least one of hemodynamic changes, degrees, and shapes of the heart and blood vessels over time based on blood flow impedance images of the heart and main blood vessels; etc.); and
calculating respiratory dynamics diagnostic parameters by using a time-series of the restored air flow EIT image (pg. 7, image processor 120 may quantify at least one of change, degree and shape/pattern of ventilation inside a lung over time based on the lung ventilation impedance image);
displaying the blood flow EIT image, a blood flow change signal, and graphs and numerical values of hemodynamic diagnostic parameters over time (pg. 6, displaying the lung perfusion impedance image and the blood flow impedance image; pg. 7, displaying measurement data as an image, a waveform and a numerical value; etc.); and
displaying the air flow EIT image, an air flow change signal, and graphs and numerical values of respiratory dynamics diagnostic parameters over time (pg. 6, displaying the lung ventilation impedance image; pg. 7, displaying measurement data as an image, a waveform and a numerical value; etc.).
Woo does not disclose the method comprises measuring airway pressure applied to the subject during mechanical ventilation, or the respiratory dynamics diagnostic parameters are calculated by using the measured airway pressure. Additionally, Woo does not expressly disclose calculating the hemodynamic diagnostic parameters includes extracting a blood flow change signal based on changes in a pixel value inside a region of interest from a time-series of the restored blood flow EIT image, or calculating the respiratory dynamics diagnostic parameters includes extracting an air flow change signal based on changes in the pixel value inside the region of interest from a time-series of the restored air flow EIT image.
Frerichs discloses/suggests a method of using electrical impedance tomography (EIT), comprising, inter alia:
measuring impedance data by attaching a plurality of electrodes to a chest of a subject (pg. 84, Execution of EIT Chest Measurements, electrodes on the chest circumference) for blood flow monitoring (pgs. 86-89, monitoring heart activity and lung perfusion) and air flow monitoring (pgs. 86-89, monitoring mechanical ventilation, pulmonary function testing, etc.);
sensing airway pressure applied to the subject during the mechanical ventilation (pg. 86, Functional EIT images, means for registering airway pressure);
extracting a blood flow impedance component and an air flow impedance data component from the measured impedance data and restoring a blood flow EIT image and an air flow EIT image from the extracted air flow impedance data component (pg. 85, EIT Waveforms and ROI, digital frequency filtering to isolate ventilation phenomena and heart action and/or lung perfusion phenomena; Supplement 3, pgs. 3-4, it is necessary to isolate the different components of EIT signals; pgs. 10-11, digital filtering can be performed by filtering raw EIT data and then reconstructing images therefrom; etc.);
extracting a blood flow change signal based on changes in a pixel value inside a region of interest from a time-series of the restored blood flow EIT image and extracting an air flow change signal based on changes in the pixel value inside the region of interest from a time-series of the restored air flow EIT image (pg. 85, EIT Waveforms and ROI, pixel(s) waveform over time); and
calculating hemodynamic diagnostic parameters by using the extracted blood flow change signal (pg. 88, Monitoring of Heart Activity and Lung Perfusion, assessing lung perfusion by amplitude of regional EIT signal pulsatility); and
calculating respiratory dynamics diagnostic parameters by using the extracted air flow change signal and the measured airway pressure (pg. 86, Functional EIT Images and EIT Measures, combination of pixel EIT waveforms with other simultaneously registered signals like the airway pressure allows the generation of. e.g., functional images showing regional respiratory system compliance).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Woo to comprise measuring airway pressure applied to the subject during mechanical ventilation; extracting a blood flow change signal and an air flow change signal from a time-series of the restored blood flow EIT images and from a time-series of the restored air flow EIT images, respectively, and using the measured airway pressure in calculating respiratory dynamics diagnostic parameters, such as tidal volume, lung compliance, as taught/suggested by Frerichs, and displaying the extracted signals and diagnostic parameters, in order to provide real-time monitoring (Woo, pg. 2) of clinically useful diagnostic parameters characterizing regional respiratory system mechanics (Frerichs, Supplement 5, pg. 10), tissue state (Frerichs, Supplement 4, pg. 22), ventilation/perfusion distribution (Frerichs, pg. 88), etc.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woo in view of Frerichs as applied to claim(s) 9 above, and further in view of US 2010/0228143 A1 (previously cited, Teschner).
Regarding claim 10, Woo as modified discloses/suggests the limitations of claim 9, and further discloses/suggests the EIT control module is configured to calculate lung compliance, and the display unit is configured to display a lung compliance image, as discussed above, but does not expressly disclose the manner in which lung compliance is calculated. Accordingly, Woo as modified does not disclose calculating lung compliance by dividing the air flow EIT image by the measured airway pressure.
Teschner discloses/suggests a system comprising an electrode unit configured to measure impedance data by attaching a plurality of electrodes to a chest of a subject for monitoring collapse and hyperinflation of lungs in real-time during mechanical ventilation (¶ [0035] plurality of electrodes which are to be placed around the thorax of a patient for measuring voltages corresponding to various injection patterns of EIT imaging device 2; ¶ [0014]; etc.); a sensing unit configured to measure airway pressure applied to the subject during the mechanical ventilation (¶ [0064] airway pressure simultaneously recorded together with EIT data); an image restoring unit configured to restore an EIT indicative of air flow (¶ [0035] EIT image); and an EIT control module configured to set a region of interest in the EIT image, extract an air flow change signal based on change in pixel value inside a region of interest from a time-series of the EIT image and calculate respiratory diagnostic parameters based on the extracted air flow change signal (¶¶ [0037]-[0040] control and analysis unit 2 determines regions of interest (ROIs) in the EIT images, and for each interval, intratidal gas distribution is calculated for each ROI based on the local impedance change in said ROI; ¶ [0038]), wherein the EIT control module is configured to calculate an lung compliance by dividing the air flow EIT image by the measured airway pressure (e.g., ¶¶ [0064]-[0054]; and a display unit configured to display the lung compliance image (e.g., ¶ [0067] compliance vs. time diagram).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woo with the EIT control module being configured to calculate lung compliance by dividing the air flow EIT image by the measured airway pressure as disclosed/suggested by Teschner as a simple substitution of one suitable lung compliance formula/equation for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 11, Woo as modified discloses/suggests the limitations of claim 10, as discussed above, but does not disclose the EIT control module is further configured to calculate a ventilation delay image by computing a time taken to reach a volume corresponding to a portion of maximum volume from start of inspiration in the corresponding pixel, wherein the display unit is further configured to display a time-series of the ventilation delay image. However, as discussed above, Woo does disclose measurement data may be displayed as images (pg. 8), including video (pg. 2).
Frerichs discloses calculating a ventilation delay data by computing a time taken to reach a volume corresponding to a portion of maximum volume from start of inspiration in the corresponding pixel, and to display a time-series of the ventilation delay image (pg. 86, EIT Measures, ventilation delay index; Supplement 4, pgs. 20-21, pixel values are obtained by finding, for each breath, the instant where each corresponding pixel waveform reaches a threshold of its overall magnitude as defined by its end-expiratory and end-inspiratory values; Fig. E4.12 (right)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woo with the EIT control module being configured to calculate a ventilation delay by computing a time taken to reach a volume corresponding to a portion of maximum volume from start of inspiration in the corresponding pixel, as taught/suggested by Frerichs, wherein the display unit is further configured to display a time-series of a ventilation delay image, in order to provide an additional useful means/parameter by which to guide therapy (Frerichs, Supplement 4, pgs. 20-22; etc.).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woo in view of Frerichs and Teschner as applied to claim(s) 11 above, and further in view of "Clinical Implication of Monitoring Regional Ventilation using Electrical Impedance Tomography" (previously cited, Shono).
Regarding claim 12, Woo as modified discloses/suggests the limitations of claim 11, as discussed above, but does not disclose the EIT control module is further configured to determine a lung area with a reduced compliance as either a collapse area or a hyperinflation area, wherein either the collapse area or the hyperinflation area is determined by comparing the lung compliance image and ventilation delay image.
Frerichs discloses/suggests determining a lung area with a reduced compliance as either a collapse area or a hyperinflation area (pg. 87, Figure 3; Supplement 4, pg. 22-23, both ovedistended and atelectatic regions are characterized by low compliance, Crs; Supplement 5, pgs. 12-13, Overdistension/Atelectasis [%]; etc.), and further discloses regions with large ventilation delays may be considered pathological (e.g., Supplement 4, pgs. 20-22, Ventilation delay fEIT images).
Shono similarly discloses an area in which lung compliance is reduced is indicative of a collapsed or hyperinflated area of the lungs (pg. 3, Overdistension and atelectasis/collapse), and further discloses when atelectatic areas exist, there is a delay in the distribution of inspired air in the lung, which may be quantified by calculating regional ventilation delay (pg. 5, Regional ventilation delay (RVD)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woo with the EIT module being configured to determine a lung area with a reduced compliance as either a collapse area or a hyperinflation area as disclosed/suggested by Frerichs, wherein either the collapse area or the hyperinflation area is determined by comparing the lung compliance image and ventilation delay image, as disclosed and/or suggested by Shono, in order to more reliably and/or accurately identify collapsed areas by considering additional parameters affected by collapse; to facilitate distinguishing collapsed (e.g., reduced compliance and increased delay) areas from hyperinflated areas (e.g., reduced compliance with no increased delay) (Shono, pgs. 3-5); etc.
Regarding claim 13, Leonhardt as modified discloses/suggests the limitations of claim 12, as discussed above, but does not disclose the EIT control module is further configured to calculate the lung compliance image and the ventilation delay image in relation with changes in positive end-expiratory pressure (PEEP), wherein the display unit is further configured to display either the collapsed or hyperinflated area of the lungs where the lung compliance and ventilation delay images are changed in relation with changes in PEEP.
Frerichs discloses calculating at least a lung compliance image in relation to changes in PEEP, and displaying either the collapsed or hyperinflated area of the lungs by displaying the changes in lung compliance in relation to changes in PEEP (e.g., Figure 3). Further, as discussed above, Shono discloses ventilation delay data/images may further indicate at least a collapsed lung area.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Woo with the EIT control module being configured to calculate the lung compliance image and the ventilation delay image in relation with changes in PEEP and display either the collapsed or hyperinflated areas of the lungs by displaying the lung compliance image and the ventilation delay image in relation with changes in PEEP as disclosed/suggested by Frerichs in order to facilitate identifying various adverse events/lung states during mechanical ventilation, thereby guiding a user to optimal mechanical ventilation settings (Frerichs, pg. 87), that avoid atelectotrauma and overdistension (Teschner, ¶ [0014]).
Response to Arguments
Applicant's arguments with respect to Vonk-Noordegraaf and US 2015/0379706 A1 to Leonhardt failing to disclose extracting various impedance data component from measured raw impedance data prior to image reconstruction (Remarks, pgs. 5-8, 12-14, 20-21, etc.), 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. Rather, as noted in the rejections of record above, Woo is relied on for disclosure of said feature(s).
To the extent Applicant's remaining arguments are relevant to the rejection(s) of record, said arguments have been fully considered but they are not persuasive.
With respect to claims 12 and 13, Applicant contends, "[The] combination…with respect to claims 12 and 13 relies on hindsight reconstruction. The cited references are selectively mined for isolated concepts such as 'reduced compliance,' 'ventilation delay,' or 'PEEP-related changes,' without any teaching or suggestion in the prior art to integrate these concepts in the specific, coordinated manner claimed-namely, determining collapse or hyperinflation areas by combining lung compliance images and ventilation delay images, and tracking changes of such images in relation to PEEP to identify pathological lung states during mechanical ventilation" (Remarks, pgs. 17-18).
The examiner respectfully disagrees. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the Applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the present case, Frerichs expressly discloses monitoring mechanical ventilation based on EIT measures, such as regional lung compliance (pgs. 86-87; Figure 3). Frerichs further discloses identification of hyperinflation (hyper-distension) and collapse (atelectasis) as clinically useful physiological information that may be determined by jointly analyzing different types of functional EIT images/measures (Supplement 4, pg. 22). Frerichs and Shono disclose/suggest a particular combination of EIT images/measures, i.e., lung compliance and ventilation delay, that may be utilized in combination to identify hyperinflated and collapsed lung regions, to distinguish hyperinflated lung regions from collapsed lung regions, etc.
Applicant further contends, "Frerichs does not disclose nor suggest extracting a blood flow impedance data component or/and an air flow impedance data component from measured impedance data and restoring a blood flow EIT image or/and an air flow EIT image from the extracted components" (Remarks, pg. 21); and the "proposed combination would require a fundamental rearchitecting of the data processing sequence disclosed in each reference" with no cited reference providing "any teaching or suggestion that such a restructuring would be desirable or even feasible," concluding the proposed combination therefore relies on impermissible hindsight reconstruction (Remarks, pgs. 21-22).
With respect to hindsight reconstruction, as noted above, as long as any judgment on obviousness takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the Applicant's disclosure, such a reconstruction is proper. The proposed modification(s), particularly with respect to claims 8 and 14, is to utilize Frerichs' region-based extraction of change signals from a time-series of restored EIT images (i.e., EIT waveforms) in order to calculate particular diagnostic parameters from the restored blood and/or air flow EIT waveforms for the reason(s) noted in the rejection(s) of record. While Woo is relied upon in the rejection(s) of record to disclose extracting a blood flow impedance data component and/or air flow impedance data component from measured impedance data and restoring a blood flow EIT image and/or an air flow EIT image therefrom, Frerichs additionally discloses/suggests said feature(s). Specifically, the claims do not recite/require any particular method for extracting the impedance data components from the measured impedance data. Frerichs discloses "Periodic signal fluctuations are induced by ventilation or by heart action and lung perfusion (figure 2). Digital frequency filtering is often used in EIT data analysis to isolate these periodic phenomena" (pg. 85). Frerichs further discloses, "Digital filtering can be performed in two ways. The raw EIT data can be filtered, and then reconstructed, or the pixel waveforms in a sequence of raw EIT images can be filtered. The results of both of these operations are identical when the reconstruction algorithm is linear, which is the case for most of the commonly used reconstruction algorithms for chest imaging" (Supplement 3, pg. 10). Accordingly, Frerichs discloses raw impedance data can be filtered to extract individual periodic components thereof, and EIT images may be reconstructed from the extracted periodic components consistent with the pending claims. Frerichs further discloses and/or suggests EIT waveforms, ROIs, functional EIT images and/or EIT measures may then be determined from said EIT images (e.g., pg. 84, Figure 1). In view of the above, it is unclear to the examiner how the proposed modification could be considered to "require a fundamental rearchitecting of the data processing sequence disclosed in each reference" as Applicant contends.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
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/Meredith Weare/Primary Examiner, Art Unit 3791