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 .
Response to Arguments
In view of interview conducted on 15 October, 2025, the examiner agreed with argument presented by applicant and withdraws final rejection mailed out on 22 July 2025.
Upon the review of claim limitations filed on 01 October 2025 and new searches, the examiner has written final rejection in view of amendment filed on 26 June 2025 and have included new rejection below.
Claim Objections
Claim 18 is objected to because of the following informalities: Claim 18 recites “a pore” which seems to be typographical error and meant to recite a bore. Moreover, claim 18 further recites “the patient-specific model 15.” “15” seems to be typographical error. 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 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 and 15-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a bore of the imaging system” twice. It is not clear whether there are two separate bores of the imaging system (in this case, amend to first and second bore) or meant to recite a same bore (in this case, amend second “a bore” to “the” or “said” bore).
Claims 2-12 and 15-17 are rejected due to their dependency upon rejected claim 1 as set forth above.
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 following rejection has been modified in view of applicant's arguments and/or amendments.
Claim(s) 1, 3-5 and 10-14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over “Demeester et al.,” US 2010/0290683 (hereinafter Demeester) and “Winter et al.,” US 2013/0235969 (hereinafter Winter), and in view of “Weiss et al.,” WO2021/083714 (hereinafter Weiss).
Regarding to claim 1, Demeester teaches a method for determining a trigger signal for imaging with an imaging system, the method comprising the steps of:
measuring a patient-specific characteristic of a patient, wherein the patient-specific characteristic is measured when the patient is located at a first position relative to the imaging system (VSM measures physiological signal [0029]),
generating a patient-specific model based on the patient-specific characteristic (motion model based on the monitored physiological signal [0030]),
measuring a triggering waveform of the patient, wherein the triggering waveform is measured when the patient is located at a second position relative to the imaging system (continued physiological signal monitoring during the PET imaging scan for selecting appropriate acquisition interval [0031]),
determining the trigger signal based on the patient-specific model and the triggering waveform, wherein the trigger signal is configured to trigger the imaging system to acquire an image of the patient in a time-resolved manner ([0036], selecting events [0038]).
Demeester does not explicitly disclose first camera positioned outside a bore of the imaging system and second camera positioned to capture images of patient within a bore of the imaging system.
However, in the analogous field of endeavor in imaging synchronized with physiological cycle, Winter discloses monitoring patient during MRI imaging, wherein two cameras, first camera and second camera can be used to monitor the patient during procedures, specifically cameras are positioned within the system room (34 Figure 3) while MR-compatible camera is mounted inside the bore of the MRI system (41 Fig. 3) for continuous monitoring. Thus, Winter discloses patient can be located in a first position (out of the bore) and second position (within the bore) ([0188]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify vital sign monitor as taught by Demeester to incorporate teaching of Winter, since patient monitoring using a first and second camera in different positions was well known in the art as taught by Winter. One of ordinary skill in the art could have combined the elements as claimed by Demeester with no change in their respective functions, monitoring patient using two cameras in different positions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide a continuous patient monitoring during medical procedures ([0188]), and there was reasonable expectation of success.
Winter does not explicitly teach measuring a patient specific characteristics, triggering waveform using cameras.
However, in the analogous field of endeavor in physiological measurement system and method in MRI, Weiss discloses monitoring patient using camera during MRI procedures, herein the camera is used to monitor vital signs and motion, cardiac motion (page 7 lines 24- page 8 line 7) and video signals obtained by camera can be used to extract PPG signal for cardiac triggering determined based on video signal from camera (page 6 lines 13-20).
Thus, Winter can monitor patient during MRI, using the video signals from first and second cameras, to extract PPG signals, as taught by Weiss, to correct MRI images, using cardiac trigger signals (page 6 lines 1-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify cameras as taught by Winter to incorporate teaching of Weiss, as both Winter and Wiess are directed to patient monitoring during MRI, and since camera measuring PPG signals was well known in the art as taught by Weiss. One of ordinary skill in the art could have combined the elements as claimed by Demeester and Winter with no change in their respective functions, extracting PPG signals from Winter’s first and second cameras, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide a correction to MRI images, using cardiac trigger signals (page 6 lines 1-20), and there was reasonable expectation of success.
Regarding to claims 3-5 and 10-12, Demeester, Winter and Weiss together teach all limitations of claim 1 as discussed above.
Demeester further teaches following limitations:
Of claim 3, wherein the triggering waveform comprises a waveform derived from photoplethysmography (PPG) (PPG pulse signal, cine image shows waveform [0020])
Of claim 4, the patient-specific characteristic comprises a characteristic derived from PPG and wherein the measuring the patient-specific characteristic comprises a measurement with a sensor (measurement of displacement of a region of interest using PPG [0020])
Of claim 5, wherein the patient-specific model comprises a patient-specific photoplethysmography (PPG) waveform profile (cine image [0020])
Of claim 10, deriving a timing parameter from the triggering waveform and/or the patient-specific model (selecting appropriate acquisition intervals [0031] and [0038]), scanning the patient triggered by the trigger signal, wherein scanning is configured to generate imaging scan data (gating performed by selecting events and appropriate time intervals, prospective or retrospective gating [0031] and [0038]), and image formation, wherein an image of the patient is formed based on processing of the imaging scan data and the timing parameter (PET reconstruction processor to generate a PET image using motion characterization [0012], [0028])
Of claim 11, a non-transitory computer program element, which, when being executed by at least one processing unit, is adapted to cause the processing unit to perform the method ( machine executable instructions [0011])
Of claim 12, a non-transitory computer readable medium having stored thereon the program element of claim 11 ( stored on a storage medium [0011]).
Regarding to claim 13, Demeester for determining a trigger signal for imaging a patient with an imaging system, the system comprising:
a patient-specific characteristic sensor configured to measure a patient-specific characteristic of a patient when the patient is located at a first position relative to the imaging system (VSM measures physiological signal [0029]-[0030]),
a triggering waveform sensor configured to measure a triggering waveform of the patient when the patient is located at a second position relative to the imaging system (VSM [0022], continued physiological signal monitoring during the PET imaging scan for selecting appropriate acquisition interval [0031]), and
a processing unit (processor [0036]-[0037]) configured to receive the patient-specific characteristic, generate a patient-specific model based on the patient-specific characteristic, receive the triggering waveform, and determine an imaging trigger signal based on the patient- specific model and the triggering waveform (selecting a range of positions for a gated acquisition is performed selecting appropriate time intervals [0036], selecting events [0038]).
Demeester does not explicitly disclose first camera positioned outside a bore of the imaging system and second camera positioned to capture images of patient within a bore of the imaging system.
However, in the analogous field of endeavor in imaging synchronized with physiological cycle, Winter discloses monitoring patient during MRI imaging, wherein two cameras, first camera and second camera can be used to monitor the patient during procedures, specifically cameras are positioned within the system room (34 Figure 3) while MR-compatible camera is mounted inside the bore of the MRI system (41 Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify vital sign monitor as taught by Demeester to incorporate teaching of Winter, since patient monitoring using a first and second camera in different positions was well known in the art as taught by Winter. One of ordinary skill in the art could have combined the elements as claimed by Demeester with no change in their respective functions, monitoring patient using cameras in different positions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide a continuous patient monitoring during medical procedures ([0188]), and there was reasonable expectation of success.
Winter does not explicitly teach measuring a patient specific characteristics, triggering waveform using cameras.
However, in the analogous field of endeavor in physiological measurement system and method in MRI, Weiss discloses monitoring patient using camera during MRI procedures, herein the camera is used to monitor vital signs and motion, cardiac motion (page 7 lines 24- page 8 line 7) and video signals obtained by camera can be used to extract PPG signal for cardiac triggering determined based on video signal from camera (page 6 lines 13-20).
Thus, Winter can monitor patient during MRI, using the video signals from first and second cameras, to extract PPG signals, as taught by Weiss, to correct MRI images, using cardiac trigger signals (page 6 lines 1-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify cameras as taught by Winter to incorporate teaching of Weiss, as both Winter and Wiess are directed to patient monitoring during MRI, and since camera measuring PPG signals was well known in the art as taught by Weiss. One of ordinary skill in the art could have combined the elements as claimed by Demeester and Winter with no change in their respective functions, extracting PPG signals from Winter’s first and second cameras, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide a correction to MRI images, using cardiac trigger signals (page 6 lines 1-20), and there was reasonable expectation of success.
Regarding to claim 14, Demeester, Winter, and Weiss together teach all limitations of claim 13 as discussed above.
Winter teaches wherein the imaging system is a computer tomography system or magnetic resonance imaging system (CT, MRI [0011] and [0112]).
Regarding to claim 18, Demeester teaches a system for determining a trigger signal for imaging a patient with an imaging system, the system comprising:
A first PPG sensor configured to measure a patient-specific characteristic of a patient when the patient is located at a first position relative to the imaging system (PPG [0020] VSM measures physiological signal [0029]-[0030]),
A second PPG sensor configured to measure a triggering waveform of the patient when the patient is located at a second position relative to the imaging system (PPG [0020] VSM [0022], continued physiological signal monitoring during the PET imaging scan for selecting appropriate acquisition interval [0031]), and
a processing unit (processor [0036]-[0037]) configured to receive the patient-specific characteristic, generate a patient-specific model based on the patient-specific characteristic, receive the triggering waveform, and determine an imaging trigger signal based on the patient- specific model and the triggering waveform (selecting a range of positions for a gated acquisition is performed selecting appropriate time intervals [0036], selecting events [0038]).
Demeester does not explicitly disclose first camera positioned outside a bore of the imaging system and second camera positioned to capture images of patient within a bore of the imaging system.
However, in the analogous field of endeavor in imaging synchronized with physiological cycle, Winter discloses monitoring patient during MRI imaging, wherein two cameras, first camera and second camera can be used to monitor the patient during procedures, specifically cameras are positioned within the system room (34 Figure 3) while MR-compatible camera is mounted inside the bore of the MRI system (41 Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify vital sign monitor as taught by Demeester to incorporate teaching of Winter, since patient monitoring using a first and second camera in different positions was well known in the art as taught by Winter. One of ordinary skill in the art could have combined the elements as claimed by Demeester with no change in their respective functions, monitoring patient using cameras in different positions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide a continuous patient monitoring during medical procedures ([0188]), and there was reasonable expectation of success.
Winter does not explicitly teach measuring a patient specific characteristics, triggering waveform using cameras.
However, in the analogous field of endeavor in physiological measurement system and method in MRI, Weiss discloses monitoring patient using camera during MRI procedures, herein the camera is used to monitor vital signs and motion, cardiac motion (page 7 lines 24- page 8 line 7) and video signals obtained by camera can be used to extract PPG signal for cardiac triggering determined based on video signal from camera (page 6 lines 13-20).
Thus, Winter can monitor patient during MRI, using the video signals from first and second cameras, to extract PPG signals, as taught by Weiss, to correct MRI images, using cardiac trigger signals (page 6 lines 1-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify cameras as taught by Winter to incorporate teaching of Weiss, as both Winter and Wiess are directed to patient monitoring during MRI, and since camera measuring PPG signals was well known in the art as taught by Weiss. One of ordinary skill in the art could have combined the elements as claimed by Demeester and Winter with no change in their respective functions, extracting PPG signals from Winter’s first and second cameras, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide a correction to MRI images, using cardiac trigger signals (page 6 lines 1-20), and there was reasonable expectation of success.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Demeester, Winter, and Weiss as applied to claim 1 above, and further in view of “Schleyer et al.,” US 2023/0298231 (filed on 04/30/2021, whereinafter Schleyer).
Regarding to claim 2, Demeester, Winter and Weiss together teach all limitations of claim 1 as discussed above.
Winter teaches using multiple cameras positioned in and outside of the bore of MRI, but does not specifically teach wherein in the first position a patient anatomy of interest is located substantially outside of a bore of the imaging system, and wherein in the second position said patient of interest is located substantially inside the bore of the imaging system (Figure 3 shows that camera 34 is for monitoring patient.
However, in the analogous field of endeavor in monitoring patient using cameras (multiple cameras) during MRI/PET imaging procedures, Schleyer teaches using more than one camera is used to monitor ([0010] and wherein the camera is mounted in a same room, to capture patient before positioning into the bore and camera is also directed capture the patient inside the bore ([0040]-[0042]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify cameras as taught by Winter to incorporate teaching of Schleyer, as both Winter and Schleyer are directed to patient monitoring during MRI, and since capturing images of the patient prior, during or after MRI/PET acquisition signals was well known in the art as taught by Schleyer. One of ordinary skill in the art could have combined the elements as claimed by Winter with no change in their respective functions, capturing images prior and during image acquisition, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide patient images prior, during and after MRI/PET acquisition ([0042]), and there was reasonable expectation of success.
Claim(s) 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Demeester, Winter, and Weiss as applied to claims 1 and 5 above, and further in view of “Jones et al.,” US 2022/0133241 (hereinafter Jones).
Regarding to claims 6-9, Demeester, Winter, and Weiss together teach all limitations of claims 1 and 5 as discussed above.
Demeester, Winter, and Weiss do not further teach camera based PPG and details of pulse transit time, R-peak, and biomarkers including diastolic phase and a flush phase of PPG.
However, in the analogous field of endeavor in physiological model based on PPG, Jones following limitations:
Of claim 6, wherein the patient-specific model comprises a patient-specific pulse transit time (times between first and second peak [0037], time difference between a first signal feature to a second signal feature [0039])
Of claim 7, wherein the patient-specific model comprises a patient-specific reliability factor of a camera-based photoplethysmography (PPG) parameter (camera generated images, and generating PPG signals based on the image data, processing and/or assessing the quality of PPG signals [0192] and [0205])
Of claim 8, wherein determining the trigger signal comprises calculating multiple PPG markers (plurality of signal features of PPG [0031]), wherein the PPG markers are derived from the triggering waveform and/or the patient-specific PPG waveform profile, and wherein the PPG markers are configured to predict an R-peak (systolic peak [0393]).
Of claim 9, wherein the PPG markers comprise a diastolic phase PPG marker (diastolic [0393]) and a flush phase PPG marker (peak, trough, dicrotic notch [0393]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify vital sign monitor as taught by Demeester to incorporate teaching of Whitehill, since camera based PPG measurement and relevant PPG features was well known in the art as taught by Jones. One of ordinary skill in the art could have combined the elements as claimed by Demeester, Winter and Weiss with no change in their respective functions, using camera to capture image and measure PPG and analyze the PPG, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide quality PPG signal based on the camera ([0224]), and there was reasonable expectation of success.
Claims 15-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Demeester, Winter, and Weiss as applied to claims 5 and 18 above, and further in view of “Bala et al.,” US 2015/0124067 (hereinafter Bala).
Regarding to claims 15-16 and 19, Demeester, Winter and Weiss together teach all limitations of claims 5 and 18 as discussed above.
Demeester, Winter and Weiss do not further teach acquiring from a first patient area and a second patient area with the first camera substantially simultaneously.
However, in the analogous field of endeavor in PPG extraction using optical camera, Bala teaches wherein the patient specific PPG waveform profile is determined based on PPG signals substantially simultaneously acquired from a first patient area and a second patient area with the first camera and wherein the first patient area is from a face of the patient and the second patient area is from at least one of a patient’s hands (For extracting pulse transit time, two series signals generated from proximal and distal regions, wherein proximal region is face region and distal region is a front of the hand, and both regions have to be captured simultaneously [0054]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify vital sign monitor using camera as taught by Weiss to incorporate teaching of Bala, since camera based PPG measurement of two different regions at the same time was well known in the art as taught by Bala. One of ordinary skill in the art could have combined the elements as claimed by Deemster, Winter, and Weiss with no change in their respective functions, using camera to capture image and measure PPG and analyze the PPG from two separate regions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide simultaneous acquisition of physiological signals from first and second areas of the patient ([0054]), and there was reasonable expectation of success.
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Demeester, Winter, Weiss, and Bala as applied to claims 15 and 19 above, and further in view of “Velo,” US 2020/0100693 (hereinafter Velo).
Regarding to claims 17 and 20, Demeester, Winter, Weiss, and Bala together teach all limitations of claims 15 and 19 as discussed above.
Bala teaches wherein information substantially acquired from the first and second patient area is used to estimate a transit time (For extracting pulse transit time, two series signals generated from proximal and distal regions, wherein proximal region is face region and distal region is a front of the hand, and both regions have to be captured simultaneously [0054]), but does not teach transit time estimation to predict timing of an R-peak value relative to the PPG.
However, in the analogous field of endeavor in PPG signal analysis, Velo teaches that pulse transit time can be computed by determining a time from a R-wave ([0040] and [0058]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify vital sign monitor as taught by Bala to incorporate teaching of Velo, since time of R-wave determination in pulse transit time was well known in the art as taught by Velo. One of ordinary skill in the art could have combined the elements as claimed by Bala with no change in their respective functions, using camera to capture image and measure PPG and analyze the PPG to compute a timing of R-wave, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide blood pressure metric ([0058]), and there was reasonable expectation of success.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 pm.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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