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 .
Note: all citations with respect to the specification of present application are citing the paragraph number in the Pre-Grant Publication US 2025/0248691 A1.
Election/Restrictions
Applicant’s election without traverse of Invention I (claim 1 – 8) in the reply filed on 03/24/2026 is acknowledged.
Claim 1 – 18 remain pending in the application;
Claim 9 – 18 are withdrawn from consideration.
Claim Objections
Claim 1 – 8 are objected to because of the following informalities:
Claim 1 line 8, limitation "said at least one electronic unit of said scanning controller" should read "said electronic unit of said at least one scanning controller".
Claim 1 line 14, limitation "renders said unit able to" should read "renders said electronic unit to".
Claim 2 line 1, preamble "An apparatus according to claim 1" should read "The apparatus according to claim 1".
Claim 2 line 9, limitation "said at least one electronic unit of said scanning controller" should read "said electronic unit of said at least one scanning controller".
Claim 2 line 11, limitation "controls the display to:" should read "causes said electronic unit to control the display to:".
Claim 2 line 13 – 14, limitation "an acquired image" should read "one of the acquired images".
Claim 2 line 17, limitation "terminates" should read "causes said electronic unit to terminate".
Claim 2 line 18 – 19, limitation "an acquired image" should read "one of the acquired images".
Claim 3 line 1, preamble "An apparatus according to claim 1" should read "The apparatus according to claim 1".
Claim 4 line 1, preamble "An apparatus according to claim 3" should read "The apparatus according to claim 3".
Claim 4 line 7, limitation "configuring said processing unit to be able to identify" should read "configuring said processing unit to identify".
Claim 4 line 14 – 15, limitation "the executed scanning plane trajectory" should read "the identified scanning plane trajectory".
Claim 5 line 1, preamble "An apparatus according to claim 3" should read "The apparatus according to claim 3".
Claim 6 line 1, preamble "An apparatus according to claim 1" should read "The apparatus according to claim 1".
Claim 7 line 1, preamble "An apparatus according to claim 6" should read "The apparatus according to claim 6".
Claim 7 line 2, limitation "the above disclosed landmark detector" should read "said automatic landmark detector".
Claim 7 line 8 – 9, limitation "said semantic descriptions matching unit being a software comprising the instructions for said processing unit to carry out" should read "said semantic descriptions matching unit being said processing unit running the software comprising the instructions for said processing unit to carry out".
Claim 7 line 12, limitation "which labels" should read "to label".
Claim 7 line 12, limitation "an acquired image" should read "one of the acquired images".
Claim 7 line 12, limitation "a reference image" should read "one of the reference images".
Claim 7 line 13 - 14, limitation "an image acquired" should read "the one of the acquired images".
Claim 7 line 16, limitation "the automatic semantic descriptor" should read "the semantic descriptor".
Claim 7 line 17, limitation "each acquired image" should read "each of the acquired images".
Claim 7 line 17, limitation "a target body" should read "the target body".
Claim 7 line 19 – 20, limitation "the imaging slice or the imaging plane" should read "the subsequence of scanning slices or scanning planes".
Claim 8 line 1, preamble "An apparatus according to claim 1" should read "The apparatus according to claim 1".
Claim 8 lien 17 – 18, limitations "units for signalling at least said results and/or displaying quality evaluation and/or displaying suggestions' should read "units for at least one of signalling said results, displaying quality evaluation, and displaying suggestions".
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Limitation “image acquisition unit” in claim 1 and 2.
Limitation “electronic unit” in claim 1 and 2.
Limitation “input units” in claim 2.
Limitation “scanning plane tracking module” in claim 3 and 4.
Limitation “semantic description matching unit” in claim 7.
Limitation “units for signalling” in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding limitation “image acquisition unit” in claim 1 and 2, the corresponding structural disclosure in the specification of present application is recited as: “FIG. 1 shows a high-level block diagram of a system for acquiring ultrasound images” in [0115]; “Probe 101 can include various transducer array configurations” in [0116].
Regarding limitation “electronic unit” in claim 1 and 2, the corresponding structural disclosure in the specification of present application is recited as: “One or more processors 106 and/or CPU 112 execute various processing operations as described herein” in [0124].
Regarding limitation “input units” in claim 2, the corresponding structural disclosure in the specification of present application is recited as: “Similarly, input interfaces may comprise keyboards, acoustic input means, gestural input means, touchscreens, point and click devices or other similar devices” in [0143].
Regarding limitation “scanning plane tracking module” in claim 3 and 4, the corresponding structural disclosure in the specification of present application is recited as: “One or more processors 106 and/or CPU 112 execute various processing operations as described herein” in [0124]; “As an embodiment, tracking the trajectory of the image slices or the image planes along which each one of the sequence of images is acquired during an imaging scan of the target body TB can be carried out by defining on each image slice or image plane of each acquired image or of the frame of each acquired image at least one of said reference points and tracking the displacement of said at least one reference point from one image slice or image plane to the following” in [0184]; “According to an embodiment, tracking of image slice or image planes displacement one with respect to the other and/or relatively to the target body TB or to a ROI can also be carried out by applying a tracking system to the ultrasound probe and using said tracking system for calculating the trajectory of the probe in a common reference system with the target body TB or a ROI thereof” in [0186]. Thus, the above tracking module is interpreted as either processor/computer executed software tracking or hardware-based tracking system as known to one with ordinary skill in the art.
Regarding limitation “semantic description matching unit” in claim 7, the corresponding structural disclosure in the specification of present application is recited as: “One or more processors 106 and/or CPU 112 execute various processing operations as described herein” in [0124]; “The correspondence or identity is determined by subjecting to a matching process the semantic descriptions of the landmarks identified in one or more of the acquired images with the semantic description of a slice or a plane of a reference image. The semantic descriptors may comprise semantic labels and/or geometric labels as defined above according to the different alternatives disclosed” in [0227]. Thus, the above matching unit is interpreted as either processor/computer executed software or equivalents.
Regarding limitation “units for signalling” in claim 8, the corresponding structural disclosure in the specification of present application is recited as: “one or more output units comprising at least a display for displaying one or more of the following items consisting in graphic interface tools for communicating with a user” in [0024]; “Together with the visual graphic communication also a written communication may be displayed as indicated by step 480. When the acquired images are destined to be archived, a label may be applied to the imaging data signalling the fact that the image acquisition has followed correctly the clinical protocol and also the data providing evidence of that may be saved together with the images” in [0200]. Thus, the above units for signalling is interpreted as graphic interface for communicating or any reasonable equivalent.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1 – 8 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 "the acquired images" in line 5 and line 6 – 7, respectively. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “an ultrasound image acquisition protocol” in line 9 – 10. It is unclear the above image acquisition protocol is a newly introduced different protocol, or the same “image acquisition protocol” as recited in claim 1 line 4.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable image acquisition protocol.
Claim 1 recites the limitation "said at least one electronic processing unit of said scanning controller" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “a display” in line 21. It is unclear the above display is a newly introduced different protocol, or one of the “at least a display” as recited in claim 1 line 6.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable display.
Claim 2 recites the limitation "one or more output units comprising at least a display" in line 6. It is unclear the above “one ore more output units” and “display” are newly introduced different output units and display, or the same “output units comprising at least a display” as recited in claim 1 line 6.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable output units with display.
Claim 2 recites the limitation "being provided in combination with a computer program containing instructions" in line 9 – 10. It is unclear the above computer program is a newly introduced different program or the same computer program as recited in claim 1 line 12 – 13.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable computer program.
Claim 2 recites the limitation "the display" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the saved reference images" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the image acquisition" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the imaging" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the same processing unit of the scanning controller" in line 2 – 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the relative position and/or the relative orientation" in line 4 – 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "said position and orientation" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the sequence of images" in line 8 – 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "a memory" in line 10. It is unclear the above memory is a newly introduced different memory or the same memory as recited in claim 1 line 8.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable memory.
Claim 4 recites the limitation "the identified scanning plane trajectory" in line 11 – 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "a ROI" in line 12 – 13. It is unclear the above ROI is a newly introduced different ROI or the same ROI as recited in claim 4 line 6.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable ROI.
Claim 4 recites the limitation "the sequence of scanning slices or scanning planes during imaging of the target object" in line 16 – 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "said scanning plane trajectory tracking" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the ultrasound imaging apparatus" in line 2 – 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the position and orientation of the ultrasound probe" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the position and orientation of each image slice or image plane along which an image is acquired during the execution of the scanning of the target body" in line 1 – 3. There is insufficient antecedent basis for this limitation in the claim.
It is unclear which “position and orientation” is recited.
It is unclear whether “each image slice or image plane” is recited the scanning slices or scanning planes introduced earlier.
It is unclear which “execution of the scanning” and “target body” are recited, since there is no corresponding scanning or target body in claim 1.
Claim 6 recites the limitation "the landmarks identified within each of the said images" in line 3 – 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation “an image” in line 5. It is unclear the above image is which image, since there are multiple different “image” terms introduced earlier.
Claim 6 recites the limitation “such as a distance between landmarks identified in an image as well their geometrical shapes in each image” in line 5 – 6. The above limitation is using exemplary language to describe a preference. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. See MPEP 2173.05(d).
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation with language “such as” is interpreted as not limiting the scope of claim.
Claim 7 recites the limitation "each landmark for each or at least some of the landmarks" in line 6. It is unclear what the meaning of “for each”.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable landmark(s).
Claim 7 recites the limitation "the images" in line 18. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the sequence of images" in line 18. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the correctness of the sequence of scanning slices or scanning planes" in line 1 – 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites limitation “a target object” in line 3, line 7, line 11 and line 16 respectively. It is unclear the above limitations are newly introduced different target object or the same target object recited in claim 8 line 2.
Thus, the above limitations render claim indefinite. For the purpose of examination, the above limitations are interpreted as any reasonable target object.
Claim 8 recites the limitation “is or may be loaded and is or may be executed” in line 9. It is unclear the algorithm is actually loaded/executed or not.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable condition.
Claim 8 recites the limitation "the image data" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the images acquired” in line 10 - 11. It is unclear the above images are the sequence of acquired images as recited in claim 8 line 5 – 6, or the acquired images as recited in claim 1.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable images acquired.
Claim 8 recites the limitation "the processing of said inputted image data by the machine learning algorithm" in line 12 – 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the sequence of subsequent image slices or image planes" in line 14 – 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “said image” in line 15. It is unclear the above image is which image, since there are multiple different “image” terms introduced earlier.
Claim 8 recites the limitation "a scanning protocol" in line 16, it is unclear the above protocol is a newly introduced different protocol or the same scanning protocol introduced in claim 8 line 3.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable scanning protocol.
Therefore, claim 1 – 8 rejected under 35 U.S.C. 112(b) as being indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim 1 – 4 and 6 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (US 2018/0161010 A1; published on 06/14/2018) (hereinafter "Choi") in view of Meng et al. (US 2023/0215000 A1; published on 07/06/2023) (hereinafter "Meng").
Regarding claim 1, Choi teaches an apparatus for performing diagnostic imaging examinations ("Provided are methods and apparatuses for generating imaging status information indicating the progression of imaging being performed on all target regions in an imaging list based on acquired at least one ultrasound image." [0009]) comprising:
an image acquisition unit ("… may include a probe 20 …" [0038]);
at least one scanning controller comprising an electronic unit ("… an ultrasound transceiver 110, a controller 120, an image processor 130, …" [0038]) for operating and controlling the execution of an image acquisition protocol by means of said image acquisition unit ("The controller 120 may control the transmitter 113 to generate and transmit the transmission signals to each of the plurality of transducers based on a position and a focal point of the plurality of transducers included in the probe 20." [0041]; "The controller 120 may control the ultrasound receiver 115 to generate ultrasound data by converting reception signals received from the probe 20 ..." [0042]) and for carrying out image processing on at least part of the acquired images ("The processor 310 generates at least one ultrasound image based on ultrasound image data acquired by the probe 20." [0068]; "According to an embodiment, the processor 310 may determine whether a target region is shown in a generated ultrasound image …" [0070]);
output units comprising at least a display for displaying one or more of the acquired images or of processed images ("The display 140 may display a generated ultrasound image and various pieces of information processed by the ultrasound image processing apparatus 100." [0044]);
said at least one electronic unit of said scanning controller being provided with a memory ("The storage 150 may store various data ... ultrasound images ... etc." [0053]) in which reference images of a sequence of said reference images acquired in following an ultrasound image acquisition protocol are stored, said reference images being univocally associated to one or more anatomical landmarks which are present on each of them ("… comparing the ultrasound images 510 with template images of the target regions." [0109]; here the template images are reference images, and the storage in memory is inherent feature for any image processing computer; ""Referring to FIG. 14, the imaging list 1400 may include target regions 1410 of an object, a recommended imaging order 1420, and standard views 1430 of each of the target regions 1410." [0077]);
said at least one electronic processing unit of said scanning controller being provided in combination with a computer program containing instructions which, when executed by said electronic unit ("The storage 150 may store various data or programs for driving and controlling the ultrasound image processing apparatus 100, input and/or output ultrasound data …" [0053]), renders said unit able to:
run an automatic landmark detector which carries out an automatic landmark detection within each image acquired by the image acquisition unit ("… an algorithm 530 for generating the first imaging status information 548 and the second imaging status information 558 may include operations S542 …" [0106]; "... the ultrasound image processing apparatus 300 may identify anatomical structures depicted in the ultrasound images 510 ..." [0109]) executing said image acquisition protocol (this is inherent feature of each acquired image);
compare one or more landmarks detected on each one of the acquired images with the sequence of reference images and the one or more landmarks identified on the said reference images ("… by respectively comparing the ultrasound images 510 with template images of the target regions." [0109]);
set the image acquisition protocol as correctly completed ("... the first imaging status information 548 indicating whether target regions in the imaging list 520 have been imaged." [0113]; "… the ultrasound image processing apparatus 300 may generate the imaging completion/incompletion list 620 that is distinguishable from the imaging list 610 b and display the first imaging status information on the imaging completion/incompletion list 620 b." [0128]);
memorize the acquired images as being obtained by a correct scan for further use ("The ultrasound image processing apparatus 300 may generate the thumbnail images 1120 b representing ultrasound images corresponding to target regions in an imaging list and display the second sub-list in such a manner that a region 1125 b corresponding to a target region of which imaging is omitted is indicated in a color or with shading that is distinguishable from that of the other regions on the thumbnail images 1120 b." [0152]; the thumbnail 1120b is associated with completed scan with correct region, this is also a memorization of correctness).
Choi fails to explicitly teach wherein the electronic unit is configured to display each of the reference images on a display and highlight the reference images in which the one or more landmark is corresponding to the one or more landmark in the acquired images.
However, in the same field of endeavor, Meng teaches wherein the electronic unit is configured to display each of the reference images on a display and highlight the reference images in which the one or more landmark is corresponding to the one or more landmark in the acquired images ("As shown in FIG. 3 , the graphical user interface 300 includes a plurality of anatomical plane schematics 301 … the user interface 300 generates a plurality of anatomical plane schematics 301 corresponding to standard anatomical planes of the fetus scanning protocol." [0053]; "... the anatomical plane schematics 301 may include a biparietal diameter schematic 311, a lateral ventricle section schematic 312, a cavity of septum pellucidum section schematic 313, a cerebellum cross-section schematic 314, a nasolabial coronal section schematic 315, a lower-mid face sagittal section schematic 316, and a two-eye socket section schematic 317." [0054]; see Fig.3).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ultrasound image display as taught by Choi with the additional processing of acquired image with respect to a plurality of anatomical plane schematics as taught by Meng. Doing so would make it possible "that a scanning operator can be easily guided to perform scanning in a regular scanning order, thereby avoiding omission" (see Meng; [0054]).
Regarding claim 2, Choi in view of Meng teaches all claim limitations, as applied in claim 1, and Choi further teaches a generator of a user interface which is comprised within said image acquisition unit ("… a display 140 … a communicator 160, i.e., a communication device or an interface, and an input interface 170." [0038]), said user interface comprising:
one or more input units for setting signal acquisition and processing procedures for obtaining images ("… the controller 120 may control the operation of the ultrasound image processing apparatus 100 by receiving a control signal from the input interface 170 …" [0045]) and for setting display modes ("The main display 121 and the sub-display 122 may provide graphical user interfaces (GUI), to receive user's inputs of data or a command to control the ultrasound image processing apparatus 100." [0057]); and
one or more output units comprising at least a display for displaying graphic interface tools for communicating with a user status information about an image acquisition workflow ("The ultrasound image processing apparatus 300 may display the imaging list 610 a or 610 b in a region of the display 140 corresponding to a user's input." [0124]; "Referring to FIG. 6A, the ultrasound image processing apparatus 300 may indicate on the imaging list 610 first imaging status information indicating whether at least one target region in the imaging list 610 a has been imaged." [0125]),
said at least one electronic unit of the scanning controller being provided in combination with a computer program containing instructions which, when executed by said electronic unit ("The above-described embodiments of the disclosure may be embodied in form of a computer-readable recording medium for storing computer executable command languages and data. The command languages may be stored in form of program codes and, when executed by a processor, may perform a certain operation by executing a certain program module." [0163]), and
controls the display ("The main display 121 and the sub-display 122 may provide graphical user interfaces (GUI), to receive user's inputs of data or a command to control the ultrasound image processing apparatus 100." [0057]).
In addition, Meng teaches wherein the electronic unit is configure to control the display to:
display at least some of the saved reference images ("As shown in FIG. 3 , the graphical user interface 300 includes a plurality of anatomical plane schematics 301 … the user interface 300 generates a plurality of anatomical plane schematics 301 corresponding to standard anatomical planes of the fetus scanning protocol." [0053]; "... the anatomical plane schematics 301 may include a biparietal diameter schematic 311, a lateral ventricle section schematic 312, a cavity of septum pellucidum section schematic 313, a cerebellum cross-section schematic 314, a nasolabial coronal section schematic 315, a lower-mid face sagittal section schematic 316, and a two-eye socket section schematic 317." [0054]; see Fig.3 and Fig.5);
highlight one after the other the reference images displayed when an acquired image has been found in which at least a landmark is detected corresponding to at least one landmark represented in respectively one of said reference images ("… after it is determined that the real-time ultrasonic image 501 is an ultrasonic image of the anatomical plane of interest (e.g., a lateral ventricle section), an ultrasonic image thumbnail 523 of the anatomical plane of interest is automatically generated ... Further, the above-described anatomical plane schematic corresponding to the anatomical plane of interest is automatically replaced with the ultrasonic image thumbnail 523 that is displayed." [0065]; "Referring first to FIG. 5 , in addition to the ultrasonic image thumbnail 523 described above, another ultrasonic image thumbnail 524 may also be present in the area of the anatomical plane schematic 301. The ultrasonic image thumbnail 524 represents an ultrasonic image thumbnail of another anatomical plane of interest ..." [0074]; see Fig.8, the replacement of anatomical plane schematic with corresponding acquired image thumbnail is a highlighting as shown in Fig.5),
terminates the image acquisition by signalling that the image acquisition protocol has been executed correctly when, for each reference image, an acquired image has been found having at least one landmark which is identical ("As shown in FIG. 3 , after the processor of the controller circuit 102 performs automatic identification on the real-time ultrasonic image 308, if no anatomical marker therein is identified, then the processor determines accordingly that the current real-time ultrasonic image is not an ultrasonic image of the anatomical plane of interest, and does not perform the next operation. In this case, the scanning operator needs to adjust the position of the probe until an ultrasonic image of the anatomical plane of interest is acquired. Subsequent processes for acquiring ultrasonic images of anatomical planes of interest are described in detail below." [0057]; it is implied that the operation will be adjusted and updated until the correct anatomical plane acquisition is completed).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ultrasound image display as taught by Choi with the additional processing of acquired image with respect to a plurality of anatomical plane schematics as taught by Meng. Doing so would make it possible "that a scanning operator can be easily guided to perform scanning in a regular scanning order, thereby avoiding omission" (see Meng; [0054]).
Regarding claim 3, Choi in view of Meng teaches all claim limitations, as applied in claim 1, and Meng further teaches an automatic scanning plane tracking module configured to automatically detect the trajectory between subsequent image slices or image planes of the images acquired during the imaging of a target object ("… on the basis of acquisition settings received by the controller circuit 102. The acquisition settings may define the … scanning angle …" [0033]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ultrasound image display as taught by Choi with the additional processing of acquired image with respect to a plurality of anatomical plane schematics as taught by Meng. Doing so would make it possible "that a scanning operator can be easily guided to perform scanning in a regular scanning order, thereby avoiding omission" (see Meng; [0054]).
Regarding claim 4, Choi in view of Meng teaches all claim limitations, as applied in claim 3, and Choi further teaches wherein said automatic scanning plane tracking module is in the form of the same processing unit of the scanning controller ("… on the basis of acquisition settings received by the controller circuit 102." [0033]),
said processing unit being able to determine the relative position and/or the relative orientation of scanning planes relatively to the target object ("The acquisition settings may define the … scanning angle …" [0033]) by executing a scanning plane tracking software comprising the instructions for configuring said processing unit ("The various embodiments may also be embedded in a computer program product that includes all features capable of implementing the methods described herein ..." [0083]) to be able to identify the said position and orientation of each or of at least some of the said subsequent scanning slices or scanning planes along which the sequence of images is acquired ("The transmitter 122 transmits a signal to the transmission beamformer 121 on the basis of acquisition settings received by the controller circuit 102. The acquisition settings may define ... scanning angle ..." [0033]),
said processing unit being further provided with a memory in which one or more reference scanning plane trajectories are saved ("The memory 106 may include a parameter, an algorithm, one or more ultrasonic examination protocols, a data value, and the like used by the controller circuit 102 to perform one or more operations described in the present application. " [0025]) and a comparator comparing the identified scanning plane trajectory followed during execution of the imaging of the target object or of a ROI thereof with the said reference trajectory ("The training image may represent different orientations and/or cross sections of the anatomical structure of interest corresponding to different fields of view." [0028]; a classifier is to compare the acquired image plane with training (reference) images, and each plane has its own trajectory),
said comparator generating warning or indication if said differences might be relevant for the correctness of the sequence of scanning slices or scanning planes during imaging of the target object ("… after the processor of the controller circuit 102 performs automatic identification on the real-time ultrasonic image 308, if no anatomical marker therein is identified, then the processor determines accordingly that the current real-time ultrasonic image is not an ultrasonic image of the anatomical plane of interest, and does not perform the next operation." [0057]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ultrasound image display as taught by Choi with the additional processing of acquired image with respect to a plurality of anatomical plane schematics as taught by Meng. Doing so would make it possible "that a scanning operator can be easily guided to perform scanning in a regular scanning order, thereby avoiding omission" (see Meng; [0054]).
Regarding claim 6, Choi in view of Meng teaches all claim limitations, as applied in claim 1, and Meng further teaches wherein the position and orientation of each image slice or image plane along which an image is acquired during the execution of the scanning of the target body is determined by using the landmarks identified within each of the said images and their geometrical relationships in relation to other landmarks present in an image ("The relationship may include orientations of the anatomical markers relative to each other. For example, the orientation of the anatomical marker based on the cavity representing the anatomical structure of interest may be used by the controller circuit 102 to identify the anatomical plane of interest." [0029]), such as a distance between landmarks identified in an image as well their geometrical shapes in each image (see 112b rejection).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ultrasound image display as taught by Choi with the additional processing of acquired image with respect to a plurality of anatomical plane schematics as taught by Meng. Doing so would make it possible "that a scanning operator can be easily guided to perform scanning in a regular scanning order, thereby avoiding omission" (see Meng; [0054]).
Regarding claim 7, Choi in view of Meng teaches all claim limitations, as applied in claim 6, and Meng further teaches wherein a landmark semantic descriptor is provided operating in combination with the above disclosed landmark detector and a semantic description matching unit ("The classification model may correspond to a machine learning algorithm based on a classifier (e.g., a random forest classifier, principal component analysis, etc.) configured to identify and/or assign anatomical markers to multiple identities or categories on the basis of an overall shape, a spatial position relative to the anatomical structure of interest, intensity, etc." [0028]; the classification model is also the matching unit),
said semantic descriptor being a processing unit running a software comprising the instructions for said processing unit ("The image analysis algorithm may correspond to an artificial neural network formed by the controller circuit 102 and/or the remote server." [0027]) to generate semantic descriptions univocally associated to each landmark for each or at least some of the landmarks identified in the said reference images and in said acquired images ("The classification model may correspond to a machine learning algorithm based on a classifier (e.g., a random forest classifier, principal component analysis, etc.) configured to identify and/or assign anatomical markers to multiple identities or categories on the basis of an overall shape, a spatial position relative to the anatomical structure of interest, intensity, etc." [0028]),
said semantic descriptions matching unit being a software comprising the instructions for said processing unit ("... the present invention further provide a non-transitory computer-readable medium storing a computer program, wherein the computer program has at least one code segment, and the at least one code segment is executable by a machine so that the machine performs steps of the method in any of the embodiments described above." [0081]) to carry out a search or a comparation between the semantic descriptions associated to the one or more landmarks present in the reference images and the semantic descriptions associated to the one or more landmarks detected in the acquired images ("The classification model may correspond to a machine learning algorithm based on a classifier (e.g., a random forest classifier, principal component analysis, etc.) configured to identify and/or assign anatomical markers to multiple identities or categories on the basis of an overall shape, a spatial position relative to the anatomical structure of interest, intensity, etc." [0028]; classifier is a model equivalent to searching and comparison with respect to reference (trained) image),
and which labels an acquired image as correctly corresponding to a reference image when the relating semantic descriptions are identical one with the other and corresponding to an image acquired along an identical image slice or image plane relatively to its position and its orientation in space or relatively to the target body or to a ROI thereof ("… after it is determined that the real-time ultrasonic image 501 is an ultrasonic image of the anatomical plane of interest (e.g., a lateral ventricle section), an ultrasonic image thumbnail 523 of the anatomical plane of interest is automatically generated ... Further, the above-described anatomical plane schematic corresponding to the anatomical plane of interest is automatically replaced with the ultrasonic image thumbnail 523 that is displayed." [0065]; see Fig.8, the corresponding acquired image thumbnail is a labeling of completion),
applying the automatic semantic descriptor and the semantic descriptions matching unit to each acquired image during an imaging scan of a target body to provide information of the correctness of the images in relation to the sequence of images defined by a certain reference scanning protocol and also information of the trajectory along which the imaging slice or the imaging plane has been displaced during the acquisition of the subsequent images of the target body ("The classification model may correspond to a machine learning algorithm based on a classifier (e.g., a random forest classifier, principal component analysis, etc.) configured to identify and/or assign anatomical markers to multiple identities or categories on the basis of an overall shape, a spatial position relative to the anatomical structure of interest, intensity, etc." [0028]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ultrasound image display as taught by Choi with the additional processing of acquired image with respect to a plurality of anatomical plane schematics as taught by Meng. Doing so would make it possible "that a scanning operator can be easily guided to perform scanning in a regular scanning order, thereby avoiding omission" (see Meng; [0054]).
Regarding claim 8, Choi in view of Meng teaches all claim limitations, as applied in claim 1, and Meng further teaches wherein the correctness of the sequence of scanning slices or scanning planes executed during imaging of a target object relatively to a predefined reference sequence according to a scanning protocol of a target object is determined ("… after it is determined that the real-time ultrasonic image 501 is an ultrasonic image of the anatomical plane of interest (e.g., a lateral ventricle section), an ultrasonic image thumbnail 523 of the anatomical plane of interest is automatically generated ... Further, the above-described anatomical plane schematic corresponding to the anatomical plane of interest is automatically replaced with the ultrasonic image thumbnail 523 that is displayed." [0065]; see Fig.8, the corresponding acquired image thumbnail is a labeling of completion) by providing:
a machine learning algorithm which has been trained in detecting, in a sequence of acquired images, the presence of images taken along one or more image slices or image planes having a certain predefined position and or orientation relatively to a target body ("The classification model may correspond to a machine learning algorithm based on a classifier (e.g., a random forest classifier, principal component analysis, etc.) configured to identify and/or assign anatomical markers to multiple identities or categories on the basis of an overall shape, a spatial position relative to the anatomical structure of interest, intensity, etc." [0028]; "… on the basis of acquisition settings received by the controller circuit 102. The acquisition settings may define the … scanning angle …" [0033]; a classifier is to compare the acquired image plane with training (reference) images, and each plane has its own trajectory);
a processing unit in which a software comprising the instruction for carrying out the said trained machine learning algorithm is or may be loaded and is or may be executed ("... the present invention further provide a non-transitory computer-readable medium storing a computer program, wherein the computer program has at least one code segment, and the at least one code segment is executable by a machine so that the machine performs steps of the method in any of the embodiments described above." [0081]),
wherein said processing unit has inputs for the image data of each or at least some of the images acquired along subsequent image slices or image planes during scanning of a target body ("Processing of ultrasonic data that includes the ultrasonic image data set may be based in part on user input, e.g., a user selection received at the user interface 142." [0042]) and outputs for the results of the processing of said inputted image data by the machine learning algorithm ("The classification model may correspond to a machine learning algorithm based on a classifier (e.g., a random forest classifier, principal component analysis, etc.) configured to identify and/or assign anatomical markers to multiple identities or categories ..." [0028]),
said results being information about the correspondence of the sequence of subsequent image slices or image planes along which said images of the target object have been acquired with said predefined reference sequence according to a scanning protocol of a target object ("… the anatomical structure of interest may be used by the controller circuit 102 to identify the anatomical plane of interest." [0029]),
said processing unit being provided with units for signalling at least said results and/or displaying quality evaluation and/or displaying suggestions ("The controller circuit 102 is operatively connected to the display 138 and the user interface 142 … The display 138 may display … or anatomical measurement, diagnosis, processing information, etc. currently acquired in real time." [0023]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ultrasound image display as taught by Choi with the additional processing of acquired image with respect to a plurality of anatomical plane schematics as taught by Meng. Doing so would make it possible "that a scanning operator can be easily guided to perform scanning in a regular scanning order, thereby avoiding omission" (see Meng; [0054]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Meng, as applied in claim 3, and further in view of Takeuchi (US 2006/0100521 A1; published on 05/11/2006).
Regarding claim 5, Choi in view of Meng teaches all claim limitations, as applied in claim 3, except wherein said scanning plane trajectory tracking is carried out by a probe tracking system provided in combination with the ultrasound imaging apparatus and configured to track the probe position and orientation in a common spatial reference system in which also the target object or at least a ROI thereof is placed and in which the position and orientation of the ultrasound probe automatically define the position and/or orientation of each scanning slice or scanning plane along which an image is acquired.
However, in the same field of endeavor, Takeuchi teaches wherein said scanning plane trajectory tracking is carried out by a probe tracking system provided in combination with the ultrasound imaging apparatus and configured to track the probe position and orientation in a common spatial reference system in which also the target object or at least a ROI thereof is placed and in which the position and orientation of the ultrasound probe automatically define the position and/or orientation of each scanning slice or scanning plane along which an image is acquired ("The position detector 13 is installed inside the ultrasonic probe 12 or fixed to the ultrasonic probe 12 with an attachment or the like, and detects position information that specifies the position and the posture (orientation) of the ultrasonic probe 12." [0028]; "The position detection processor 14 specifies the position and the posture of the ultrasonic probe 12 (that is, a tilt with respect to a horizontal plane and a rotational angle about the central axis of the ultrasonic probe 12) based on the position information detected by the position detector 13." [0029]; see Fig.2, the scanning plane includes the target object or ROI for imaging; see also Fig.7A).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the ultrasound image display as taught by Choi with the additional tracking information with respect to the acquired views as taught by Takeuchi. By providing the operator with reference images and navigation information, the operator would be “able to pick-up diagnosis images while understanding, for example, a difference and a correspondence between a reference image and a currently picked-up ultrasonic image. Hence, even when a less experienced technician or a patient picks up images, appropriate diagnosis images of a region to be diagnosed can be acquired” (see Takeuchi; [0066]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Endo (US 2019/0029647 A1; published on 01/31/2019) teaches an ultrasound diagnostic apparatus, wherein processors are configured to determine whether all of the plurality of examination parts related to the content of examination has ended correctly, and further to assign end tags to the examination record.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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