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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 Apr 2026 has been entered.
Response to Arguments
Applicant’s arguments, see pg. 6, filed 24 Apr 2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 24 Feb 2026 have been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 6-9, filed 24 Apr 2026, with respect to the 35 U.S.C. 112 rejections have been fully considered but are not persuasive in part.
Regarding independent claims 1 and 12, Applicant argues, see pg. 8, that “the
Specification, Figures, and Claims repeatedly and consistently teach that, in biplane mode, "two image planes are scanned simultaneously in an interleaved manner," producing side-by-side long- axis and transverse views. Applicant respectfully submits that Fig. 9 steps 903-905 and the related text reasonably read as an operator workflow for setting Doppler direction/angle and acquiring the second plane “at a plane in the Doppler line direction” of the first, which is exactly the claimed relationship between the biplane images and the Doppler line/beam direction”. However, Examiner respectfully disagrees. The amended limitations "wherein the ultrasound probe is further adapted to simultaneously acquire in a time-interleaved manner a long axis view of a vessel in a first image, and a transverse view of the vessel in a second image" in claim 1 and "scanning with the ultrasound probe in the biplane mode to simultaneously acquire in a time-interleaved manner a second Doppler image in a transverse view of the target vessel in an image plane aligned with a Doppler angle of the first Doppler image" in claim 12 each explicitly recites the contradiction of "simultaneously" yet "in a time-interleaved manner" in performing an ultrasound scan. A review of the specification of the instant application does not disclose any special definition to the term "simultaneously" nor the phrase "time-interleaved manner". The term "simultaneously" is well known in the art to mean "at the same time" or "concurrently", and the phrase "time-interleaved manner" is well known in the art to mean "alternating in time" (see previously provided Advisory Action Appendix of Merriam-Webster dictionary definitions). Per Applicant’s argument with respect to steps 903-905 in Fig. 9 of the instant application, first Doppler image is acquired in step 903 then second Doppler image is acquired in step 905: these steps are in “a time-interleaved manner”, not “simultaneously”. Therefore, the metes and bounds of the claims are still unclear in view of “simultaneously acquire in a time-interleaved manner”. See the 35 U.S.C. 112 (b) rejections to the independent claims 1 and 12 below.
The 35 U.S.C. 112(b) rejections to specifically claims 2, 13, and 16-18 of 24 Feb 2026 have been withdrawn in view of the amended claims.
Applicant's arguments, see pg. 9-11, filed 24 Apr 2026 with respect the 35 U.S.C. 103 rejections have been fully considered but are not persuasive.
Regarding independent claim 1, Applicant argues, see pg. 9, that "volume flow calculator is for determining a measure of volume flow and not just flow velocity. Such determination requires an understanding of flow variation over the cross-section of the vessel ... by scanning with a plurality of parallel Doppler beams, volume flow calculation across a non-circular or turbulent vessel cross-section would be more accurate". However, the Examiner respectfully disagrees. As previously explained in the Advisory Action of 11 May 2026, Applicant is reminded that Applicant explicitly defines "volume flow" to be a value calculated from Gauss's theorem formula disclosed in pg. 13 of the specification of the instant application (also explicitly recited in dependent claim 10):
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. Applicant even admits in pg. 10 that Sumanaweera discloses calculating a volume flow: “Sumanaweera et al. teach the calculation of Volume Flow by an equation having an integration of a flow velocity across an axis of a structure”. Therefore, Applicant’s argument with respect to “volume flow” is unclear, as it even contradicts the claimed and disclosed formula for the volume flow.
Applicant additionally argues, see pg. 10, that "none of Sumanaweera et al. Jago et al., Routh et al., and Frisa et al. teach or suggest using parallel Doppler beams to determine volume flow". However, the Examiner respectfully disagrees. As previously explained in the Advisory Action, Claim 1 merely recites "a volume flow calculator, responsive to Doppler image data of the second one of the Doppler images and a Doppler angle established by the user-provided Doppler line and the user-provided flow cursor displayed in the first image, adapted to determine an angle-corrected measure of the volume flow" without any specific algorithm associated with determining the angle-corrected measure of the volume flow. Furthermore, "responsive" under a broadest reasonable interpretation includes "after", that the limitation does not even specify the relationship between the Doppler image data and the Doppler angle established by the user-provided Doppler line and the user-provided flow cursor.
Applicant further argues, see pg. 10, that "None of Sumanaweera et al., Jago et al., Routh et al., nor Frisa et al. contemplate scanning an image plane with a plurality of parallel Doppler beams. Nowhere in any raised reference is there contemplation of the use of parallel Doppler beams." However, the Examiner respectfully disagrees. Jago at least discloses acquiring a Doppler image by scanning an image plane with a plurality of parallel Doppler beams transmitted in a Doppler beam direction (Fig. 2: color box 70 parallel to beam direction line 68; [0015]: Doppler interrogation is done inside the color box 70, Doppler beams for the spectral Doppler data are transmitted and received along the beam direction line 68, and vertical angle of color box 70 and beam direction line 68 are generally parallel). See the 35 U.S.C. 103 rejection to claim 1 below.
Regarding claims 2 and 8-19, Applicant argues, see pg. 11, that they "are patentable over the Sumanaweera et al., Jago et al. Frisa et al., and Routh et al. references under similar reasoning as provided in support of Claim 1". However, the Examiner respectfully disagrees at least for the reasons explained above for claim 1. Also, see the 35 U.S.C. 103 rejections to claims 2 and 8-19 below.
Status of Claims
Claims 1-2 and 8-19 are currently under examination. Claim 7 has been cancelled since the Final Office Action of 24 Feb 2026.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2 and 7-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “wherein the ultrasound probe is further adapted to simultaneously acquire in a time-interleaved manner a long axis view of a vessel in a first image, and a transverse view of the vessel in a second image”. As noted above in the Response to Arguments, the limitation explicitly recites the contradiction of "simultaneously" yet "in a time-interleaved manner" in performing an ultrasound scan. Steps 903-905 in Fig. 9 of the instant application disclose acquiring first Doppler image in step 903 then acquiring second Doppler image in step 905: these steps are in “a time-interleaved manner”, not “simultaneously”. A review of the specification of the instant application does not disclose any special definition to the term "simultaneously" nor the phrase "time-interleaved manner". The term "simultaneously" is well known in the art to mean "at the same time" or "concurrently", and the phrase "time-interleaved manner" is well known in the art to mean "alternating in time" (see previously provided Advisory Action Appendix of Merriam-Webster dictionary definitions). Claims 2 and 8-11 inherit the deficiency by the nature of their dependency on claim 1. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the ultrasound probe is further adapted to acquire in a time-interleaved manner a long axis view of a vessel in a first image, and a transverse view of the vessel in a second image”.
Claim 12 recites the limitation “scanning with the ultrasound probe in the biplane mode to simultaneously acquire in a time-interleaved manner a second Doppler image in a transverse view of the target vessel in an image plane aligned with a Doppler angle of the first Doppler image”. As noted above in the Response to Arguments, the limitation explicitly recites the contradiction of "simultaneously" yet "in a time-interleaved manner" in performing an ultrasound scan. Steps 903-905 in Fig. 9 of the instant application disclose acquiring first Doppler image in step 903 then acquiring second Doppler image in step 905: these steps are in “a time-interleaved manner”, not “simultaneously”. A review of the specification of the instant application does not disclose any special definition to the term "simultaneously" nor the phrase "time-interleaved manner". The term "simultaneously" is well known in the art to mean "at the same time" or "concurrently", and the phrase "time-interleaved manner" is well known in the art to mean "alternating in time" (see previously provided Advisory Action Appendix of Merriam-Webster dictionary definitions). Claims 13-15 inherit the deficiency by the nature of their dependency on claim 12. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “scanning with the ultrasound probe in the biplane mode to acquire in a time-interleaved manner a second Doppler image in a transverse view of the target vessel in an image plane aligned with a Doppler angle of the first Doppler image”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2 and 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera et al. (US Patent No. 6293914B1, provided by the Applicant in the IDS of 21 Oct 2022) – hereinafter referred to as Sumanaweera – in view of Jago et al. (US PG Pub No. 2015/0250453) – hereinafter referred to as Jago; and Routh et al. (EP0842638, a copy previously provided with the Non-Final Office Action of 01 Aug 2025) – hereinafter referred to as Routh.
Regarding claim 1, Sumanaweera discloses an ultrasonic diagnostic imaging system for analyzing volume flow of blood (at least Abstract and Fig. 1-2) comprising:
an ultrasound probe comprising a two-dimensional matrix array transducer (Fig. 7 and Col 9, lines 26-40 and line 61 - Col 10, line 5: two-dimensional transducer 80) adapted to acquire Doppler image data from two image planes intersecting along a Doppler beam direction (Fig. 6-7 and Col 9, lines 41-65: scan planes associated with views A and B substantially at or less than 90 degrees);
wherein the ultrasound probe is further adapted to acquire in a time-interleaved manner a long axis view of a vessel in a first image, and a transverse view of the vessel in a second image (Fig. 6a-c, 10a,d: views A,B; Col 9, lines 26-65: once positioned, the longitudinal view of the enclosed structure 32 associated with one scan plane 72 or 76 (e.g., view B) and another scan plane (e.g., view A), such as one of scan planes 70, 74, 78, is substantially perpendicular to the scan plane 72 or 76 are acquired; Fig. 5 and Col 6, line 46 – Col 7, line 5: subapertures A and B are each used to sequentially transmit ultrasound waves and receive echoes);
an image data processor (Fig. 2: signal processor 106 and scan converter 108) responsive to the acquired Doppler image data and adapted to produce two Doppler images of flow (Col 4, lines 18-33: provide Doppler estimates from the representative ultrasound data and formatting the estimates into a Cartesian coordinate system for display; Fig. 10a-b and Col 13, lines 39-43);
a display (Fig. 2: display 110) adapted to display the two Doppler images (Col 4, lines 34-38: scan converted ultrasound data representing the scan plane is displayed on display device; Fig. 10a-b and Col 13, lines 39-43);
a graphics generator (Fig. 2: processor 112) adapted to be responsive to a user control (Col 4, lines 60-64: user designates an ROI on a displayed ultrasound image; Col 13, lines 44-63) and adapted to display a user-provided Doppler line (Fig. 10b-d: vertical line 246 for axial insonification or horizontal line 244 for azimuthal insonification for Doppler imaging; Col 13, lines 44-63: user sizes vertical or horizontal line 244 to begin axial or azimuthal insonification) and a user-provided flow cursor over a first one of the Doppler images (Fig. 10c-d: cursor 244; Col 13, lines 44-63: user positions cursor 244 approximately at the center of the enclosed structure 32 along the horizonal line 240); and
a volume flow calculator (processor 112), responsive to Doppler image data of the second one of the Doppler images (Fig. 10a and Col 13, lines 39-43: image associated with cross-section view) and a Doppler angle established by the user-provided Doppler line and the user-provided flow cursor displayed in the first image (Fig. 10b-d and Col 13, lines 51-67: determine angle of flow at the cursor 244 along horizontal line 240 on longitudinal view), adapted to determine an angle-corrected measure of the volume flow (Col 5, lines 6-29: determine volume flow based on flow angle; Fig. 10e and Col 14, lines 1-20: volume flow is estimated).
Sumanaweera does not explicitly disclose:
the display adapted to display the two Doppler images simultaneously;
the user-provided Doppler line is obtained from a user manipulation of the ultrasound probe, and the user-provided flow cursor having a user-provided direction aligned with a displayed flow in a vessel as displayed by a first one of the Doppler images;
wherein the first image is acquired by scanning one of the image planes with a plurality of parallel Doppler beams transmitted in the Doppler beam direction, and
wherein the user-provided Doppler line is aligned with the Doppler beam direction.
Jago in the same field of analyzing a blood flow using Doppler imaging, however, teaches:
acquiring a Doppler image by scanning an image plane with a plurality of parallel Doppler beams transmitted in a Doppler beam direction (Fig. 2: color box 70 parallel to beam direction line 68; [0015]: Doppler interrogation is done inside the color box 70, Doppler beams for the spectral Doppler data are transmitted and received along the beam direction line 68, and vertical angle of color box 70 and beam direction line 68 are generally parallel);
displaying two Doppler images simultaneously (Fig. 4: two biplane images 42 and 44 each with a Doppler beam line 68);
obtaining a user-provided Doppler line (Fig. 2, 4: Doppler beam line 68) from a user manipulation of the ultrasound probe (Fig. 3: steps 83-84 and [0016]: in step 83, clinician tils probe 10 to ensure that the scan plane of the image intersects the vessel 64 at the location of peak flow velocity, and in step 84, once the clinician is confident she is imaging the peak velocity location, the PW (pulse wave) Doppler mode is activated to display the PW Doppler beam direction line 68; Fig. 4 and [0018]: clinician adjusts the positions of PW Doppler beam lines 68 displayed on left image 60a), and
wherein the user-provided Doppler line is aligned with a Doppler beam direction ([0016]: Once the clinician is confident she is imaging the peak velocity location, the PW Doppler mode is activated to display the PW Doppler beam direction line 68, thus the user-provided Doppler line is aligned with a Doppler beam direction at the peak velocity location; [0015]: Doppler beams for the spectral Doppler data are transmitted and received along the beam direction line 68).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sumanaweera’s system to include Jago’s transmission of parallel Doppler beams, simultaneous display of two images, and acquisition of a user-provided Doppler beam direction. The combination would have yielded a reasonable expectation of success, since both Sumanaweera and Jago are directed to biplane Doppler imaging. The motivation for the combination would have been “to maximize the PW Doppler signal strength and/or velocity, to ensure that the maximum flow velocities (and other parameters of blood flow) are being recorded in the spectral display”, as taught by Jago ([0016]).
Routh in the same field of calculating a volume flow additionally teaches:
a user-provided flow cursor (Fig. 4: cursor 1 comprising flow direction line 4) having a user-provided direction aligned with a displayed direction of flow in a vessel as displayed by a Doppler image (Fig. 4 and Col 3, lines 32-58: flow direction line 4 of cursor 1 is positioned by the user in line with the direction of blood flow through the vessel 70).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sumanaweera’s system to include Routh’s user-provided flow cursor. The combination would have yielded a reasonable expectation of success, since both Sumanaweera and Routh are directed to determining volume flow using Doppler imaging. The motivation for the combination would have been “alignment of the line 4 with the direction of flow assures that a second line 5, orthogonal to the flow direction line 4, is orthogonal to the walls of the vessel. This is important, as the line 5 is a line which is intended to delineate the diameter of the vessel 70. Since the diameter of the vessel must be normal to the vessel walls, the orthogonal relationship between the diameter line 5 and the flow direction line 4 assures that the line 5 depicts the vessel diameter, and not some skewed chord line across the vessel. Correspondingly, when the diameter line 5 is normal to the vessel walls 72,74, the orthogonal flow direction line is properly aligned with the direction of flow”, as taught by Routh (Col 3, lines 38-58).
Regarding claim 2, Sumanaweera in view of Jago and Routh discloses all limitations of claim 1, as discussed above, and Sumanaweera further discloses:
wherein the user-provided Doppler line is aligned with the Doppler beam direction in the first image (Col 13, lines 58-68: vertical line 246 for axial insonification or horizontal line 244 for azimuthal insonification by one or more uniform transmit beams for axial or azimuthal insonification); and
wherein an image plane of the second image is aligned with the Doppler beam direction (Fig. 10a-d and Col 13, lines 39-68: horizontal line 240 is placed in the image 242 is at the same depth as the cursor 214).
Regarding claim 8, Sumanaweera in view of Jago and Routh discloses all limitations of claim 1, as discussed above, and Sumanaweera further discloses:
wherein the ultrasound probe is adapted to scan the two image planes at a selected nonorthogonal angle to a plane of the matrix array transducer (Col 13, lines 61-65: Scan plane associated with View A may be at an angle less than 90 degrees to the Scan plane associated with View B; Fig. 5 and Col 6, lines 5-16: scan lines 42, 44 within the same image plane are at different angles from the face of the transducer).
Regarding claim 9, Sumanaweera in view of Jago and Routh discloses all limitations of claim 1, as discussed above, and Sumanaweera further discloses:
wherein the ultrasound probe is adapted to scan an image plane at a selected nonorthogonal angle to a direction of flow (Fig. 5 and Col 6, lines 5-16: scan lines 42, 44 within the same image plane are at different angles from the face of the transducer; Fig. 10b-d: enclosed structure 32 at a non-orthogonal angle from image plane).
Regarding claim 10, Sumanaweera in view of Jago and Routh discloses all limitations of claim 1, as discussed above, and Sumanaweera further discloses:
wherein the volume flow calculator is further adapted to calculate an algorithm of the form
Q
=
∫
S
v
∙
d
A
where Q is the volume flow, v is the angle-corrected flow velocity, dA is an area of the vessel over which a Doppler value integration is to occur, and surface S is a cut plane through the vessel containing Doppler data (Col 3, lines 11-32).
Regarding claim 11, Sumanaweera in view of Jago and Routh discloses all limitations of claim 10, as discussed above, and Sumanaweera further discloses:
wherein the volume flow calculator is further adapted to sum values of angle-corrected Doppler data within a lumen of the vessel (Col 9, lines 10-24: instantaneous volume flow calculation is repeated in real time, and average of instantaneous volume flow quantities is calculated and displayed).
It is noted that averaging is well known in the art to require summing.
Regarding claim 12, Sumanaweera discloses a method of using an ultrasonic diagnostic imaging system to conduct an ultrasound exam to measure volume flow (at least Abstract and Fig 1-2) comprising:
scanning with an ultrasound probe adapted to operate in a biplane mode to acquire a first Doppler image of a target vessel in a long axis view (Fig. 6-7 and Col 9, lines 41-65: scan planes associated with views A and B substantially at or less than 90 degrees, wherein view B is longitudinal view of the enclosed structure 32);
scanning with the ultrasound probe in the biplane mode to acquire in a time-interleaved manner a second Doppler image in a transverse view of the target vessel in an image plane aligned with a Doppler angle of the first Doppler image (Fig. 6a-c, 10a,d: views A,B; Col 9, lines 26-65: view A is one of scan planes 70, 74 or 78, is substantially perpendicular to the scan plane 72 or 76 associated with view B; Fig. 5 and Col 6, line 46 – Col 7, line 5: subapertures A and B are each used to sequentially transmit ultrasound waves and receive echoes);
displaying the first Doppler image and the second Doppler image (Col 4, lines 34-38: scan converted ultrasound data representing the scan plane is displayed on display device; Fig. 10a-b and Col 13, lines 39-43);
manually setting an adjustable user-provided flow cursor in the displayed first Doppler image (Fig. 10c-d and Col 13, lines 51-67: user positions cursor 244 approximately at the center of the enclosed structure 32 along the horizontal line 240 for determination of angle of flow);
determining angle correction in accordance with a user-provided Doppler beam direction (Fig. 10b-d: vertical line 246 for axial insonification or horizontal line 244 for axial or azimuthal insonification for Doppler imaging; Col 13, lines 44-63: user sizes vertical or horizontal line 244 to begin axial or azimuthal insonification) and the flow cursor of the first Doppler image (Col 13, lines 44-67: system 100 determines the angle of flow at the cursor 244 and estimates volumes flow based on the cursor 244 and vertical or horizontal line 244 or 246 of axial or azimuthal insonification); and
calculating volume flow from data of the second Doppler image using angle correction determined from the first Doppler image (Col 13, lines 39-67: based on cursors 214, 244 in cross-section and longitudinal images, respectively, angle of flow is determined at the cursor 244 for insonification and volume flow is estimated).
Sumanaweera does not explicitly disclose:
wherein the first image is acquired by scanning one of the image planes with a plurality of parallel Doppler beams transmitted in a direction of a user-provided Doppler beam direction;
displaying the first Doppler image and the second Doppler image simultaneously; and
manually setting a flow direction with the adjustable user-provided flow cursor having a line aligned with the flow direction.
Jago in the same field of analyzing a blood flow using Doppler imaging, however, teaches:
acquiring a Doppler image by scanning an image plane with a plurality of parallel Doppler beams transmitted in a Doppler beam direction (Fig. 2: color box 70 parallel to beam direction line 68; [0015]: Doppler interrogation is done inside the color box 70, Doppler beams for the spectral Doppler data are transmitted and received along the beam direction line 68, and vertical angle of color box 70 and beam direction line 68 are generally parallel);
displaying two Doppler images simultaneously (Fig. 4: two biplane images 42 and 44 each with a Doppler beam line 68);
obtaining a user-provided Doppler beam direction (Fig. 2, 4: Doppler beam line 68) for acquiring a Doppler image (Fig. 3: steps 83-84 and [0016]: in step 83, clinician tils probe 10 to ensure that the scan plane of the image intersects the vessel 64 at the location of peak flow velocity, and in step 84, once the clinician is confident she is imaging the peak velocity location, the PW (pulse wave) Doppler mode is activated to display the PW Doppler beam direction line 68, thus the user-provided Doppler line is aligned with a Doppler beam direction at the peak velocity location; [0015]: Doppler beams for the spectral Doppler data are transmitted and received along the beam direction line 68; Fig. 4 and [0018]: clinician adjusts the positions of PW Doppler beam lines 68 displayed on left image 60a).
It is noted that “a user-provided Doppler beam direction” recited in the claim has been given a broadest reasonable interpretation to include a user manipulation of the ultrasound probe in acquiring the first Doppler image. As noted above, Jago discloses a user manipulating the ultrasound probe in providing a Doppler beam direction for acquiring a Doppler image.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sumanaweera’s method to include Jago’s transmission of parallel Doppler beams, simultaneous display of two images, and acquisition of a user-provided Doppler beam direction. The combination would have yielded a reasonable expectation of success, since both Sumanaweera and Jago are directed to biplane Doppler imaging. The motivation for the combination would have been “to maximize the PW Doppler signal strength and/or velocity, to ensure that the maximum flow velocities (and other parameters of blood flow) are being recorded in the spectral display”, as taught by Jago ([0016]).
Routh in the same field of calculating a volume flow using Doppler imaging further teaches:
manually setting a flow direction with the adjustable user-provided flow cursor having a line aligned with the flow direction (Fig. 4: cursor 1 comprising flow direction line 4; Col 3, lines 32-58: flow direction line 4 of cursor 1 is positioned by the user in line with the direction of blood flow through the vessel 70).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sumanaweera’s method to include Routh’s method of manually setting a flow direction. The combination would have yielded a reasonable expectation of success, since both Sumanaweera and Routh are directed to determining volume flow using Doppler imaging. The motivation for the combination would have been “alignment of the line 4 with the direction of flow assures that a second line 5, orthogonal to the flow direction line 4, is orthogonal to the walls of the vessel. This is important, as the line 5 is a line which is intended to delineate the diameter of the vessel 70. Since the diameter of the vessel must be normal to the vessel walls, the orthogonal relationship between the diameter line 5 and the flow direction line 4 assures that the line 5 depicts the vessel diameter, and not some skewed chord line across the vessel. Correspondingly, when the diameter line 5 is normal to the vessel walls 72,74, the orthogonal flow direction line is properly aligned with the direction of flow”, as taught by Routh (Col 3, lines 38-58).
Regarding claim 13, Sumanaweera in view of Jago and Routh discloses all limitations of claim 12, as discussed above, and Sumanaweera further discloses:
manually adjusting the Doppler beam direction for the first Doppler image (Fig. 10b-d: vertical line 246 for axial insonification or horizontal line 244 for azimuthal insonification for Doppler imaging; Col 13, lines 44-63: user sizes vertical or horizontal line 244 to begin axial or azimuthal insonification) to intersect the flow direction at a nonorthogonal angle (Fig. 10b-d and Col 13, lines 44-55: user moves transducer 200 in the elevation dimension where horizontal line 240 is non-orthogonal to the enclosed structure 32 and horizontal line 244 is confirmed by the user for the system 100 to generate one or more uniform transmit beams of insonification).
Regarding claim 14, Sumanaweera in view of Jago and Routh discloses all limitations of claim 13, as discussed above, and Sumanaweera further discloses:
segmenting a blood flow in the second Doppler image with a template (Fig. 10a and Col 12, lines 27-34: region of interest around the enclosed structure is automatically determined).
It is noted that although Sumanaweera does not explicitly disclose a template, Sumanaweera's automatic determination of the region of interest inherently requires a template, or a reference, in determining the region of interest.
Regarding claim 15, Sumanaweera in view of Jago and Routh discloses all limitations of claim 13, as discussed above, and Sumanaweera further discloses:
wherein calculating the volume flow further comprises integrating flow value pixels of the target vessel in the second image (Col 4, lines 60-64: user designated region of interest corresponds to pixels associated with the enclosed structure for calculation of volume flow; Fig. 3(a) and Col 5, lines 6-29: instantaneous volume flow calculated across thickness of intersection 38).
Regarding claim 16, Sumanaweera discloses an ultrasonic diagnostic imaging system for analyzing volume flow of blood (at least Abstract and Fig. 1-2) comprising:
an image data processor (Fig. 2: signal processor 106 and scan converter 108) responsive to an input of acquired Doppler image data from two image planes intersecting along a Doppler beam direction (Fig. 6a-c: intersection between scan planes 72, 74 or 76, 78; Col 9, lines 26-60) and adapted to produce two Doppler images of flow (Col 4, lines 18-33: provide Doppler estimates from the representative ultrasound data and formatting the estimates into a Cartesian coordinate system for display; Fig. 10a-b and Col 13, lines 39-43);
a display (Fig. 2: display 110) adapted to display the two Doppler images (Col 4, lines 34-38: scan converted ultrasound data representing the scan plane is displayed on display device; Fig. 10a-b and Col 13, lines 39-43);
a graphics generator (Fig. 2: processor 112) adapted to be responsive to a user control (Col 4, lines 60-64: user designates an ROI on a displayed ultrasound image; Col 13, lines 44-63) and adapted to display a user-provided Doppler line (Fig. 10b-d: vertical line 246 for axial insonification or horizontal line 244 for azimuthal insonification for Doppler imaging; Col 13, lines 44-63: user sizes vertical or horizontal line 244 to begin axial or azimuthal insonification) and a user-provided flow cursor over a first one of the Doppler images (Fig. 10c-d: cursor 244; Col 13, lines 44-63: user positions cursor 244 approximately at the center of the enclosed structure 32 along the horizonal line 240); and
a volume flow calculator (processor 112), responsive to Doppler image data of the second one of the Doppler images (Fig. 10a and Col 13, lines 39-43: image associated with cross-section view) and a Doppler angle established by the user-provided Doppler line and the user-provided flow cursor displayed in the first image (Fig. 10b-d and Col 13, lines 51-67: determine angle of flow at the cursor 244 along horizontal line 240 on longitudinal view), adapted to determine an angle-corrected measure of the volume flow (Col 5, lines 6-29: determine volume flow based on flow angle; Fig. 10e and Col 14, lines 1-20: volume flow is estimated).
Sumanaweera does not explicitly disclose:
the display adapted to display the two Doppler images simultaneously;
the user-provided Doppler line is obtained from a user manipulation of the ultrasound probe, and the user-provided flow cursor having a user-provided direction aligned with a displayed flow in a vessel as displayed by a first one of the Doppler images;
wherein the first one of the Doppler images is acquired by scanning one of the image planes with a plurality of parallel Doppler beams transmitted in the direction of the Doppler beam.
Jago in the same field of analyzing a volume flow using Doppler imaging, however, teaches:
acquiring a Doppler image by scanning an image plane with a plurality of parallel Doppler beams transmitted in a Doppler beam direction (Fig. 2: color box 70 parallel to beam direction line 68; [0015]: Doppler interrogation is done inside the color box 70, Doppler beams for the spectral Doppler data are transmitted and received along the beam direction line 68, and vertical angle of color box 70 and beam direction line 68 are generally parallel);
displaying two Doppler images simultaneously (Fig. 4: two biplane images 42 and 44 each with a Doppler beam line 68);
obtaining a user-provided Doppler line (Fig. 2, 4: Doppler beam line 68) from a user manipulation of the ultrasound probe (Fig. 3: steps 83-84 and [0016]: in step 83, clinician tils probe 10 to ensure that the scan plane of the image intersects the vessel 64 at the location of peak flow velocity, and in step 84, once the clinician is confident she is imaging the peak velocity location, the PW (pulse wave) Doppler mode is activated to display the PW Doppler beam direction line 68; Fig. 4 and [0018]: clinician adjusts the positions of PW Doppler beam lines 68 displayed on left image 60a), and
wherein the user-provided Doppler line is aligned with a direction of the Doppler line ([0016]: Once the clinician is confident she is imaging the peak velocity location, the PW Doppler mode is activated to display the PW Doppler beam direction line 68, thus the user-provided Doppler line is aligned with a Doppler beam direction at the peak velocity location; [0015]: Doppler beams for the spectral Doppler data are transmitted and received along the beam direction line 68).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sumanaweera’s system to include Jago’s transmission of parallel Doppler beams, simultaneous display of two images, and acquisition of a user-provided Doppler beam direction. The combination would have yielded a reasonable expectation of success, since both Sumanaweera and Jago are directed to biplane Doppler imaging. The motivation for the combination would have been “to maximize the PW Doppler signal strength and/or velocity, to ensure that the maximum flow velocities (and other parameters of blood flow) are being recorded in the spectral display”, as taught by Jago ([0016]).
Routh in the same field of calculating a volume flow additionally teaches:
a user-provided flow cursor (Fig. 4: cursor 1 comprising flow direction line 4) having a user-provided direction aligned with a displayed flow in a vessel as displayed by a Doppler image (Fig. 4 and Col 3, lines 32-58: flow direction line 4 of cursor 1 is positioned by the user in line with the direction of blood flow through the vessel 70).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sumanaweera’s system to include Routh’s user-provided flow cursor. The combination would have yielded a reasonable expectation of success, since both Sumanaweera and Routh are directed to determining volume flow using Doppler imaging. The motivation for the combination would have been “alignment of the line 4 with the direction of flow assures that a second line 5, orthogonal to the flow direction line 4, is orthogonal to the walls of the vessel. This is important, as the line 5 is a line which is intended to delineate the diameter of the vessel 70. Since the diameter of the vessel must be normal to the vessel walls, the orthogonal relationship between the diameter line 5 and the flow direction line 4 assures that the line 5 depicts the vessel diameter, and not some skewed chord line across the vessel. Correspondingly, when the diameter line 5 is normal to the vessel walls 72,74, the orthogonal flow direction line is properly aligned with the direction of flow”, as taught by Routh (Col 3, lines 38-58).
Regarding claim 17, Sumanaweera in view of Jago and Routh discloses all limitations of claim 16, as discussed above, and Sumanaweera further discloses:
wherein the image plane of the second one of the Doppler images is aligned with the direction the Doppler line (Fig. 10a-d and Col 13, lines 39-68: horizontal line 240 is placed in the image 242 is at the same depth as the cursor 214).
Regarding claim 18, Sumanaweera in view of Jago and Routh discloses all limitations of claim 16, as discussed above, and Sumanaweera further discloses:
wherein the volume flow calculator is further adapted to calculate an algorithm of the form
Q
=
∫
S
v
∙
d
A
where Q is the volume flow, v is the angle-corrected flow velocity, dA is an area of the vessel over which a Doppler value integration is to occur, and surface S is a cut plane through the vessel containing Doppler data (Col 3, lines 11-32).
Regarding claim 19, Sumanaweera in view of Jago and Routh discloses all limitations of claim 10, as discussed above, and Sumanaweera further discloses:
wherein the volume flow calculator is further adapted to sum values of angle-corrected Doppler data within a lumen of the vessel (Col 9, lines 10-24: instantaneous volume flow calculation is repeated in real time, and average of instantaneous volume flow quantities is calculated and displayed).
It is noted that averaging is well known in the art to require summing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Koch et al. (US PG Pub No. 2014/0098049) discloses a user manipulation of Doppler line and flow cursor via a user interface (at least Fig. 3C-D: Doppler line 332 and Doppler gate 334; [0034]-[0040]).
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
5/25/26
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