DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged that application claims priority to foreign application with application number EP23179272.2 dated 6/14/2023. Copies of certified papers required by 37 CFR 1.55 have been received. Priority is acknowledged under 35 USC 119(e) and 37 CFR 1.78.
Claim Objections
Claim 28 is objected to because of the following informalities:
Claim 28, line 35, should be “according to
Claim 27 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n).
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.
Claim 20 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Regarding claim 20, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Information Disclosure Statement
The IDS dated 6/04/2024 has been considered and placed in the application file.
1st Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
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.
Claims 1, 2, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 20, 21, 22, 23, 24, 25, 26, 27, and 28 are rejected under 35 U.S.C. 103 as obvious over US Patent Publication 2014 0066749 A1, (Dickerson) in view of CN Patent 115187608 A, (Yu et al.).
Claim 1
Regarding claim 1, Dickerson teach a hybrid continuous positive pressure and surface imaging system for use in a radiotherapy system, comprising: a positive pressure unit adapted to apply a continuous positive pressure to lungs of a patient ("a CPAP machine, which is configured to provide a constant positive airway pressure," par. 24) during radiotherapy; ("during a radiation therapy, the patient may be undergoing breathing motion. In such cases, it may be desirable to monitor the breathing motion of the patient during the treatment delivery session," par. 3) and a camera system configured to continuously, or at intervals, capture body surface images of the patient; ("a device (such as a strain gauge, or a camera) for determining a breathing amplitude of the patient may be employed to determine breathing amplitudes as the patient is breathing," par. 46).
While Dickerson teaches a processing unit operating in response to positive pressure application, Dickerson does not explicitly teach all of a processing unit configured to continuously, or at intervals, model chest and/or abdominal movement of the patient, based on the body surface images.
However, Yu et al. teach a processing unit configured to continuously, or at intervals, model chest and/or abdominal movement of the patient, ("establishing body surface voxel model of chest and abdomen respiratory movement," pg. 4, par. 2), based on the body surface images ("using the calibration calibration plate to unify the RGB-D depth camera coordinates fixed at the two positions to the same coordinate system; collecting the point cloud information of the chest and abdomen surface by the RGB-D depth camera fixed at the two positions; using the statistical filtering algorithm to remove the noise point and using the ICP algorithm to register the two groups of point cloud information," pg. 4, par. 3).
Therefore, taking the teachings of Dickerson and Yu et al. as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify the CPAP controlling and breath monitoring system as taught by Dickerson to use the chest modelling techniques as taught by Yu et al. The suggestion/motivation for doing so would have been that, “The feature extraction of the effective area of the body surface can more accurately obtain body surface movement information, which is good for establishing more accurate body surface-in-vivo movement information association model, providing more accurate treatment precision for the radiation therapy robot. in the future research, combining different respiratory modalities of human body, establishing more accurate evaluation function to adapt to the condition of change of respiratory mode” as noted by the Yu et al. disclosure in pg. 5 par. 7, which also motivates combination because the combination would predictably have a greater efficiency as there is a reasonable expectation of more accurately track body surface movements to dynamically adapt to changes in a patient's respiratory modes, thereby improving overall treatment precision and monitoring reliability; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claim 2
Regarding claim 2, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson do not explicitly teach all of wherein the processing unit is configured to continuously, or at intervals, extract an amplitude metric translatable to chest and/or abdominal movement.
However, Yu et al. teach wherein the processing unit is configured to continuously, or at intervals, extract an amplitude metric translatable to chest and/or abdominal movement ("the calculation process of the motion amplitude value," pg. 5, par. 6).
Dickerson and Yu et al. are combined as per claim 1.
Claim 5
Regarding claim 5, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson do not explicitly teach all of wherein the processing unit is configured to extract a change of an amplitude of chest and/or abdominal height movement during a respiratory cycle.
However, Yu et al. teach wherein the processing unit is configured to extract a change of an amplitude of chest and/or abdominal height movement during a respiratory cycle ("Further, the calculation process of the motion amplitude value is as follows: smoothing the region dimension reduction data to obtain the motion amplitude of the region after smoothing the region reduction data," pg. 5, par. 5).
Dickerson and Yu et al. are combined as per claim 1.
Claim 6
Regarding claim 6, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson do not explicitly teach all of wherein the processing unit is configured to detect a deviation of height, shape or movement of the chest and/or abdomen of the patient.
However, Yu et al. teach wherein the processing unit is configured to detect a deviation of height, shape or movement of the chest and/or abdomen of the patient ("different areas of the patient body surface, the movement amplitude is different, the average amplitude distribution of each area point cloud the respiratory movement body model in 30 s is shown in FIG. 5, the average movement amplitude of the three different areas," pg. 8, par. 4).
Dickerson and Yu et al. are combined as per claim 1.
Claim 8
Regarding claim 8, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson teach further comprising a control unit configured to optimize the continuous positive pressure to minimize the chest and/or abdominal movement of the patient ("if the sensor value has reached certain limit (e.g., the sensed pressure value may reach a maximum limit, or the sensed flow value in the inhale direction may reach a minimum limit), then the processing unit in the breathing monitoring system 10 may determine that the patient has reached an end of inspiration. In such cases, the system 10 may reduce the airflow/pressure to allow elastic recoil of the chest for expiration," par. 68) based on the body surface images ("the processing unit 654 processes the signals from the camera to determine respiratory phases of the patient," par. 51).
Dickerson and Yu et al. are combined as per claim 1.
Claim 9
Regarding claim 9, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson do not explicitly teach all of wherein the processing unit is configured to continuously, or at intervals, model chest and/or abdominal movement of the patient in substantially real-time.
However, Yu et al. teach wherein the processing unit is configured to continuously, or at intervals, model chest and/or abdominal movement of the patient in substantially real-time ("it can realize real-time updating the body surface effective area," pg. 5, par. 7).
Dickerson and Yu et al. are combined as per claim 1.
Claim 10
Regarding claim 10, Dickerson and Yu et al. teach the hybrid continuous positive pressure and surface imaging system according to claim 1 as noted above.
Dickerson teach further comprising a control unit configured to control the continuous positive pressure to maintain the chest and/or abdominal movement within a predefined limit ("the breathing monitoring system 10 may be configured to detect an end of inspiration (or beginning of exhalation) by using a sensor (e.g., pressure sensor, flow sensor, etc.) to detect resistance to filling. For example, if the sensor value has reached certain limit (e.g., the sensed pressure value may reach a maximum limit, or the sensed flow value in the inhale direction may reach a minimum limit), then the processing unit in the breathing monitoring system 10 may determine that the patient has reached an end of inspiration," par. 68) based on the body surface images ("the processing unit 654 processes the signals from the camera to determine respiratory phases of the patient," par. 51).
Dickerson and Yu et al. are combined as per claim 1.
Claim 11
Regarding claim 11, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 10 as noted above.
Dickerson teach wherein the continuous positive pressure is gradually increased until the chest and/or abdominal movement is within the predefined limit ("if the sensor value has reached certain limit (e.g., the sensed pressure value may reach a minimum limit, or the sensed flow value in the exhale direction may reach a minimum limit), then the processing unit in the breathing monitoring system 10 may determine that the patient has reached an end of exhalation. In such cases, the system 10 may increase airflow/pressure to provide support for inspiration," par. 68).
Dickerson and Yu et al. are combined as per claim 1.
Claim 12
Regarding claim 12, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson teach wherein the positive pressure unit comprises an air pump unit and a flow tube ("a breathing device comprising an air pressure generator for generating air pressure, a tube for delivering the air pressure to a patient," par. 5).
Dickerson and Yu et al. are combined as per claim 1.
Claim 13
Regarding claim 13, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 12 as noted above.
Dickerson teach wherein the air pump unit comprises a blower ("the operation parameter may be a flow rate set in the generator 14, which may correspond with the actual flow rate experienced by the patient," par. 38).
Dickerson and Yu et al. are combined as per claim 1.
Claim 14
Regarding claim 14, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson teach further comprising a control unit configured to control the positive pressure unit based on the body surface images ("to generate a signal to trigger an imaging process to image the internal target region when the processing unit 654 determines that there is non-periodicity in the patient's 628 breathing based on signals received from the sensor," par. 54).
Dickerson and Yu et al. are combined as per claim 1.
Claim 15
Regarding claim 15, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 14 as noted above.
Dickerson teach wherein the control unit provides a signal for adjustment of the continuous positive pressure provided by the positive pressure unit ("if the sensor value has reached certain limit (e.g., the sensed pressure value may reach a minimum limit, or the sensed flow value in the exhale direction may reach a minimum limit), then the processing unit in the breathing monitoring system 10 may determine that the patient has reached an end of exhalation. In such cases, the system 10 may increase airflow/pressure to provide support for inspiration," par. 68).
Dickerson and Yu et al. are combined as per claim 1.
Claim 20
Regarding claim 20, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson teach further comprising a radiation beam generator, such as a gated radiation beam generator, adapted to generate a radiation beam for irradiating a target volume ("The system 610 also includes a radiation source 620 that projects a beam 626 of radiation towards a patient," par. 48).
Dickerson and Yu et al. are combined as per claim 1.
Claim 21
Regarding claim 21, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 20 as noted above.
Dickerson teach wherein a control unit is configured to discontinue operation of the radiation beam upon a deviation of height, shape or movement of the chest and/or abdomen of the patient with respect to an expected height, shape or movement of the chest and/or abdomen of the patient or a deviation in surface caused by the change in lung volume ("When the processing unit 654 determines that there is non-periodicity in the patient's 628 breathing, the processing unit 654 may generate a signal (e.g., a beam-stop signal) to cause the radiation source 620 to stop delivering radiation," par. 53).
Dickerson and Yu et al. are combined as per claim 1.
Claim 22
Regarding claim 22, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 20 as noted above.
Dickerson teach wherein a control unit is configured to synchronize the radiation beam with the extracted height or shape of the chest and/or abdomen of the patient ("the processing unit 654 monitors the patient's 628 breathing, and correlates feature(s) of the breathing (such as sensor signals, breathing amplitudes, breathing phases, etc.) with positions of internal target region that is being irradiated by the radiation beam," par. 52).
Dickerson and Yu et al. are combined as per claim 1.
Claim 23
Regarding claim 23, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 20 as noted above.
Dickerson teach wherein a control unit is configured to discontinue operation of the radiation beam if a mismatch occurs ("When the processing unit 654 determines that there is non-periodicity in the patient's 628 breathing, the processing unit 654 may generate a signal (e.g., a beam-stop signal) to cause the radiation source 620 to stop delivering radiation," par. 53).
Dickerson and Yu et al. are combined as per claim 1.
Claim 24
Regarding claim 24, Dickerson teach a computer-implemented method of providing real-time feedback to a positive pressure unit, the method comprising the steps of: ("The processing unit 14 may further include software running on the processor," par. 25) acquiring continuous positive pressure data ("the non-transitory medium 46 may be configured to store signals transmitted from the sensor 30, and/or data derived from the signals transmitted from the sensor 30. The non-transitory medium 46 may also store operating parameters that are used in the operation of the air pressure generator 14 in some embodiments," par. 26) from continuous positive pressure applied to lungs of a patient ("a CPAP machine, which is configured to provide a constant positive airway pressure," par. 24) during radiotherapy; ("during a radiation therapy, the patient may be undergoing breathing motion. In such cases, it may be desirable to monitor the breathing motion of the patient during the treatment delivery session," par. 3) and continuously, or at intervals, capturing body surface images of the patient using a camera system; ("a device (such as a strain gauge, or a camera) for determining a breathing amplitude of the patient may be employed to determine breathing amplitudes as the patient is breathing," par. 46).
While Dickerson teaches a processing unit operating in response to positive pressure application, Dickerson does not explicitly teach all of a processing unit configured to continuously, or at intervals, model chest and/or abdominal movement of the patient, based on the body surface images.
However, Yu et al. teach continuously, or at intervals, modelling chest and/or abdominal movement of the patient ("establishing body surface voxel model of chest and abdomen respiratory movement," pg. 4, par. 2) based on the body surface images ("using the calibration calibration plate to unify the RGB-D depth camera coordinates fixed at the two positions to the same coordinate system; collecting the point cloud information of the chest and abdomen surface by the RGB-D depth camera fixed at the two positions; using the statistical filtering algorithm to remove the noise point and using the ICP algorithm to register the two groups of point cloud information," pg. 4, par. 3).
Dickerson and Yu et al. are combined as per claim 1.
Claim 25
Regarding claim 25, Dickerson and Yu et al. teach the computer-implemented method of providing real-time feedback according to claim 24 as noted above.
Dickerson teach further comprising applying a continuous positive pressure to lungs of a patient ("a CPAP machine, which is configured to provide a constant positive airway pressure," par. 24) during radiotherapy ("during a radiation therapy, the patient may be undergoing breathing motion. In such cases, it may be desirable to monitor the breathing motion of the patient during the treatment delivery session," par. 3).
Dickerson and Yu et al. are combined as per claim 1.
Claim 26
Regarding claim 26, Dickerson and Yu et al. teach the computer-implemented method of providing real-time feedback according to claim 24 as noted above.
Dickerson teach further comprising the step of optimizing the continuous positive pressure to minimize the chest and/or abdominal movement of the patient and/or to control the continuous positive pressure to maintain the chest and/or abdominal movement within a predefined limit ("if the sensor value has reached certain limit (e.g., the sensed pressure value may reach a minimum limit, or the sensed flow value in the exhale direction may reach a minimum limit), then the processing unit in the breathing monitoring system 10 may determine that the patient has reached an end of exhalation. In such cases, the system 10 may increase airflow/pressure to provide support for inspiration," par. 68).
Dickerson and Yu et al. are combined as per claim 1.
Claim 27
Regarding claim 27, Dickerson and Yu et al. teach the computer-implemented method of providing real-time feedback according to claim 24 wherein in the method is performed using the hybrid continuous positive pressure and surface imaging system according to claim 1 as noted above.
Dickerson and Yu et al. are combined as per claim 1.
Claim 28
Regarding claim 28, Dickerson and Yu et al. teach the method of providing real-time feedback to a positive pressure unit according to claim 24 as noted above.
Dickerson teach a computer program having instructions which, when executed by a computing device or computing system, cause the computing device or computing system ("The processing unit 14 may further include software running on the processor," par. 25).
Dickerson and Yu et al. are combined as per claim 1.
2nd Claim Rejections - 35 USC § 103
Claim 3 is rejected under 35 U.S.C. 103 as obvious over US Patent Publication 2014 0066749 A1, (Dickerson) and CN Patent 115187608 A, (Yu et al.) in view of US Patent Publication 2016 0271423 A1, (Takahashi).
Claim 3
Regarding claim 3, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson do not explicitly teach all of wherein the processing unit is configured to continuously, or at intervals, extract a height of the chest wall and/or abdomen of the patient.
However, Takahashi teach wherein the processing unit is configured to continuously, or at intervals, extract a height of the chest wall and/or abdomen of the patient ("a radiation treatment apparatus may measure the height of the abdomen of the patient from the couch in real time," par. 62).
Therefore, taking the teachings of Dickerson, Yu et al., and Takahashi as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify the CPAP controlling and breath monitoring system as taught by Dickerson and the chest modelling techniques as taught by Yu et al. to use measuring the height of the abdomen as taught by Takahashi. The suggestion/motivation for doing so would have been that, “Movement of a predetermined portion of a patient may be measured more directly, for example, the control device 12 for a radiation treatment apparatus may measure the height of the abdomen of the patient from the couch in real time, and the result thereof may be used as the position-related information” as noted by the Takahashi disclosure in paragraph [0062], which also motivates combination because the combination would predictably have a higher accuracy as there is a reasonable expectation that there is a reasonable expectation that measuring the height of the abdomen in real time would yield a more precise and dynamic chest model for tracking patient respiration; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
3rd Claim Rejections - 35 USC § 103
Claims 4, 18, and 19 rejected under 35 U.S.C. 103 as obvious over US Patent Publication 2014 0066749 A1, (Dickerson) and CN Patent 115187608 A, (Yu et al.) in view of US Patent Publication 2021 0169375 A1, (Slepian).
Claim 4
Regarding claim 4, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson do not explicitly teach all of wherein the processing unit is configured to continuously, or at intervals, model chest and/or abdominal movement in six degrees of freedom (6DOF).
However, Slepian teach wherein the processing unit is configured to continuously, or at intervals, model chest and/or abdominal movement in six degrees of freedom (6DOF) ("signatures may be derived from recorded accelerations in 3 dimensions (X, Y, and Z) and angular movements (pitch, yaw, and roll) by integrating accelerations to get velocity and integrating again to get approximate chest positions," par. 34).
Therefore, taking the teachings of Dickerson, Yu et al., and Slepian as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify the CPAP controlling and breath monitoring system as taught by Dickerson and the chest modelling techniques as taught by Yu et al. to use modelling the chest movement in six degrees of freedom and stereoscopic imaging as taught by Slepian. The suggestion/motivation for doing so would have been that, “the stereo images are used to extract three dimensional models of the chest and abdomen of the subject at multiple points during the subject's breathing cycle, differences between the three-dimensional models being used to determine changes in chest and abdomen volume during the breathing cycle and to thereby determine airflow” as noted by the Slepian disclosure in paragraph [0025], which also motivates combination because the combination would predictably have a higher accuracy as there is a reasonable expectation that stereoscopic imaging from multiple angles would more precisely capture complex, non-uniform surface movements of the torso, reducing the tracking errors common in limited single-point sensors; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claim 18
Regarding claim 18, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson do not explicitly teach all of wherein the surface camera system is adapted to provide stereoscopic body surface images of the patient.
However, Slepian teach wherein the surface camera system is adapted to provide stereoscopic body surface images of the patient ("two electronic cameras 156, 158 are positioned to record stereo image pairs of chest and abdomen of subject," par. 24).
Dickerson, Yu et al., and Slepian are combined as per claim 4.
Claim 19
Regarding claim 19, Dickerson, Yu et al., and Slepian teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson do not explicitly teach all of wherein the processing unit is configured to process the stereoscopic body surface images and generate a model of the surface of the chest and/or abdomen of the patient.
However, Slepian teach wherein the processing unit is configured to process the stereoscopic body surface images and generate a model of the surface of the chest and/or abdomen of the patient ("the stereo images are used to extract three dimensional models of the chest and abdomen of the subject at multiple points during the subject's breathing cycle," par. 25).
Dickerson, Yu et al., and Slepian are combined as per claim 4.
4th Claim Rejections - 35 USC § 103
Claim 7 is rejected under 35 U.S.C. 103 as obvious over US Patent Publication 2014 0066749 A1, (Dickerson) and CN Patent 115187608 A, (Yu et al.) in view of CN Patent 116128838 A, (Fei et al.).
Claim 7
Regarding claim 7, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson do not explicitly teach all of wherein the processing unit is configured to distinguish between patient movement and chest and/or abdominal movement based on the body surface images.
However, Fei et al. teach wherein the processing unit is configured to distinguish between patient movement and chest and/or abdominal movement based on the body surface images ("The abdomen of the patient is fixed with a bellyband, the pressure difference caused by respiratory movement is measured, the pressure signal is used for representing respiratory movement," pg. 3, par. 1).
Therefore, taking the teachings of Dickerson, Yu et al., and Fei et al. as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify the CPAP controlling and breath monitoring system as taught by Dickerson and the chest modelling techniques as taught by Yu et al. to use distinguishing between patient and breath movements as taught by Fei et al. The suggestion/motivation for doing so would have been that, “The technology provides a group of three-dimensional CT Image containing each respiratory phase of the motion information, more truly reproducing the shape of chest and abdomen organs, effectively eliminating the motion artefact in the image. 4 DCT technology is combined with the radiotherapy technology, according to the motion feature of the patient target area for individual radiotherapy planning design, which is good for reducing the target area outer boundary, at the same time of improving the target area irradiation dose, reducing the toxic and side effect of the normal tissue, so as to improve the radiotherapy precision” as noted by the Fei et al. disclosure in pg. 2 par. 3, which also motivates combination because the combination would predictably have a higher efficiency as there is a reasonable expectation of achieving accurate differentiation between patient motion and breathing motion to improve treatment precision; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
5th Claim Rejections - 35 USC § 103
Claims 16 and 17 are rejected under 35 U.S.C. 103 as obvious over US Patent Publication 2014 0066749 A1, (Dickerson) and CN Patent 115187608 A, (Yu et al.) in view of US Patent Publication 2025 0058069 A1, (Euliano).
Claim 16
Regarding claim 16, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 1 as noted above.
Dickerson do not explicitly teach all of further comprising a pressure measurement unit for measuring a lung pressure.
However, Euliano teach further comprising a pressure measurement unit for measuring a lung pressure ("A hardware processor is configured to electronically access measurement data during regular ventilation operations from two or more sensors for each esophageal pressure data," par. 32).
Therefore, taking the teachings of Dickerson, Yu et al., and Euliano as a whole, it would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify the CPAP controlling and breath monitoring system as taught by Dickerson and the chest modelling techniques as taught by Yu et al. to use measuring lung pressure against the estimated lung pressure by Euliano. The suggestion/motivation for doing so would have been that, “a system to improve the ventilation of a patient is disclosed. A hardware processor is configured to electronically access measurement data during regular ventilation operations from two or more sensors for each esophageal pressure data, airway pressure data, and airway flow data from a ventilated patient. The hardware processor periodically and temporarily modifies the ventilator settings for a single or a small number of breaths to create a region of zero flow in the ventilator. Next, the hardware processor automatically compares the esophageal pressure data, which is difficult for a user to interpret, with changes to both the airway pressure data and the airflow data to determine the accuracy of the esophageal pressure data” as noted by the Euliano disclosure in paragraph [0032], which also motivates combination because the combination would predictably have a higher accuracy as there is a reasonable expectation that comparing the measured lung pressure against the estimated lung pressure would successfully validate the readings to ensure the detected lung pressure is accurate; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claim 17
Regarding claim 16, Dickerson and Yu et al. teach the respiration tracking and imaging system according to claim 16 as noted above.
Dickerson do not explicitly teach all of wherein the processing unit is configured to compare a measured lung pressure against an expected lung pressure, and wherein the processing unit is further configured to verify a mismatch between the measured lung pressure and the expected lung pressure against the continuously modelled chest and/or abdominal movement.
However, Euliano teach wherein the processing unit is configured to compare a measured lung pressure against an expected lung pressure, ("the model uses as inputs one or more of airway pressure data, flow data, from the measurement data and the model compares predicted esophageal pressure data to the measured esophageal pressure data," par. 20) and wherein the processing unit is further configured to verify a mismatch between the measured lung pressure and the expected lung pressure against the continuously modelled chest and/or abdominal movement ("the hardware processor automatically compares the esophageal pressure data, which is difficult for a user to interpret, with changes to both the airway pressure data and the airflow data to determine the accuracy of the esophageal pressure data. An automatic accuracy indicator is sent by the processor to indicate the reliability of the esophageal pressure data," par. 32).
Dickerson, Yu et al., and Euliano are combined as per claim 16.
Reference Cited
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US Patent Publication 2016 0256710 A1 to Goldstein et al. discloses a medical device to perform a procedure at a target body site and a controller that manages a CPAP machine to provide continuous positive airway pressure to the patient's lungs during the operation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARSTEN F LANTZ whose telephone number is (571) 272-4564. The examiner can normally be reached Monday-Friday 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ms. Jennifer Mehmood can be reached on 571-272-2976. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Karsten F. Lantz/Examiner, Art Unit 2664
Date: 9/10/2026
/JENNIFER MEHMOOD/Supervisory Patent Examiner, Art Unit 2664
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