Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 1-10 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 05/29/2026.
Response to Arguments
Applicant's arguments filed 08/13/2026 have been fully considered but they are not persuasive.
For claim 1, the applicant argues “These are operations recorded in P[0104], P[0144] and FIG. 6 [of Bricker] are clearly operation of user and clearly not "input to the image analysis model and output generated by the image analysis model" as claimed.” (see pg. 9, para. 2), and the examiner disagrees.
Bricker teaches the local controller 108, which includes pressure elastography software 110 performing machine learning operations (Fig. 1; see para. 0009 "…a second data set associated with an ultrasound scan of a second breast mass detection procedure contemporaneously conducted on the subject following the pressure elastography measurement (e.g., acquired from a portable ultrasound device)… wherein the first data set and the second data set are...ii) subsequently analyzed via machine learning or deep learning operations (e.g., in a remote/cloud server or the device) to provide an indication associated with the assessment of the breast mass.").
Bricker teaches logging any functions or monitoring operations, and their outputs, being executed on the controller 108, which includes machine learning operations, where machine learning operations include inputs and outputs of the machine learning model. Therefore, Bricker teaches logging inputs and outputs of the machine learning model (Fig. 6B; see para. 0144 – “In essence, the local controller (e.g., 108) can log any input made to the interface 600, the sensor device (e.g., the buttons on the devices 104, 106) as detected by the controller, as well as any functions or monitoring operations, and their outputs, being executed on the controller (e.g., 108).”).
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.
Claims 1-2, 4-5, and 8-10 are rejected under35 U.S.C. 103asbeing unpatentable over Bricker et al. (US 20220133279A1, published May 5, 2022) in view of Kikuchi et al. (JP 2023062448A, published May8, 2023), hereinafter referred to as Bricker and Kikuchi, respectively.
Regarding claim 1, and similarly for claims 8 and 9, Bricker teaches an ultrasound diagnostic system (Fig. 1A, pressure elastography system 100a) comprising:
a processor is configured to analyze ultrasound images using an image analysis model trained through machine learning (see para. 0009 "…a second data set associated with an ultrasound scan of a second breast mass detection procedure contemporaneously conducted on the subject following the pressure elastography measurement (e.g., acquired from a portable ultrasound device)… wherein the first data set and the second data set are...ii) subsequently analyzed via machine learning or deep learning operations (e.g., in a remote/cloud server or the device) to provide an indication associated with the assessment of the breast mass.");
create a log including a plurality of operation records by recording a plurality of operations including operations of the image analysis model in time series order (Fig. 6; see para. 0104- "During operation, the local controller 108 may be configured to generate an event log comprising a timestamped list of key events during an exam, e.g., screen change, start/stop recording, mass finding identified, patient data edited, among others. The event log can be provided to the local cloud infrastructure 102a, e.g., as 154 a. Sensor log is a timestamped list of exam forces measured by the sensor throughout the exam, along with other diagnostic information.");
save, for each of the operations of the image analysis model, detailed information including input to the image analysis model and output generated by the image analysis model (see para. 0144 "In essence, the local controller (e.g., 108) can log [save] any input made to the interface 600, the sensor device (e.g., the buttons on the devices 104, 106) as detected by the controller, as well as any functions or monitoring operations, and their outputs, being executed on the controller (e.g., 108)."); and
display the plurality of operation records included in the log (see para. 0144 "FIG. 6B shows an example display of panel 608 (shown as 608 a). The panel 608 a includes the exam log 616, which can include events relating to the start of the exam (616 a), the timestamp and location of a detected mass (616 b), the start of a recording (616 c), the current displayed views of the interface (616 d), edits to the appointment or patient information (616 e), and the end of the exam (6160." Information of Fig. 6B as plurality of operation records on display).
Bricker teaches displaying the plurality of operation records, but does not explicitly teach selecting a specific operation record among the displayed operation records.
Whereas, Kikuchi, in an analogous field of endeavor, teaches
in response to selection of a specific operation record among the displayed operation records that corresponds to an operation of the image analysis model, retrieve the detailed information associated with the specific operation record (Fig. 3; see pg. 6, para. 4 "The first display area G10 is a display area of a user interface that receives input of an operation for selecting a log to be displayed. The second display area G20 is an area where the content of the log selected as the display target is displayed. The third display area G30 is a display area of a user interface that accepts input of a keyword (hereinafter referred to as "search key") for searching the selected log. Note that when a search key is entered, search results of each selected log are displayed in the second display area G20. The fourth display area G40 is an area in which an ultrasound image selected as a display target is displayed [retrieved detailed information]."); and
create a model operation report including the retrieved detailed information (Fig. 3; see pg. 6, para. 4 "The fourth display area G40 is an area in which an ultrasound image selected as a display target is displayed [retrieved detailed information, report].").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified displaying the plurality of operation records, as disclosed in Bricker, by also selecting a specific operation record among the displayed operation records, as disclosed in Kikuchi. One of ordinary skill in the art would have been motivated to make this modification in order for the maintenance worker to refer to the corresponding ultrasonic image simply by selecting the entry of the target log displayed on the investigation screen, and an abnormality occurring in the ultrasonic diagnostic apparatus can be investigated efficiently, as taught in Kikuchi (see pg. 13, para. 4).
Furthermore, regarding claim 2, Bricker further teaches wherein the processor is further configured to save an analysis target image as the detailed information for each operation of the image analysis model, the analysis target image is an ultrasound image input to the image analysis model or an image corresponding to the ultrasound image, and the model operation report includes the analysis target image (see para. 0134 "The local controller (e.g., 108) can maintain the scan or recordings as time-series data or convert the data to a video or image file (e.g., healthcare video or image file format) [save images]…At the conclusion of the exam, the cloud infrastructure 103' or local controller 108' may initiate (524) the generation of a report that includes the pressure elastography results.").
Furthermore, regarding claim 4, Bricker further teaches wherein the processor saves an analysis result of the image analysis model as the detailed information for each operation of the image analysis model, and the model operation report includes the analysis result (see para. 0134 "The local controller (e.g., 108) can maintain the scan or recordings as time-series data or convert the data to a video or image file (e.g., healthcare video or image file format) At the conclusion of the exam, the cloud infrastructure 103' or local controller 108' may initiate (524) the generation of a report that includes the pressure elastography results.").
Furthermore, regarding claim 5, Bricker further teaches wherein the analysis result includes a plurality of scores corresponding to a plurality of classes, the report creation unit creates a graph based on the plurality of scores, and the model operation report includes the graph (Fig. 6; see para. 0146 "The aggregated visualization can include findings of masses [graph of scores/classes] (646) (e.g., by site location/office, examiner, time period).").
Furthermore, regarding claim 10, Bricker further teaches wherein the operation of the image analysis model includes event occurrence and processing execution (see para. 0144 "FIG. 6B shows an example display of panel 608 (shown as 608 a). The panel 608 a includes the exam log 616, which can include events relating to the start of the exam (616 a), the timestamp and location of a detected mass (616 b), the start of a recording (616 c), the current displayed views of the interface (616 d), edits to the appointment or patient information (616 e), and the end of the exam (6160."), and
the detailed information includes an input image and an analysis result corresponding to the operation of the image analysis (see para. 0009 "…a second data set associated with an ultrasound scan of a second breast mass detection procedure contemporaneously conducted on the subject following the pressure elastography measurement (e.g., acquired from a portable ultrasound device)… wherein the first data set and the second data set are...ii) subsequently analyzed via machine learning or deep learning operations (e.g., in a remote/cloud server or the device) to provide an indication associated with the assessment of the breast mass.").
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Bricker in view of Kikuchi, as applied to claim 2 above, and in further view of Lee (US 20220061816 A1, published March 3, 2022), hereinafter referred to as Lee.
Regarding claim 3, Bricker in view of Kikuchi teaches all of the elements disclosed in claim 2 above.
Bricker in view of Kikuchi teaches inputting an ultrasound image into an image analysis model, but does not explicitly teach where the ultrasound image is a low-resolution ultrasound image.
Whereas, Lee, in an analogous field of endeavor, teaches wherein the processor is further configured to convert the ultrasound image input to the image analysis model into a low-resolution image, wherein the analysis target image is the low-resolution image (Fig. 7; see para. 0102 "At 706, method 700 includes acquiring first scan data with the 1D transducer, wherein the first scan data is obtained by scanning a first volume of a given volume of interest."; see para. 0104 "At 708, method 700 includes generating a first ultrasound image using the first scan data. The first ultrasound image has a lower resolution profile."; see para. 0105 "Next, method 700 proceeds to 710 at which the method includes providing, as input to the trained resolution mapping algorithm, the first ultrasound image with a lower resolution profile.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified inputting an ultrasound image into an image analysis model, as disclosed in Bricker in view of Kikuchi, by inputting a low-resolution ultrasound image to the image analysis model, as disclosed in Lee. One of ordinary skill in the art would have been motivated to make this modification in order to reduce complexity of scanning and without bulkiness of additional mechanical controls, as taught in Lee (see para. 0103).
Furthermore, regarding claim 6, Bricker further teaches wherein the processor includes
an image saving unit that saves an analysis target image for each operation ofthe image analysis model, and a record saving unit that saves a detailed record including an analysis result of the image analysis model for each operation ofthe image analysis model (see para. 0134 "The local controller (e.g., 108) can maintain the scan or recordings as time-series data or convert the datato a video or image file (e.g., healthcare video or image file format) [save images]… At the conclusion of the exam, the cloud infrastructure 103' or local controller 108' may initiate (524) the generation of a report that includes the pressure elastography results."),
the detailed information in the model operation report includes the analysis target image, which is input information of the image analysis model, and the analysis result, which is output information of the image analysis model (see para. 0144 "In essence, the local controller (e.g., 108) can log [save] any input made to the interface 600, the sensor device (e.g., the buttons on the devices 104, 106) as detected by the controller, as well as any functions or monitoring operations, and their outputs, being executed on the controller (e.g., 108)."), and
Lee further teaches the analysis target image is a low-resolution image generated from an ultrasound image input to the image analysis model (Fig. 7; see para. 0102 "At 706, method 700 includes acquiring first scan data with the 1Dtransducer, wherein the first scan data is obtained by scanning a first volume of a given volume of interest."; see para. 0104 "At 708, method 700 includes generating a first ultrasound image using the first scan data. The first ultrasound image has a lower resolution profile."; see para. 0105 "Next, method 700 proceeds to 710 atwhich the method includes providing, as input tothe trained resolution mapping algorithm, the first ultrasound image with a lower resolution profile.").
The motivation for claim 6 was shown previously in claim 3.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bricker in view of Kikuchi, as applied to claim 1 above, and in further view of Holvey et al. (US 20040054935 A1, published March 18, 2004), hereinafter referred to as Holvey.
Regarding claim 7, Bricker in view of Kikuchi teaches all of the elements disclosed in claim 1 above.
Bricker in view of Kikuchi teaches selecting an operation record in a log, but does not explicitly teach selecting a hyperlink in a log.
Whereas, Holvey, in an analogous field of endeavor, teaches wherein each operation record included in the log includes a portion embedded with a hyperlink for specifying a location of the detailed information associated with the operation record, and the model operation report is displayed upon selection of the portion (Fig. 4-6; see para. 0032 "At step 432 the authorized user uses the subset, for example, selects a hyperlink in the document log, to access the rest of the set of user information stored in the user information database 142 or 242, for example the scanned medical record page associated with the hyperlink."; see para. 0035 "Column 554 gives the document ID for each document of a patient's medical records stored in user information DB 142. Cell570 has document ID457, which is a hyperlink to the document image. When link "457" is selected a separate window (FIG. 6) opens with the document's image.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified selecting an operation record in a log, as disclosed in Bricker in view of Kikuchi, by also selecting a hyperlink in a log, as disclosed in Holvey. One of ordinary skill in the art would have been motivated to make this modification in order to provide indirect access to a user's information in databases reduces the exposure to hackers compared to the conventional Web server which has the user's information available directly on Web server database, as taught in Holvey (see para. 0032).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lo et al. (US 20190057501 A1, published February 21, 2019) discloses a logging module 330 in the image processing system 335 records the tagged image and possibly other information used in processing the image (e.g., parameters to the landmark engine 315 and machine learning models 320). In this way, operation of the image processing system 335 can be verified and validated. Additionally, the logging module 330 may be used to debug the image processing system 335 if any erroneous tags or other data are detected (Fig. 3).
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 Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
