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
Applicant's claim amendments filed on 06/29/2026 have been entered. Accordingly, claims 1-16, 39, 42-43, and 48 remain pending, claims 1 and 16 have been amended, and claims 4-15 and 39 have previously been withdrawn without traverse in the response filed 12/23/2024, and as remarked in the office action mailed 01/15/2025.
Response to Arguments
Rejections under 35 USC 112
In light of applicant’s claim amendments filed 06/29/2026, previous 112 rejections of the claims have been rendered moot and have been withdrawn.
Rejections under 35 USC 103
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new grounds of rejection have been presented. Consequently, the arguments do not apply to new references or the new combination of the references being used in the current rejection.
Nonetheless, in response to applicant’s specific remarks on ¶¶ 5-7 of page 10 through ¶1 of page 11,
“i) In page 8 of the Office Action, applicant is advised to amend in subject matter from applicant's elected embodiments depicted in FIG. 10, specifically, relating to the processes of the human-machine interactive unit via which input provided by the user for control/instruction of the claimed method and or the step of the region of interest having been determined through the disclosed automatic image recognition process (see as described in [0112]-[0114]).
Applicant is very grateful for this suggestion and has amended claim 1 to read ‘automatically determining the region of interest on the ultrasonic image through an automatic image recognition process’ as suggested.
Osaka discloses in paragraphs [0066]-[0067] that ‘An examiner can freely change the position of the measurement line 22 using the console 19…and determines the cross section for acquiring a shear wave image’…
Furthermore, although Osaka includes an ‘automatic measurement’ button, as can be seen from paragraphs [0073]-[0076] (The automatic measurement 24 automatically acquires the boundary (edge) of a shear wave image for acquiring elasticity information... The examiner sets the edge detection region 34 on a shear wave image via the console 19), it is evident that the term ‘automatic’ in Osaka refers solely to the automatic edge detection process following the generation of the shear wave image. This is entirely different from the technical solution of amended claim 1, which involves ‘determining the region of interest on the ultrasonic image through an automatic image recognition process’ prior to generating the shear wave”.
As a preliminary matter it is noted that the prior suggestion for what subject matter applicant should amend into the claims did not pertain nor relate to the prior art rejection. This suggestion was made solely in relation to the former rejections under 112 where applicant had outstanding rejections for claiming withdrawn subject matter that was not disclosed as being combinable with applicant’s elected embodiment. The suggestion in the prior office action was for applicant to claim additional subject matter of applicant’s elected embodiment.
While it is noted that the present claim rejections do not rely on [0066]-[0067] of primary reference Osaka (and the prior rejection also did not rely on [0066]), it is noted that [0072] of primary reference Osaka distinctly discloses that the selection by the examiner is “via the console 19 from either the automatic measurement 24 or the manual measurement 26 that are displayed on the image display unit 18 (step 5)”. From here, it is clear from this cited disclosure that automatic or manual measurement are alternates, and automatic measurement processes include more than just “edge detection”, as illustrated in steps 6-9 of the automatic measurement in FIG. 7 (see left side of figure).
It is noted that while applicant has amended claim 1 to now recited “automatically determining the region of interest on the ultrasonic image through an automatic image recognition process” applicant has not defined, nor disclosed what specific algorithms nor steps of the automatic image recognition process for which applicant has applied in applicant’s elected embodiment. Therefore, the automatic image recognition process has been interpreted under the broadest reasonable interpretation as defined by the computer vision arts.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the “‘determining the region of interest on the ultrasonic image through an automatic image recognition process’ prior to generating the shear wave”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Accordingly, it is noted that the arguments presented are unsupported by objective evidence. Applicant is reminded that arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
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(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Osaka et al. (US20120123263, hereafter “Osaka”), in view of Liu et al. (US20210059643, hereafter “Liu”), further in view of Sumi et al. (US20160157828, hereafter “Sumi”).
Regarding claim 1, Osaka discloses ultrasonic viscoelasticity measuring method, comprising:
outputting a first transmitting/receiving sequence* to a transducer of an ultrasonic probe to control the transducer to transmit a first ultrasonic wave to a target object including a region of interest, receive an echo of the first ultrasonic wave (abstract, [0021] the ultrasonic probe (4) configured to transmit/receive an ultrasonic wave to/from an object (5), the executed reception process on the reflected echo signal of the transmitted ultrasonic wave for detecting propagation position of a shear wave,), and acquire a first ultrasonic echo signal based on the echo of the first ultrasonic wave ([0021] the propagation position of a shear wave is obtained by the time that the ultrasonic wave for detecting propagation position reflects to a shear wave and returns);
generating an ultrasonic image based on the first ultrasonic echo signal and displaying the ultrasonic image ([0022] the image constructing unit is configured to construct a tomographic image based on the reflected echo signal received and processed by the transmission/reception unit), and automatically determining the region of interest on the ultrasonic image ([0024], [0070]-[0071], FIG. 7, see left side of FIG. 7, the image construction unit is configured to automatically determine the shear wave image generation corresponding to the region selected on a tomographic image displayed on the image display unit can be displayed on the image display unit) through an automatic* image* recognition* process*,* ([0046], [0049], [0070]-[0085], FIGS. 7-8, see automatic measurement steps 6-9 in FIG. 7, by inputting the RF frame signal from the phasing and adding unit 7, the tomographic image constructing unit 8 executes signal processing such as gain compensation, log compression, detection, edge enhancement and filtering, the detecting of a moving vector is the block matching steps that divide an image into blocks formed by, for example N×N pixels, focuses on the block within the region of interest, searches the block which is most approximated to the focused block from the previous frame, and determines the sample value by the predictive coding, where image preprocessing is executed for improving accuracy of edge detection, and the edge detection is executed by automatic extracting operation, the propagation velocity and the Young's modulus of a shear wave calculated in step 8 and subsequently displayed, which, when taken together are known in the computer vision arts to be constitute automatic image recognition processes);
outputting drive signals to a vibrator of the ultrasonic probe ([0042], [0050]-[0051] the calculation unit 11 calculates strain or elasticity modulus with respect to the data outputted from the displacement measurement unit 10), to drive the transducer by the vibrator to exert mechanical vibrations on the target object based on at least a vibrati1on signal ([0029], [0040], [0072] the process of receiving an ultrasonic wave by an ultrasonic probe that transmits/receives the ultrasonic wave drives a vibrator to make an object to generate a low-frequency shear wave), to generate shear waves propagating within the region of interest ([0040], [0042]-[0043], [0049], generate shear wave in the region of interest in the object);
outputting a second transmitting/receiving sequence** to the transducer to control the transducer to transmit a second ultrasonic wave to the region of interest to detect the shear waves propagating within the region of interest ([0042]-[0043], [0047]-[0049], the displacement is generated and measured in the region of interest of the biological tissue of the object in order to determine strain and elasticity modulus for later calculation of the elasticity value, the shear rate propagation detection unit acquires the propagation position and propagation time of each shear wave generated in response to each ultrasound wave transmitted by probe), receive an echo of the second ultrasonic wave ([0040], [0057], FIG. 3, the transmission unit 2 is configured to repeatedly transmit an ultrasonic wave to the object 5 via the ultrasonic probe 4 at time intervals and the reception unit 6 is configured to receive the reflected echo signal produced from the object 5 in time series, the ultrasonic wave for detecting propagation position is transmitted one time for each time that a plurality of ultrasonic waves 20 for detecting a tomographic image are transmitted, and the transmission interval is α, see the plurality of intervals representing a plurality transmit/receive sequences including a second transmit/receive sequence), and acquire a second ultrasonic echo signal based on the echo of the second ultrasonic wave (see steps 3-6 in FIG. 7);
displaying the final elasticity parameter of the region of interest (abstract, [0026]-[0029], [0050]-[0054], [0060]-[0069], [0071]-[0073], FIG. 7, the elasticity information calculating unit (15) is configured to calculate elasticity information based on the boundary of the shear wave image and the image construction unit is configured to display elasticity modulus/parameter distribution so that the elasticity modulus distribution is corresponded to and synthesized with the tomographic image displayed on the image display unit); and
determining a validity of the at least one elasticity parameter of the region of interest according to whether a pressure signal between ultrasonic probe and the target object ([0069], [0075]-[0084] elasticity parameter that has been calculated is measured as quantitative numeric values in order to be recognized by the user which is used to calculate an average value between the propagation velocity and the elasticity parameter which are then displayed as a graph that is displayed in a way to the correspondent to a given measurement line respect space, which as a straight line, having the two measurement points set substantially away from other interconnected parts of the line allows for the reduction of the influence of error of noise as an error noise has been eliminated as such which leads to the improvement in accuracy of the determined propagation velocity and elasticity parameter, thus by determining the accuracy of the elasticity parameter the cited disclosure reads on the determining of the validity, as recited in claim), detected by a pressure sensor provided on the ultrasonic probe ([0042], [0050]-[0051] the calculation unit 11 calculates strain or elasticity modulus with respect to the data outputted from the displacement measurement unit 10 by using a pressure value measured by a pressure sensor connected to the ultrasonic probe 4), falls into a preset pressure range (see as indicated in graphs illustrated in FIGS. 5, 9), but the disclosed drive signals outputted to the vibrator are not explicitly disclosed as does not explicitly being different drive signals, to exert various mechanical vibrations on the target object based on at least two different vibration signals, nor the step of separately processing the second ultrasonic echo signal of the region of interest to obtain multiple measured elasticity values and multiple measured viscosity values of the region of interest; the displayed parameter(s) disclosed by Osaka do not explicitly include the display of the final viscosity parameter of the region of interest.
However, in the same field of endeavor, Liu teaches outputting different drive signals to a vibrator ([0057], FIGS. 2, 8-9, the DSP control signal chain of the vibration adjusting device is used to adjust in real time the waveform of the shear wave generated by the vibration device by changing the output frequency and amplitude of the vibration device in real time) of the ultrasonic probe to drive the transducer by the vibrator to exert various mechanical vibrations on the target object based on at least two different vibration signals (abstract, [0042]-[0044], FIGS. 2 &4, shear wave elastography is performed using different vibration frequencies, abstract, [0042]-[0043], FIGS. 1, 9, shear wave elastography is performed on the object at a plurality of different vibration frequencies, then a plurality of images are generated corresponding to the plurality of different vibration frequencies), based on the different drive signals ([0057]-[0058], FIGS. 2, 8-9, see the vibration adjusting device illustrated in FIG. 9);
separately processing the second ultrasonic echo signal of the region of interest to obtain multiple measured elasticity values and multiple measured viscosity values of the region of interest ([0011], [0033], [0045], [0052], claim 2, separately calculate an average velocity of a shear wave in the region of interest in each image for each of the plurality of different vibration frequencies corresponding to a plurality of images containing the second ultrasound data, the shear wave velocities is used to reconstruct the multiple measured elasticity and viscosity values); and
displaying the final elasticity parameter and the final viscosity parameter of the region of interest ([0033], [0042]-[0049], FIGS. 2 &4, an average velocity of a shear wave in the region of interest in each image corresponding to each of the vibration frequencies is calculated separately for each of the plurality of different vibration frequencies using a fitted curve. From here, the curve describes the frequency-velocity relationship is generally affected by both a viscosity parameter and an elasticity parameter of the tissue. This displayed graph is an elasticity graph, a viscosity graph or any suitable graph representing a contrast between different tissue).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Osaka with outputting different drive signals to a vibrator of the ultrasonic probe to drive the transducer by the vibrator to exert various mechanical vibrations on the target object based on at least two different vibration signals, separately processing the second ultrasonic echo signal of the region of interest to obtain multiple measured elasticity values and multiple measured viscosity values of the region of interest, and the displaying the final elasticity parameter and the final viscosity parameter of the region of interest as taught by Liu in order to perform shear wave elastography using different vibration frequencies by adjusting the vibration frequency as one or a plurality of different values, so as to obtain images corresponding to the different vibration frequencies, in addition, this system saves time, and automatically determines the optimal vibration frequency so as to ensure the image quality of elastography and the accuracy of elastography can be improved as non-zero viscous interference is basically eliminated ([0042], [0049], and [0058] of Liu).
Osaka, in view of the Liu, discloses performing averaging calculations on the multiple measured elasticity values to obtain a final elasticity parameter of the region of interest and on the multiple measured viscosity values to obtain a final viscosity parameter of the region of interest ([0011]-[0013], [0045]-[0047] calculating an average velocity of a shear wave in the region of interest in each image corresponding to each of the vibration frequencies, the shear wave velocities is used to reconstruct the multiple measured elasticity and viscosity values), but does not explicitly disclose performing fusion calculation on the multiple measured elasticity values to obtain a final elasticity parameter of the region of interest, performing fusion calculation on the multiple measured viscosity values to obtain a final viscosity parameter of the region of interest
However, in the same field of endeavor, Sumi teaches performing fusion calculation on the multiple measured elasticity values to obtain a final elasticity parameter of the region of interest, performing fusion calculation on the multiple measured viscosity values to obtain a final viscosity parameter of the region of interest ([0563], [0629] fusion of measurement results or the data mining is performed using reception transducers or reception sensors with respect to plural different types of waves on the basis of the observed physical, high order processing such as approaches of an inverse problem etc., is performed to calculate (visco) elastic moduli [plural/multiple] or elastic moduli [plural/multiple], viscosities [plural/multiple]).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Osaka with teaches performing fusion calculation on the multiple measured elasticity values to obtain a final elasticity parameter of the region of interest, performing fusion calculation on the multiple measured viscosity values to obtain a final viscosity parameter of the region of interest as taught by Sumi to provide high spatial resolution measurement and viscoelastic measurements ([0667] of Sumi).
*For the purposes of examination, the terms “automatic”, “image” , “recognition”, in the phrase “automatic image recognition process” have been defined as known in the computer vision arts to mean performed by a machine without human intervention; a function describing some quantity (such as brightness) in terms of spatial layout [using techniques such as registration]; to refer to the concept of identification which is defined as the process of associating some observations with a particular instance or class of object that is already known; and Oxford’s Dictionary of Computer Science defining “digital image” and “process” to be consisting of data as a set of elements defined on an n-dimensional regular grid that has the potential for display, the set of elements which are pixels that represent a variety of types of information such as velocity, tissue density, etc.; to mean a task, stream of activity defined by its code. Accordingly, the phrase “automatic image recognition process” has been interpreted in light of the definitions above and under the broadest reasonable interpretation to mean any process executed by a machine that identifies information from/within an image and associates/categorizes/classifies this information according to a known type of information based on criteria as known in the computer vision arts.
**For the purposes of examination, the term a “transmitting/receiving sequence” has been interpreted under the broadest reasonable interpretation to be inclusive of a singular sequence for controlling transmission and reception events occurring either sequentially or simultaneously for at least one transducer element of the transducer array, and at least two separate sequences, each for respective transmission and reception events which may occur sequentially or simultaneously for at least one transducer element of the transducer array in relation to these processes occurring at another transducer element of the transducer array.
Regarding claim 2, Osaka, in view if Liu, substantially discloses all the limitations of the claimed invention, specifically, Liu discloses wherein the at least two different vibration signals have different vibration waveforms from one another ([0057], FIGS. 8-9, the used to adjust in real time the waveform of the shear wave generated by the vibration device by changing the output frequency and amplitude of the vibration device in real time).
Regarding claim 3, Osaka, in view if Liu, substantially discloses all the limitations of the claimed invention, specifically, Liu discloses wherein the at least two of the different vibration waveforms differ in frequency from one another ([0057], FIGS. 8-9, the used to adjust in real time the waveform of the shear wave generated by the vibration device by changing the output frequency of the vibration device in real time).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Osaka, in view of Liu and Sumi, further in view of Oikawa et al. (US20140206995, hereafter “Oikawa”).
Regarding claim 16, Osaka, in view if Liu, substantially discloses all the limitations of the claimed invention, specifically, Liu discloses further comprising:
displaying the ultrasonic image that is generated based on* the first ultrasonic echo signal while displaying the final elasticity parameter and the final viscosity parameter of the region of interest ([0033], [0044], FIG. 2, the shear wave is detected using an acoustic beam sequence, namely, “shear wave detection”, is used to acquire shear wave ultrasonic data from the tissue to be imaged at a high pulse repetition frequency and an elasticity or viscosity graph of the tissue is reconstructed from the detected shear wave data using an algorithm, namely, “shear wave elastographic reconstruction”); but does not explicitly disclose wherein the final elasticity parameter and the final viscosity parameter of the region of interest are displayed in the ultrasonic image.
However, in the same field of endeavor, Oikawa teaches wherein the final elasticity parameter and the final viscosity parameter of the region of interest are displayed in the ultrasonic image ([0025] displaying the tomographic image of the region where the image is based on the viscoelasticity of the tissue based on the coefficient of viscosity distribution/parameter and the modulus of elasticity distribution/parameter).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Osaka the final elasticity parameter and the final viscosity parameter of the region of interest are displayed in the ultrasonic image as taught by Oikawa in order to provide a specimen information acquisition apparatus that is effectively used for diagnosis of a tumor tissue because of independent calculation of the modulus of elasticity and the coefficient of viscosity of a specimen ([0013] of Oikawa).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring the at least one elasticity parameter and the at least one viscosity parameter of the region of interest are displayed in the ultrasonic image; or requiring the at least one elasticity parameter and the at least one viscosity parameter of the region of interest are displayed side by side with the ultrasonic image; or requiring generating and displaying at least one ultrasonic image based on the second ultrasonic echo signal while displaying the at least one elasticity parameter and the at least one viscosity parameter of the region of interest, wherein the at least one elasticity parameter and the at least one viscosity parameter of the region of interest are displayed in the ultrasonic image or displayed side by side with the ultrasonic image.
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 AMY SHAFQAT whose telephone number is (571)272-4054. The examiner can normally be reached Monday-Friday 9:30AM-5:30PM MST.
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, Keith Raymond can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.S./Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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