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
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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 1-5, 7, 10-14, 16-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Poland (US 20230301631) and further in view of Neban (US 20230148995).
Regarding claims 1 and 16, Poland discloses an ultrasound imaging system (Abstract – “The present disclosure describes an ultrasound imaging system”) comprising: [claim 1]
a method ([0003] – “Provided herein are ultrasound systems and methods for automated ultrasound imaging”) comprising: [claim 16]
a transducer configured to transmit and receive an ultrasound signal in a first plane and a second plane, the first plane orthogonal to the second plane, the transducer configured to emit an ultrasound beam (Fig. 6B, [0022] – “The ultrasound sensor array 112 includes at least one transducer array configured to transmit and receive ultrasonic energy”, [0056] – “In FIG. 6B, an ultrasound probe 606 is configured to transmit and receive (via a sensor array, and responsive to a controller) ultrasound energy along a plurality of scan lines 608 in accordance with a second scan line pattern 610…The second scan line pattern 610 can be used to obtain imaging data for two orthogonal scan planes 612 and 614”); and
a processing circuit having a processor ([0040] – “The controller circuit 136 may include one or more processors”) coupled to a memory device storing instructions thereon that, when executed, cause the processing circuit to perform operations ([0009] – “executable instructions stored on non-transitory computer-readable medium, which when executed cause a processor of a medical imaging system to be programmed to perform the processes embodied in the non-transitory computer-readable medium.”) comprising:
receiving a first image data obtained by an ultrasound probe along the first plane (Fig. 6B, [0056] – “transmit and receive (via a sensor array, and responsive to a controller) ultrasound energy along a plurality of scan lines 608 in accordance with a second scan line pattern 610… The second scan line pattern 610 can be used to obtain imaging data for two orthogonal scan planes 612 and 614, each image plane reconstructed from signals received along the plurality of scan lines in the respective plane.”);
receiving a second image data obtained by the ultrasound probe along the second plane (Fig. 6B, [0056] – “transmit and receive (via a sensor array, and responsive to a controller) ultrasound energy along a plurality of scan lines 608 in accordance with a second scan line pattern 610… The second scan line pattern 610 can be used to obtain imaging data for two orthogonal scan planes 612 and 614, each image plane reconstructed from signals received along the plurality of scan lines in the respective plane.”);
identifying an anatomical feature based on the first image data and the second image data (Abstract – “These data sets are assessed for a target characteristic specific to the object targeted for imaging”, the target characteristic is identified to determine the optimum scan plan in two orthogonal scan planes as shown in the example in 6B therefore the target characteristic would be identified in both the elevation and azimuth directions);
As cited above Poland teaches imaging data in two different planes to provide optimal images in two orthogonal planes additionally Poland discloses in [0033] “A-lines, by contrast, are merely visual artifacts generated by reverberating ultrasound echoes that may be especially bright when ultrasound beams reflect off the pleural interface at a perpendicular angle”, [0022] “The system 100 may also include a scan line controller 120 communicatively coupled with the ultrasound data acquisition unit 110 and configured to control the direction (i.e. steer) the transmit and receive beams”, and [0044] “Beams may be steered straight ahead from (orthogonal to) the transducer array, or at different angles”. Conversely Poland does not explicitly teach determining, based on the first image data and the second image data, an angle between the ultrasound beam and a normal of the anatomical feature;
determining a transmit direction that would adjust the angle between the ultrasound beam and the normal of the anatomical feature to a desired angle; and
at least one of outputting the transmit direction via a user interface of the ultrasound imaging system or automatically aligning a second ultrasound signal in the transmit direction to adjust the angle to the desired angle.
However Neban discloses determining, based on the first image data and the second image data, an angle between the ultrasound beam and a normal of the anatomical feature ([0106] – “An aperture/acoustic beam translation may be used to avoid rib shadowing that occurs when the center of the aperture is directly above a rib”, [0107] – “elevational steering may ensure that the imaging plane, i.e., the elevation plane, is perpendicular to the lung pleura. Assuming, for example, that the ultrasound probe was tilted forward or backward, then the imaging plane would traverse the tissues (e.g., soft tissue, lung pleura) at an oblique angle. By performing an elevational tilting to correct for the tilted ultrasound probe, it can be ensured that the elevational plane is hitting the tissue at a 90-degree angle”, therefore it would be obvious for one with ordinary skill in the art to determine an angle between the ultrasound beam and normal of the anatomical feature so that elevational tilting can be performed to hit the tissue at a 90-degree angle, it would be obvious to make this determination in both image planes of Poland to obtain the optimum image of the A-lines in both planes).
determining a transmit direction that would adjust the angle between the ultrasound beam and the normal of the anatomical feature to a desired angle ([0107] – “elevational steering may ensure that the imaging plane, i.e., the elevation plane, is perpendicular to the lung pleura. Assuming, for example, that the ultrasound probe was tilted forward or backward, then the imaging plane would traverse the tissues (e.g., soft tissue, lung pleura) at an oblique angle. By performing an elevational tilting to correct for the tilted ultrasound probe, it can be ensured that the elevational plane is hitting the tissue at a 90-degree angle”); and
at least one of outputting the transmit direction via a user interface of the ultrasound imaging system or automatically aligning a second ultrasound signal in the transmit direction to adjust the angle to the desired angle ([0065] – “if the quality of the ultrasound image frame falls below a threshold, then this may trigger the auto-steer operation”).
The disclosure of Neban is an analogous art considering it is in the field of obtaining an optimum view of the lungs.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Poland to incorporate the determination of an angle between the ultrasound beam and a normal of the anatomical feature of Neban to achieve the same results. One would have motivation to combine because it would automatically provide a clearer image of the pleura of the lungs.
Regarding claim 2, Poland and Neban disclose all the elements of the claimed invention as cited in claim 1.
Poland further discloses wherein the first plane is an azimuth plane and the second plane is an elevation plane (see Fig. 6B, [0022] – “The 2D matrix arrays may be configured to scan electronically in both the elevational and azimuth dimensions”).
Regarding claim 3, Poland and Neban disclose all the elements of the claimed invention as cited in claim 1.
Poland further discloses wherein the anatomical feature is a pleura ([0005] – “the target characteristic may be a characteristic of the object that meets an image quality threshold. In embodiments, the target characteristic may be an intensity level of a feature specific to the object. According to some of such examples, the object may be a lung and the feature may be a pleural line”).
Regarding claim 4, Poland and Neban disclose all the elements of the claimed invention as cited in claims 1 and 3.
Conversely Poland does not explicitly teach wherein the desired angle is 0° with respect to the normal of the pleura such that adjusting the ultrasound beam and/or the ultrasound probe to the desired angle adjusts the ultrasound beam to be perpendicular to the pleura.
However, Neban discloses wherein the desired angle is 0° with respect to the normal of the pleura such that adjusting the ultrasound beam and/or the ultrasound probe to the desired angle adjusts the ultrasound beam to be perpendicular to the pleura ([0107] – “elevational steering may ensure that the imaging plane, i.e., the elevation plane, is perpendicular to the lung pleura. Assuming, for example, that the ultrasound probe was tilted forward or backward, then the imaging plane would traverse the tissues (e.g., soft tissue, lung pleura) at an oblique angle. By performing an elevational tilting to correct for the tilted ultrasound probe, it can be ensured that the elevational plane is hitting the tissue at a 90-degree angle”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Poland to incorporate the desired angle of 0 degrees of Neban to achieve the same results. One would have motivation to combine because it would allow for clearer imaging of A-lines to provide diagnostic imaging of the lung.
Regarding claim 5, Poland and Neban disclose all the elements of the claimed invention as cited in claim 1.
Poland further discloses wherein the operations further comprise causing the transducer to transmit the second ultrasound signal and to receive third image data […] ([0036] – “Based on the determination made by the data processor 122, the scan line controller 120 may be configured to automatically steer the ultrasound sensor array 112 to emit ultrasound beams 111 in accordance with the target scan line pattern 125 to generate an ultrasound image of the object 114. In this manner, the object 114 is imaged in the target scan line pattern 125”).
Conversely Poland does not explicitly teach wherein the operations further comprise causing the transducer to transmit the second ultrasound signal and to receive third image data after automatically aligning the second ultrasound signal to adjust the angle to the desired angle.
However, Neban discloses wherein the operations further comprise causing the transducer to transmit the second ultrasound signal and to receive a third image data after automatically aligning the second ultrasound signal to adjust the angle to the desired angle (paragraph [0079]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Poland to incorporate the second ultrasound signal to adjust the angle of Neban to achieve the same results. One would have motivation to combine because it would allow for clearer imaging of A-lines to provide diagnostic imaging of the lung.
Regarding claims 7, 14, and 20, Poland and Neban disclose all the elements of the claimed invention as cited in claims 1, 12, and 16.
As cited above Poland discloses the determination of an optimal imaging plane in two orthogonal planes and that the target feature may be the pleura of the lungs. Conversely Poland does not explicitly teach wherein determining the transmit direction comprises: determining a first angle between the ultrasound beam in the first plane and a first normal of the anatomical feature in the first image data; and determining a second angle between the ultrasound beam in the second plane and a second normal of the anatomical feature in the second image data.
However Neban discloses wherein determining the transmit direction comprises: determining a first angle between the ultrasound beam in the first plane and a first normal of the anatomical feature in the first image data ([0107] – “The elevational steering may ensure that the imaging plane, i.e., the elevation plane, is perpendicular to the lung pleura…By performing an elevational tilting to correct for the tilted ultrasound probe, it can be ensured that the elevational plane is hitting the tissue at a 90-degree angle”); and determining a second angle between the ultrasound beam in the second plane and a second normal of the anatomical feature in the second image data ([0108] – “allowing tilting and steer in both (azimuth and elevation) directions in order to get a better angle for viewing”, although [0106] recites tilting the acoustic beam in the azimuth direction would not help because the rib would still partially block the acoustic beam paragraph [0107] discloses that tilting of the probe can cause imaging of the pleura at an oblique angle which can be corrected by tilting/steering the ultrasound beam to ensure the beam is hitting the pleura at a 90-degree angle. Therefore, it would be obvious to one with ordinary skill in the art to perform the aperture translation as well as beam steering/ tilting in the azimuth plane to ensure the rib is not blocking the beam and the beam is hitting the pleura at a 90-degree angle to acquire a good image of the pleura.)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Poland to incorporate the determination of an angle between the ultrasound beam and a normal of the anatomical feature of Neban to achieve the same results. One would have motivation to combine because it would allow for clearer imaging of A-lines to provide diagnostic imaging when the anatomical feature is a lung.
Regarding claim 10, Poland and Neban disclose all the elements of the claimed invention as cited in claim 1.
Poland further discloses wherein the operations further comprise:
receiving third image data along the first plane and receiving fourth image data along the second plane from the second ultrasound signal responsive to at least one of a user adjusting the ultrasound probe […] ([0041] – “the system 100 may be configured to periodically identify the target scan line pattern 125, implementing scan line pattern adjustments as necessary such that optimal images of the object 114 are obtained over time without the need for manual intervention”, [0056] – “The second scan line pattern 610 can be used to obtain imaging data for two orthogonal scan planes 612 and 614”);
Conversely Poland does not explicitly teach adjusting the ultrasound probe to the transmit direction to transmit the second ultrasound signal or automatically aligning the second ultrasound signal in the transmit direction to transmit the second ultrasound signal;
determining, based on the third image data and the fourth image data, a second angle between the ultrasound beam and a normal of the anatomical feature;
determining a second transmit direction that would adjust the second angle between the ultrasound beam and the normal of the anatomical feature to the desired angle; and
at least one of outputting the second transmit direction via a user interface of the ultrasound imaging system or automatically aligning a third ultrasound signal in the second transmit direction to adjust the second angle to the desired angle.
However, Neban discloses adjusting the ultrasound probe to the transmit direction to transmit the second ultrasound signal or automatically aligning the second ultrasound signal in the transmit direction to transmit the second ultrasound signal ([0065] – “if the quality of the ultrasound image frame falls below a threshold, then this may trigger the auto-steer operation”);
determining, based on the third image data and the fourth image data, a second angle between the ultrasound beam and a normal of the anatomical feature ([0062] – “The subsequently described steps may be performed in real-time, e.g., at a frame rate of an ultrasound system so that the imaging plane is adjusted in real-time”, [0106] – “An aperture/acoustic beam translation may be used to avoid rib shadowing that occurs when the center of the aperture is directly above a rib”, [0107] – “elevational steering may ensure that the imaging plane, i.e., the elevation plane, is perpendicular to the lung pleura. Assuming, for example, that the ultrasound probe was tilted forward or backward, then the imaging plane would traverse the tissues (e.g., soft tissue, lung pleura) at an oblique angle. By performing an elevational tilting to correct for the tilted ultrasound probe, it can be ensured that the elevational plane is hitting the tissue at a 90-degree angle”, therefore it would be obvious for one with ordinary skill in the art to determine an angle between the ultrasound beam and normal of the anatomical feature so that elevational tilting can be performed to hit the tissue at a 90-degree angle, Figs. 5A and 5B show that the process is repeated).
determining a second transmit direction that would adjust the second angle between the ultrasound beam and the normal of the anatomical feature to the desired angle (Method of Fig. 5 A is repeated which includes the steps of requesting an initiation to auto-steer and obtaining a search scan pattern, [0067] – “Steps 506-510 may result in variation of the elevational and azimuthal steering angles”, therefore a second transmit direction would be determined, [0107] – “elevational steering may ensure that the imaging plane, i.e., the elevation plane, is perpendicular to the lung pleura.”); and
at least one of outputting the second transmit direction via a user interface of the ultrasound imaging system or automatically aligning a third ultrasound signal in the second transmit direction to adjust the second angle to the desired angle ([0065] – “if the quality of the ultrasound image frame falls below a threshold, then this may trigger the auto-steer operation”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Poland to incorporate the determination of an angle between the ultrasound beam and a normal of the anatomical feature of Neban to achieve the same results. One would have motivation to combine because it would allow for the clearer imaging of A-lines to provide diagnostic imaging when the anatomical feature is a lung.
Regarding claim 11, Poland and Neban disclose all the elements of the claimed invention as cited in claim 1.
Poland further discloses wherein the transducer is further configured to transmit and receive ultrasound signals in a plurality of planes, the plurality of planes to form a 3D image ([0026] – “automatically scan a 3D volume of a patient in search of the selected object 114”, [0028] – “a matrix probe may be configured to transmit a plurality of individual scan lines along an azimuthal scan plane that is successively stepped in the elevational direction until the entire 3D volume is scanned. In this manner, electronically steering the plurality of scan line patterns may create a series of rastered scan planes”), and wherein the first plane and the second plane are extracted from the 3D image ([0034] – “Out of the plurality of scan line patterns 125 generated by the ultrasound data acquisition unit 110, the data processor 122 may be configured to assess the image data sets 119 for a target characteristic 123 specific to the object 114 and identify an image data set that includes the target characteristic 123”, [0056] – “The second scan line pattern 610 can be used to obtain imaging data for two orthogonal scan planes 612 and 614”).
Regarding claim 12, Poland discloses an ultrasound imaging system ((Abstract – “The present disclosure describes an ultrasound imaging system”) comprising:
a transducer configured to transmit and receive an ultrasound signal in a first plane and a second plane, the second plane orthogonal to the first plane, the transducer configured to emit an ultrasound beam, the transducer used to obtain first image data along the first plane and the transducer used to obtain second image data along the second plane (Fig. 6B, [0022] – “The ultrasound sensor array 112 includes at least one transducer array configured to transmit and receive ultrasonic energy”, [0056] – “In FIG. 6B, an ultrasound probe 606 is configured to transmit and receive (via a sensor array, and responsive to a controller) ultrasound energy along a plurality of scan lines 608 in accordance with a second scan line pattern 610…The second scan line pattern 610 can be used to obtain imaging data for two orthogonal scan planes 612 and 614”);
an image processing circuit configured to identify an anatomical feature based on the first image data and the second image data ([0009] – “executable instructions stored on non-transitory computer-readable medium, which when executed cause a processor of a medical imaging system to be programmed to perform the processes embodied in the non-transitory computer-readable medium”, Abstract – “These data sets are assessed for a target characteristic specific to the object targeted for imaging”, the target characteristic is identified to determine the optimum scan plan in two orthogonal scan planes as shown in the example in 6B therefore the target characteristic would be identified in both the elevation and azimuth directions),
As cited above Poland teaches imaging data in two different planes to provide optimal images in two orthogonal planes additionally Poland discloses in [0033] “A-lines, by contrast, are merely visual artifacts generated by reverberating ultrasound echoes that may be especially bright when ultrasound beams reflect off the pleural interface at a perpendicular angle”, [0022] “The system 100 may also include a scan line controller 120 communicatively coupled with the ultrasound data acquisition unit 110 and configured to control the direction (i.e. steer) the transmit and receive beams”, and [0044] “Beams may be steered straight ahead from (orthogonal to) the transducer array, or at different angles”. Conversely Poland does not explicitly teach wherein an angle between the ultrasound beam and a normal of the anatomical feature is determined;
a control circuit configured to compute, based on the anatomical feature identified in the first image data and the anatomical feature identified in the second image data a transmit direction that would adjust the angle between the ultrasound beam and the normal of the anatomical feature towards a desired angle; and
the ultrasound imaging system is configured to at least one of output the transmit direction via a user interface of the ultrasound imaging system or automatically align a second ultrasound signal in the transmit direction to adjust the angle to the desired angle.
However, Neban discloses wherein an angle between the ultrasound beam and a normal of the anatomical feature is determined ([0107] – “elevational steering may ensure that the imaging plane, i.e., the elevation plane, is perpendicular to the lung pleura. Assuming, for example, that the ultrasound probe was tilted forward or backward, then the imaging plane would traverse the tissues (e.g., soft tissue, lung pleura) at an oblique angle. By performing an elevational tilting to correct for the tilted ultrasound probe, it can be ensured that the elevational plane is hitting the tissue at a 90-degree angle”, therefore it would be obvious for one with ordinary skill in the art to determine an angle between the ultrasound beam and normal of the anatomical feature so that elevational tilting can be performed to hit the tissue at a 90-degree angle);
a control circuit configured to compute, based on the anatomical feature identified in the first image data and the anatomical feature identified in the second image data a transmit direction that would adjust the angle between the ultrasound beam and the normal of the anatomical feature towards a desired angle ([0107] – “elevational steering may ensure that the imaging plane, i.e., the elevation plane, is perpendicular to the lung pleura. Assuming, for example, that the ultrasound probe was tilted forward or backward, then the imaging plane would traverse the tissues (e.g., soft tissue, lung pleura) at an oblique angle. By performing an elevational tilting to correct for the tilted ultrasound probe, it can be ensured that the elevational plane is hitting the tissue at a 90-degree angle” therefore the transmit angle is computed based on the identified pleura and as cited above Poland discloses two optimal orthogonal planes that can be used to image the pleura therefor it would be obvious to one with ordinary skill in the art to compute an adjustment angle for both planes to view optimal planes in both directions); and
the ultrasound imaging system is configured to at least one of output feedback based on the transmit direction via a user interface of the ultrasound imaging system or automatically align a second ultrasound signal in the transmit direction to adjust the angle to the desired angle([0065] – “if the quality of the ultrasound image frame falls below a threshold, then this may trigger the auto-steer operation”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Poland to incorporate the determination of an angle between the ultrasound beam and a normal of the anatomical feature of Neban to achieve the same results. One would have motivation to combine because it would allow for the clearer imaging of A-lines to provide diagnostic imaging when the anatomical feature is a lung.
Regarding claim 13, Poland and Neban disclose all the elements of the claimed invention as cited in claim 12.
Poland further discloses wherein the anatomical feature is a pleura ([0005] – “the target characteristic may be a characteristic of the object that meets an image quality threshold. In embodiments, the target characteristic may be an intensity level of a feature specific to the object. According to some of such examples, the object may be a lung and the feature may be a pleural line”).
Conversely Poland does not explicitly teach the desired angle is 0° with respect to the normal of the pleura such that adjusting the ultrasound beam to the desired angle adjusts the ultrasound beam to be perpendicular to the pleura.
However, Neban discloses wherein the anatomical feature is a pleura, and the desired angle is 0° with respect to the normal of the pleura such that adjusting the ultrasound beam to the desired angle adjusts the ultrasound beam to be perpendicular to the pleura ([0107] – “elevational steering may ensure that the imaging plane, i.e., the elevation plane, is perpendicular to the lung pleura. Assuming, for example, that the ultrasound probe was tilted forward or backward, then the imaging plane would traverse the tissues (e.g., soft tissue, lung pleura) at an oblique angle. By performing an elevational tilting to correct for the tilted ultrasound probe, it can be ensured that the elevational plane is hitting the tissue at a 90-degree angle”, therefore an angle between the ultrasound beam and the normal of the pleura would be 0°).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Poland to incorporate the desired angle of 0 degrees of Neban to achieve the same results. One would have motivation to combine because it would allow for the clearer imaging of A-lines to provide diagnostic imaging of the lung.
Regarding claim 17, Poland and Neban disclose all the elements of the claimed invention as cited in claim 16.
Poland further discloses wherein the anatomical feature is a pleura ([0005] – “the target characteristic may be a characteristic of the object that meets an image quality threshold. In embodiments, the target characteristic may be an intensity level of a feature specific to the object. According to some of such examples, the object may be a lung and the feature may be a pleural line”).
Conversely Poland does not teach wherein the anatomical feature is a pleura, and the desired angle is 0° with respect to the normal of the pleura such that adjusting the ultrasound beam and/or the ultrasound probe to the desired angle adjusts the ultrasound beam to be perpendicular to the pleura.
However, Neban discloses wherein the anatomical feature is a pleura, and the desired angle is 0° with respect to the normal of the pleura such that adjusting the ultrasound beam to the desired angle adjusts the ultrasound beam to be perpendicular to the pleura ([0107] – “elevational steering may ensure that the imaging plane, i.e., the elevation plane, is perpendicular to the lung pleura. Assuming, for example, that the ultrasound probe was tilted forward or backward, then the imaging plane would traverse the tissues (e.g., soft tissue, lung pleura) at an oblique angle. By performing an elevational tilting to correct for the tilted ultrasound probe, it can be ensured that the elevational plane is hitting the tissue at a 90-degree angle”, therefore an angle between the ultrasound beam and the normal of the pleura would be 0°).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Poland to incorporate the desired angle of 0 degrees of Neban to achieve the same results. One would have motivation to combine because it would allow for the clearer imaging of A-lines to provide diagnostic imaging of the lung.
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Poland (US 20230301631) and Neban (US 20230148995) as applied to claims 1 and 16 above, and further in view of Alkan (US 20250302442).
Regarding claims 6 and 18, Poland and Neban disclose all the elements of the claimed invention as cited in claims 1 and 16.
Conversely Poland does not teach wherein the operations further comprise using the user interface to provide real-time feedback to a user to manually adjust an angle of the ultrasound probe such that the transducer can transmit the second ultrasound signal in the desired angle and consequently receive a third image data.
However, Alkan discloses wherein the operations further comprise using the user interface to provide real-time feedback to a user to manually adjust an angle of the ultrasound probe such that the transducer can transmit the second ultrasound signal in the desired angle and consequently receive a third image data ([0063] – “produce probe navigational guidance for reducing the difference between the current positioning of the probe and the ideal positioning. Algorithms then produce real-time guidance. This guidance can be presented to the user via a user interface in real-time to provide timely guidance for the user to improve image quality”, [0049] – “guide a user to acquire an improved image of a target organ (for example, through a visual depiction of a new landing spot, or an instruction to slide, rotate, tilt, or otherwise adjust an imaging transducer according to any of the guidance movements described herein) 203; and subsequent images that are improved (for example, in terms of diagnostic quality and/or feature visualization) are acquired after the user has repositioned the imaging probe 204”).
The disclosure of Alkan is an analogous art considering it is in the field of adjusting an ultrasound plane based on an optimal plane.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Poland to incorporate the real-time feedback to adjust the ultrasound probe of Alkan to achieve the same results. One would have motivation to combine because “even a non-specialist user may follow prescriptive guidance and optimize the positioning score to get a point where the diagnostic quality is achieved” (Alkan [0063]).
Claims 8, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Poland (US 20230301631) and Neban (US 20230148995) as applied to claims 1, 12, and 16 above, and further in view of Mazo (US 20180240235).
Regarding claims 8, 15, and 19, Poland and Neban disclose all the elements of the claimed invention as cited in claims 1, 12, and 16.
Poland further discloses wherein: the first image data and the second image data comprise pixels (Fig. 6B, [0056] – “obtain imaging data for two orthogonal scan planes 612 and 614”, [0038] – “a display screen configured to display ultrasound images obtained via the ultrasound data acquisition unit 110”); and
Conversely Poland does not teach identifying the anatomical feature comprises: training a segmentation model for segmentation of the anatomical feature, the segmentation model configured to output a probability for each pixel being the anatomical feature or not the anatomical feature; and determining the pixels that classify as the anatomical feature with a threshold such that a binary mask of the anatomical feature is produced.
However Mazo discloses identifying the anatomical feature comprises: training a segmentation model for segmentation of the anatomical feature ([0041] – “training an multi-slice FCN for automatic segmentation of a target two dimensional (2D) slice”, Abstract – “a segmentation region including a defined intra-body anatomical feature”), the segmentation model configured to output a probability for each pixel being the anatomical feature or not the anatomical feature ([0103] – “At the end of expanding path 406, a 1×1 convolution 416 is applied followed by a softmax, which results in a probability map of the same dimensions as the input image (also referred to as a segmentation mask)”, [0147] – “A pixel was considered positive when its probability was higher than 0.5”); and determining the pixels that classify as the anatomical feature with a threshold such that a binary mask of the anatomical feature is produced ([0147] – “A pixel was considered positive when its probability was higher than 0.5”, [0110] – “Segmentation mask 514 may represent a classification of each pixel of target slice 502, as belonging to the segmented region, or not belonging to the segmented region”).
The disclosure of Mazo is an analogous art considering it is in the field of obtaining 3D image data.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Poland to incorporate the segmentation model of Mazo to achieve the same results. One would have motivation to combine because it provides “an increase in accuracy, sensitivity, specificity, and/or Dice score, of segmenting the predefined anatomical feature(s)” (Mazo [0008]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Poland (US 20230301631) and Neban (US 20230148995), and Mazo (US 20180240235) as applied to claim 8 above, and further in view of Perrey (US 20180125460).
Regarding claim 9, Poland, Neban, and Mazo disclose all the elements of the claimed invention as cited in claims 1 and 8.
Poland discloses imaging of the lung pleura in a azimuth plane and an elevation plane (See Fig. 6B, para. [0056], and para. [0005]).
Conversely Poland does not teach wherein the anatomical feature is represented as a first vector in the first image data and as a second vector in the second image data, the first vector and the second vector determined by using a method to fit a boundary of the anatomical feature into a best-fit line.
However Perrey discloses wherein the anatomical feature is represented as a first vector in the first image data […], the first vector […] determined by using a method to fit a boundary of the anatomical feature into a best-fit line ([0046] – “the controller circuit 136 may determine edges of the anatomical structure 502 based on one or more feature vectors determined from each pixel of the ultrasound image 500…Based on changed in the feature vectors between the pixels, the controller circuit 136 may identify a boundary of the anatomical structure 502.”).
Perrey does not disclose a second vector in the second image data. However, because Poland teaches the selection of optimal scan planes in two orthogonal planes one would find it obvious to represent the anatomical feature as a second vector in the second image data to correctly adjust the acoustic beam to obtain the best images in both planes.
The disclosure of Perrey is an analogous art considering it is in the field of obtaining images in two orthogonal planes.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Poland to incorporate the representing the anatomical feature using a vector of Perrey to achieve the same results. One would have motivation to combine because “the controller circuit 136 may identify a boundary of the anatomical structure” (Perrey [0046]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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/R.C.L./Examiner, Art Unit 3797
/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
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