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
Applicant’s argument on Pages 7-9 regarding the rejection of Claim 1 under 35 U.S.C. 103 over Honjo in view of Hong has been fully considered but is not persuasive. Applicant argues that the Office “has not established that Honjo describes calculating an attenuation characteristic based on an attenuation rate at various positions of a predetermined area of the target site” and that in Honjo, “there is no attenuation characteristic (singular) based on attenuation rates (plural).” However, Honjo teaches that the quantitative value acquisition function 221 is executed by the control circuitry 22 to analyze B-mode image data, attenuation image data, and dispersion image data (plural) to acquire a predetermined tissue property parameter (singular), as in [0071]. Additionally, applicant argues that Honjo “does not describe the ‘real-time’ element of this claim recitation.” However, as mapped above, in [0169], the quantitative tissue properties are acquired in a real-time manner as the ultrasound images are obtained.
Therefore, the rejection of Claims 1-4 and 7-8 under 35 U.S.C. 103 over Honjo in view of Hong is maintained.
Applicant’s argument on Pages 9-10 regarding the rejection of Claims 5-6 under 35 U.S.C. 103 over Honjo in view of Hong further in view of Ye has been fully considered but is not persuasive. Applicant argues that “the EchoScore Algorithm of Ye is not what determines the preset number of pieces of the data determined to be satisfactory […] it is merely a quality assessment of the ultrasound.” It is of note that Hong teaches the “EchoScore Algorithm.” However, the “number of frames of the ultrasound image” and “threshold value” of Ye is interpreted as the preset number of pieces of data determined to be satisfactory. The claim is broadly interpreted under reasonable interpretation that a “preset number of pieces of data” can be any data type, e.g., frames, amount of data stored, etc. that is a satisfactory or desired quality.
Therefore, the rejection of Claims 5-6 under 35 U.S.C. 103 over Honjo in view of Hong further in view of Ye is maintained.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 10 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
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.
Claims 1-4 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Honjo et al. (US 20190254634) in view of Hong et al. (US 20240252153).
Regarding Claims 1 and 8, Honjo teaches an ultrasonic diagnostic apparatus, ([0036] “ultrasound diagnostic apparatus 1”), comprising:
a) a transmitter/receiver that acquires a reception signal from a target site of a subject by transmission and reception of an ultrasonic wave (Fig. 1, [0037] “The piezoelectric transducers generate ultrasound based on a drive signal supplied from ultrasound transmission circuitry 11,” and [0041] “The ultrasound reception circuity 12 is a processor that performs various processes on the reflected wave signal received by the ultrasound probe 70 to generate a reception signal.”); and
b) a hardware processor, ([0039] “control circuitry 22”), that:
i) calculates in real time an attenuation characteristic based on an attenuation rate at each of a plurality of positions in a predetermined area of the target site by using the reception signal acquired by the transmitter/receiver ([0071] “The quantitative value acquisition function 221 is a function of acquiring tissue property parameters of a region of interest of a subject P. When the quantitative value acquisition function 221 is executed, the control circuitry 22 analyzes B-mode image data, […] attenuation image data, or dispersion image data, and acquires a predetermined tissue property parameter,” Claim 1 “An analysis apparatus comprising processing circuitry configured to: obtain quantitative values of a plurality of types of tissue properties relating to a region of interest of a subject,” and Claim 19 “wherein the quantitative values include […] an attenuation rate”); and
ii) determines in real time whether data including the calculated attenuation characteristics at the plurality of positions is satisfactory ([0057] “The internal memory circuitry 17 stores a plurality of thresholds for each type of tissue properties in advance” and [0169] “the diagram data (radar chart data) is generated in the ultrasound diagnostic apparatus 1 by using quantitative values of tissue properties that are acquired by the ultrasound probe 70 in a real-time manner”).
Furthermore, the cited actions are computer implemented, which necessitate associated computer-readable media, as in [0202] (“The term “processor” used in the above explanation means, for example, circuitry such as a CPU (central processing unit), a GPU (graphics processing unit), an ASIC (application specific integrated circuit), or a programmable logic device (for example, an SPLD (simple programmable logic device), a CPLD (complex programmable logic device), or an FPGA (field programmable gate array)). The processor realizes its function by reading and executing the program stored in the memory circuitry. Each processor of the present embodiment is not limited to a case where each processor is configured as a single circuit; a plurality of independent circuits may be combined into one processor to realize the function of the processor. Furthermore, a plurality of constituent elements shown in FIGS. 1 and 12 may be integrated into one processor to implement the functions.”).
However, Honjo does not explicitly teach a hardware processor that stores in real time the data determined to be satisfactory.
In an analogous ultrasound guidance field of endeavor, Hong teaches an ultrasonic diagnostic apparatus, (Claim 1 “ultrasound system”), comprising: a hardware processor, (Claim 1 “ultrasound system comprising at least one processor”), that: stores in real time the data determined to be satisfactory ([0123] “an algorithm or model can be used to grade the quality of the imagery and determine whether it meets diagnostic purposes (which may depend on the type of ultrasound imaging procedure or targeted sub-view) and is therefore suitable for capturing and/or saving for downstream analysis” and [0142] “any given sub-view can include one or more of the following data parameters: echo distance (ED) corresponding to the distance from the current probe position to the optimal position, image quality (IQ) corresponding to the clinical image quality of the image derived from echo distance,” where echo distance is interpreted as an attenuation characteristic.).
Furthermore, the cited actions are computer implemented, which necessitate associated computer-readable media, as in [0226] (“In some embodiments, the platforms, systems, media, and methods disclosed herein include at least one computer program, or use of the same.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the hardware processor of Honjo with the actions of Hong because the modification allows for saving with minimal interruption to the user, as taught by Hong in [0163].
Regarding Claim 2, the modified apparatus of Honjo teaches all limitations of Claim 1, as discussed above. Furthermore, Hong teaches wherein the hardware processor determines that the data is satisfactory when a variance of the attenuation characteristics at the plurality of positions is equal to or less than a preset threshold value ([0144] “Confidence can be based on an echo distance basis of one or more particular probe movements. The echo distance basis can comprise identification of a confidence expectation based on a particular echo distance parameter, such as the magnitude of a movement needed to reach a particular pose with a sub-view quality meeting a quality threshold” and [0145] “An echo distance parameter can have a threshold point that determines whether an image has a diagnostic quality or a non-diagnostic quality. The threshold point can be set based on a selected, particular, anatomical target, pathology, clinical question or sub-view. The confidence value for a particular probe movement with a shorter echo distance or expected to be over a given diagnostic threshold can be higher than for one or more probe movements with longer echo distances or expected to result in an images below the threshold quality. The threshold values can be adjusted for different anatomical targets, ultrasound scanning modes, sub-views, clinical questions, image quality goals, or other parameters, and probe movements that exceed these thresholds more than others can be given a higher confidence level.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the hardware processor of Honjo with the actions of Hong because the modification allows for a user to adjust the probe to correctly image the region of interest, resulting in accurate and efficient ultrasound imaging, as taught by Hong in [0003] and [0006].
Regarding Claim 3, the modified apparatus of Honjo teaches all limitations of Claim 1, as discussed above. Furthermore, Hong teaches wherein storage of the data by the hardware processor and scanning to acquire the reception signal for a next frame by the transmitter/receiver are performed simultaneously ([0040] “any of the methods described herein can comprise providing a user with a real-time output of acquisition status (e.g. saving and/or detection of required sub-views) for a selected diagnostic procedure.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the hardware processor of Honjo with the actions of Hong for the same reason as Claim 1, as discussed above.
Regarding Claim 4, the modified apparatus of Honjo teaches all limitations of Claim 1, as discussed above. Furthermore, Hong teaches wherein the hardware processor makes a notification when the hardware processor determines that the data is satisfactory ([0218] “a display 1132, computer system 1100 may include one or more other peripheral output devices 1134 including, but not limited to, an audio speaker, a printer, a storage device, and any combinations thereof” and [0331] “providing the user with a real-time output of acquisition status (e.g. saving and/or detection of required sub-views) for a selected diagnostic procedure.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the hardware processor of Honjo with the actions of Hong because the modification ensures a user is updated on the imaging procedure and is performing the procedure accurately and efficiently (i.e., if no data obtained was satisfactory, there would be no notifications, and therefore the user must adjust imaging procedure).
Regarding Claim 7, Honjo teaches an ultrasonic diagnostic method comprising:
a) acquiring a reception signal from a target site of a subject by transmission and reception of an ultrasonic wave (Fig. 1, [0037] “The piezoelectric transducers generate ultrasound based on a drive signal supplied from ultrasound transmission circuitry 11,” and [0041] “The ultrasound reception circuity 12 is a processor that performs various processes on the reflected wave signal received by the ultrasound probe 70 to generate a reception signal.”);
b) calculating in real time an attenuation characteristic based on an attenuation rate at each of a plurality of positions in a predetermined area of the target site by using the reception signal acquired in the acquiring ([0071] “The quantitative value acquisition function 221 is a function of acquiring tissue property parameters of a region of interest of a subject P. When the quantitative value acquisition function 221 is executed, the control circuitry 22 analyzes B-mode image data, elasticity image data, viscosity image data, attenuation image data, or dispersion image data, and acquires a predetermined tissue property parameter,” Claim 1 “An analysis apparatus comprising processing circuitry configured to: obtain quantitative values of a plurality of types of tissue properties relating to a region of interest of a subject,” and Claim 19 “wherein the quantitative values include […] an attenuation rate”); and
c) determining in real time whether data including the attenuation characteristics at the plurality of positions calculated in the calculating is satisfactory ([0057] “The internal memory circuitry 17 stores a plurality of thresholds for each type of tissue properties in advance” and [0169] “the diagram data (radar chart data) is generated in the ultrasound diagnostic apparatus 1 by using quantitative values of tissue properties that are acquired by the ultrasound probe 70 in a real-time manner”).
However, Honjo does not explicitly teach storing in real time the data determined to be satisfactory in the determining.
In an analogous ultrasound guidance field of endeavor, Hong teaches an ultrasonic diagnostic method, ([0003] “methods for real-time ultrasound guidance”), comprising: storing in real time the data determined to be satisfactory in the determining ([0123] “an algorithm or model can be used to grade the quality of the imagery and determine whether it meets diagnostic purposes (which may depend on the type of ultrasound imaging procedure or targeted sub-view) and is therefore suitable for capturing and/or saving for downstream analysis” and [0142] “any given sub-view can include one or more of the following data parameters: echo distance (ED) corresponding to the distance from the current probe position to the optimal position, image quality (IQ) corresponding to the clinical image quality of the image derived from echo distance,” where echo distance is interpreted as an attenuation characteristic.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the hardware processor of Honjo with the actions of Hong because the modification allows for saving with minimal interruption to the user, as taught by Hong in [0163].
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Honjo et al. (US 20190254634) in view of Hong et al. (US 20240252153) as applied to Claim 1 above, and further in view of Ye et al. (CN 117898764), see translation.
Regarding Claim 5, the modified apparatus of Honjo teaches all limitations of Claim 1, as discussed above. However, the modified apparatus of Honjo does not explicitly teach wherein when having acquired a preset number of pieces of the data determined to be satisfactory, the hardware processor causes the transmitter/receiver to end scanning of a next frame.
In an analogous ultrasonic exploring field of endeavor, Ye teaches an ultrasonic diagnostic apparatus, (Claim 1 “ultrasonic detection device”), wherein when having acquired a preset number of pieces of the data determined to be satisfactory, the hardware processor causes the transmitter/receiver to end scanning of a next frame (Claim 6 “monitoring the frame amount of the ultrasonic image in real time, when the frame amount of the ultrasonic image exceeds the threshold value, pausing to transmit the ultrasonic image to the reasoning module”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the hardware processor of Honjo with the actions of Ye because the modification ensures accurate and efficient acquisition of the ultrasonic images during the procedure and additionally provides efficient use of the user’s time.
Regarding Claim 6, the modified apparatus of Honjo teaches all limitations of Claim 5, as discussed above. Furthermore, Hong teaches wherein the hardware processor determines the number based on a magnitude of a variance of the data ([0196] “An EchoScore Algorithm can take time-aggregated coordinate and variance estimates from EchoGPS Algorithm and compute an EchoScore, a quantity in a scale of 0 to 100 that would represent the quality of the image for the target view the user intends to acquire. EchoScore is used both to guide the user and to programatically record echocardiographic clips via “Auto-Capture” and “Save-Best-Clip” features.”).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Honjo et al. (US 20190254634) in view of Hong et al. (US 20240252153) as applied to Claims 1 and 7-8 above, and further in view of Kanayama (US 20170258438).
Regarding Claims 9 and 11, the modified apparatus of Honjo teaches all limitations of Claims 1 and 8, as discussed above. However, the modified apparatus of Honjo does not explicitly teach wherein the attenuation characteristic is one of a plurality of attenuation characteristics, which are respectively calculated for one of a plurality of corresponding local regions that are each defined between first and second depth positions.
In an analogous medical diagnostic processing field of endeavor, Kanayama teaches an ultrasonic diagnostic apparatus wherein the attenuation characteristic is one of a plurality of attenuation characteristics, which are respectively calculated for one of a plurality of corresponding local regions that are each defined between first and second depth positions (Fig. 7, where the attenuation constants are depicted within regions ROI1 and ROI2, which are defined by first and second depth positions (via the circled section), and [0166] “the processing circuitry 29 calculates a representative value of the attenuation amount in the measurement ROI based on the attenuation amount at each of a plurality of positions in the measurement ROI. Specifically, the processing circuitry 29 calculates representative values such as a mean value, median, and mode of attenuation constants, based on the attenuation constants included in the measurement ROI. The processing circuitry 29 may calculate the representative values with the use of a differential value (hereinafter referred to as a mean differential value) obtained by differentiating a mean value of the measurement ROI in attenuation data along the depth direction.”).
Furthermore, the cited actions are computer implemented, which necessitate associated computer-readable media, as in [0213] (“each function associated with each embodiment can also be implemented by installing programs for executing the corresponding processing in a computer such as a workstation and mapping them in a memory. In this case, the programs which can cause the computer to execute the corresponding techniques can be distributed by being stored in recording media such as magnetic disks (hard disks and the like), optical disks (CD-ROMs, DVDs, and the like), and semiconductor memories.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the attenuation characteristic of Kanayama because the modification allows the operator to determine the attenuation characteristics within different regions of the patient’s body, ensuring that the ultrasonic signal reaches the tissue intended to be imaged, in order to provide quality images.
Regarding Claim 10, the modified method of Honjo teaches all limitations of Claim 7, as discussed above. However, the modified method of Honjo does not explicitly teach wherein the attenuation characteristic is one of a plurality of attenuation characteristics, which are respectively calculated for one of a plurality of corresponding local regions that are each defined between first and second depth positions.
In an analogous medical diagnostic processing field of endeavor, Kanayama teaches an ultrasonic diagnostic apparatus wherein the attenuation characteristic is one of a plurality of attenuation characteristics, which are respectively calculated for one of a plurality of corresponding local regions that are each defined between first and second depth positions (Fig. 7, where the attenuation constants are depicted within regions ROI1 and ROI2, which are defined by first and second depth positions (via the circled section), and [0166] “the processing circuitry 29 calculates a representative value of the attenuation amount in the measurement ROI based on the attenuation amount at each of a plurality of positions in the measurement ROI. Specifically, the processing circuitry 29 calculates representative values such as a mean value, median, and mode of attenuation constants, based on the attenuation constants included in the measurement ROI. The processing circuitry 29 may calculate the representative values with the use of a differential value (hereinafter referred to as a mean differential value) obtained by differentiating a mean value of the measurement ROI in attenuation data along the depth direction.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the attenuation characteristic of Kanayama because the modification allows the operator to determine the attenuation characteristics within different regions of the patient’s body, ensuring that the ultrasonic signal reaches the tissue intended to be imaged, in order to provide quality images.
Conclusion
THIS ACTION IS MADE FINAL. 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 MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
Prosecution Insights