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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/12/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1-7, 10-13, 15 and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is 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 15 is invalid under 35 USC 112(b) since a claim which purports to be both machine and process is ambiguous and therefore does not particularly point out and distinctly claim the subject matter of the invention. Ex parte Lyell, 17 USPQ2d 1548 (1990). It is unclear if claim 15 is directed towards a non-transitory computer readable medium or a method. For examination purposes the claim will be interpreted as a non-transitory computer readable medium.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 4, 10, 11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Annangi (US 20200069285) and further in view of Maximo (US 20210177295).
Regarding claims 1, 10, and 15, Annangi discloses an ultrasound imaging system (Title), comprising: [claim1]
an ultrasound imaging method (Title), comprising: [claim 10]
a non-transitory computer readable medium comprising computer program code that in response to execution on a processor implements the method of claim 10 ([0078] – “process steps such as those that may be performed by the system may be implemented by suitable code on a processor-based system, such as a general-purpose or special-purpose computer”, [0057] – “the computer executable instructions may be located in both local and remote computer storage media, including memory storage devices”) [claim 15]
a 3D ultrasound imaging probe ([0020] – “three-dimensional (3D) ultrasound images…is also envisaged”, although the use of a 3D ultrasound imaging probe is not explicitly disclosed one with ordinary skill in the art would find it obvious to use a 3D ultrasound imaging probe to acquire three-dimensional (3D) ultrasound images because creating 3D images with a 2D ultrasound probe requires more image processing) for acquiring real-time 3D images of a field of view volume with the 3D ultrasound imaging probe manually positioned by a user ([0053] – “during the real-time scanning”, [0019] – “the clinician, typically positions an ultrasound probe”, [0020] – “three-dimensional (3D) ultrasound images…is also envisaged”);
a controller ([0074] – “a control processor 516”) configured to:
perform a real-time image analysis of the 3D images ([0034] – “process the acquired ultrasound image to identify, in real-time”, [0020] – “three-dimensional (3D) ultrasound images…is also envisaged”) thereby to:
identify anatomical structure and landmarks in the 3D images ([0048] – “the anatomy cognition unit 206 is configured to detect the presence of the right kidney in the ultrasound images 202”, [0052] – “to acquire the long axis of the right kidney, points corresponding to the interior of the personalized anatomical model are circumscribed by an ellipsoid”);
based on a model-based reconstruction of the identified anatomical structure and landmarks, determine if a region of interest of a target anatomical structure is present ([0063] – “step 308, the ultrasound image 202 is quantified, in real-time, to determine suitability of that ultrasound image 202 to one or more scan planes corresponding to a determined clinical protocol”, [0051] – “customize the personalized anatomical model as the patient 102 is scanned”, [0052] – “to acquire the long axis of the right kidney, points corresponding to the interior of the personalized anatomical model are circumscribed by an ellipsoid. In addition, a plane passing through the major axis of the ellipsoid is identified”);
if, based on the model-based reconstruction of the identified anatomical structure and landmarks, it is determined that the region of interest is not present, infer the location of the region of interest outside the field of view volume from the model-based reconstruction of the anatomical structure and landmarks that are detected within the field of view ([0034] – “a personalized anatomical model of the patient 102 based on a current position of the ultrasound probe”, [0052] – “in certain embodiments, to acquire the long axis of the right kidney, points corresponding to the interior of the personalized anatomical model are circumscribed by an ellipsoid. In addition, a plane passing through the major axis of the ellipsoid is identified”);
identify the position of at least one reference anatomical plane for the target anatomical structure ([0052] – “a plane passing through the major axis of the ellipsoid is identified”);
determine a relative position between the reference anatomical plane and a position and orientation of the 3D ultrasound imaging probe ([0052] – “a plane passing through the major axis of the ellipsoid is identified. Further, an orientation of the identified plane is computed. The desired trajectory is then computed from the current location of the ultrasound probe 104 to the location of the identified plane”); and
provide ultrasound guidance information based on the determined relative position ([0019] – “automatically guide the clinician to a desired target location for scanning”).
Conversely Annangi does not teach infer the location of the region of interest […] from a statistical prior comprising a probability distribution describing a shape variability used to find likely positions of other landmarks.
However Maximo discloses infer the location of the region of interest […] from a statistical prior comprising a probability distribution describing a shape variability used to find likely positions of other landmarks ([0020] – “mapping MR calibration images to landmark maps using trained deep neural networks, wherein landmark maps may indicate one or more of a position, a center point, an orientation, a size/extent, a shape, and an anatomical classification/identification of one or more landmarks included in the MR calibration image, and one or more diagnostic-scan planes/volumes may be determined based on this information”, [0077] – “image is assigned a probability score for each of a pre-determined set of landmarks/classes, wherein a highest probability score may be used to uniquely assigned each voxel to one of the pre-determined set of landmarks/classes”).
The disclosure of Maximo is an analogous art considering it is in the field of using a neural network to indicate anatomies in a medical image.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Annangi to incorporate the probability score of landmarks within an image of Maximo to achieve the same results. One would have motivation to combine because it “may be used to acquire one or more diagnostic images, bypassing the need to acquire localizer images” (Maximo – [0019]).
Regarding claim 3, Annangi and Maximo disclose all the elements of the claimed invention as cited in claim 1.
Annangi further discloses wherein the controller is configured to determine the relative position by: identifying one or more main directions of the anatomy of the target of interest ([0054] – “the feedback unit 214 may be configured to communicate the desired movement of the ultrasound probe 104 to the clinician via a real-time indicator…the real-time indicator may include a…“directional” indicator”); and
determining a distance and orientation between the one or main directions and one or more axes of the ultrasound imaging probe ([0052] – “a plane passing through the major axis of the ellipsoid is identified. Further, an orientation of the identified plane is computed. The desired trajectory is then computed from the current location of the ultrasound probe 104 to the location of the identified plane. In one example, the desired trajectory may be determined based on minimum manifold distance”).
Regarding claims 4 and 11, Annangi and Maximo disclose all the elements of the claimed invention as cited in claims 1 and 10.
Annangi further discloses wherein the guidance information provides: advice as to whether or not imaging a desired reference anatomical plane of the region of interest is achievable from the current position and orientation of the ultrasound imaging probe ([0063] – “the ultrasound image 202 is quantified, in real-time, to determine suitability of that ultrasound image 202 to one or more scan planes corresponding to a determined clinical protocol”, [0068] – “the quantification of the ultrasound image 202, and the like may also be visualized on the display 118”); or
recommendations about the nearest achievable acquisitions of a reference anatomical plane of the region of interest from the current position and orientation of the ultrasound probe ([0052] – “the desired trajectory may be determined based on minimum manifold distance between the current location of the ultrasound probe 104 and the location of the identified plane”); or
warnings or guidance to indicate required correction of the probe position to enable acquisition of a desired reference anatomical plane ([0066] – “actionable instructions are provided in real-time to the clinician based on the computed trajectory from the current location of the ultrasound probe 104 to the target location on the patient 102”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Annangi (US 20200069285) and Maximo (US 20210177295) as applied to claim 1 above, and further in view of Ribes (US 20160113632).
Regarding claim 2, Annangi and Maximo disclose all the elements of the claimed invention as cited in claim 1.
Conversely Annangi does not teach wherein the controller is further configured to perform an image quality assessment for the field of view volume and discard images determined as unsuitable for the identification of anatomical structure and landmarks.
However Ribes discloses wherein the controller is further configured to perform an image quality assessment for the field of view volume and discard images determined as unsuitable for the identification of anatomical structure and landmarks ([0027] – “automatically determining if the current ultrasound image has at least a pixel in the volume of interest, wherein in case the current image has no pixel in the volume of interest, the current image is automatically discarded”).
The disclosure of Ribes is an analogous art considering it is in the field of a guiding a probe and generating an anatomical model based on the ultrasound images.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Annangi to incorporate the discarding of images of Ribes to achieve the same results. One would have motivation to combine because it would save on storage space of the system and would also provide a high quality anatomical model of the specific anatomical structure.
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Annangi (US 20200069285) and Maximo (US 20210177295) as applied to claims 1 and 10 above, and further in view of Schauf (US 20130194890).
Regarding claims 5 and 12, Annangi and Maximo disclose all the elements of the claimed invention as cited in claims 1 and 10.
Conversely Annangi does not teach wherein the controller is configured, in response to an input command, to acquire simultaneously a set of views of reference anatomical planes.
However Schauf discloses wherein the controller is configured, in response to an input command, to acquire simultaneously a set of views of reference anatomical planes ([0017] – “both a sequence of reference images and an independent sequence of variable orientation images which were acquired at the same time”, [0018] – “the system can be commanded to sweep through and acquire images over the full range of tilt angles from +45° to −45°”).
The disclosure of Schauf is an analogous art considering it is in the field of imaging a specific plane to view the target.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Annangi to incorporate the command to acquire a set of views simultaneously of Schauf to achieve the same results. One would have motivation to combine because it “allows the clinician to scan and observe two image planes at the same time, while constantly maintaining his or her navigational bearings of the image locations within the three dimensional volume being scanned” (Schauf – [0002]).
Claims 6-7, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Annangi (US 20200069285) and Maximo (US 20210177295) as applied to claims 1 and 10 above, and further in view of Gupta (US 20130190600).
Regarding claim 6, Annangi and Maximo disclose all the elements of the claimed invention as cited in claim 1.
Conversely Annangi does not teach wherein the controller is configured to detect if the region of interest is present by using a landmarks detection algorithm for tracking key anatomical points.
However Gupta discloses wherein the controller is configured to detect if the region of interest is present by using a landmarks detection algorithm for tracking key anatomical points ([0071] – “the method for identifying the optimal image frame entails verifying, in real-time, the presence of one or more features of interest”).
The disclosure of Gupta is an analogous art considering it is in the field of a identifying an optimal image frame.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Annangi to incorporate the landmarks detection of Gupta to achieve the same results. One would have motivation to combine because it “provides a framework for robust determination of an optimal image frame for imaging a desired anatomical region of interest, such as the heart, the fetal head, and/or the fetal femur” (Gupta – [0093]).
Regarding claim 7, Annangi, Maximo, and Gupta disclose all the elements of the claimed invention as cited in claims 1 and 6.
Conversely Annangi does not teach wherein the key anatomical points comprise the heart valves for cardiac imaging.
However Gupta discloses wherein the key anatomical points comprise the heart valves for cardiac imaging ([0068] – “identify/verify the presence of one or more anatomical landmarks. These anatomical landmarks may include…the aortic valve 712…the mitral valve 716”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Annangi to incorporate the detection of heart valves of Gupta to achieve the same results. One would have motivation to combine because it “provides a framework for robust determination of an optimal image frame for imaging a desired anatomical region of interest, such as the heart, the fetal head, and/or the fetal femur” (Gupta – [0093]).
Regarding claim 13, Annangi and Maximo disclose all the elements of the claimed invention as cited in claim 10.
Conversely Annangi does not teach detecting if the region of interest is present by: using a landmarks detection algorithm for tracking key anatomical points.
However Gupta discloses detecting if the region of interest is present by: using a landmarks detection algorithm for tracking key anatomical points ([0071] – “the method for identifying the optimal image frame entails verifying, in real-time, the presence of one or more features of interest”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Annangi to incorporate the landmarks detection of Gupta to achieve the same results. One would have motivation to combine because it “provides a framework for robust determination of an optimal image frame for imaging a desired anatomical region of interest, such as the heart, the fetal head, and/or the fetal femur” (Gupta – [0093]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Annangi (US 20200069285) and Maximo (US 20210177295) as applied to claim 1 above, and further in view of Wong (US 20170000461).
Regarding claim 19, Annangi and Maximo disclose all the elements of the claimed invention as cited in claim 1.
As cited above Annangi discloses the 3D images conversely Annangi does not teach wherein the real-time image analysis of the […] images is run as a continuous background task.
However Wong discloses wherein the real-time image analysis of the […] images is run as a continuous background task ([0045] – “performing the calculation continuously or at other repetition in real-time during scanning and imaging in the background”).
The disclosure of Wong is an analogous art considering it is in the field of ultrasound imaging.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Annangi to incorporate the image analysis as a background task of Wong to achieve the same results. One would have motivation to combine because “workflow interruption may be avoided” (Wong – [0045]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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/R.C.L./Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797