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 .
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.
Claims 7-8 and 16-17 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.
Claims 7 and 16 recite the limitation “when it is determined that the at least two anatomical structures are unidentifiable, acquiring an estimated position of the at least two anatomical structures on the ultrasonic 2D image based on the positional relationship information”, which is considered indefinite. It is not clear to the examiner how an estimated position of the at least two anatomical structures can be based on the positional relationship information when the positional relationship information is obtained after the at least two anatomical structures have already been identified in claim 1. Therefore, there would be no need to estimate a position because the at least two anatomical structures were already identified or the estimated position could not be based on the positional relationship because the positional relationship information would not have been obtained if the anatomical structures were unidentifiable. Examiner further notes that there is no previous determination step for determining whether the at least two anatomical structures are identifiable, therefore it is unclear when it is determined that the anatomical structures are unidentifiable.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 9-10, 13, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Zhao et al. (US 20110237949, hereinafter Zhao).
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).
Regarding claim 10, Zhao teaches an ultrasonic imaging apparatus ([0020] and fig. 1 disclose an ultrasonic imaging system) comprising:
a display unit ([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 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).
Regarding claims 4 and 13, Zhao 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 9, 18, and 20, Zhao 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 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) 2-3, 5, 11-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao in view of Lysyansky et al. (US 20100249589, hereinafter Lysyansky).
Regarding claims 2 and 11, Zhao teaches the display method of claim 1 and the apparatus of claim 10, as set forth above. Zhao does not specifically teach the identified anatomical structures are determined based on an input of a user.
However,
Lysyansky in a similar field of endeavor teaches the identified anatomical structures are determined based on an input of a user ([0054] “a user may identify one or more anatomical landmarks (e.g., mitral valve annulus)”).
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 Lysyansky to the method and apparatus of Zhao 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 Lysyansky teaches the display method of claim 2 and the apparatus of claim 11, as set forth above. Lysyansky 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 ([0053] “identifying one or more landmarks, for example the apical point of the myocardium, which may be manually identified by a user (e.g., by pointing and clicking with a mouse)”).
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 a click event of the user of Lysyansky to the method and apparatus of Zhao in view of Lysyansky 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 5 and 14, Zhao teaches the display method of claim 4 and the apparatus of claim 13, as set forth above. Zhao does not specifically teach 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.
However,
Lysyansky in a similar field of endeavor 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 ([0054] “a user may identify one or more anatomical landmarks (e.g., mitral valve annulus)”, where the landmark is selected from a plurality of potential landmarks being displayed within the image).
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 Lysyansky to the method and apparatus of Zhao 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.
Claim(s) 6 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao in view of Labyed (US 20190261949).
Regarding claims 6 and 15, Zhao teaches the display method of claim 1 and the apparatus of claim 10, as set forth above. Zhao 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 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 Jeong et al. (US 20160155222, hereinafter Jeong).
Regarding claims 7 and 16, Zhao teaches the display method of claim 1 and the apparatus of claim 10, as set forth above. Zhao does not specifically teach the identifying at least two anatomical structures includes: when it is determined that the at least two anatomical structures are unidentifiable, acquiring an estimated position of the at least two anatomical structures on the ultrasonic 2D image based on the positional relationship information.
However,
Jeong in a similar field of endeavor teaches identifying at least two anatomical structures includes: when it is determined that the at least two anatomical structures are unidentifiable, acquiring an estimated position of the at least two anatomical structures on the ultrasonic 2D image based on the positional relationship information ([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 (reference point) and the solar plexus (anatomical structure of interest).
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 to have the identifying at least two anatomical structures includes: when it is determined that the at least two anatomical structures are unidentifiable, acquiring an estimated position of the at least two anatomical structures on the ultrasonic 2D image based on the positional relationship information 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 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 Jeong teaches the display method of claim 7 and the apparatus of claim 16, as set forth above. Zhao in view of 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 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. This would result in a more accurate procedure being performed.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 5712701790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798