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 .
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.
Claim(s) 1, 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thiele et al. (US Pub No. 2015/0148679) in view of Walker et al. (US Pub No. 2017/0151027) and Hastings et al. (US Pub No. 2005/0256398).
With regards to claim 1, Thiele et al. disclose an apparatus comprising:
one or more processors (paragraphs [0020], [0021], referring to the processors, such as the image processor (30), Doppler processor (28), flow quantification processor (34), graphics processor (36), etc.; Figure 1); and
memory in communication with the one or more processors (paragraphs [0020]-[0021], referring to the temporary storage for display and inherent memory associated with the processors (28, 30, 34, 36, etc.); Figure 1), wherein the memory contains instructions configured to cause the one or more processors to:
receive, from a first imaging device (10), first image data (i.e. “processed signals” which are coupled to the B-mode processor (26) and Doppler processor (28), wherein the Doppler processor processes temporally distinct signals from tissue and blood flow for the detection of the motion of substances such as the flow of blood cells in the image field and/or referring to the “blood flow velocity values” produced by the Doppler processor (28)) of a plurality of image frames of a target heart valve of a subject, wherein the first image data indicates blood flow through the target heart valve (Abstract, referring to the Doppler processor producing Doppler velocity measurements of blood flow around a regurgitant valve; paragraphs [0016], [0019], referring to the transducer array (10’ scanning about the location of the mitral valve for 3D imaging [wherein 3D imaging would encompass a plurality of frames] and Doppler processing for obtaining flow velocity values; paragraph [0021], referring to the blood flow velocity values produced by the Doppler processor (28); Figure 1);
determine, from the first image data, each of a direction and a magnitude of a regurgitant flow through the target heart valve based on one or more of a jet width, a jet area, or a flow convergence region width (paragraphs [0021]-[0023], referring to the flow quantification processor (34) producing a measure of the flow rate through a regurgitant orifice, the volume flow through the orifice, and the spatial location of the orifice, and thus the magnitude of the regurgitant flow can be quantified, further referring to use of the PISA technique to assess the regurgitant flow, wherein, as set forth in paragraphs [0003]-[0004], the PISA [acronym for Proximal Iso-Velocity Surface Area] technique is a technique to quantify the regurgitant blood flow, wherein in the PISA method, the suspect valve and the region inside the LV heart chamber and proximal to the valve are imaged by colorflow Doppler imaging and at the time of occurrence of the jet a flow convergence region (FCR) is formed in the proximal region as blood flow velocities in the region instantaneously accelerate toward the regurgitant orifice and thus the regurgitant flow is quantified based on a jet area and/or flow convergence region width [which defines the iso-velocity surface inside of which the flow convergence region exists]; paragraphs [0023]-[0025], [0030]-[0031], referring to the ultrasound image of mitral regurgitation [which is obtained from using the PISA technique], wherein the area and extent of the jet is depicted and a color bar is used with the different colors representing different velocity values, with a +/- velocity associated with a particular flow direction, and thus a magnitude and direction of the regurgitant flow is depicted; Figure 1, 5-6, 8)
generate a reference marker (i.e. via use of the color bar, the color overlay on the B-mode image serves as a reference marker) indicating each of the direction and magnitude of the regurgitant flow (paragraph [0020], referring to the scan converter overlaying a B-mode structural image with “colors corresponding to motion at points in the image field corresponding with their Doppler-estimated velocities to produce a color Doppler image which depicts the motion of tissue and blood flow in the image field”; paragraphs [0023]-[0025], [0030]-[0031], referring to the ultrasound image of mitral regurgitation [which is obtained from using the PISA technique], wherein the area and extent of the jet is depicted and a color bar is used with the different colors representing different velocity values, with a +/- velocity associated with a particular flow direction, and thus a magnitude and direction of the regurgitant flow is depicted; Figure 1, 5-6, 8); and
output, to one or more image display devices (40), the first image data (i.e. processed signals/Doppler flow velocity values) and the generated reference marker (i.e. color overlay, with the different colors representing different velocity values of the regurgitant flow/jet) overlaid over one or more of the image frame (i.e. B-mode image frame) in a position and orientation that indicates a position and the direction of the regurgitant flow (paragraphs [0019]-[0020], referring to the scan converter overlaying a B-mode structural image with “colors corresponding to motion at points in the image field corresponding with their Doppler-estimated velocities to produce a color Doppler image which depicts the motion of tissue and blood flow in the image field”; paragraphs [0022]-[0025], [0030]-[0031], referring to the ultrasound image of mitral regurgitation [which is obtained from using the PISA technique], wherein the area and extent of the jet is depicted and a color bar is used with the different colors representing different velocity values, with a +/- velocity associated with a particular flow direction, and thus a magnitude, position and direction of the regurgitant flow is depicted via the color overlay; Figures 1, 8).
However, Thiele et al. do not specifically disclose the processor is further configured to determine a recommended location for a transseptal crossing by a needle; generate a recommendation reference marker indicating the recommended location and a recommended trajectory for the transseptal crossing; output, to one or more image display devices, the first image data and the recommendation reference marker overlaid over the one or more image frames at the recommended location; receive, from the first imaging device, subsequent image data of the target heart valve; determine a distal tip trajectory of the needle from the subsequent image data; determine a difference between the recommended trajectory indicated by the recommendation reference marker and the distal tip trajectory; and set a color of the recommendation reference marker based on the determined difference.
Walker et al. disclose systems and method for driving a flexible medical instrument to a target, such as the annulus of a coronary valve [i.e. and thus a transeptal crossing] in an anatomical space for minimally invasive procedures, such as for aortic valve repairs, wherein imaging and tracking is used to assist users in navigating instruments within the human body (Abstract; paragraphs [0004], [0012], [0043], [0093]). The system can automatically calculate where the targets would be (paragraph [0094], note that the processor is therefore configured to determine a recommended location for a target, which, as set forth in paragraph [0093], can correspond to an annulus of a coronary valve (i.e. transseptal crossing). As depicted in Figure 13, dotted lines or other indicators are provided to show the ideal instrument path/trajectory or the boundary of suitable paths for the instrument, and the user is able to see the difference between the actual instrument shape and the ideal instrument path to identify if a deviation is occurring, wherein the instrument may correspond to a needle (paragraphs [0043], [0119], Figure 13). The target may be specially highlighted and visual cutes, such as colors, etc. may be displayed to show the relationship between the instrument and the target or the recommended path (i.e. “recommended trajectory”/”ideal instrument path”)and the current path (paragraphs [0119]-[0120], note that the highlighted target corresponds to the claimed “recommendation reference marker” and the visual cues provide an indication of a difference between the recommended trajectory/path indicated by the reference marker (i.e. highlighted target) and the distal tip trajectory (i.e. needle path); Figure 13). The visualization frame that the user is viewing may include a live 2D or 3D image, wherein the live image may be acquired via ultrasound or other live imaging source (paragraphs [0045], [0070], [0085], [0090], [0095]-[0096], note that “live” ultrasound imaging would correspond to receiving from an ultrasound device “subsequent” image data of the target region, which can include the target heart valve). A color on or around the target can be used to show when the instrument is far from the target, near the target and aligned with the target, such as providing a red border around the target when the instrument is far from the target, yellow when nearing the target and green is displayed when the instrument is aligned with the target (paragraphs [0115]-[0116]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the processor of Thiele et al. be further configured to determine a recommended location for a transseptal crossing by a needle; generate a recommendation reference marker indicating the recommended location and a recommended trajectory; output, to one or more image display devices, the first image data and the recommendation reference marker overlaid over the one or more image frames at the recommended location; receive, from the first imaging device, subsequent image data of the target heart valve; determine a distal tip trajectory of the needle from the subsequent image data, determine a difference between the recommended trajectory indicated by the recommendation reference marker and the distal tip trajectory and set a color of the recommendation reference marker based on the determined difference, as taught by Walker et al., in order to assist users in navigating instruments within the human body to provide valve repair (paragraphs [0004], [0012], [0043]).
However, though Walker et al. do disclose that the cardiovascular procedures for their invention can be for aortic valve repairs and vascular stent implantations which are performed by entering the patient’s vasculature via small incision in the femoral artery, the above combined references do not specifically disclose that the recommended trajectory is specifically for the transeptal crossing.
Hastings et al. disclose an automated system for navigating a medical device through the lumens and cavities in an operating region in a patient, wherein a catheter is first introduced into a femoral artery of vein in the groin area of the patient and then may be introduced into the left atrium via a trans-septal puncture (paragraphs [0065], [0070]; Figure 1). When the left atrium is addressed from the arterial system, the catheter must go through the aorta, down through the left ventricle, then up through the mitral valve into the left atrium (paragraph [0070]). The system allows tissue contact to be easily made at any point within the left atrium, facilitating a non-surgical cure for atrial fibrillation (paragraph [0070]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the recommended trajectory of the above combined references be specifically for the transeptal crossing, as taught by Hastings et al., in order to allow tissue contact to be easily made at any point within the left atrium, facilitating a non-surgical cure for atrial fibrillation (paragraph [0070]).
With regards to claim 3, Thiele et al. disclose that the direction of the regurgitant flow is indicated by a first property (i.e. spatial position of the color overlay on the B-mode image which provides an indication of the direction of the regurgitant flow), and wherein the magnitude of the regurgitant flow is indicated by a second property (i.e. specific colors are associated with specific velocity values [see color bar], wherein the velocity values represent the magnitude of the regurgitant flow) of the reference marker (paragraphs [0030]-[0031]; Figure 8).
With regards to claim 5, Thiele et al. disclose that the instructions are configured to cause the one or more processors to determine, from the first image data, a range of the regurgitant flow through the heart valve, wherein the generated reference marker indicates the range by a third property (i.e. iso-velocity surface which is distinguished as a distinct black line 108 and represents the boundary of the jet and/or the boundary of the jet marked as distinct black lines 114 and 116 in the image, and thus the extent/range of the regurgitant flow is depicted by this third property (i.e. black line/borders) of the reference marker/color overlay) (paragraphs [0030]-[0031]; Figure 8).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thiele et al. in view of Walker et al. and Hastings et al. as applied to claim 1 above, and further in view of Sato (US Pub No. 2013/0150717), as evidenced by Wiki_CardiacCycle (“Cardiac Cycle”, Wiki article accessed on 11/15/24).
With regards to claim 2, as discussed above, the above combined references meet the limitations of claim 1. Further, Thiele et al. disclose that the instructions are configured to cause the one or more processors to calculate flow data from the plurality of image frames, determine the direction and magnitude of the regurgitant flow based on the flow data, wherein the generated reference marker is representative of flow data of the subject (paragraphs [0021]-[0023], referring to the flow quantification processor (34) producing a measure of the flow rate through a regurgitant orifice, the volume flow through the orifice, and the spatial location of the orifice, and thus the magnitude of the regurgitant flow can be quantified, further referring to use of the PISA technique to assess the regurgitant flow, wherein, as set forth in paragraphs [0003]-[0004], the PISA [acronym for Proximal Iso-Velocity Surface Area] technique is a technique to quantify the regurgitant blood flow, wherein in the PISA method, the suspect valve and the region inside the LV heart chamber and proximal to the valve are imaged by colorflow Doppler imaging and at the time of occurrence of the jet a flow convergence region (FCR) is formed in the proximal region as blood flow velocities in the region instantaneously accelerate toward the regurgitant orifice and thus the regurgitant flow is quantified based on a jet area and/or flow convergence region width [which defines the iso-velocity surface inside of which the flow convergence region exists]; paragraphs [0023]-[0025], [0030]-[0031], referring to the ultrasound image of mitral regurgitation [which is obtained from using the PISA technique], wherein the area and extent of the jet is depicted and a color bar is used with the different colors representing different velocity values, with a +/- velocity associated with a particular flow direction, and thus a magnitude and direction of the regurgitant flow is depicted; paragraph [0020], referring to the scan converter overlaying a B-mode structural image with “colors corresponding to motion at points in the image field corresponding with their Doppler-estimated velocities to produce a color Doppler image which depicts the motion of tissue and blood flow in the image field”; paragraphs [0023]-[0025], [0030]-[0031], referring to the ultrasound image of mitral regurgitation [which is obtained from using the PISA technique], wherein the area and extent of the jet is depicted and a color bar is used with the different colors representing different velocity values, with a +/- velocity associated with a particular flow direction, and thus a magnitude and direction of the regurgitant flow is depicted; Figure 1, 5-6, 8).
However, Thiele et al. do not specifically disclose that the calculated flow data is specifically “autocorrelated” flow data and wherein the generated reference marker is representative of the autocorrelated flow data “over a period of multiple cardiac cycles”.
Sato discloses an ultrasonic diagnosis apparatus comprising a processor configured to acquire 2D or 3D blood flow information in a time sequence in a scan range formed of a plurality of scan lines, from 2D or 3D echo data, wherein, in order to observe the blood flow behavior in a 2D or 3D region of interest precisely with good time resolution, a color flow mapping (CFM) processing unit acquired 2D or 3D blood flow information in a time sequence in a scan range by autocorrelation (Abstract; paragraphs [0004], [0069]). Movement information data may thus be displayed, wherein, as depicted in Figures 7B and 11, the movement information data is obtained over a period of multiple cardiac cycles of the subject (paragraph [0087]; Figures 7B, 11, wherein the time range is 1.6 seconds, and thus is over a period of multiple cardiac cycles (i.e. as evidenced by Wiki_CardiacCycle, a typical cardiac cycle for a healthy heart is known in the art to be approximately 0.8 seconds, and thus a range of 1.6 seconds would encompass multiple cardiac cycles).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the calculated flow data of the above combined references be “autocorrelated” flow data and have the generated reference marker be representative of the autocorrelated flow data “over a period of multiple cardiac cycles”, as taught by Sato, in order to observe the blood flow behavior in a 2D or 3D region of interest precisely with good time resolution and observe movement information (Abstract; paragraph [0069]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thiele et al. in view of Walker et al. and Hastings et al. as applied to claim 3 above, and further in view of Calkoen et al. (“Characterization and quantification of dynamic eccentric regurgitation of the left atrioventricular valve after atrioventricular septal detect correction with 4D Flow cardiovascular magnetic resonance and retrospective valve tracking”, 20015), as cited by Applicant.
With regards to claim 4, as discussed above, the above combined references meet the limitations of claim 3. However, they do not specifically disclose that the reference marker is an arrow, wherein the direction of the regurgitant flow is indicated by a direction of the arrow, and wherein the magnitude of the regurgitant flow is indicated by one of a color or length of the arrow.
Calkoen et al. disclose a method for characterizing and directly quantifying regurgitant jets of left atrioventricular valve (LAVV) in patients, wherein the jet direction was visualized using streamlines and an arrow is used to depict the direction and magnitude of the regurgitant jet (Abstract; pg. 3, left column, 4th paragraph, referring to visualizing the jet direction, wherein at each phase during systole, the MPR with the largest regurgitant jet projection was used “to measure the angel between the jet and the valve annulus (Figure 1)”, wherein, as depicted in Figure 1, the jet angle in Figure 1C and 1D are depicted as the angle between the displayed arrow and the black dots [which represent the annulus plane as set forth in the caption of Figure 1], and thus it is clear in Figure 1 that the displayed arrows and corresponding direction represent the direction of the regurgitant jet flow and the arrows further take on the color of the jet, with the colors representing a velocity/magnitude value of the jet, and thus the color of the jet represents the magnitude of the regurgitant flow; Figure 1). By measuring jet angles at different phases of systole, useful information on jet direction at specific time points may be provided (pg. left column, 2nd paragraph).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the prior art to have the reference marker of the above combined references further comprise an arrow, wherein the direction of the regurgitant flow is indicated by a direction of the arrow, and wherein the magnitude of the regurgitant flow is indicated by one of a color or length of the arrow, as taught by Calkoen et al., in order to provide an additional way to visualize the jet direction and provide the ability to measure the angle between the jet and the valve annulus, wherein the measurement of jet angles at different phases of systole provides useful information on jet direction at specific time points (pg. 8, left column, 2nd paragraph; Figure 1).
Claim(s) 6 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thiele et al. in view of Calkoen et al. (“Characterization and quantification of dynamic eccentric regurgitation of the left atrioventricular valve after atrioventricular septal detect correction with 4D Flow cardiovascular magnetic resonance and retrospective valve tracking”, 20015), as cited by Applicant.
With regards to claims 6 and 21-22, Thiele et al. disclose an apparatus comprising:
one or more processors (paragraphs [0020], [0021], referring to the processors, such as the image processor (30), Doppler processor (28), flow quantification processor (34), graphics processor (36), etc.; Figure 1); and
memory in communication with the one or more processors (paragraphs [0020]-[0021], referring to the temporary storage for display and inherent memory associated with the processors (28, 30, 34, 36, etc.); Figure 1), wherein the memory contains instructions configured to cause the one or more processors to:
receive, from a first imaging device (10), first image data (i.e. “processed signals” which are coupled to the B-mode processor (26) and Doppler processor (28), wherein the Doppler processor processes temporally distinct signals from tissue and blood flow for the detection of the motion of substances such as the flow of blood cells in the image field and/or referring to the “blood flow velocity values” produced by the Doppler processor (28)) of a plurality of image frames of a target heart valve of a subject, wherein the first image data indicates blood flow through the target heart valve (Abstract, referring to the Doppler processor producing Doppler velocity measurements of blood flow around a regurgitant valve; paragraphs [0016], [0019], referring to the transducer array (10’ scanning about the location of the mitral valve for 3D imaging [wherein 3D imaging would encompass a plurality of frames] and Doppler processing for obtaining flow velocity values; paragraph [0021], referring to the blood flow velocity values produced by the Doppler processor (28); Figure 1);
determine, from the first image data, each of a direction and a magnitude of a regurgitant flow through the target heart valve based on one or more of a jet width, a jet area, or a flow convergence region width (paragraphs [0021]-[0023], referring to the flow quantification processor (34) producing a measure of the flow rate through a regurgitant orifice, the volume flow through the orifice, and the spatial location of the orifice, and thus the magnitude of the regurgitant flow can be quantified, further referring to use of the PISA technique to assess the regurgitant flow, wherein, as set forth in paragraphs [0003]-[0004], the PISA [acronym for Proximal Iso-Velocity Surface Area] technique is a technique to quantify the regurgitant blood flow, wherein in the PISA method, the suspect valve and the region inside the LV heart chamber and proximal to the valve are imaged by colorflow Doppler imaging and at the time of occurrence of the jet a flow convergence region (FCR) is formed in the proximal region as blood flow velocities in the region instantaneously accelerate toward the regurgitant orifice and thus the regurgitant flow is quantified based on a jet area and/or flow convergence region width [which defines the iso-velocity surface inside of which the flow convergence region exists]; paragraphs [0023]-[0025], [0030]-[0031], referring to the ultrasound image of mitral regurgitation [which is obtained from using the PISA technique], wherein the area and extent of the jet is depicted and a color bar is used with the different colors representing different velocity values, with a +/- velocity associated with a particular flow direction, and thus a magnitude and direction of the regurgitant flow is depicted; Figure 1, 5-6, 8)
generate a reference marker (i.e. via use of the color bar, the color overlay on the B-mode image serves as a reference marker) indicating each of the direction and magnitude of the regurgitant flow (paragraph [0020], referring to the scan converter overlaying a B-mode structural image with “colors corresponding to motion at points in the image field corresponding with their Doppler-estimated velocities to produce a color Doppler image which depicts the motion of tissue and blood flow in the image field”; paragraphs [0023]-[0025], [0030]-[0031], referring to the ultrasound image of mitral regurgitation [which is obtained from using the PISA technique], wherein the area and extent of the jet is depicted and a color bar is used with the different colors representing different velocity values, with a +/- velocity associated with a particular flow direction, and thus a magnitude and direction of the regurgitant flow is depicted; Figure 1, 5-6, 8); and
output, to one or more image display devices (40), the first image data (i.e. processed signals/Doppler flow velocity values) and the generated reference marker (i.e. color overlay, with the different colors representing different velocity values of the regurgitant flow/jet) overlaid over one or more of the image frame (i.e. B-mode image frame) in a position and orientation that indicates a position and the direction of the regurgitant flow (paragraphs [0019]-[0020], referring to the scan converter overlaying a B-mode structural image with “colors corresponding to motion at points in the image field corresponding with their Doppler-estimated velocities to produce a color Doppler image which depicts the motion of tissue and blood flow in the image field”; paragraphs [0022]-[0025], [0030]-[0031], referring to the ultrasound image of mitral regurgitation [which is obtained from using the PISA technique], wherein the area and extent of the jet is depicted and a color bar is used with the different colors representing different velocity values, with a +/- velocity associated with a particular flow direction, and thus a magnitude, position and direction of the regurgitant flow is depicted via the color overlay; Figures 1, 8).
With regards to the limitation concerning that “the first imaging device is one of a trans-esophageal echocardiography (TEE) imaging device or a trans-thoracic echocardiography (TTE) imaging device”, Examiner notes that claim 6 is directed to an apparatus comprising one or more processors and a memory, but does not positively set forth the first imaging device as part of the claimed apparatus. As such, the limitation directed to the “first imaging device” is directed to an intended use and/or manner of operating the claimed apparatus. Since the processor of Thiele et al. is capable of being used with any echocardiography device, including one of a TEE imaging device or a TTE imaging device, Thiele et al. meet the above limitation. However, it should be noted that Thiele et al. does disclose that the first imaging device is a TTE imaging device (Abstract; paragraphs [0016], referring to the transducer array (10’) being a two dimensional array of transducer elements capable of scanning about the location of the mitral valve for 3D imaging, and therefore the probe is a TTE imaging device as the probe would inherently scan across the chest/thoracic region in order to scan the mitral valve).
However, Thiele et al. do not specifically disclose that the reference marker is in the form of a single arrow. Further, Thiele et al. do not specifically disclose that the reference marker indicates the direction of the regurgitant flow by an orientation of the arrow and indicates the magnitude of the regurgitant flow by one of a color or length of the arrow.
Calkoen et al. disclose a method for characterizing and directly quantifying regurgitant jets of left atrioventricular valve (LAVV) in patients, wherein the jet direction was visualized using streamlines and an arrow is used to depict the direction and magnitude of the regurgitant jet (Abstract; pg. 3, left column, 4th paragraph, referring to visualizing the jet direction, wherein at each phase during systole, the MPR with the largest regurgitant jet projection was used “to measure the angle between the jet and the valve annulus (Figure 1)”, wherein, as depicted in Figure 1, the jet angle in Figure 1C and 1D are depicted as the angle between the displayed single arrow and the black dots [which represent the annulus plane as set forth in the caption of Figure 1], and thus it is clear in Figure 1 that the displayed arrows and corresponding direction represent the direction of the regurgitant jet flow and the arrows further take on the color of the jet, with the colors representing a velocity/magnitude value of the jet, and thus the color of the jet represents the magnitude of the regurgitant flow; Figure 1). By measuring jet angles at different phases of systole, useful information on jet direction at specific time points may be provided (pg. left column, 2nd paragraph).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the prior art to have the reference marker of the above combined references be in the form of a single arrow and further have the reference marker indicate the direction of the regurgitant flow by an orientation of the arrow and indicate the magnitude of the regurgitant flow by one of a color or length of the arrow, as taught by Calkoen et al., in order to provide an additional way to visualize the jet direction and provide the ability to measure the angle between the jet and the valve annulus, wherein the measurement of jet angles at different phases of systole provides useful information on jet direction at specific time points (pg. 8, left column, 2nd paragraph; Figure 1).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thiele et al. in view of Calkoen et al., as applied to claim 6 above, and further in view of Takimoto et al. (US Pub No. 2011/0092819).
With regards to claims 7 and 8, as discussed above, the above combined references meet the limitations of claim 6. Further, Thiele et al. disclose that the first image data includes color Doppler data (paragraph [0020], referring to the scan converter overlaying a B-mode structural image with colors corresponding to motion at points in the image field corresponding with their Doppler-estimated velocities to produce a color Doppler image which depicts the motion of tissue and blood flow in the image field).
However, Thiele et al. do not specifically disclose that the instructions are configured to cause the one or more processors to output the first image data without the color Doppler data. Further, with regards to claim 8, Thiele et al. do not specifically disclose that the instructions are configured to cause the one or more processors to receive a user input indicating a desired image output mode from among: color Doppler data without reference markers, reference markers without color Doppler data, or both color Doppler data and reference markers; and output the first image data according to the user input.
Takimoto et al. disclose an ultrasonic diagnosis apparatus, wherein under the control of a system controller (25), the heart of an object is scanned by using B mode and the display unit displays the scanned image (Abstract; paragraphs [0034]-[0035], [0037], note that the B mode image corresponds to first image data without the color Doppler data, wherein the B mode image is displayed). A sound ray marker (i.e. reference marker) for the execution of the continuous wave Doppler method can be superimposed on the displayed image under the control of the system controller (25) in accordance with an instruction to decide continuous wave Doppler conditions from the user via the input device (13) (paragraphs [0034]-[0035], [0037]; Figures 1-3). A sound ray marker can be set on the color Doppler mode displayed on the display unit (14) (paragraphs [0037]-[0038]; Figures 1-3, note that user input is thus displayed indicating a desired image output mode, such as reference markers without color Doppler data (i.e. sound ray marker on B mode image) and both color Doppler data and reference markers (i.e. Fig. 3)). The display unit displays morphological information and blood information in the living body as images based on the video signals from the scan converter (31) (paragraph [0035]; Figures 1-3).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the instructions of Thiele et al. be configured to cause the one or more processors output the first image data without the color Doppler data and have the instructions be further configured to cause the one or more processors to receive a user input indicating a desired image output mode from among: color Doppler data without reference markers, reference markers without color Doppler data, or both color Doppler data and reference markers; and output the first image data according to the user input, as taught by Takimoto et al., in order to be able to provide both morphological information and blood information in the living body as images and allow a user to decide continuous wave Doppler conditions (paragraphs [0034]-[0035], [0037]).
Claim(s) 14-15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thiele et al. in view of Walker et al. and Hastings et al. as applied to claim 1 above, and further in view of Zentgraf et al. (US Pub No. 2013/0150710).
With regards to claim 14, as discussed above, the above combined references meet the limitations of claim 1. However, the above combined references do not specifically disclose that the one or more processors are further configured to receive a device user input indicating a device present in the first image data; select, from a library of computer-generated device models, a model corresponding to the device indicated in the user input; determine a position, orientation and scaling of the computer-generated device model indicated in the user input based on the first image data; and output, to one or more image display devices, the first image data and the computer-generated device model overlaid over the one or more image frame at the determined position, orientation and scaling.
Zentgraf et al. disclose a visualization environment that uses tracking technology to locate both a heart valve repair tool and a transesophageal echocardiogram (TEE) probe in 3D space, making it possible to represent real-time echo images with virtual geometric models of both devices and interactively defined anatomy within a common coordinate system (Abstract; paragraphs [0037], [0049]-[0051], [0060], note that a position, orientation and scaling of computer-generated device models (i.e. virtual geometric models) is determined and overlaid over the images at the determined position, orientation and scaling via the rendering; Figure 11, note that when the devices are within the field of view of the imaging device (110), the pose of the devices would be visible in the images). A tracked tools dialog window (232) can provide a tool pull down menu (240) that allows selection of a specific tool, wherein geometric models of each device can be implanted using the Visualization Toolbox (paragraphs [0054]-[0055], note that a device user input indicating a device present in the ultrasound image is received and a model corresponding to the device is selected from a library (i.e. toolbox) of computer-generated device models; Figures 14-18). Such a surgical navigation system can significantly reduce the surgical time needed to perform a minimally invasive procedure, such as repair of a heart valve leaflet, and leads to more direct navigation paths to the target tissue which results in a safer procedure (paragraph [0061]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the processor of the above combined references be further configured to receive a device user input indicating a device present in the first image data; select, from a library of computer-generated device models, a model corresponding to the device indicated in the user input; determine a position, orientation and scaling of the computer-generated device model indicated in the user input based on the first image data; and output, to one or more image display devices, the first image data and the computer-generated device model overlaid over the one or more image frame at the determined position, orientation and scaling, as taught by Zentgraf et al., in order to significantly reduce the surgical time needed to perform a minimally invasive procedure, such as repair of a heart valve leaflet, and provide more direct navigation paths to the target tissue which results in a safer procedure (paragraph [0061]).
With regards to claim 15, Zentgraf et al. disclose that the device is a mitral valve clip (i.e. suture), and the computer-generated device model of the device is a three-dimensional CAD drawing (paragraphs [0044], [0062], referring to the suture (154); paragraph [0052], referring to the CAD drawing renderings of the device; paragraphs [0008]-[0009], [0039], referring to the augmented reality technique providing a robust three-dimensional context, wherein location and orientation data of devices is provided in real-time three-dimensional space; Figures 1 and 11).
With regards to claim 17, as discussed above, the above combined references meet the limitations of claim 15. However, the above combined references do not specifically disclose that the one or more processors are configured to receive a puncture device user input indicating a puncture device; determine, based on prestored puncture height data, a recommended puncture height for the puncture device indicated by the puncture device user input; generate a puncture reference marker indicating the recommended puncture height based on the prestored puncture height data; and output, to one or more image display devices, the first image data and the puncture reference marker overlaid over the one or more image frames at a location of the recommended puncture. Zentgraf et al. disclose a visualization environment that uses tracking technology to locate both a heart valve repair tool and a transesophageal echocardiogram (TEE) probe in 3D space, making it possible to represent real-time echo images with virtual geometric models of both devices and interactively defined anatomy within a common coordinate system (Abstract; paragraphs [0037], [0049]-[0051], [0060], note that a position, orientation and scaling of computer-generated device models (i.e. virtual geometric models, puncture reference marker) is determined and overlaid over the images at the determined position, orientation and scaling via the rendering; Figure 11, note that when the devices are within the field of view of the imaging device (110), the pose of the devices would be visible in the images). A tracked tools dialog window (232) can provide a tool pull down menu (240) that allows selection of a specific tool, wherein geometric models of each device can be implanted using the Visualization Toolbox, and wherein the tool selected can correspond to a needle (152) [i.e. puncture device] (paragraphs [0044], [0054]-[0055], note that a puncture device user input indicating a puncture device present in the ultrasound image is received and a model corresponding to the device is selected from a library (i.e. toolbox) of computer-generated device models, wherein it is inherent that such a library/toolbox of puncture devices would include stored characteristics of the puncture device, such as puncture height/length data; Figures 14-18). Such a surgical navigation system can significantly reduce the surgical time needed to perform a minimally invasive procedure, such as repair of a heart valve leaflet, and leads to more direct navigation paths to the target tissue which results in a safer procedure (paragraph [0061]). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the processor of the above combined references be further configured to receive a puncture device user input indicating a puncture device; determine, based on prestored puncture height data, a recommended puncture height for the puncture device indicated by the puncture device user input; generate a puncture reference marker indicating the recommended puncture height based on the prestored puncture height data; and output, to one or more image display devices, the first image data and the puncture reference marker overlaid over the one or more image frames at a location of the recommended puncture, as taught by Zentgraf et al., in order to significantly reduce the surgical time needed to perform a minimally invasive procedure, such as repair of a heart valve leaflet, and provide more direct navigation paths to the target tissue which results in a safer procedure (paragraph [0061]).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thiele et al. in view of Walker et al. and Hastings et al. as applied to claim 1 above, and further in view of Dormer et al. (“Image Guided Mitral Valve Replacement: Registration of 3D Ultrasound and 2D X-ray Images”, February 2020).
With regards to claim 18, as discussed above, the above combined references disclose a system comprising the apparatus of claim 1 [see the above rejection of claim 1]. Further, with regards to claim 19, Thiele et al. disclose that the one or more display devices include a first display image device (40) and wherein the instructions are configured to cause the one or more processors to output to the first image display device, the first image data including one or more reference markers generated from the first image data (paragraphs [0019]-[0020], referring to the scan converter overlaying a B-mode structural image with “colors corresponding to motion at points in the image field corresponding with their Doppler-estimated velocities to produce a color Doppler image which depicts the motion of tissue and blood flow in the image field”; paragraphs [0022]-[0025], [0030]-[0031], referring to the ultrasound image of mitral regurgitation [which is obtained from using the PISA technique], wherein the area and extent of the jet is depicted and a color bar is used with the different colors representing different velocity values, with a +/- velocity associated with a particular flow direction, and thus a magnitude and direction of the regurgitant flow is depicted via the color overlay; Figures 1, 8). Additionally, with regards to claim 20, Thiele et al. disclose that the first imaging device is an echocardiography device (paragraph [0016], referring to the transducer array providing scanning of the mitral valve [which is in the heart], and thus the transducer array is an echocardiography device).
However, Thiele et al. do not specifically disclose that their system further comprises a second imaging device, wherein the instructions are configured to cause the one or more processors to receive, from the second imaging device, second image data of a plurality of image frames of the target heart valve; co-register the first image data with the second image data; and output, to one or more image display devices, at least portions of the first image data and the second image data overlaid on one another in a composite image. Additionally, with regards to claims 19-20, Thiele et al. do not specifically disclose that the one or more image display devices include a second image display device, and wherein the instructions are configured to cause the one or more processors to output, to the second image display device, the second image data and the one or more reference markers generated form the first image data overlaid on the second image data and that the second imaging device is one of a fluoroscopy device, a contrast-flow MRI device or a CT device.
Dormer et al. disclose registering 3D ultrasound to fluoroscopy images [acquired using a “second imaging device”] acquired during a mitral valve repair or replacement procedure in order to allow a physician to gain a greater understanding of the mitral valve region during transcatheter mitral valve replacement surgery, wherein one of the most common cardiac valve-related diseases is mitral regurgitation which requires the mitral valve to be repaired (Abstract; pg. 1, Section “Introduction”; pg. 3, Section 2.3, further, note that a fluoroscopy imaging device is inherently required for acquiring the fluoroscopy images). A graphical user interface (i.e. second image display device) allows the registration of two co-planar X-ray images with 3D ultrasound during the mitral valve replacement surgery (Abstract; pg. 3, Section 2.3). After the registration is completed, a GUI displays the registered images, wherein the ultrasound volume can be overlaid onto the X-ray image (pg. 3, Section 2.3, pg. 4, Section 2.4; Figure 8 [see caption, Figure 8B depicts the registered composite image]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of Thiele et al. further comprise a second imaging device, wherein the instructions are configured to cause the one or more processors to receive, from the second imaging device, second image data of a plurality of image frames of the target heart valve; co-register the first image data with the second image data; and output, to one or more image display devices, at least portions of the first image data and the second image data overlaid on one another in a composite image [claim 18] and further have the one or more image display devices include a second image display device, and wherein the instructions are configured to cause the one or more processors to output, to the second image display device, the second image data and the one or more reference markers generated form the first image data overlaid on the second image data and that the second imaging device is one of a fluoroscopy device, a contrast-flow MRI device or a CT device [claims 19, 20], as taught by Dormer et al., in order to allow a physician to gain a greater understanding of the mitral valve region during transcatheter mitral valve replacement surgery, wherein one of the most common cardiac valve-related diseases is mitral regurgitation which requires the mitral valve to be repaired (Abstract).
Allowable Subject Matter
Claims 9 and 12-13 are allowed.
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to claim 12, the prior art does not teach or suggest detecting an edge of a leaflet of the target heart valve from the offset image data; interpolate, from the offset image data, a position of the edge of the leaflet in the image plane; generate an edge reference marker indicating the edge of the leaflet in the image plane; and output, to one or more image display devices, the first image data with the generated reference marker displayed in a position and orientation that indicates a position and the direction of the regurgitant flow, and with the generated edge reference marker displayed when the user input indicating to detect leaflet edges is received, wherein a position of the edge reference marker in the first image data corresponds to the interpolated position of the edge of the leaflet, in combination with the other claimed elements.
With regards to claim 9, the prior art does not teach or suggest generate a second reference marker based on the second image data, wherein the target heart valve is a mitral valve, the second angle is from one of a short-axis base view or a four- chamber view, and the second reference marker is configured to identify at least one of a left atrium, right atrium, superior vena cava, or a height from a transeptal crossing to the mitral valve; and output, to the one or more image display devices, a composite image, with the generated first reference marker displayed in a position and orientation that indicates a position and direction of the regurgitant flow and the generated second reference marker both displayed on the composite image, in combination with the other claimed elements.
With regards to claim 23, the prior art does not teach or suggest that the reference marker indicates a range of the regurgitant flow “by a width of the arrow”, in combination with the other claimed elements.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 12-15 and 17-23 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. Hastings has been introduced to teach that the recommended trajectory is specifically “for the transeptal crossing”.
With regards to claim 6, previously applied Calkoen has been introduced to teach that the reference marker is in the form of a single arrow. Applicant argues that the multiple streamlines of Calkoen are not a reference marker in the form of a single arrow as claimed, wherein the analysis tools used are to measure angles and not reference markers output on display markers.
Examiner respectfully disagrees and notes that as depicted in Figure 1 of Calkoen, the jet angle in Figure 1C and 1D are depicted as the angle between the displayed arrow and the black dots [which represent the annulus plane as set forth in the caption of Figure 1], and thus it is clear in Figure 1 that the displayed arrows and corresponding direction represent the direction of the regurgitant jet flow and the arrows further take on the color of the jet, with the colors representing a velocity/magnitude value of the jet, and thus the color of the jet represents the magnitude of the regurgitant flow; Figure 1). Further, claim 6 is rejected under the combination of Thiele and Calkoen, wherein Thiele discloses that the reference marker is output on display images. As such, even if it’s not clear that the depicted single arrow in Calkoen is output on the display images, the single arrow of Calkoen does indicate each of the direction and magnitude of the regurgitant flow, and therefore the displayed/outputted reference marker of Thiele can be modified in view of Calkloen to be in the form of a single arrow, thus meeting the limitation.
With regards to claim 1, Applicant argues that Walker does not teach a transeptal crossing or needle procedures.
However, the claims previously only referred to the recommended location being determined “for a transeptal crossing by a needle”, which encompasses a location for a target which may be accessed by a transeptal crossing. Walker discloses in column 1, lines 42-45 that aortic valve repairs may be accomplished via entering the patient’s vasculature via a small incision in the femoral artery, wherein such a path through the femoral artery to the aorta would require a septum to be crossed, and thus the end location for such a path requiring the transeptal crossing would be met by Thiele. Claims have been additionally been amended to set forth that a recommended trajectory for the transeptal crossing is generating, thus requiring the actual trajectory/path corresponding to a transeptal crossing to be generated and Hastings has been introduced to teach this. Walker further discloses in column 8, lines 33-38 that the instrument may be a biopsy needle, and thus the transeptal crossing can be “by a needle”.
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.
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798