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 Arguments
Regarding claim interpretation
Examiner notes that the previously set forth 112(f) claim interpretation is withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 112(b)
Examiner notes that while amendments are made to the claims, such amendments do not fully address the 112(b) clarity issues, see below 112(b) rejections for further information. For at least these reasons, the 112(b) rejections are maintained/updated. Examiner notes that an amendment was discussed (see interview summary and proposed amendments/email for interview held on 02/03/2026) but no agreement was reached. Examiner acknowledges applicant’s response in the email that the images are different, however, this does not appear to be supported in applicant’s specification and the claims do not make clear that the images are different when they are used for the apparent same processing functions (e.g. detecting excrement region/properties).
Regarding prior art
Examiner notes that the amendments to claims 1 and 26 and new claims 27-28 distinguish over the prior art collectively as noted below.
Applicant’s arguments that claim 7 is written in independent claim 1 and that claim 7 now distinguishes over the prior art is not found persuasive. Specifically, examiner notes that claim 7 does not include the distinguishing elements of claim 1 and has been merely amended to be in independent form with attempts to overcome the 112(b) rejections. Therefore, arguments that claim 7 distinguishes over the prior art is found to be merely conclusory without any specific arguments as to why the prior art does not teach the specific elements of claim 7. For at least these reasons, claim 7 remains rejected as being taught by the combination of Tanabe and Truyen.
Claim Interpretation
*Examiner notes that claim 26 recites the limitation “a step of highlight-displaying, via an the processor, the excrement region in the ultrasound image displayed on the monitor in a case where it is specified that the excrement is present” and “a step of notifying a user of, via the processor, a message suggesting a change of an approach of the ultrasound probe during performing the scanning in a case where it is not specified that the excrement is present within a predetermined period”. The limitations are contingent limitations found in a method claim. The broadest reasonable interpretation of a method claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (MPEP 2111.04(II)). Thus it is noted that claim 26 may require a step of highlight displaying or notifying depending on which conditions precedent has been met, but does not require both limitations.
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 1-26 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 1, 7, and 26-28 recite the limitation “by detecting the excrement region from one or more ultrasound images based on a detection result of the excrement region”. The limitation is unclear as to whether the one or more ultrasound images is or includes the ultrasound image, especially since the preceding limitation recites “detect an excrement region…. From the ultrasound image”. In other words, the claim appears to define a new one or more ultrasound image, however, it is unclear if the specifying the presence or absence is done using ultrasound image which is generated by the processor or if the claim is intending to recite that the specifying is done using one or more different ultrasound images. If applicant intends for the specifying to use different ultrasound images, examiner notes there does not appear to be support for using different images other than those that are generated by the processor and recommends pointing to support for generating one ultrasound image, detecting the excrement region therefrom, and then specifying by detecting the excrement region from different ultrasound image(s). For examination purposes, it has been interpreted that the one or more ultrasound images at least includes the ultrasound image, however, clarification is required.
Claim 1 and 26 recite the limitation “wherein the processor detects, for each ultrasound image of a plurality of ultrasound images and for each pixel of each ultrasound image of the plurality of ultrasound images, a probability that the pixel is a pixel of the excrement, determines whether or not the pixel is a pixel of the excrement by comparing the probability that the pixel is the pixel of the excrement with a first threshold value, and detects, as the excrement region, a collection of a plurality of pixels that are determined as pixels of the excrement”. The limitation is unclear for a plurality of reasons.
First - It is unclear if the plurality of ultrasound images is or includes any of the ultrasound image or the one or more ultrasound images previously recited. More specifically, the limitation appears to be further defining the detection of the excrement region and the previous recitations of detecting an excrement region refer to the ultrasound image and the one or more ultrasound images, thus making it unclear if the claim is attempting to further define either of the previous detections of the excrement region such that they use a plurality of ultrasound images or if this is intended to be a different detecting of the excrement region. If applicant intends for these to be a different plurality of ultrasound images and/or a different detecting of the excrement region, examiner notes that there does not appear to be support for such different detections using different ultrasound images and recommends pointing to support in the specification. For examination purposes, it has been interpreted that the detection is the same and the one or more ultrasound images is the same as the plurality of ultrasound images, however, clarification is required.
Second – it is unclear if the determining of whether or not the pixel is a pixel of the excrement by comparing the probability that the pixel is the pixel of the excrement with a first threshold is intended to be done for each pixel of each ultrasound image as the “for each pixel of each ultrasound image” is tied to the detecting of the probability or if the limitation is referring to merely one of the pixels in which case it is unclear which pixel the claim is referring to. For examination purposes, it has been interpreted that determining whether or not the pixel is a pixel of the excrement is performed for each pixel, however, clarification is required.
Third – a plurality of pixels that are determined as pixels of the excrement is unclear as the limitation previously recites determine whether or not the pixel is a pixel of the excrement. It is unclear at what point a plurality of pixels are determined as pixels of excrement since the claim appears to previously refer to only one determination of whether or not the pixel is a pixel of excrement and does not require determination of a pixel or a plurality of pixels to be determined as excrement. For examination purposes, it has been interpreted that the processor is configured to determine a plurality of pixels as excrement, however, clarification is required.
Claims 1 and 26 recite the limitation “a first statistic value of probabilities of all the pixels in the excrement region”. It is unclear if the probabilities of the all the pixels is or includes the previously recited probability that the pixel is the pixel of the excrement or if these are different probabilities. In other words, the limitation appears to introduce new probabilities, however, it would appear that the probabilities of all the pixels may be the same as or include the probability recited previously especially if the probability that the pixel is the pixel of the excrement is determined for each pixel. For examination purposes, it has been interpreted to mean that the probabilities of all the pixels is the same as the probability that the pixel is the pixel of the excrement determined for each pixel, however, clarification is required.
Claims 1 and 26 recite the limitation “obtains, as an index value, a first statistic value of probabilities of all the pixels in the excrement region of one ultrasound image generated by the processor, and specifies the presence or absence of the excrement by comparing a second statistic value of index values of the plurality of ultrasound images”. The limitation is unclear for a plurality of reasons.
First- it is unclear if the one ultrasound image is the same as or different from any of the previously recited ultrasound images (e.g. the ultrasound image, the one or more ultrasound images, or the plurality of ultrasound images). Specifically, it is noted that the specifying is previously recited as being performed by detecting the excrement region in one or more ultrasound images, the plurality of ultrasound images is further used for detecting the excrement region, and now the specifying appears to be done using an index value obtained from the one ultrasound image, therefore appearing to tie all of the recited ultrasound images together. By reciting “one ultrasound image”, without specifically tying it back to other ultrasound images, it is unclear if this one ultrasound image is or corresponds with any of the previously recited ultrasound images. If applicant intends for the one ultrasound image to be different from each of the previously recited ultrasound images, examiner notes there appears to be a lack of support for such an interpretation and it is recommended that applicant point specifically to support thereof.
Second – it is unclear if the index values is or include the index value of the one ultrasound image. In other words, it is unclear if the index values are the same as the first statistic value of probabilities and is determined for all of the plurality of ultrasound images as opposed to just one ultrasound image as previously recited or if these are a different index values. If they are different index value, it is unclear what the index values are and does not appear to be support for different index values and examiner recommends pointing to support for such an interpretation. For examination purposes, it has been interpreted that the first statistic value of probabilities as the index value is obtained for each of the plurality of ultrasound images, however, clarification is required.
Claims 3 and 21 recite the limitation “one ultrasound image”. It is unclear if this is the same one ultrasound image previously recited, any of the other previously recited ultrasound images, or if this is a different one ultrasound image. For examination purposes, it has been interpreted to mean any of the previously recited ultrasound images, however, clarification is required.
Claims 4 and 22 recite the limitation “the excrement region is detected from each of ultrasound images of a predetermined number or more among a plurality of continuous ultrasound images”. Examiner notes that claim 1 recites the processor is configured to detect the excrement region from an ultrasound images, one or more ultrasound images, and a plurality of ultrasound images. It is therefore unclear if the ultrasound images and/or the plurality of continuous ultrasound images are the same as or different from any of the previously recited ultrasound images. Examiner notes that it appears the plurality of continuous ultrasound images and the ultrasound images of the predetermine number or more would be the same as the plurality of ultrasound images previously recited. If applicant intends for them to be different examiner notes that there appears to be a lack of support for such an interpretation. For examination purposes, it has been interpreted to mean the same plurality of ultrasound images, however, clarification is required.
Claims 5 and 23 recite the limitation “the excrement region in each of adjacent ultrasound images”. It is unclear if the adjacent ultrasound images is or correspond with any of the previously recited ultrasound images. Because claim 1 recite the excrement region in one or more ultrasound images and detecting in a plurality of ultrasound images, it would appear that these are adjacent ultrasound images of the plurality of ultrasound images. If applicant intends for them to be different examiner notes that there appears to be a lack of support for such an interpretation. For examination purposes, it has been interpreted to mean the adjacent ultrasound images of the plurality of ultrasound images, however, clarification is required.
Claim 6 recites the limitation “in a case where the plurality of excrement regions are detected in one ultrasound image”. It is unclear if this is the same one ultrasound image previously recited, any of the other previously recited ultrasound images, or if this is a different one ultrasound image. For examination purposes, it has been interpreted to mean any of the previously recited ultrasound images, however, clarification is required.
Claim 7 recites the limitation “detects, for each ultrasound image of a plurality of ultrasound images generated by the processor, the excrement region and a probability”. Examiner notes that the claim previously recites detecting an excrement region from the ultrasound image and detecting the excrement region from one or more ultrasound images, therefore, it is unclear whether the plurality of ultrasound images are the same as or include the ultrasound image and/or the one or more ultrasound images from which the claim previously recites detecting the excrement region and whether the detecting is different or the same. Examiner notes that the images would all appear to be the same, however, due to the introduction of a new plurality of ultrasound images the claim is unclear. If applicant intends for the images to be different, there appears to be a lack of support for such an interpretation. For examination purposes, it has been interpreted that the processor generates a plurality of ultrasound images and detection occurs for each of the images, however, clarification is required.
Claim 7 recites the limitation “a statistic value of probabilities of the plurality of ultrasound images”. It is unclear if the probabilities are the same as the probability detected for each image as recited previously or if these are different probabilities. For examination purposes, it has been interpreted to mean the same probabilities, however, clarification is required.
Claim 17 recites the limitation “the ultrasound image” in multiple instances. It is unclear which of the previously recited ultrasound images the claim is referring to. For examination purposes, it has been interpreted to mean any of the previously recited ultrasound images having the excrement region, however, clarification is required.
Claim 20 recites the limitation “the ultrasound image”. It is unclear which of the previously recited ultrasound images the claim is referring to. For examination purposes, it has been interpreted to mean any of the previously recited ultrasound images having the excrement region, however, clarification is required.
Claim 27 recites the limitation “detects for each ultrasound image of a plurality of ultrasound images”. It is unclear if the plurality of ultrasound images are the same as or different from any of the previously recited ultrasound images. More specifically, the plurality of ultrasound images is used to specify an excrement property and the claim previously recites detecting excrement property of the excrement from the ultrasound image, thus would appear to include at least the ultrasound image. If applicant intends for them to be different images, examiner notes that there appears to be a lack of support for performing two different detections/specifying steps for different ultrasound images and it is recommended to point to support for such an interpretation. For examination purposes, it has been interpreted to mean that a plurality of ultrasound images are generated and the processor detects/specifies the excrement property from the plurality of ultrasound images, however, clarification is required.
Claim 27 recites the limitation “specifies the excrement property based on one first/second comparison result in one ultrasound image of the plurality of ultrasound images”. It is unclear if the one ultrasound image is or corresponds with the ultrasound image or the one or more ultrasound images recited previously. For examination purposes, it has been interpreted that the one ultrasound image may be the same as any of the ultrasound images recited previously, however, clarification is required.
ultrasound images
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Foreign Tanabe et al. 9US 2016195748 A1), hereinafter Tanabe in view of Truyen et al. (US 20080228067 A1), hereinafter Truyen.
Regarding claim 7,
Tanabe teaches an ultrasound diagnostic apparatus comprising:
An ultrasound probe (at least fig. 1 (3) and corresponding disclosure in at least [0020]-[0022]);
A monitor (at least fig. 1 (9) and corresponding disclosure in at least [0020]);
A processor (at least fig. 1 (5 and 7) and corresponding disclosure in at least [0022]-[0024]), wherein the processor is configured to:
generate and ultrasound image based on a reception signal obtained by scanning an examination area of a subject with ultrasound beams using the ultrasound probe ([0022] which discloses the image generation unit 5 generates ultrasonic image data from the echo signal detected by the probe unit 3 and [0027] which discloses the image generation unit 5 generates an ultrasound image)
display the ultrasound image on the monitor ([0023] which discloses the display unit 9 is a touch panel, and displays an image or an echo signal on a monitor, displays an evaluation result of the feces state evaluation unit 7, or receives an input from a user see also at least fig. 5 depicting displayed ultrasound images);
detect an excrement region from the ultrasound image ([0025] which discloses first, a hard stool determination line for determining whether or not there is hard stool is obtained in advance by learning from a plurality of echo signals of the large bowel in a hard stool state and in a non hard stool state (step STK1). Then, the large bowel portion to be evaluated is set as a region of interest, and an echo signal from the region of interest is detected (step STK2));
specify a presence or absence of excrement based on a detection result of the excrement region ([0025] If it becomes significantly larger, it is evaluated as hard stool (step STK6). Otherwise, it is evaluated that there is no hard stool (step STK7) and [0027] which discloses Similarly, it can be evaluated as soft feces by determining the presence or absence of a small-sized granular retained object using the echo signal).
Display a result of the excrement specification on the monitor ([0023] which discloses the display unit 9 is a touch panel, and displays an image or an echo signal on a monitor, displays an evaluation result of the feces state evaluation unit 7, or receives an input from a user); and
Notify a user of a message suggesting a change of an approach of the ultrasound probe during performing the scanning in a case where it is not specified that the excrement is present within a predetermined period ([0023] which discloses the display unit 9 is a touch panel, and displays an image or an echo signal on a monitor, displays an evaluation result of the feces state evaluation unit 7, or receives an input from a user. Examiner notes that displaying such evaluation results and/or images would notify a user of a message suggesting a change of an approach. In other words, the claim broadly encompasses notifying a user, where the displayed data would notify a user of whether to change an approach of the ultrasound probe during performing the scanning in a case where excrement is not specified (e.g. the probe is not imaging the excrement region for example a user would recognize this from the ultrasound image/evaluation result data and would thus be notified to change an approach),
Wherein the processor detects, for each ultrasound image of a plurality of ultrasound images generated by the processor, the excrement region and a probability that the excrement is present in the excrement region, and the processor specifies the presence of the absence of the excrement by comparing a statistic value of probabilities of the plurality of ultrasound images with a threshold value ([0030] which discloses the soft feces evaluation unit calculates a change and/or speed of the inside of the large bowel from the successive ultrasound images before and after (step STD3). In the soft feces state, since the amount of water is large, the small-sized granular retained matter moves faster than the normal movement of the feces, the large intestine, and the tissues in front of the large intestine, and moves randomly in various directions. Therefore, it is determined whether or not the speed is confirmed to be higher than the soft feces evaluation value (step STD4). If a high-speed movement is confirmed, it is determined to be soft feces. Otherwise, it is not evaluated as soft feces. Examiner notes that detection of the small- sized granular retained matter is considered to be an excrement region and a probability corresponds with the detection of the small-sized granular retained matter or the movement thereof for each image and the speed is considered a statistic value of probabilities that is confirmed to be higher than the soft feces evaluation value thus is compared to a threshold to specify the presence or absence of at least the soft feces).
While Tanabe teaches binarizing the ultrasound image, it is unclear if such binarization highlight-displays the excrement region in the ultrasound image displayed on the monitor in a case where it is specified that the excrement is present.
Nonetheless, Truyen, in a similar field of endeavor involving medical imaging, teaches highlight-displaying an excrement region in an image displayed on a monitor ([0010] which discloses identifying a region which is suspected to include residual stool, and highlighting the identified region on an image of the rendered surface).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Tanabe to include highlight-displaying the excrement region as taught by Truyen in order to provide enhanced visualization of the excrement region to a user. Such a modification would allow a user to easily recognize the positioning of the excrement/excrement region during an evaluation thereby enhancing the diagnostic procedure.
Allowable Subject Matter
Claims 1-6 and 9-28 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art remains to be Tanabe and Truyen as noted above, however, Tanabe fails to explicitly teach aspects relating to specifying as an index value a statistic value of the probabilities of all the pixels in the excrement region of an ultrasound image of one frame and specifies the presence or absence of the excrement by comparing a statistic value of the index values of ultrasound images of a plurality of frames with a second threshold value as required by claims 1 and 26, detecting a statistic value of brightness or a brightness ratio and comparing the statistic value of brightness or brightness ratio with a threshold value as required by claim 27, obtaining a total area of the classes for each of the classes of the excrement properties, and specifies a class having a largest total area, as the excrement property of the excrement region as required by claim 28, and wherein the statistic value of the probabilities which is compared with a threshold value is an average value, a weighted average value, or a median value as required by claim 25.
A person having ordinary skill in the art would not have been motivated to have modified the teachings of Tanabe, as modified by Truyen to include such recited features as noted above. It is therefore noted that the combination of elements found in claims 1 and 26-28 distinguish over the prior art collectively.
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 BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797