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
This application is a 371 of PCT/AU2022/050787 filed 07/27/2022 to which it claims domestic benefit of.
Information Disclosure Statement
The information disclosure statements (IDS) submitted were filed on 01/27/2025 and 04/16/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 6 is objected to because of the following informalities:
“over a rolling window” should be corrected to
“over the rolling window”
Claim 7 is objected to because of the following informalities:
“the percentage Doppler data percentage” should be corrected to:
“the power Doppler data percentage”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Collins (“Influence of power Doppler gain setting on Virtual Organ Computer-aided AnaLysis indices in vivo: can use of individual sub-noise gain level optimize information?”). Collins is cited in the IDS filed 01/27/2025.
Regarding claim 1, Collins teaches a method for determining a sub-noise gain level for performing a power Doppler ultrasound scan of a tissue volume of interest (Title, Objective, “…define a point, the sub-noise gain (SNG), at which maximum information is available without noise artifact”, Methods, “Five identical static 3D power Doppler volumes of the placenta were acquired using identical machine settings apart from altering the power Doppler gain setting”), the method comprising:
receiving a series of ultrasound data sets, each ultrasound data set corresponding to a same tissue volume of interest, each ultrasound data set having been acquired at a different respective power Doppler gain level (Page 76, Methods, “A static 3D power Doppler volume of the placenta was acquired… with the power Doppler gain set at -3 dB… Without moving either the participant or the probe, the power Doppler gain was quickly changed to -5 dB…-7 dB, -9 dB and the individualized ‘sub-noise- gain (SNG) setting for that participant”, “To ensure that all five volumes captured contained exactly the same anatomy, if either the probe or participant moved, the sequence of the five scans was started again”, “The data were then stored using Sonoview… and analyzed off-line on a personal computer”; five power Doppler volumes were acquired from each participant at different power Doppler gain levels and of their placenta);
for each ultrasound data set, determining a power Doppler data percentage, being a percentage of data in the ultrasound data set which corresponds to power Doppler data (Page 76, Methods, “The VOCAL histogram was viewed and the values of the vascularization index (VI)… were recorded”, wherein vascularization index (VI) is defined as a percentage of power Doppler data within a volume of interest, as evidenced by Jones (“In Vitro Dual Perfusion of Human Placental Lobules as a Flow Phantom to Investigate the Relationship between Fetoplacental Flow and Quantitative 3D Power Doppler Angiography”, Abstract), attached),
wherein the determined power Doppler data percentages form a series of power Doppler data percentages corresponding to the series of ultrasound data sets (Page 76, Methods, “This meant that for each participant the only difference in the five samples analyzed was the setting of the power Doppler gain. The VOCAL histogram was then viewed and the values of the vascularization index (VI)… were recorded”; wherein five VI values per participant were recorded at each respective power Doppler gain level sample);
applying statistical analysis to the series of power Doppler data percentages (Page 77, “The relationship between the percentage value and the absolute difference in gain value from the SNG value was explored using linear regression analysis… Statistical analysis was performed using SPSS version 16.0”, Abstract, “Vascularization index (VI)… were calculated for the same sample at five different power Doppler gain levels. The relationship between the values calculated for the VOCAL indices and the gain value was explored using linear regression analysis”),
to determine a breakpoint in the series of power Doppler data percentages which corresponds with a noise bloom (Fig. 2(a), Abstract, “There was a distinct ‘turning point’ at the SNG level with linear relationships above and blow”, Page 76, “The value of the SNG setting was set by increasing the gain until artifactual noise was present (seen as a power Doppler signal scattered throughout the whole image), then slowly reducing it to a level just below this threshold (i.e. to where the noise artifact just disappeared)”, Page 77, “While the relationships above and below the SNG point were both linear, their gradients were significantly different…Above the SNG point the slope was steeper as the noise artifact appeared”, Page 78, “From histogram analysis of volumes it appears that as the power Doppler gain is increased there is uniform lifting of the scalar color values”, “Above the SNG point a significantly different linear relationship is seen, with a steeper slope, as the image rapidly becomes disrupted by noise artifact”); and
determining a sub-noise gain level based upon a power Doppler gain level corresponding to the breakpoint (Abstract, “There was a distinct ‘turning point’ at the SNG level”) or based upon a power Doppler gain level corresponding to a point calculated from the breakpoint (Page 76, “The value of the SNG setting was set by increasing the gain until artifactual noise was present (seen as a power Doppler signal scattered throughout the whole image), then slowly reducing it to a level just below this threshold (i.e. to where the noise artifact just disappeared)”, wherein determining the SNG value by reducing gain to a level just below a threshold, i.e. breakpoint, comprises determining a sub-noise gain level based upon a power Doppler gain level corresponding to a point calculated from the breakpoint).
Regarding claim 2, Collins teaches the invention as claimed above in claim 1.
Collins further teaches wherein said determining of the sub-noise gain level comprises looking up a power Doppler gain level at which an ultrasound data set corresponding to the breakpoint as acquired (Abstract, “There was a distinct ‘turning point’ at the SNG level with linear relationships above and below”, page 77, “While the relationships above and below the SNG point were both linear, their gradients were significantly different… Above the SNG point the slope was steeper as the noise artifact appeared”; the SNG level is the turning point or breakpoint in the Doppler gain level).
Regarding claim 3, Collins teaches the invention as claimed above in claim 1.
Collins further teaches wherein said determining of the sub-noise gain level comprises determining a power Doppler gain level of a point calculated from the breakpoint (Page 76, “The value of the SNG setting was set by increasing the gain until artifactual noise was present (seen as a power Doppler signal scattered throughout the whole image), then slowly reducing it to a level just below this threshold (i.e. to where the noise artifact just disappeared)”, wherein determining the SNG value by reducing gain to a level (point) just below a threshold, i.e. breakpoint, comprises determining a sub-noise gain level by determining a power Doppler gain level of a point calculated from the breakpoint).
Regarding claim 9, Collins teaches the invention as claimed above in claim 1.
Collins further teaches wherein the statistical analysis comprises determining an inflection point in the series of power Doppler data percentages (Abstract, Page 77, Fig. 2a; Collins determines a turning point or SNG point with significantly different gradients or slopes above and below).
Regarding claim 10, Collins teaches the invention as claimed above in claim 1.
Collins further teaches wherein the statistical analysis comprises a piece-wise separation of the series of the power Doppler data percentages into two or more regression models based on a known number of segments (Fig. 2(a), Table 2, Page 77, “To test the difference in the gradients between the lines above and below the SNG we proposed a null hypothesis that the gradient of the line above was equal to the gradient of the line below…While the relationships above and below the SNG point were both linear, their gradients were significantly different (P<0.001)”, wherein Table 2 and figure 2(a) show two regression models were ran and two r2 values, one above and one below the SNG value point; piece-wise separation occurs at the SNG point, based on a known number of segments, i.e. two segments, one above and one below the SNG point).
Regarding claim 11, Collins teaches the invention as claimed above in claim 1.
Collins teaches the invention further comprising initializing an ultrasound machine by controlling the ultrasound machine to generate the series of power Doppler ultrasound data sets by performing a plurality of power Doppler ultrasound scans at different power Doppler gain levels at a same location on the tissue volume of interest (Page 76 left column, “Without moving either participant or the probe, the power Doppler gain was quickly changed…” Doppler gain set at -3 dB, -5 dB, -7 dB, -9 dB, and individualized ‘sub-noise’ gain setting, Page 76 right column, “Throughout the data acquisition the participant was asked to remain as still as possible. To ensure that all five volumes captured contained exactly the same anatomy”).
Regarding claim 12, Collins teaches the invention as claimed above in claim 1.
Collin further teaches wherein the sub-noise gain level is determined for the tissue volume of interest, and wherein the method further comprises performing a power Doppler ultrasound scan of the tissue of interest at the determined sub-noise gain level (Page 76 left column, “A static 3D power Doppler volume of the placenta was acquired…This technique was repeated for gain settings of -7 dB, -9 dB and the individualized ‘sub-noise’ gain (SNG) setting for that participant”, Page 76 right column, “The volume was captured and the SNG value was recorded”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Collins (“Influence of power Doppler gain setting on Virtual Organ Computer-aided AnaLysis indices in vivo: can use of individual sub-noise gain level optimize information?”) in view of Wang (US20120172725). Collins is cited in the IDS filed 01/27/2025.
Regarding claim 4, Collins teaches the invention as claimed above in claim 3.
However, Collins fails to teach wherein the point calculated from the breakpoint is offset by a predetermined amount.
In an analogous gain adjustment for ultrasound Doppler field of endeavor, Wang teaches such a feature. Wang teaches automatic gain optimization technology for determining an optimum gain level that incurs little to no noise while ensuring flow sensitivity ([0013-0014], [0026], [0061], [0094], [0121], [0127], [0130]) and teaches a system configured to implement methods described herein ([0133]). Wang teaches selecting an overflow gain level is used as a lower limit of optimal gain levels and a noise gain level is used as an upper limit of optimal gain levels ([0063], [0123-0124]). Wang teaches a gain level between the lower limit and upper limit is selected to perform color gain adjustment, and the gain level is selected according to a preset rule ([0063], [0125]). Wang teaches the rule is that according to a preset percentage, a suitable color gain level between the upper and lower limit of the optimal levels is selected to perform automatic gain adjustment ([0063], [0126]). Because the preset percentage is based on the upper limit comprising a noise gain level, Wang therefore teaches wherein a point (SNG gain level) is offset by a predetermined amount (a preset percentage).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Collins to have the SNG point calculated be offset by a predetermined amount as taught by Wang ([0063], [0126]). By automating it, i.e. having it be offset by a preset percentage, time may be saved compared to manual adjustment as recognized by Wang ([0014]).
Regarding claim 14, Collins teaches receiving a series of ultrasound data sets, each ultrasound data set corresponding to a same tissue volume of interest, each ultrasound data set having been acquired at a different respective power Doppler gain level (Page 76, Methods, “A static 3D power Doppler volume of the placenta was acquired… with the power Doppler gain set at -3 dB… Without moving either the participant or the probe, the power Doppler gain was quickly changed to -5 dB…-7 dB, -9 dB and the individualized ‘sub-noise- gain (SNG) setting for that participant”, “To ensure that all five volumes captured contained exactly the same anatomy, if either the probe or participant moved, the sequence of the five scans was started again”, “The data were then stored using Sonoview… and analyzed off-line on a personal computer”; five power Doppler volumes were acquired from each participant at different power Doppler gain levels and of their placenta);
for each ultrasound data set, determining a power Doppler data percentage, being a percentage of data in the ultrasound data set which corresponds to power Doppler data (Page 76, Methods, “The VOCAL histogram was viewed and the values of the vascularization index (VI)… were recorded”, wherein vascularization index (VI) is defined as a percentage of power Doppler data within a volume of interest, as evidenced by Jones (“In Vitro Dual Perfusion of Human Placental Lobules as a Flow Phantom to Investigate the Relationship between Fetoplacental Flow and Quantitative 3D Power Doppler Angiography”, Abstract), attached),
wherein the determined power Doppler data percentages form a series of power Doppler data percentages corresponding to the series of ultrasound data sets (Page 76, Methods, “This meant that for each participant the only difference in the five samples analyzed was the setting of the power Doppler gain. The VOCAL histogram was then viewed and the values of the vascularization index (VI)… were recorded”; wherein five VI values per participant were recorded at each respective power Doppler gain level sample);
applying statistical analysis to the series of power Doppler data percentages (Page 77, “The relationship between the percentage value and the absolute difference in gain value from the SNG value was explored using linear regression analysis… Statistical analysis was performed using SPSS version 16.0”, Abstract, “Vascularization index (VI)… were calculated for the same sample at five different power Doppler gain levels. The relationship between the values calculated for the VOCAL indices and the gain value was explored using linear regression analysis”),
to determine a breakpoint in the series of power Doppler data percentages which corresponds with a noise bloom (Fig. 2(a), Abstract, “There was a distinct ‘turning point’ at the SNG level with linear relationships above and blow”, Page 76, “The value of the SNG setting was set by increasing the gain until artifactual noise was present (seen as a power Doppler signal scattered throughout the whole image), then slowly reducing it to a level just below this threshold (i.e. to where the noise artifact just disappeared)”, Page 77, “While the relationships above and below the SNG point were both linear, their gradients were significantly different…Above the SNG point the slope was steeper as the noise artifact appeared”, Page 78, “From histogram analysis of volumes it appears that as the power Doppler gain is increased there is uniform lifting of the scalar color values”, “Above the SNG point a significantly different linear relationship is seen, with a steeper slope, as the image rapidly becomes disrupted by noise artifact”); and
determining a sub-noise gain level based upon a power Doppler gain level corresponding to the breakpoint (Abstract, “There was a distinct ‘turning point’ at the SNG level”) or based upon a power Doppler gain level corresponding to a point calculated from the breakpoint (Page 76, “The value of the SNG setting was set by increasing the gain until artifactual noise was present (seen as a power Doppler signal scattered throughout the whole image), then slowly reducing it to a level just below this threshold (i.e. to where the noise artifact just disappeared)”, wherein determining the SNG value by reducing gain to a level just below a threshold, i.e. breakpoint, comprises determining a sub-noise gain level based upon a power Doppler gain level corresponding to a point calculated from the breakpoint).
However, Collins fails to expressly teach a non-transitory machine readable storage medium storing instructions executable by a processor to perform the method steps above.
In an analogous gain adjustment for ultrasound Doppler field of endeavor, Wang teaches such a feature. Wang teaches a non-transitory computer-readable storage medium may be utilized to implement methods described herein ([0133]). Wang teaches automatic gain optimization technology for determining an optimum gain level that incurs little to no noise while ensuring flow sensitivity ([0013-0014], [0026], [0061], [0094], [0121], [0127], [0130]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Collins to utilize a non-transitory computer-readable storage medium to implement the methods as taught by Wang ([0013-0014], [0130], [0133]). Collins teaches wherein analysis of power Doppler gain setting is performed on a personal computer (Page 76, Methods, right column). By having the instructions to perform the method stored on a storage medium executable by a processor would predictably allow for the method to be distributed and used by multiple computers.
Regarding claim 15, Collins teaches a transducer for sending and receiving an ultrasound signal (Page 76, Methods, left column, “The scans were undertaken by a single operator (S.C.) with the participant in a semi-recumbent position using an RAB4-8-D 3D/4D curved array abdominal transducer (4—8.5- MHz) on a Voluson E8™”);
a controller for controlling the transducer to perform a power Doppler ultrasound scan (Page 76, Methods, “A static 3D power Doppler volume of the placenta was acquired using a previously saved machine configuration…”; Collins teaches controlling a transducer to perform power Doppler volume scans and therefore the system Collins uses inherently includes a controller for performing such);
determine a sub-noise gain level for performing power Doppler ultrasound on a tissue volume of interest by (Title, Objective, “…define a point, the sub-noise gain (SNG), at which maximum information is available without noise artifact”, Methods, “Five identical static 3D power Doppler volumes of the placenta were acquired using identical machine settings apart from altering the power Doppler gain setting”):
receiving a series of ultrasound data sets, each ultrasound data set corresponding to a same tissue volume of interest, each ultrasound data set having been acquired at a different respective power Doppler gain level (Page 76, Methods, “A static 3D power Doppler volume of the placenta was acquired… with the power Doppler gain set at -3 dB… Without moving either the participant or the probe, the power Doppler gain was quickly changed to -5 dB…-7 dB, -9 dB and the individualized ‘sub-noise- gain (SNG) setting for that participant”, “To ensure that all five volumes captured contained exactly the same anatomy, if either the probe or participant moved, the sequence of the five scans was started again”, “The data were then stored using Sonoview… and analyzed off-line on a personal computer”; five power Doppler volumes were acquired from each participant at different power Doppler gain levels and of their placenta);
for each ultrasound data set, determining a power Doppler data percentage, being a percentage of data in the ultrasound data set which corresponds to power Doppler data (Page 76, Methods, “The VOCAL histogram was viewed and the values of the vascularization index (VI)… were recorded”, wherein vascularization index (VI) is defined as a percentage of power Doppler data within a volume of interest, as evidenced by Jones (“In Vitro Dual Perfusion of Human Placental Lobules as a Flow Phantom to Investigate the Relationship between Fetoplacental Flow and Quantitative 3D Power Doppler Angiography”, Abstract), attached),
wherein the determined power Doppler data percentages form a series of power Doppler data percentages corresponding to the series of ultrasound data sets (Page 76, Methods, “This meant that for each participant the only difference in the five samples analyzed was the setting of the power Doppler gain. The VOCAL histogram was then viewed and the values of the vascularization index (VI)… were recorded”; wherein five VI values per participant were recorded at each respective power Doppler gain level sample);
applying statistical analysis to the series of power Doppler data percentages (Page 77, “The relationship between the percentage value and the absolute difference in gain value from the SNG value was explored using linear regression analysis… Statistical analysis was performed using SPSS version 16.0”, Abstract, “Vascularization index (VI)… were calculated for the same sample at five different power Doppler gain levels. The relationship between the values calculated for the VOCAL indices and the gain value was explored using linear regression analysis”),
to determine a breakpoint in the series of power Doppler data percentages which corresponds with a noise bloom (Fig. 2(a), Abstract, “There was a distinct ‘turning point’ at the SNG level with linear relationships above and blow”, Page 76, “The value of the SNG setting was set by increasing the gain until artifactual noise was present (seen as a power Doppler signal scattered throughout the whole image), then slowly reducing it to a level just below this threshold (i.e. to where the noise artifact just disappeared)”, Page 77, “While the relationships above and below the SNG point were both linear, their gradients were significantly different…Above the SNG point the slope was steeper as the noise artifact appeared”, Page 78, “From histogram analysis of volumes it appears that as the power Doppler gain is increased there is uniform lifting of the scalar color values”, “Above the SNG point a significantly different linear relationship is seen, with a steeper slope, as the image rapidly becomes disrupted by noise artifact”); and
determining a sub-noise gain level based upon a power Doppler gain level corresponding to the breakpoint (Abstract, “There was a distinct ‘turning point’ at the SNG level”) or based upon a power Doppler gain level corresponding to a point calculated from the breakpoint (Page 76, “The value of the SNG setting was set by increasing the gain until artifactual noise was present (seen as a power Doppler signal scattered throughout the whole image), then slowly reducing it to a level just below this threshold (i.e. to where the noise artifact just disappeared)”, wherein determining the SNG value by reducing gain to a level just below a threshold, i.e. breakpoint, comprises determining a sub-noise gain level based upon a power Doppler gain level corresponding to a point calculated from the breakpoint).
However, Collins fails to teach an ultrasound apparatus comprising: the transducer and the controller, a display for displaying ultrasound data; and a sub-noise gain module configured to determine the sub-noise gain level; wherein the sub-noise gain module is implemented by a processor.
In an analogous ultrasound imaging field of endeavor, Wang teaches such a feature. Wang teaches an ultrasound apparatus (Fig. 1) including a transducer, gain control unit, and a display configured to display ultrasound data (Fig. 1, [0012-0013]). Wang teaches wherein the gain control unit is configured to adjust color gain while suppressing background noise caused by higher gain levels ([0013]). Wang further teaches wherein the gain adjustment may be automatic, and gain level is increased or decreased to determine an optimal gain level in which noise is suppressed ([0014-0015], [0127], [0130]). Wang further teaches a logic module for calculating abnormal pixel point ratio and an adjustment module for adjusting color gain based on the abnormal pixel point ratio and a preset threshold (Fig. 4, [0018], [0027]). Wang therefore teaches an ultrasound apparatus comprising a display and a sub-noise gain module. Wang lastly teaches wherein the methods described herein may be implemented by a general purpose computer or programmable data processing apparatus, thereby teaching a processor configured to implement the sub-noise gain module (i.e. the gain control unit and/or the logic and adjustment module).
Regarding claim 16, Collins in view of Wang teaches the invention as claimed above in claim 15.
Collins further teaches wherein the sub-noise gain module is configured to determine the sub-nose gain level by determining a power Doppler gain level of a point calculated from the breakpoint (Page 76, “The value of the SNG setting was set by increasing the gain until artifactual noise was present (seen as a power Doppler signal scattered throughout the whole image), then slowly reducing it to a level just below this threshold (i.e. to where the noise artifact just disappeared)”, wherein determining the SNG value by reducing gain to a level (point) just below a threshold, i.e. breakpoint, comprises determining a sub-noise gain level by determining a power Doppler gain level of a point calculated from the breakpoint).
Regarding claim 17, Collins in view of Wang teaches the invention as claimed above in claim 15.
Collins further teaches wherein the statistical analysis comprises a piece-wise separation of the series of power Doppler data percentages into two or more regression models based on a known number of segments (Fig. 2(a), Table 2, Page 77, “To test the difference in the gradients between the lines above and below the SNG we proposed a null hypothesis that the gradient of the line above was equal to the gradient of the line below…While the relationships above and below the SNG point were both linear, their gradients were significantly different (P<0.001)”, wherein Table 2 and figure 2(a) show two regression models were ran and two r2 values, one above and one below the SNG value point; piece-wise separation occurs at the SNG point, based on a known number of segments, i.e. two segments, one above and one below the SNG point).
Regarding claim 18, Collins in view of Wang teaches the invention as claimed above in claim 14.
Collins further teaches wherein the instructions include instructions to determine the sub-noise gain level by looking up a power Doppler gain level at which an ultrasound data set corresponding to the breakpoint was acquired (Abstract, “There was a distinct ‘turning point’ at the SNG level with linear relationships above and below”, page 77, “While the relationships above and below the SNG point were both linear, their gradients were significantly different… Above the SNG point the slope was steeper as the noise artifact appeared”; the SNG level is the turning point or breakpoint in the Doppler gain level).
Regarding claim 19, Collins in view of Wang teaches the invention as claimed above in claim 14.
Collins further teaches wherein the instructions include instructions to determine the sub-noise gain level by determining a power Doppler gain level of a point calculated from the breakpoint (Page 76, “The value of the SNG setting was set by increasing the gain until artifactual noise was present (seen as a power Doppler signal scattered throughout the whole image), then slowly reducing it to a level just below this threshold (i.e. to where the noise artifact just disappeared)”, wherein determining the SNG value by reducing gain to a level (point) just below a threshold, i.e. breakpoint, comprises determining a sub-noise gain level by determining a power Doppler gain level of a point calculated from the breakpoint).
Regarding claim 20, Collins in view of Wang teaches the invention as claimed above in claim 14.
Collins further teaches wherein the statistical analysis comprises a piece-wise separation of the series of power Doppler data percentages into two or more regression models based on a known number of segments (Fig. 2(a), Table 2, Page 77, “To test the difference in the gradients between the lines above and below the SNG we proposed a null hypothesis that the gradient of the line above was equal to the gradient of the line below…While the relationships above and below the SNG point were both linear, their gradients were significantly different (P<0.001)”, wherein Table 2 and figure 2(a) show two regression models were ran and two r2 values, one above and one below the SNG value point; piece-wise separation occurs at the SNG point, based on a known number of segments, i.e. two segments, one above and one below the SNG point).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Collins (“Influence of power Doppler gain setting on Virtual Organ Computer-aided AnaLysis indices in vivo: can use of individual sub-noise gain level optimize information?”) in view of Arditi (US20060161062). Collins is cited in the IDS filed 01/27/2025.
Regarding claim 5, Collins teaches the invention as claimed above in claim 1.
However, Collins fails to teach the invention further comprising filtering the power Doppler data percentages with a rolling window.
In an analogous ultrasound imaging field of endeavor, Arditi teaches such a feature. Arditi teaches wherein signals used for analysis may be obtained via Doppler such as harmonic power Doppler ([0227]). Arditi teaches filtering experimental data by using a moving average to smooth the data before performing curve fitting ([0124]). Arditi teaches the signals may be processed through a low-pass filter or other smoothing function (i.e., moving average discussed earlier) before being adjusted by parametric fitting function ([0235]). A moving average is a rolling window.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Collins to apply a moving average filter to the experimental data before performing curve fitting as taught by Arditi ([0124], [0235]). The data may predictably be smoothened out, thereby reducing noise in the individual measurements and improve fitting, i.e. fitting a linear regression model. Collins modified by the teachings of Arditi to apply a moving average filter to experimental data would predictably result in applying the moving average filter to the power Doppler data percentages (vascularization index (VI)) which comprise experimental data.
Regarding claim 6, Collins in view of Arditi teaches the invention as claimed above in claim 5.
However, Collins fails to teach wherein said filtering of the power Doppler data percentages with the rolling window comprises averaging the power Doppler data percentages over a rolling window.
In an analogous ultrasound imaging field of endeavor, Arditi teaches such a feature. Arditi teaches wherein signals used for analysis may be obtained via Doppler such as harmonic power Doppler ([0227]). Arditi teaches filtering experimental data by using a moving average to smooth the data before performing curve fitting ([0124]). Arditi teaches the signals may be processed through a low-pass filter or other smoothing function (i.e., moving average discussed earlier) before being adjusted by parametric fitting function ([0235]). Wherein applying a moving average filter comprises averaging the values within the moving window/rolling window.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Collins to apply a moving average filter to the experimental data before performing curve fitting as taught by Arditi ([0124], [0235]). The data may predictably be smoothened out, thereby reducing noise in the individual measurements and improve fitting, i.e. fitting a linear regression model. Collins modified by the teachings of Arditi to apply a moving average filter to experimental data would predictably result in averaging the power Doppler data percentages (vascularization index (VI)) over the moving window/rolling window.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Collins (“Influence of power Doppler gain setting on Virtual Organ Computer-aided AnaLysis indices in vivo: can use of individual sub-noise gain level optimize information?”) in view of Thirsk (US5471990). Collins is cited in the IDS filed 01/27/2025.
Regarding claim 7, Collins teaches the invention as claimed above in claim 1.
However, Collins fails to teach wherein each ultrasound data set includes an ultrasound image comprising an ultrasound cone portion, and the percentage Doppler data percentage for each ultrasound data set is determined by segmenting pixels in the ultrasound cone portion of the image which have power Doppler data values.
In an analogous power Doppler field of endeavor, Thirsk teaches such a feature. Thirsk teaches displaying color power Doppler images in a sector format (60) (Fig. 2, Column 3 lines 13-22). Thirsk therefore teaches acquiring ultrasound data comprising an ultrasound cone portion (ultrasound images in sector format, i.e. figure 2). Thirsk teaches calculating a power index of a vascular network (72) (Fig. 5, Column 5 lines 1-32). Thirsk teaches pixels with a color below an adjustable threshold level “min” has a Doppler power value of zero (Column 4 lines 19-23). Thirsk teaches summing the Doppler power values for all image pixels within the box (86) encompassing the network (72) that exceed the “min” threshold (Fig. 5, Column 5 lines 1-32); Thirsk thereby teaches identifying, e.g. segmenting via thresholding, pixels in cone portion (sector image) which have power Doppler data values. Thirsk teaches wherein the power index is calculated by summing the Doppler power values for all image pixels within the box that exceed the “min” threshold level (i.e. all pixels which have a Doppler value) and dividing the summation by the active area of the pixels multiplied by the number of pixels (Fig. 5, Column 5 lines 1-32). Thirsk therefore teaches wherein a Doppler data percentage (power index) is determined by segmenting (via thresholding) pixels which have power Doppler data values.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Collins to identify or segment pixels within an ultrasound sector image or cone image as taught by Thirsk (Fig. 5, Column 5 lines 1-32). The doppler Power index may provide clinicians with a quantified measure of blood perfusion in the body as recognized by Thirsk (Column 1 line 60 – Column 2 line 5). Substituting Collins’ method with Thirsk’s method of pixel identification amounts to use of a known technique to obtain a known quantity, yielding predictably results of a Doppler power index.
Regarding claim 8, Collins in view of Thirsk teaches the invention as claimed above in claim 7.
However, Collins fails to teach wherein the ultrasound image further includes a power Doppler colour bar portion, wherein the segmented pixels have colour values which are also found in any of the pixels in the power Doppler colour bar portion.
In an analogous power Doppler field of endeavor, Thirsk teaches such a feature. Thirsk teaches displaying color power Doppler images in a sector format (60) (Fig. 2, Column 3 lines 13-22). Thirsk therefore teaches acquiring ultrasound data comprising an ultrasound cone portion (ultrasound images in sector format, i.e. figure 2). Thirsk teaches calculating a power index of a vascular network (72) (Fig. 5, Column 5 lines 1-32). Thirsk teaches wherein the power index is calculated by summing the Doppler power values for all image pixels within the box that exceed the “min” threshold level (i.e. all pixels which have a Doppler value) and dividing the summation by the active area of the pixels multiplied by the number of pixels (Fig. 5, Column 5 lines 1-32). Thirsk teaches wherein colors used to depict the intensities of the Doppler signals are based on a color bar (64) shown to the left of the image sector (60) (Fig. 2, Column 3 lines 13-34). Thirsk teaches a subsystem (50) calibrates the color power Doppler display colors by utilizing the colors of the color bar (64) (i.e. the color Doppler pixels have colour values which correspond to the pixels of the power Doppler colour bar portion) (Figs. 2-3, Column 3 lines 35-42). Thirsk teaches the color bar is examined and the range of colors between min and max are divided into discrete color values that are assigned a corresponding or proportional power Doppler value (Column 3 lines 50-61, Column 4 lines 34-59). Thirsk therefore teaches assigning a color to a doppler Power value, wherein the color is based on pixels of a color bar.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Collins to color the pixels having Doppler values according to a color bar as taught by Thirsk (Figs. 2-3, Column 3 lines 13-61). The color and color bar may predictably provide visual indication to a user of the intensity of the power Doppler signal, indicating the amount of moving red blood cells.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Collins (“Influence of power Doppler gain setting on Virtual Organ Computer-aided AnaLysis indices in vivo: can use of individual sub-noise gain level optimize information?”) in view of Kim (US20160120508) and Dubberstein (US20050107701). Collins is cited in the IDS filed 01/27/2025.
Regarding claim 13, Collins teaches the invention as claimed above in claim 1.
However, Collins fails to teach wherein the tissue volume of interest is divided into a plurality of sub-volumes of interest based on depth, wherein each sub-volume of interest corresponds to a different depth.
In an analogous ultrasound imaging field of endeavor, Kim teaches such a feature. Kim teaches dividing an ultrasound image into a plurality of different depth regions, each region having a predetermined depth (Fig. 29A, [0097], [0202], [0236]). Moreover, Kim teaches adjusting a gain of the reflected echo for each depth region ([0086], [0097], [0100], [0232]). Kim therefore teaches at least dividing a region of interest into a plurality of sub-regions of interest based on depth, wherein each sub-region of interest correspond to a different depth. Collins teaches wherein a volume is acquired and thus Collins modified by the teachings of Kim results in division of the volume into sub-volumes of different depths.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Collins to divide the volume into a plurality of sub-volumes of different depths as taught by Kim (Fig. 29A, [0086], [0097], [0100], [0202], [0232], [0236]). Gain may be set at each different depth, thereby alleviating or compensating for depth based attenuation as recognized by Kim ([0086]). Collins teaches wherein the acquired ultrasound scan is a volume and thus Collins modified by the teachings of Kim predictably results in division of the volume into sub-volumes of different depths.
However, the combination noted above fails to teach wherein the method comprises determining a sub-noise gain level for each sub-volume of interest.
In an analogous power Doppler field of endeavor, Dubberstein teaches such a feature. Dubberstein teaches color power Doppler imaging (Claim 1, [0005-0006], [0015-0016]). Dubberstein teaches increasing gain may correspondingly increase noise in a displayed region, consequently causing a need for an ultrasound system to adjust gain level and equalize gain level as a function of depth ([0012]). Dubberstein teaches adjusting the gain to bring the gain to within a few decibels of a noise floor ([0017-0018], [0037-0038]). Dubberstein teaches after the gain has been adjusted to be within a predetermined range of the noise floor, equalizing the gain as a function of depth (Claim 10, [0018], [0042]). Dubberstein therefore teaches determining a sub-noise gain level as a function of depth.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Collins to determine a sub-noise gain level as a function of depth as taught by Dubberstein (Claim 10, [0017-0018], [0037-0038], [0042]). Gain may be used to compensate for depth attenuation, but increasing gain may also increase noise as recognized by Dubberstein ([0011-0012]). Therefore, by determining a sub-noise gain level as a function of depth, noise may be predictably minimized while maximizing signal per depth. Since Collins in view of Kim teaches dividing the volume into a plurality of sub-volumes of different depths, Collins in view of Kim modified further by the teachings of Dubberstein to determine a sub-noise gain level and to equalize it across depths would predictably result in determining a sub-noise gain level for each sub-volume of interest.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
Prosecution Insights