DETAILED ACTION
This office action is in response to the communication received on May 1, 2026 concerning application No. 19/020,598 filed on January 14, 2025.
Claims 1-20 are currently pending.
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 filed 05/01/2026 regarding the 35 USC 112 rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 112b rejection of claims 7 and 16 previously set forth.
Applicant’s arguments with respect to claim(s) 1, 10, and 19 on pgs. 7-10 of the arguments 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 § 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.
Claim(s) 1-5, 9-14, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable by Zhao et al. (US 20110237949, hereinafter Zhao) in view of Baba et al. (US 20060173292, hereinafter Baba).
Regarding claims 1 and 19, Zhao teaches an ultrasonic 2-dimensional (2D) image display method ([0034], figs. 4 and 6 disclose displaying a image generated using a two-dimensional dynamic ultrasonic imaging technique) an a non-transitory computer readable recording medium for storing a computer program code for, when being read and executed by a processor, performing an ultrasonic 2-dimensional (2D) image display method ([0012] discloses the processor includes instructions configured to cause the processor to carry out the steps of generating the images), wherein the method includes:
acquiring the ultrasonic 2D image including a proximal carpal tunnel ([0032] discloses “a time series of ultrasound images is acquired”. [0034] discloses the imaging is two-dimensional and [0030] discloses the imaging is performed to analyze carpal tunnel, therefore the image includes the carpal tunnel), wherein the ultrasonic 2D image includes a cross section of the proximal carpal tunnel ([0035] and fig. 6 disclose the image includes a cross section of the proximal carpal tunnel. Markers 700 within the image show the location of the carpal tunnel);
identifying at least two anatomical structures in the cross section of the proximal carpal tunnel, wherein the identified anatomical structures are a plurality of landmark anatomical structures included in the proximal carpal tunnel ([0035] discloses markers 700 are placed within the portions of the image to track anatomical features of the carpal tunnel including the flexor digitorum superficialis (FDS) and the subsynovial connective tissue (SSCT));
obtaining a positional relationship information of each of the identified anatomical structures ([0035] discloses placing the markers on the image to represent the location of the anatomical structure, thereby obtaining a positional relationship information for each identified structure); and
displaying an area of each of the identified anatomical structures at the cross section of the proximal carpal tunnel based on the obtained positional relationship information ([0035] and fig. 6 disclose displaying the markers 700 within the image to track the position of the anatomical structures. The placing of the markers 700 is considered the displayed area of each anatomical structure).
Zhao does not specifically teach displaying a closed curve representing a shape of each of the identified anatomical structures.
However,
Baba in a similar field of endeavor teaches displaying a closed curve representing a shape of the identified anatomical structure ([0053], [0067] and fig. 19 shows the anatomical structure is represented by a closed curve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the marker of Zhao for the closed curve of Baba because it amounts to simple substitution of one known element for another to obtain the predictable results of tracking the anatomical structures.
Regarding claim 10, Zhao teaches an ultrasonic imaging apparatus ([0020] and fig. 1 disclose an ultrasonic imaging system) comprising:
a display ([0021] and fig. 1 disclose display system 17);
a user interface ([0021] the display system 17 is considered the user interface because it allows the user to interact and view the displayed image);
a memory configured to store one or more instructions ([0012] discloses the processor includes instructions configured to cause the processor to carry out the steps of generating the images. The part of the processor where the instructions are stored is considered the memory), and
a processor (the electronic circuitry of the system shown in fig. 1) configured to:
acquire the ultrasonic 2D image including a proximal carpal tunnel ([0032] discloses “a time series of ultrasound images is acquired”. [0034] discloses the imaging is two-dimensional and [0030] discloses the imaging is performed to analyze carpal tunnel, therefore the image includes the carpal tunnel), wherein the ultrasonic 2D image includes a cross section of the proximal carpal tunnel ([0035] and fig. 6 disclose the image includes a cross section of the proximal carpal tunnel. Markers 700 within the image show the location of the carpal tunnel);
identify at least two anatomical structures in the cross section of the proximal carpal tunnel, wherein the identified anatomical structures are a plurality of landmark anatomical structures included in the proximal carpal tunnel ([0035] discloses markers 700 are placed within the portions of the image to track anatomical features of the carpal tunnel including the flexor digitorum superficialis (FDS) and the subsynovial connective tissue (SSCT));
obtain a positional relationship information of each of the identified anatomical structures ([0035] discloses placing the markers on the image to represent the location of the anatomical structure, thereby obtaining a positional relationship information for each identified structure); and
display, through the display, an area of each of the identified anatomical structures at the cross section of the proximal carpal tunnel based on the obtained positional relationship information ([0035] and fig. 6 disclose displaying the markers 700 within the image to track the position of the anatomical structures. The placing of the markers 700 is considered the displayed area of each anatomical structure).
Zhao does not specifically teach displaying a closed curve representing a shape of each of the identified anatomical structures.
However,
Baba in a similar field of endeavor teaches displaying a closed curve representing a shape of the identified anatomical structure ([0053], [0067] and fig. 19 shows the anatomical structure is represented by a closed curve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the marker of Zhao for the closed curve of Baba because it amounts to simple substitution of one known element for another to obtain the predictable results of tracking the anatomical structures.
Regarding claims 2 and 11, Zhao in view of Baba teaches the display method of claim 1 and the apparatus of claim 10, as set forth above. Baba further teaches the identified anatomical structures are determined based on an input of a user ([0035] and [0067] disclose identifying the ROIs (anatomical structures) based on an input from a user).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the identified anatomical structures be determined based on an input of a user of Baba to the method and apparatus of Zhao in view of Baba to allow for the predictable results of ensuring the region the user wants to be selected is actually selected in the correct location in the image, thereby increasing the accuracy of the analysis.
Regarding claims 3 and 12, Zhao in view of Baba teaches the display method of claim 2 and the apparatus of claim 11, as set forth above. Baba further teaches the identified anatomical structures are determined based on a click event of the user at a specific position in the ultrasonic 2D image or an input of the user related to position coordinates ([0035] and [0067] disclose the identified ROIs are identified based on a command from a mouse (click event) at the location of the ROI).
Regarding claims 4 and 13, Zhao in view of Baba teaches the display method of claim 1 and the apparatus of claim 10, as set forth above. Zhao further teaches the identified anatomical structures are determined based on a point at which at least one reference anatomical structure is located on the ultrasonic 2D image ([0035] discloses the anatomical features are located within the image by placing markers at the point within the image the features are located).
Regarding claims 5 and 14, Zhao teaches the display method of claim 4 and the apparatus of claim 13, as set forth above. Baba further teaches the at least one reference anatomical structure is determined based on an input of a user selecting a specific anatomical structure from among a plurality of anatomical structures ([0035] and [0067] disclose identifying the ROIs (anatomical structures) in an image based on an input from a user. By selecting the ROI in an image the user is selecting the specific anatomical structure from among a plurality of anatomical structures).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the at least one reference anatomical structure be determined based on an input of a user selecting a specific anatomical structure from among a plurality of anatomical structures of Baba to the method and apparatus of Zhao in view of Baba to allow for the predictable results of ensuring the region the user wants to be selected is actually selected in the correct location in the image, thereby increasing the accuracy of the analysis.
Regarding claims 9, 18, and 20, Zhao in view of Baba teaches the display method of claim 1, the apparatus of claim 10, and the non-transitory computer-readable recording medium of claim 19, as set forth above. Zhao further teaches the plurality of landmark anatomical structures included in the proximal carpal tunnel includes at least one of an ulnar artery, an ulnar nerve, a median nerve, a scaphoid tubercle, a pisiform, a flexor retinaculum, and a flexor pollicis longus ([0005] discloses ultrasound imaging of carpal tunnel syndrome (CTS) can detect at least the flexor tendons, flexor retinaculum and medium nerve which are considered landmark anatomical structures of the proximal carpal tunnel).
Claim(s) 6 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao in view of Baba as applied to claims 1 and 10 above, and further in view of Labyed (US 20190261949).
Regarding claims 6 and 15, Zhao in view of Baba teaches the display method of claim 1 and the apparatus of claim 10, as set forth above. Zhao in view of Baba does not specifically teach the obtaining the positional relationship information of each of the identified anatomical structure includes: applying data about the identified anatomical structure to a learning model, and training the learning model through position context information.
However,
Labyed in a similar field of endeavor teaches the obtaining the positional relationship information of each of the identified anatomical structure includes: applying data about the identified anatomical structure to a learning model ([0005] discloses “the ultrasound scanner detects a location of a liver capsule in an ultrasound image and determines a position of an ROI in a FOV of the ultrasound image. the position of the ROI is determined based on the location of the liver capsule” where the ROI is considered the anatomical structure of interest and liver capsule is the reference point. [0042] further discloses a machine learnt network is applied to determine the ROI position), and training the learning model through position context information ([0042] discloses the machine-learnt network is trained using expertly placed ROIs and the detected anatomy of act 10 in order to learn where to place the ROI, [0043] further discloses the ROI is positioned at a specific orientation and distance from the landmark (liver capsule) which would also have to be learned by the machine-learnt network).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and apparatus disclosed by Zhao in view of Baba to have the obtaining the positional relationship information of each of the identified anatomical structure include: applying data about the identified anatomical structure to a learning model, and training the learning model through position context information in order to improve consistency of measures over time and between sonographers, as recognized by Labyed (Abstract).
Claim(s) 7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao in view of Baba as applied to claims 1 and 10 above, and further in view of Jeong et al. (US 20160155222, hereinafter Jeong).
Regarding claims 7 and 16, Zhao in view of Baba teaches the display method of claim 1 and the apparatus of claim 10, as set forth above. Zhao does not specifically teach determining a landmark anatomical structure from among the plurality of landmark anatomical structures as a reference point, and wherein the identifying of the at least two anatomical structures includes: determining whether the at least two anatomical structures are identifiable; and when it is determined that the at least two anatomical structures are unidentifiable, estimating position of the at least two anatomical structures on the ultrasonic 2D image based on a position of the reference point.
However,
Jeong in a similar field of endeavor teaches determining a landmark anatomical structure from among the plurality of landmark anatomical structures as a reference point, and wherein the identifying of the at least two anatomical structures includes: determining whether the at least two anatomical structures are identifiable; and when it is determined that the at least two anatomical structures are unidentifiable, estimating position of the at least two anatomical structures on the ultrasonic 2D image based on a position of the reference point ([0079] and step 910 in fig. 7 discloses determining whether a reference point (anatomical structure) is located within the image. [0081] “if a reference point is not present at the second medical image, the medical image processing apparatus may estimate a virtual reference point at the second medical image”. [0075] and fig. 6B further disclose determining the virtual reference point VP using the pre-learned geometric relationship between the superior tip of the liver (determined reference point).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and apparatus disclosed by Zhao in view of Baba to determine a landmark anatomical structure from among the plurality of landmark anatomical structures as a reference point, and wherein the identifying of the at least two anatomical structures includes: determining whether the at least two anatomical structures are identifiable; and when it is determined that the at least two anatomical structures are unidentifiable, estimating position of the at least two anatomical structures on the ultrasonic 2D image based on a position of the reference point in order to be able to properly register multiple images together when at least one image does not have a corresponding reference point, as recognized by Jeong ([0075]).
Claim(s) 8 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao in view of Baba and Jeong as applied to claims 7 and 16 above, and further in view of Cho et al. (US 20150265251, hereinafter Cho).
Regarding claims 8 and 1, Zhao in view of Baba and Jeong teaches the display method of claim 7 and the apparatus of claim 16, as set forth above. Zhao in view of Baba and Jeong does not specifically teach calculating a probability of the estimated position; and displaying the calculated probability.
However,
Cho in a similar field of endeavor teaches calculating a probability of the estimated position ([0007]-[0008] discloses verification and adjusted information being determined, [00019] discloses “the verified and adjusted information…include confidence level information indicating a confidence level that each of the plurality of anatomical elements is actually an anatomical element”); and displaying the calculated probability (fig. 14 shows the confidence level information being displayed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of calculating a probability of the estimated position; and displaying the calculated probability of Cho to the method and apparatus of Zhao in view of Baba and Jeong to allow for the predictable results of indicating to the user the likelihood that the identified anatomical structure is correctly identified, thereby indicating whether the procedure is being performed correctly or if modifications need to be made, resulting in a more accurate procedure being performed.
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 ANDREW BEGEMAN whose telephone number is (571)272-4744. The examiner can normally be reached Monday-Thursday 8:30-5:00.
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/ANDREW W BEGEMAN/Primary Examiner, Art Unit 3798
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