DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see pg. 6, filed 03 Nov 2025, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 01 Aug 2025 have been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 7-12, filed 03 Nov 2025, with respect to the 35 U.S.C. 103 rejections have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Status of Claims
Claims 1-2 and 7-19 are currently under examination. Claims 4-5 have been cancelled since the Non-Final Office Action of 01 Aug 2025.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
“the image planes” should read “the two image planes” (claim 1); and
“the first image” should read “the first Doppler image” (claim 12).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 7-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended claim 1 recites the limitations “wherein the ultrasound probe is further adapted to simultaneously acquire a long axis view of a vessel in a first image, and a transverse view of the vessel in a second image” and “a graphics generator adapted to be responsive to a user control and adapted to display a user-provided Doppler line that is obtained from a user manipulation of the ultrasound probe”. A review of the original specification of the instant application, however, discloses each of these two limitations in two mutually exclusive embodiments, thus the amended claim 1 is not supported by a single embodiment of the original specification and introduces a new matter. In particular, regarding the new limitation “a graphics generator adapted to be responsive to a user control and adapted to display a user-provided Doppler line that is obtained from a user manipulation of the ultrasound probe”, the original specification discloses in Fig. 9 and in pg. 20, lines 16-23 that the first image is acquired at step 903, the Doppler line is adjusted by a user manipulation of the probe at step 904, and then the second image is acquired based on the user manipulation of the probe at step 905. Thus, the first and second images are acquired sequentially. However, the limitation “wherein the ultrasound probe is further adapted to simultaneously acquire a long axis view of a vessel in a first image, and a transverse view of the vessel in a second image” also in claim 1 requires that both the first and second images are acquired simultaneously, which contradicts sequential acquisition of the first and second images according to the embodiment disclosing the user-provided Doppler line that is obtained from a user manipulation of the ultrasound probe. Claims 2 and 7-11 inherit the deficiency by the nature of their dependency on claim 1.
Amended claim 12 recites the limitations “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; scanning with the ultrasound probe in the biplane mode to simultaneously acquire a second Doppler image in a transverse view of the target vessel in an image plane aligned with a Doppler angle of the first image” and “wherein the first image is acquired by scanning the image plane with a plurality of parallel Doppler beams transmitted in a given direction, and wherein the user-provided Doppler line is aligned with the direction of the Doppler beams”. A review of the original specification of the instant application, however, discloses each of these two limitations in two mutually exclusive embodiments, thus the amended claim 12 is not supported by a single embodiment of the original specification and introduces new matter. In particular, regarding the new limitation “wherein the first image is acquired by scanning the image plane with a plurality of parallel Doppler beams transmitted in a given direction, and wherein the user-provided Doppler line is aligned with the direction of the Doppler beams”, the original specification discloses in Fig. 9 and in pg. 20, lines 16-23 that the first image is acquired at step 903, the Doppler line is adjusted by a user manipulation of the probe at step 904, and then the second image is acquired based on the user manipulation of the probe at step 905. Thus, the first and second images are acquired sequentially. However, the limitation “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; scanning with the ultrasound probe in the biplane mode to simultaneously acquire a second Doppler image in a transverse view of the target vessel in an image plane aligned with a Doppler angle of the first image” also in claim 16 requires that both the first and second images are acquired simultaneously, which contradicts sequential acquisition of the first and second images according to the embodiment disclosing the user-provided Doppler line. Claims 13-15 inherit the deficiency by the nature of their dependency on claim 12.
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 limitations “wherein the ultrasound probe is further adapted to simultaneously acquire a long axis view of a vessel in a first image, and a transverse view of the vessel in a second image” and “a graphics generator adapted to be responsive to a user control and adapted to display a user-provided Doppler line that is obtained from a user manipulation of the ultrasound probe”. As noted above in the 35 U.S.C. 112(a) rejections, the claimed subject matter combines mutually exclusive embodiments disclosed in the original specification of the instant application. Thus, there is a conflict or inconsistency between the claimed subject matter and the original specification disclosure, which renders the scope of the claimed uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP 2173.03 and In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ 236, 239 (CCPA 1971); In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In re Hammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970). For purposes of the examination, a broadest reasonable interpretation is being given to claim 1 to recite “wherein the ultrasound probe is further adapted to acquire a long axis view of a vessel in a first image, and a transverse view of the vessel in a second image”.
Claim 1 recites the new limitation “a user-provided flow cursor having a user-provided direction aligned with a displayed direction of flow in a vessel as displayed by a first one of the Doppler images”. It is unclear whether “a vessel” recited in the limitation is the same or different from “a vessel” recited in lines 5-6 of claim 1. Claims 2 and 7-11 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 “a user-provided flow cursor having a user-provided direction aligned with a displayed direction of flow in the vessel as displayed by a first one of the Doppler images”.
Claim 1 recites the new limitations “wherein the first image is acquired by scanning one of the image planes with a plurality of parallel Doppler beams transmitted in a given direction” and “wherein the user-provided Doppler line is aligned with the direction of the Doppler beams”. It is unclear whether “a given direction” and “the direction of the Doppler beams” are each the same or different from “a Doppler beam direction” recited in line 4 of claim 1. Claims 2 and 7-11 inherit the deficiency by the nature of their dependency on claim 1. For purposes of the examination, a broadest reasonable interpretation is being given to “a given direction” in the limitation to include “a Doppler beam direction” recited in line 4 of claim 1.
Claim 2 recites the limitation “wherein the image plane of the second image is aligned with …” The antecedent basis for “the image plane of the second image” is unclear. In particular, claim 1, to which claim 2 depends, recites “wherein the first image is acquired by scanning one of the image planes with a plurality of parallel Doppler beams …”. Thus, it is unclear whether “the image plane of the second image” should read “an image plane of the second image” or “the image plane of the first image”. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein an image plane of the second image is aligned with …”
Claim 2 recites the limitations “the direction of the Doppler beams”. As noted above in claim 1, the antecedent basis for “the direction of the Doppler beams” is unclear. It is unclear whether “the direction of the Doppler beams” is the same or different from “a Doppler beam direction” recited in line 4 of claim 1. For purposes of the examination, a broadest reasonable interpretation is being given to “the direction of the Doppler beams” in the limitation to include “a Doppler beam direction” recited in line 4 of claim 1.
Claim 12 recites the limitations “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; scanning with the ultrasound probe in the biplane mode to simultaneously acquire a second Doppler image in a transverse view of the target vessel in an image plane aligned with a Doppler angle of the first image” and “wherein the first image is acquired by scanning the image plane with a plurality of parallel Doppler beams transmitted in a given direction, and wherein the user-provided Doppler line is aligned with the direction of the Doppler beams”. As noted above in the 35 U.S.C. 112(a) rejections, the claimed subject matter combines mutually exclusive embodiments disclosed in the original specification of the instant application. Thus, there is a conflict or inconsistency between the claimed subject matter and the original specification disclosure, which renders the scope of the claimed uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP 2173.03 and In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ 236, 239 (CCPA 1971); In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In re Hammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970). For purposes of the examination, a broadest reasonable interpretation is being given to claim 12 to recite “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; scanning with the ultrasound probe in the biplane mode to acquire a second Doppler image in a transverse view of the target vessel in an image plane aligned with a Doppler angle of the first image”.
Claim 12 recites the limitation “wherein the first image is acquired by scanning the image plane with a plurality of parallel Doppler beams transmitted in a given direction”. The antecedent basis for “the image plane” in the limitation is unclear. In particular, claim 12 also recites “scanning with the ultrasound probe in the biplane mode to simultaneously acquire a second Doppler image in a transverse view of the target vessel in an image plane aligned with a Doppler angle of the first image”. Thus, the antecedent basis for “the image plane” appears to be for an image plane of the second Doppler image, but the limitation recites “wherein the first image is acquired by scanning the image plane with a plurality of parallel Doppler beams transmitted in a given direction”, suggesting that the image plane is associated with the first image, not the second image. 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 “wherein the first image is acquired by scanning an image plane with a plurality of parallel Doppler beams transmitted in a given direction”.
Claim 12 recites the new limitations “wherein the first image is acquired by scanning the image plane with a plurality of parallel Doppler beams transmitted in a given direction” and “wherein the user-provided Doppler line is aligned with the direction of the Doppler beams”. First, it is unclear whether “a given direction” and “the direction of the Doppler beams” are each the same or different from “a user-provided Doppler beam direction” recited in line 13 of claim 12. Second, the antecedent basis for “the user-provided Doppler line” is unclear as it is first recited in claim 12. Claims 13-15 inherit the deficiency by the nature of their dependency on claim 12. For purposes of the examination, a broadest reasonable interpretation is being given to “a given direction” and “the direction of the Doppler beams” in the new limitations to include “a Doppler beam direction” recited in line 13 of claim 12, and “the user-provided Doppler line” in the new limitation is being given a broadest reasonable interpretation as “a user-provided Doppler line”.
Claim 13 recites the limitations “the direction of the Doppler beams”. As noted above in claim 12, the antecedent basis for “the direction of the Doppler beams” is unclear. It is unclear whether “the direction of the Doppler beams” is the same or different from “a user-provided Doppler beam direction” recited in line 13 of claim 12. Claim 14 inherits the deficiency by the nature of its dependency on claim 13. For purposes of the examination, a broadest reasonable interpretation is being given to “the direction of the Doppler beams” in the limitations to include “a Doppler beam direction” recited in line 13 of claim 12.
Claim 16 recites the new limitations “wherein the first image is acquired by scanning the image plane with a plurality of parallel Doppler beams transmitted in a given direction” and “wherein the user-provided Doppler line is aligned with the direction of the Doppler beams”. First, the antecedent basis for “the first image” is unclear. In particular, it is unclear whether “the first image” is referring to “a first one of the Doppler images” or not. Second, the antecedent basis for “the image plane” is unclear. It is unclear whether “the image plane” is referring to one of “two image planes” recited in lines 3-4 of claim 16; should read “the image planes”; or otherwise. Thirdly, it is unclear whether “a given direction” and “the direction of the Doppler beams” are each the same or different from “a Doppler beam direction” recited in line 4 of claim 16. Lastly, it is unclear whether “the user-provided Doppler line” is the same or different from “a Doppler line” recited in line 8 of claim 16. Claims 17-19 inherit the deficiency by the nature of their dependency on claim 16. For purposes of the examination, a broadest reasonable interpretation is being given to “the first image” in the new limitation as “the first one of the Doppler images”; “the image plane” in the new limitation as “one of the two image planes”; “a given direction” and the direction of the Doppler beams” in the new limitations to include “a Doppler beam direction” recited in line 4 of claim 16.
Claim 17 recites the limitations “the direction of the Doppler beam” and “the direction of the Doppler beam of the first image”. As noted above in claim 16, the antecedent basis for “the direction of the Doppler beam” in each of these limitations is unclear. It is unclear whether “the direction of the Doppler beam” is the same or different from “a Doppler beam direction” recited in line 8 of claim 16. For purposes of the examination, a broadest reasonable interpretation is being given to “the direction of the Doppler beam” in the limitations to include “a Doppler beam direction” recited in line 8 of claim 16.
Claim 17 recites the limitation “wherein the image plane of the second image is aligned with …” The antecedent basis for “the image plane” is unclear. In particular, claim 16, to which claim 17 depends, recites “wherein the first image is acquired by scanning the image plane with a plurality of parallel Doppler beams …”. Thus, it is unclear whether “the image plane of the second image” should read “an image plane of the second image” or “the image plane of the first image”. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein an image plane of the second image is aligned with …”
Claim 18 recites the limitation “dA is an area of a vessel over which a Doppler value integration is to occur”. It is unclear whether “a vessel” recited in the limitation is the same or different from “a vessel” recited in claim 16, to which claim 18 depends. For purposes of the examination, the limitation in claim 18 is being given a broadest reasonable interpretation as “dA is an area of the vessel over which a Doppler value integration is to occur”.
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 7-19 are rejected under 35 U.S.C. 103 as being unpatentable over Sumanaweera et al. (US Patent No. 6293914, 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; Routh et al. (EP0842638, a copy previously provided with the Non-Final Office Action of 01 Aug 2025) – hereinafter referred to as Routh; and Frisa et al. (US Patent No. 6709394, provided by the Applicant in the IDS of 21 Oct 2022) – hereinafter referred to as Frisa.
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 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);
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 a given direction, and
wherein the user-provided Doppler line is aligned with the direction of the Doppler beams.
Jago in the same field of analyzing a volume flow using Doppler imaging, however, teaches:
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 Doppler beams ([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 simultaneous display of two images and user-provided Doppler line. 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 measure the peak flow velocity, which is correlated with the degree of stenosis … (by) precisely visualiz(ing) the location of peak velocity blood flow”, as taught by Jago ([0002]).
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).
Frisa in the same field of Doppler imaging further teaches:
acquiring a Doppler image by scanning an image plane with a plurality of parallel Doppler beams transmitted in a given direction (Col 5, lines 21-37: steered linear scan formats are employed for Doppler imaging; Col 4, lines 12-21: echo signals for Doppler processing).
It is noted that, as the original specification of the instant application even acknowledges in pg. 5, lines 19-21, steered linear scanning is well known in the art for transmitting a plurality of parallel beams in a direction.
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 Frisa’s steered linear scanning. The combination would have yielded a reasonable expectation of success, since both Sumanaweera and Frisa are directed to Doppler imaging. The motivation for the combination would have been to steer transmitted and received beams in a direction and inclination in front of the two dimensional array in optimizing Doppler signal acquisition (Col 5, lines 24-37 of Frisa).
Regarding claim 2, Sumanaweera in view of Jago, Routh, and Frisa discloses all limitations of claim 1, as discussed above, and Sumanaweera further discloses:
wherein the user-provided Doppler line is aligned with the direction of a Doppler beam which scans 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 the image plane of the second image is aligned with the direction of the Doppler beam of the first image (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 7, Sumanaweera in view of Jago, Routh, and Frisa discloses all limitations of claim 1, as discussed above, and Sumanaweera further discloses:
wherein the ultrasound probe is adapted to operate in a biplane mode to scan the two image planes in a time-interleaved manner (Col 9, lines 26-56: 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; Col 13, lines 39-68: user successively acquires and confirms placement of transducer).
Regarding claim 8, Sumanaweera in view of Jago, Routh, and Frisa discloses all limitations of claim 7, 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, Routh, and Frisa discloses all limitations of claim 7, 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, Routh, and Frisa 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, Routh, and Frisa 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 a second Doppler image in a transverse view of the target vessel in an image plane aligned with a Doppler angle of the first 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);
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 given direction, and
wherein the user-provided Doppler line is aligned with the direction of the Doppler beams;
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.
Frisa in the same field of Doppler imaging, however, teaches:
acquiring a Doppler image by scanning an image plane with a plurality of parallel Doppler beams transmitted in a given direction (Col 5, lines 21-37: steered linear scan formats are employed for Doppler imaging; Col 4, lines 12-21: echo signals for Doppler processing).
It is noted that, as the original specification of the instant application even acknowledges in pg. 5, lines 19-21, steered linear scanning is well known in the art for transmitting a plurality of parallel beams in a direction.
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 Frisa’s steered linear scanning. The combination would have yielded a reasonable expectation of success, since both Sumanaweera and Frisa are directed to Doppler imaging. The motivation for the combination would have been to steer transmitted and received beams in a direction and inclination in front of the two dimensional array in optimizing Doppler signal acquisition (Col 5, lines 24-37 of Frisa).
Jago in the same field of analyzing a volume flow using Doppler imaging additionally teaches:
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 Doppler beams ([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 method to include Jago’s simultaneous display of two images and user-provided Doppler line. 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 measure the peak flow velocity, which is correlated with the degree of stenosis … (by) precisely visualiz(ing) the location of peak velocity blood flow”, as taught by Jago ([0002]).
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 Frisa, 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 Frisa, 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 Frisa, 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 image is acquired by scanning one of the image planes with a plurality of parallel Doppler beams transmitted in a given direction, and
wherein the user-provided Doppler line is aligned with the direction of the Doppler beams.
Jago in the same field of analyzing a volume flow using Doppler imaging, however, teaches:
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 Doppler beams ([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 simultaneous display of two images and user-provided Doppler line. 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 measure the peak flow velocity, which is correlated with the degree of stenosis … (by) precisely visualiz(ing) the location of peak velocity blood flow”, as taught by Jago ([0002]).
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).
Frisa in the same field of Doppler imaging further teaches:
acquiring a Doppler image by scanning an image plane with a plurality of parallel Doppler beams transmitted in a given direction (Col 5, lines 21-37: steered linear scan formats are employed for Doppler imaging; Col 4, lines 12-21: echo signals for Doppler processing).
It is noted that, as the original specification of the instant application even acknowledges in pg. 5, lines 19-21, steered linear scanning is well known in the art for transmitting a plurality of parallel beams in a direction.
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 Frisa’s steered linear scanning. The combination would have yielded a reasonable expectation of success, since both Sumanaweera and Frisa are directed to Doppler imaging. The motivation for the combination would have been to steer transmitted and received beams in a direction and inclination in front of the two dimensional array in optimizing Doppler signal acquisition (Col 5, lines 24-37 of Frisa).
Regarding claim 17, Sumanaweera in view of Jago, Routh, and Frisa discloses all limitations of claim 16, as discussed above, and Sumanaweera further discloses:
wherein the Doppler line is aligned with the direction of a Doppler beam which scans 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 the image plane of the second image is aligned with the direction of the Doppler beam of the first image (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, Routh, and Frisa 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, Routh, and Frisa 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
02/20/26