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 objections
Examiner notes that the previously set forth claim objections are withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 101
Examiner notes that the previously set forth 101 rejections are withdrawn in view of the amendments to the claims. Specifically, claim 1 has been amended to incorporate the elements of claim 5 (i.e. an ultrasound array included in the ultrasound probe including a first ultrasound array and a second ultrasound array disposed perpendicular to the first ultrasound array at one end of the first ultrasound array). Such an ultrasound array as noted in the previous Office Action is found to be a particular machine for which the judicial exception is applied, thus amounts to significantly more than the judicial exception.
Regarding claim interpretation
Examiner notes that the previously set forth 112(f) claim interpretations are withdrawn in view of the amendments to the claims which now recite a processor.
Regarding 35 U.S.C. 112(a)
Applicant’s arguments, see REMARKS, filed 04/17/2026, with respect to claim 1 have been fully considered and are persuasive. The 112(a) rejections have been withdrawn.
Regarding 35 U.S.C. 112(b)
Examiner notes that the previously set forth 112(b) rejections of claim 1-8 are withdrawn, however, the 112(b) rejections regarding the score which is now recited in claim 1 is maintained/updated in light of the amendments to the claims. Regarding claims 9-10, examiner notes that while amendments are made to the claims examiner notes that the claims remain rejected under 112(b) for lacking clarity as to what constitutes a weight and how it is determined and further whether the sum result is the same as or different from the comparison result of claim 1.
Regarding prior art
Applicant's arguments filed 04/17/2026 have been fully considered but they are not persuasive. For example, applicant argues “Ebata merely discloses measuring 1-dimensional lengths of the urinary bladder region to acquire the largest diameters LX, LY, and LZ, and then inserting these three lengths LX, LY, and LZ into an ellipsoidal volume formula: (LX x LY x LZ) * π/6. Ebata does not teach calculating an area score of the bladder area (i.e., 2-dimenisonal value) from the ultrasound images. Measuring a linear length (diameter) across an image is technically distinct from calculating an area score of the bladder area as claimed. Therefore, the Examiner’s contention that acquiring the largest diameters requires scoring the areas goes well beyond the broadest reasonable interpretation” (REMARKS pg. 8). Examiner respectfully disagrees in that there is nothing in the claims which specifies the nature of “an area score” such that it is precluded from being a diameter/length. Examiner notes that the claim merely requires that the area score(s) are of the bladder areas and are based on sizes of the bladder areas, where there is no requirement that the area score requires the use of or is a calculation/determination of an area (i.e. 2-dimensional value). In other words, claim 1 as currently amended merely recites calculate a first area score of the first bladder areas included in the first directional ultrasound images based on sizes of the first bladder area. It is noted that the diameter/length (or prioritized value thereof when determining a largest) constitutes such an area score in its broadest reasonable interpretation.
Applicant further argues “Further, even assuming arguendo that the Ebata’s diameters may be construed as the claimed area scores Ebata still fails to explicitly teach or even suggest to ‘determine a higher area score with a higher priority and a lower area score with a lower priority among the first area score and the second area score based on user settings; and compare the higher area score with a predetermined reference score to provide the comparison result’ as recited in claim 1. As discussed above, Ebata merely discloses multiplying the three diameters LX, LY, and LZ to calculate the ellipsoidal volume. There is no teaching or suggestion in Ebata of determining a diameter with a higher priority and a diameter with a lower priority among the first diameter (the alleged first area score; e.g. LX) and the second diameter (the alleged second area score; e.g. LY) into based on user settings. Nor is there any teaching or suggestion of comparing the higher area score with a predetermined reference score to provide the comparison result for calculating the volume of the bladder” (REMARKS pg. 8-10). Examiner respectfully disagrees in that it is noted that the claim merely recites determine a higher area score with a higher priority and a lower area score with a lower priority among the first area score and the second area score based on user settings, it is first noted that the claim is broadly recited such that it merely requires determining the score (i.e. diameter) where a diameter may be a higher or lower and thus be considered to have a respective, higher or lower priority. In other words, determining that LX = 7 cm and LY = 6 cm, and LX and LY are both determined, then LX is considered a higher area score with a higher priority which is determined and LY is considered a lower area score with a lower priority which is determined. In other words, the claim does not specify the nature of the determining or comparing of the first/second scores. Additionally/alternatively, the claim is broad it is noted that the first area score may be LX or one of the other diameters which has not been determined as the largest diameter, thus may be considered a higher score (largest diameter) or lower score (smaller diameter) with a higher or lower priority and the second area score may be LY or one of the other diameters which has not been determined as the largest diameter, thus may be considered a higher score (largest diameter) or lower score (smaller diameter). In which case, the system functions to determine a higher area score and a lower area score among the first area score and second area score. Regarding applicant’s arguments that the processor does not compare the higher area score with a predetermined reference score, examiner notes that each of the scores (i.e. diameters) are compared with all other scores (a predetermined reference score) for each directional imaging procedure in order to determine the largest diameter. For at least the reasons listed above, applicant’s arguments against the teachings of Ebata are not found persuasive.
Claim Rejections - 35 USC § 112(b)
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 1-4 and 9-10 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 “calculate a first area score” and “calculate a second area score”. It is unclear what the metes and bounds of an area score is. For example, it is unclear if the score is a qualitative, quantitative, binary, or other type of scoring and unclear what determines a score for an area of the bladder. For examination purposes, it has been interpreted to mean any type of score, however, clarification is required.
Claim 9 recites the limitation “determine a first weight value associated with the higher area score and the lower area score”. It is unclear what is meant by weight values and how such weight values are determined. It is further unclear if the weight values are the same as the area score or if these are different elements. For examination purposes, it has been interpreted that the weight value may merely be a priority value, score, or a multiplication of 1, however, clarification is required.
Claim 10 recites the limitation “calculate the volume of the bladder according to the sum result”. It is unclear if the sum result is the same as the comparison result of claim 1 or if this is a different result. In other words, claim 1 previously sets forth according to a comparison result and comparing a higher area score with a predetermined reference score to provide the comparison result. If the elements are different it is unclear how the calculation of the volume is according to both or if this is a different calculation of the volume. For examination purposes, it has been interpreted that the sum result and comparison result may be the same or different and the calculation may use one or both, however, clarification is required.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Ebata (US 20220378397 A1), hereinafter Ebata in view of Foreign Yoo (KR 102375824 B1 and cited by applicant), hereinafter Yoo (Examiner notes that citations to Yoo are with respect to the translated copy provided herein).
Regarding claim 1,
Ebata discloses a bladder volume measuring device comprising:
an ultrasound probe (at least fig. 1 (21) and corresponding disclosure in at least [0041]) configured to transmit an ultrasound signal to an inside of a human body and to receive an ultrasound signal reflected from the inside of the human body ([00544] which discloses the transducer array 2 of the ultrasound probe 21 illustrated in FIG. 1 has a plurality of transducers arranged in a one-dimensional or two-dimensional manner. According to a drive signal supplied from the transmission and reception circuit 3, each of the transducers transmits an ultrasonic wave and receives an ultrasound echo from a subject to output a signal based on the ultrasound echo); and
a processor (at least fig. 1 (22) and corresponding disclosure in at least [0043]) configured to calculate a volume of a bladder included in a plurality of ultrasound images generated based on the reception ultrasound signal according to at least one bladder area among bladder areas included in the ultrasound images and a comparison result ([0078] which discloses the urine volume measurement unit 13 calculates the volume of the urinary bladder B of the subject based on the ultrasound image of the measurement frame selected by the measurement frame selection unit 12 to measure the urine volume in the urinary bladder B. For example, when ultrasound images of two measurement frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other are selected by the measurement frame selection unit 12, the urine volume measurement unit 13 measures lengths of the urinary bladder region BR in the ultrasound images of the two measurement frames, acquires the largest diameters LX, LY, and LZ in the three directions orthogonal to each other, and calculates (LX×LY×LZ)×π/6. In this manner, the urine volume measurement unit 13 can calculate the volume of the urinary bladder B of the subject),
wherein the ultrasound probe includes an ultrasound array, and
wherein the processor is further configured to:
when the ultrasound probe is placed at a first point of the human body, generate first directional ultrasound images based on a first directional reception ultrasound signal received using the ultrasound array and generate second directional ultrasound images based on a second directional reception ultrasound signal received using the ultrasound array ([0118] which discloses it is determined that the ultrasound images of the two measurement frames corresponding to the two scan cross-sections of the urinary bladder B of the subject orthogonal to each other are not selected, the process returns to step S3, in which the scan with the ultrasonic beam is resumed. At this time, the user rotates the orientation of the ultrasound probe 21 by 90 degrees and performs the scan with the ultrasonic beam), the plurality of ultrasound images including the first directional ultrasound images and the second directional ultrasound images;
calculate a first area score of first bladder areas included in the first directional ultrasound images based on sizes of the first bladder areas ([0078] which discloses the urine volume measurement unit 13 calculates the volume of the urinary bladder B of the subject based on the ultrasound image of the measurement frame selected by the measurement frame selection unit 12 to measure the urine volume in the urinary bladder B. For example, when ultrasound images of two measurement frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other are selected by the measurement frame selection unit 12, the urine volume measurement unit 13 measures lengths of the urinary bladder region BR in the ultrasound images of the two measurement frames, acquires the largest diameters LX, LY, and LZ in the three directions orthogonal to each other, and calculates (LX×LY×LZ)×π/6. Examiner notes that acquiring the largest diameters requires determining a first area score (e.g. diameter) of the bladder area included in the first directional ultrasound images (i.e. a measurement frame in the first directional ultrasound images));
calculate a second area score of second bladder areas included in the second directional ultrasound images based on sizes of the second bladder areas ([0078] which discloses the urine volume measurement unit 13 calculates the volume of the urinary bladder B of the subject based on the ultrasound image of the measurement frame selected by the measurement frame selection unit 12 to measure the urine volume in the urinary bladder B. For example, when ultrasound images of two measurement frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other are selected by the measurement frame selection unit 12, the urine volume measurement unit 13 measures lengths of the urinary bladder region BR in the ultrasound images of the two measurement frames, acquires the largest diameters LX, LY, and LZ in the three directions orthogonal to each other, and calculates (LX×LY×LZ)×π/6. Examiner notes that acquiring the largest diameters requires calculating a second area score (e.g. diameter) of the bladder area included in the second directional ultrasound images (i.e. a measurement frame in the second directional ultrasound images));
determine a higher area score with a higher priority and a lower area score with a lower priority among the first area score and the second area score based on user settings ([0078] which discloses the urine volume measurement unit 13 calculates the volume of the urinary bladder B of the subject based on the ultrasound image of the measurement frame selected by the measurement frame selection unit 12 to measure the urine volume in the urinary bladder B. For example, when ultrasound images of two measurement frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other are selected by the measurement frame selection unit 12, the urine volume measurement unit 13 measures lengths of the urinary bladder region BR in the ultrasound images of the two measurement frames, acquires the largest diameters LX, LY, and LZ in the three directions orthogonal to each other, and calculates (LX×LY×LZ)×π/6. Examiner notes that determining a largest diameter LX, LY, and LZ requires determining a higher area score (e.g. diameter) with a higher priority for a larger diameter and lower area score (diameter) with a lower priority for a smaller diameter. Furthermore, it is noted that determining the values of LX, LY, and LZ are considered to determine a higher area score and a lower area score where one would be higher than another the score is determined. Finally, any of the measurements are necessarily based on user settings (e.g. settings for the imaging/system)); and
compare the higher area score with a predetermined reference score to provide the comparison result (Examiner notes that determining the largest diameter LX, LY, and LZ requires comparing a higher area score (e.g. diameter) with a predetermined reference score (i.e. other diameters) to provide the comparison result).
Ebata fails to explicitly teach wherein the ultrasound array includes a first ultrasound array and a second ultrasound array, and the second ultrasound array is disposed perpendicular to the first ultrasound array at one end of the first ultrasound array.
Yoo, in a similar field of endeavor involving ultrasound volume measurement, teaches an ultrasound array including a first ultrasound array (at least fig. 1 (120) and corresponding disclosure in at least pg. 2) and a second ultrasound array (at least fig. 1 (110) and corresponding disclosure in at least pg. 2) and the second ultrasound array is disposed perpendicular to the first ultrasound array (120) at one end of the first ultrasound array (120) (See at least fig. 1), and
Wherein the processor is configured to when the ultrasound probe is placed at a first point of the human body, generate first directional ultrasound images based on a first directional reception ultrasound signal using the first ultrasound array and generate second directional ultrasound images based on a second directional reception signal using the second ultrasound array (see at least figs. 5-7 and 8-9 and corresponding disclosure in at least pg. 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ebata, as currently modified, to include a first ultrasound array and a second ultrasound array as taught by Yoo in order to provide multi-directional ultrasound image data for identifying the height and width of the bladder for enhanced accuracy of the bladder volume (Yoo Summary of invention pg. 8). Furthermore, Ebata recognizes the benefit of performing measurement one ultrasound images of two frames corresponding to scan cross-sections that pass through the center of the urinary bladder B and are orthogonal to each other in [0063], therefore, such a modified ultrasound transducer to include the first ultrasound array and a second ultrasound array would be beneficial to the system of Ebata for providing such orthogonal ultrasound images without having to rotate the orientation of the probe.
Examiner notes that in the modified system, the first directional ultrasound images and second directional ultrasound images of Ebata are generated based on the first directional reception ultrasound signal using the first ultrasound array and second directional reception signal using the second ultrasound array of Yoo accordingly.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ebata and Yoo as applied to claim 1 above, and further in view of WIPO Srinivasan et al. (WO 2023177397 A1), hereinafter Srinivasan.
Regarding claim 2,
Ebata teaches the elements of claim 1 as previously stated. Ebata further teaches wherein the processor is further configured to provide the plurality of ultrasound images at scan intervals, while the ultrasound probe scans the inside of the human body in a first direction ([0050] which discloses the image generation unit generates an ultrasound image of a frame including the urinary bladder region, the user usally scans the urinary bladder by changing a position or angle of the probe)
And control a scan interval ([0045] which discloses under the control of the device control unit 14, the transmission/reception circuit 3 transmits ultrasonic waves from the transducer array).
Ebata, fails to explicitly teach wherein the processor is configured to: adjust subsequent scan intervals according to the bladder areas included in the plurality of ultrasound images generated at the scan intervals.
Srinivasan, in a similar field of endeavor involving ultrasound imaging, teaches a processor configured to adjust a subsequent scan interval ([055] which discloses the scanning condition or parameter may comprise, for example, the transmit pulse, pulse width, pulse power, pulse repetition interval, pulse order, pulse timing, pulse cycle, transmit frequency, pulse start time, pulse end time, pulse duration, or pulse type (e.g., unipolar pulses, multi-state bipolar pulses), or any other property associated with a pulse that is transmittable by the imaging device and [084] which discloses the scan table may comprise one or more events and one or more scanning conditions associated with the one or more events. The one or more scanning conditions may comprise one or more scanning parameters (or sets of scanning parameters) that dictate or control an operation of the imaging device (e.g., a scanning operation performable using the imaging device) and [012] which discloses the map enables a dynamic selection of one or more optimal scan tables comprising one or more predetermined sets of operating conditions for one or more imaging events) according to an area of interest included in the ultrasound images generated at every scan interval ([047] which discloses Such imaging event or imaging operation may involve obtaining or capturing one or more images or videos or extracting one or more image frames from such images or videos. In some cases, the event may be defined by or associated with a specific imaging device, an imaging location or region or field of view, an imaging time, an imaging parameter (e.g., scan frequency), or an imaging vector (i.e., a vector or a series of vectors defining a path along which imaging can be performed)..
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ebata to include adjusting a scan interval as taught by Srinivasan in order to enable live adaption and selection of optimal scanning parameters (Srinivasan [052]) and to optimize imaging for different features of interest ([076]).
Examiner notes that in the modified system the scan adjustment unit would function to adjust the scan interval according to the feature of interest, thus according to the area of the bladder of Ebata.
Regarding claim 3,
Ebata, as modified, teaches the elements of claim 2 as previously stated. Ebata, as currently modified, further teaches wherein the processor is configured to reduce the scan interval. Examiner thus notes that the processor thus functions to reduce the scan interval in any instance including as the bladder areas generated at the scan intervals increase.
Alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ebata, as currently modified, to include reducing the scan interval as bladder area at the scan intervals increase in order to provide optimal scanning parameters for the larger area of the bladder. Such a modification amounts to merely routine optimization yielding predictable results with respect to ultrasound imaging thereby rendering the claim obvious (MPEP 2144).
Regarding claim 4,
Ebata, as modified, teaches the elements of claim 3 as previously stated. Ebata further teaches wherein the processor is configured to calculate a largest maximum area among the bladder areas included in the plurality of ultrasound images generated at the scan intervals ([0139] which discloses thus, for example, the measurement frame selection unit 12 can analyze the graph representing the time-series change of the feature quantity, extract all the local maximum values of the feature quantity, acquire the maximum value among the extracted local maximum values, and select the ultrasound image of the frame corresponding to the acquired maximum value as the ultrasound image UD of the measurement frame and [0055] which discloses the feature quantity calculation unit 10 can calculate, as the feature quantity, an area of the extracted urinary bladder region BR, for example); and
calculate the volume of the bladder according to the maximum area ([0141] which discloses the ultrasound image UD of the measurement frame is selected from among the ultrasound images of the frames for which the feature quantity of the urinary bladder region BR becomes a local maximum, so that it is more likely that the ultrasound image UD of the measurement frame suitable for urine volume measurement is selected).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ebata and Yoo, as applied to claim 1 above, and further in view of Ganguly et al. (US 6213949 B1), hereinafter Ganguly.
Regarding claim 9,
Ebata, as modified, teaches the elements of claim 8 as previously stated. Ebata, as modified, fails to explicitly teach wherein the processor is further configured to: determine a first weight value associated with the higher area score and a second weight value associated with the lower area score, apply the first weight value to the higher area score to provide a first weighted value and apply the second weight to the lower area score to provide a second weighted score; and sum the first weighted score and the second weighted score to provide a sum score.
Ganguly, in a similar field of endeavor involving ultrasound bladder imaging, teaches a processor is configured to determine a first weight value associated with the higher area score and a second weight value associated with the lower area score, apply the first weight value to the higher area score to provide a first weighted value and apply the second weight to the lower area score to provide a second weighted score; and sum the first weighted score and the second weighted score to provide a sum score. (Col. 4 lines 45-47 which discloses after determining the cross-sectional areas in the P planes, the processor 18 calculates an estimate of the volume of urine in the bladder, by weighting and combining the P areas. See also Col. 7 lines 48-54).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ebata, as currently modified, to include applying weight values to the higher area score and the lower area score and summing the weighted scores as taught by Ganguly in order to provide an estimate of the volume of the bladder which takes into account the angle at which the ultrasound image was obtained with respect to a horizontal plane (Ganguly Col. 7 lines 48-54). Such a modification would enhance the volume estimation by ensuring that all image planes are summed and take into account the plane at which the images were captured.
Regarding claim 10,
Ebata, as modified, teaches the elements of claim 9 as previously stated. Ebata, as currently modified, fails to explicitly teach wherein the processor is further configured to:
compare the sum score with a predetermined reference sum score to provide a sum result The estimated volume may be compared with a predetermined overflow threshold, to determine if the user should then void; and calculate the volume of the bladder according to the sum result.
Nonetheless, Ganguly further teaches wherein processor is further configured to compare the sum score with a predetermined reference sum score to provide a sum result (The estimated volume may be compared with a predetermined overflow threshold, to determine if the user should then void Col. 4 lines 47-52); and
calculate the volume of the bladder according to the sum result (Col. 4 lines 45-47 which discloses the processor 18 calculates an estimate of the volume of urine in the bladder, by weighting and combining the P areas. Examiner notes that the volume is calculated necessarily according to the sum result as the sum result has a direct correspondence with the volume).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ebata, as currently modified, to include a result unit and volume calculation unit as taught by Ganguly in order to provide an alert that the volume of urine in the bladder has crossed an overflow threshold (Ganguly Col. 4 lines 47-52) which may prevent overdistention and subsequent kidney damage/renal failure (Ganguly Col. 1 lines 15-20) as well as to prevent leakage accidents (Ganguly Col. 1 lines 60-64).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 5712700552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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