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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's claim amendments filed on 03/16/2026 have been entered. Accordingly, claims 1-16, 39, 42-43, and 48 remain pending, claims 1-5, 10-11, 13, 16, and 48 have been amended, and claims 4-15 and 39 have previously been withdrawn without traverse in the response filed 12/23/2024, and as remarked in the office action mailed 01/15/2025.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
Election/Restrictions
Applicant's arguments filed 03/16/2026 have been fully considered but they are not persuasive.
Applicant argues in the final two paragraphs of page 10
“Applicant hereby amends claims 1-5, 10-11, 13, 16, and 48. These changes introduce no new matter, and their entry is respectfully requested. Support for the amendments may be found throughout the application as originally filed, including the original claims, the original drawings, and the original specification.
For example, support for amended claim 1 can be found at least in paragraphs [0032], [0067]-[0071], [0115], and [0124], and FIG. 12 of the original specification. According to the Description, various mechanical vibrations are exerted on the target object based on at least two different vibration signals to generate shear waves propagating within the region of interest, and then a second ultrasonic wave is transmitted to the region of interest to detect the shear waves. FIG. 12 depicts an ultrasonic probe including a transducer and a vibrator (see also paragraph [0122]), and thus belongs to the elected embodiment having the ultrasonic probe including a vibrator and a transducer. Further, paragraph [0115] explains that the measured result of viscoelasticity in paragraph [0124] including the viscosity parameter(s) and/or the elasticity parameter(s). Claim 2 has been amended to remove duplicate features. Claim 4 has been amended to emphasize one measurement, which can find support in the context of claim 4, for example, performing on the target object with one measurement, in said one measurement ... Claim 16 has been amended for clarification purposes. Support can be found at least in paragraph [0064] of the original specification, for example, which recites that ‘Further, the ultrasonic image may be displayed while displaying the elasticity parameter(s) and the viscosity parameter(s) of the region of interest. The ultrasonic image may be generated based on the first ultrasonic echo signal or the second ultrasonic echo signal...the elasticity parameter(s) / measured value(s) and the viscosity parameter(s) / measured value(s) of the region of interest may be displayed...in the ultrasonic image (e.g. at lower right corner or at middle of region of interest)... the elasticity parameter(s) /measured value(s) and the viscosity parameter(s) / measured value(s) of the region of interest may be displayed...side by side with the ultrasonic image.’
Throughout the arguments, Applicant reminds the Examiner that the claims are given their broadest reasonable meaning in view of the specification, and any paraphrasing of the claim features is not to be interpreted as reading any features into, or characterizing of, the claims”.
In response, it is noted that applicant cites as support for applicant’s amendments paragraphs [0067]-[0071] which correspond to steps S710 through steps S750 of FIG. 7 which corresponds to non-elected embodiment species 3 from the ultrasonic viscosity measuring method group, which is been withdrawn without traverse by the applicant in their response filed 12/23/2024.
Applicant then cites FIG. 12, which corresponds to the nonelected embodiment of species D of the ultrasonic viscoelasticity measuring apparatus group, which is been withdrawn without traverse by the applicant in the response filed 12/23/2024.
Applicant also cites paragraphs [0124] which corresponds to the nonelected embodiment of species E from the ultrasonic viscoelasticity measuring apparatus group, which is been withdrawn without traverse by the applicant in their response filed 12/23/2024.
It is noted that there is no cited disclosure which contemplates the combination of applicant’s elected embodiment depicted in FIG. 10 from the ultrasonic viscoelasticity measuring apparatus group being combined with one of the other non-elected species of the same group.
In the contrary, applicant’s disclosure appears to contemplate combining nonelected species C (depicted as FIG. 11) with non-elected species D (depicted as FIG. 12), as described in [0119].
Nonelected species D (depicted as FIG. 12) is described in [0121] as another embodiment of the ultrasonic viscoelasticity measuring apparatus including an ultrasonic probe, and in [0122] the ultrasonic probe is disclosed as may including a transducer and a vibrator, although it is noted that the drawing of FIG. 12 illustrates the transducer as being a wholly separate structure from both the vibration control and the external vibration.
In [0124] the ultrasonic probe is disclosed as “may further provide” with a pressure sensor, the pressure may include initial pressure or measurement and during the measurement. The processor may then judge the validity of the measured results of the viscoelasticity according to a pressure signal outputted by the pressure sensor, specifically, according to whether the pressure signal falls into a pre-set pressure range. The above cited portion of the specification appears to be attributed to yet another nonelected embodiment (species E, depicted as FIG. 13) which is also withdrawn without traverse. It is noted that regardless of if the pressure sensor described in [0124] is to be attributed to either nonelected and withdrawn without traverse species D or nonelected withdrawn without traverse species E, neither of these species were elected by the applicant and the description of the pressure sensor and the ultrasound probe in [0124] does not disclose the pressure sensor as being “on” the probe. In the paragraph above, FIG. 12 does not illustrate the ultrasound probe nor the vibrator being inside the probe, and the vibration control and ask neural vibration are depicted as being separate structures from the transducer. It is noted that while “pressure detection” as shown in the – box that connects to the vibration control through dashed line in FIG. 12, the pressure detection is not illustrated as being a pressure sensor located on the ultrasound probe. It is noted that FIG. 13, as with FIG. 12 described above, also does not depict an ultrasound probe, vibrator nor pressure sensor.
In response, it is noted that applicant elected sub-species 1a without traverse in which only a singular ultrasonic measurement is obtained in order to calculate the measured elasticity and viscosity values. However, withdrawn claim 4 is still directed to a group of multiple ultrasonic measurements. Therefore, withdrawn claim 4 is still directed to matter that has been withdrawn without traverse by the applicant.
While applicant elected embodiments having a vibrator included in the probe, applicant did not elect any embodiment of the device having a pressure sensor nor an embodiment of a method which relies on the collection of a pressure signal by a pressure sensor. All of the effort mentioned discussion was discussed with the applicant during the interview conducted on 07/15/2025 and has been notated on the corresponding interview summary in response to previously provided draft amendments by the applicant which were reviewed with the applicant during the above referenced interview.
Applicant provides further arguments in the fourth - final paragraphs of page 10 through the second paragraph of page 11 against the restrictions of withdrawn claims 4 and 15.
In response it is noted that applicant’s elected embodiment of sub-species 1a problem the ultrasonic viscoelasticity measuring method group, is drawn to the disclosure provided in [0054] in which the “group” refers to a singular measured elasticity value and singular measured viscosity value, whereas the “group of measured elasticity values and measured viscosity values” recited in withdrawn claim 4 correspond to at least one of the non-elected embodiments, such as including, but not limited to the nonelected embodiment of sub-species 1d described in [0059], which has been withdrawn without traverse by the applicant’s in their response filed 12/23/2024. It appears that in the amendments filed 04/15/2025, 08/14/2025, and presently in 03/16/2026, applicant has amended withdrawn claim four to recited features of different separate embodiments which have not been recited as being combinable. Thus, as the restricted subject matter that is been is still being recited in withdrawn claim 4, withdrawn claim 4 remains withdrawn.
Similarly, as with withdrawn claim 4 described above, applicant argues against the restriction of previously withdrawn claim 15, which recites subject matter drawn to multiple nonelected embodiments which is been withdrawn without traverse by the applicant in the response filed 12/23/2024. Specifically, withdrawn claim 15 recites “wherein after being exerted with mechanical vibrations based on one vibration signal to acquire a corresponding ultrasonic echo signal, the target object is exerted with mechanical vibrations based on another vibration signal after a predetermined cooling time” (emphasis added). The italicized portion of the withdrawn claim refers to subject matter belonging to non-elected species A, depicted in FIG. 9 and described in [0107], of the ultrasonic viscoelasticity measuring apparatus group and also to nonelected species 4, depicted in FIG. 8, and described in [0073]-[0087], both of which have been withdrawn without traverse by the applicant in their response filed 12/23/2024.
Accordingly, withdrawn claim 15 remains withdrawn.
Rejections under 35 USC 112
In light of applicant’s claim amendments filed 03/16/2026, previous 112(b) rejections of the claims have been rendered moot and have been withdrawn. However, the present amendments presented in independent claim 1 have brought on new issues regarding clarity of the claim and have been outlined in the corresponding rejection below.
Regarding the 112(a) rejections, applicant’s remarks filed 03/16/2026 have been fully considered, however they are not persuasive. It is noted that while applicant has canceled some of the rejected claim language outlined in the previous rejection, as applicant appears to acknowledge in the fifth paragraph of page 11 of their response when arguing
“In response to the rejections to ‘outputting different drive signals to a vibrator of the ultrasonic probe in response to a sensed pressure exerted on the target object by the ultrasonic probe being within a preset range, so as for the vibrator to generate at least two different vibration signals, based on the different drive signals’, the related features allegedly drawn to new matter have been removed from claim 1, and thus the rejections become moot”;
Applicant has reintroduced much of same above canceled claim language later in the claim in combination other newly presented subject matter which together are rejected for presenting new matter when introducing the new newly presented amendments in the last stanza of the claim of “determining a validity of the at least one elasticity parameter and the at least one viscosity parameter of the region of interest according to whether a pressure signal between the ultrasonic probe and the target object, detected by a pressure sensor provided on the ultrasonic probe, falls into a preset pressure range” (emphasis added). See the rejection below.
Further, please see the response provided under the “Restriction/Elections” header above regarding applicant amendments drawn to nonelected species which have been withdrawn without traverse. Applicant has again amended in subject matter of withdrawn species that were withdrawn without traverse by applicant’s election filed 12/23/2024, to which no support is provided for the combination of the nonelected and restricted subject matter with applicant’s elected embodiments, as applicant appears to be claiming features of structurally separate device(s) with different mode(s) of operation which part from applicant’s elected embodiment.
To avoid having independent claim one being withdrawn from consideration, applicant should amend the claim to remove all subject matter drawn to non-elected species which have been withdrawn without traverse by the applicant in their response filed 12/23/2024.
In the spirit of moving prosecution forward and differentiating applicant’s claimed invention from the prior art and part to aid in resolving the outstanding 112 issues, 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]).
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite “determining a validity of the at least one elasticity parameter and the at least one viscosity parameter of the region of interest according to whether a pressure signal between the ultrasonic probe in the target object, detected by a pressure sensor provided on the ultrasonic probe, falls into a preset pressure range” in lines 22-25, while support can be found for the elected embodiment having the ultrasonic probe including a vibrator and a transducer which includes one or more array elements, the vibrator is configured to drive the transducer to vibrate, at least part of the array elements may be configured to, after the transducer is vibrated, transmit an ultrasonic wave to a region of interest of a target object, receive an echo of the ultrasonic wave, and acquire an ultrasonic echo signal based on the echo of the ultrasonic wave to determine the region of interest, once the region of interest has been determined as just described, different drive signals are output by the transmitting/receiving sequence controller to control the vibrator to drive the transducer to exert various mechanical vibrations on the target object based on at least two different vibration signals to vibrate the transducer, output a transmitting/receiving sequence to the transducer to control the transducer to transmit the ultrasonic wave, to generate a shear wave propagating in the depth direction inside a target object, followed by receiving the echo of the ultrasonic wave and acquire the ultrasonic echo signal based on the echo of the ultrasonic wave (see FIG. 10, [0110]-[0112]);
in a first separate non-elected embodiment that has been withdrawn without traverse, the ultrasonic viscoelasticity measuring apparatus of this separate non-elected embodiment includes a processor may be configured to acquire the elasticity parameter(s) and the viscosity parameter(s) of the target object based on the ultrasonic echo signal of the target object under various mechanical vibrations, the ultrasonic viscoelasticity measuring apparatus of this separate non-elected embodiment also includes a pressure sensor and the output of the pressure sensor is coupled to the scanning controller for feeding back a sensed pressure and a sensed vibration intensity that the vibrator exerts on the target object to the scanning controller so that the scanning controller is to be configured to control the vibrator to vibrate when the value of the pressure is within a preset range (see FIG. 11, [0117]-[0119]), the viscoelasticity measuring apparatus of the first non-elected embodiment withdrawn without traverse may include a vibrator which is separate from the ultrasonic probe (see [0117], FIG. 11), the viscoelasticity measuring apparatus of the first nonelected embodiment withdrawn without traverse also may include a pressure sensor output is coupled to the scanning controller, the pressure sensor is not disclosed as being included in the ultrasonic probe (see [0119]);
in a second separate nonelected embodiment which has been withdrawn without traverse, can be combined with the ultrasonic viscoelasticity measuring apparatus of the first nonelected embodiment which has been withdrawn without traverse (see the ultrasonic viscoelasticity measuring apparatus of the period 11 may be understood in combination with FIG. 12), the second separate nonelected embodiment which is been withdrawn without traverse may include an ultrasonic probe having a transducer and a vibrator;
in a third nonelected embodiment withdrawn without traverse having an ultrasonic probe provided with a pressure sensor to detect pressure between the ultrasonic probe and the target object, the pressure includes an initial pressure obtained before the measurement and during the measurement the processor then performing a judgment step of the validity of the measurement result of the viscoelasticity by judging whether the measured results of viscoelasticity the pressure falls into a preset range (see [0124]-[0128], FIG. 13).
However, neither the original claims, original drawings, nor the specification as originally filed provides support for this limitation in the elected embodiment with the vibrator included inside the ultrasound probe (FIG. 10), be combined with the n non-elected embodiment that has been withdrawn without traverse that requires measuring [sensing] a pressure exerted on the target object (as in the nonelected first and second separate embodiments withdrawn without traverse depicted in FIGS. 11-12) by the ultrasonic probe being within a preset range (as depicted in the third nonelected separate embodiment withdrawn without traverse in FIG. 13), in order to determine the validity of the at least one elasticity parameter and the at least one viscosity parameter of the region of interest. No basis has been pointed to for these new limitations combining elected embodiment with a non-elected embodiment, has been presented in applicant' s remarks. In the absence of support for the newly recited limitations, these claims and claims dependent thereon are deemed to constitute new matter. This is a NEW MATTER rejection.
Applicant is advised to cancel all subject drawn to new matter to remedy the issues outlined in the rejection above.
All dependent claims are also rejected by the nature of their dependency.
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 1-3 and 16 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 has been amended to recite “determining a validity of the at least one elasticity parameter and the at least one viscosity parameter of the region of interest according to whether a pressure signal between the ultrasonic probe in the target object, detected by a pressure sensor provided on the ultrasonic probe, falls into a preset pressure range” in lines 22-25, which renders the claim indefinite because it is unclear by what applicant meant in reciting a “validity” as being determined of the at least one elasticity parameter and the at least one viscosity parameter. It is unclear if the “validity” is meant to be interpreted as a single or both or taking into account both the at least one elasticity parameter and the at least one discussing parameter or if a validity determination is performed for each of the at least one elasticity parameter and the at least one viscosity parameter. It is also unclear what aspect or quantitative or qualitative representation of either the at least one elasticity parameter and/or the at least one viscosity parameter is being evaluated to make the “validity” determination.
It is also unclear what to what pressure signal which is recited as being detected by what pressure sensor on the probe, as applicant’s elected embodiment depicted in FIG. 10 does not include a pressure sensor in the ultrasonic probe in addition to the vibrator which is disclosed as being in the ultrasonic probe. In fact, applicant discloses that the problem of inaccurate and unstable measurements is solved by the device shown in FIG. 10 as the viscoelasticity measurements as being based on different vibration signals (see [0111]-[0116]). There is no subject matter in applicant’s original disclosure which would inform one of ordinary skill in the art that applicant’s elected embodiment may be combined with one of the nonelected embodiments having a pressure sensor, which have been withdrawn without traverse by the applicant in their response on 12/23/2024, as applicant’s elected embodiment depicted in FIG. 10 has a materially different, structurally different design, and mode of operation than is disclosed in the nonelected embodiments withdrawn without traverse which have a pressure sensor as illustrated in FIGS. 11-12 (see [0119]).
All dependent claims are also rejected by the nature of their dependency.
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 and 16 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 Oikawa et al. (US20140206995, hereafter “Oikawa”).
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 acquiring the region of interest on the ultrasonic image ([0024], [0067], [0071], FIGS. 6-7, see left side of FIG. 6, and see step 2 in FIG .7, the image construction unit can be configured for the shear wave image will correspond to the region selected on a tomographic image displayed on the image display unit can be displayed on the image display unit);
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 vibration 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);
acquiring and displaying at least one elasticity parameter of the region of interest based on the second ultrasonic echo signal 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, the disclosed acquired and displayed parameter(s) additionally include at least one viscosity parameter of the region of interest based on the second ultrasonic echo signal of the region of interest, nor explicitly discloses determining the validity of the at least one 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); and
acquiring and displaying at least one elasticity parameter and at least one viscosity parameter of the region of interest based on the second ultrasonic echo signal 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, and the steps of acquiring and displaying at least one elasticity parameter and at least one viscosity parameter of the region of interest being based on the second ultrasonic echo signal 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 determining the validity of the at least one viscosity parameter of the region of interest ([0062] of Lou discloses that by using the different vibration frequencies and average velocities of a given shear wave in the region of interest which corresponds the different frequencies which are then fitted he is using a least-squares message or any other fitting calculation method so that they are fitted into a viscoelasticity model, e.g., Voigt model, which is known in the physical artists to determine the validity of measured values of complex/mixed materials, such as biological tissue), but does not explicitly disclose the determining the validity of the at least one viscosity parameter of the region of interest as being made according to whether a pressure signal between the ultrasonic probe and the target object, detected by a pressure sensor provided on the ultrasonic probe, falls into a preset pressure range.
However, in the same field of endeavor, Oikawa teaches determining the validity of the at least one viscosity parameter of the region of interest according to whether a pressure signal between the ultrasonic probe and the target object ([0032]-[0063], FIG. 2, the viscoelasticity measurement is measured with the stepwise pressurization being performed using the pressure sensor to the reference layers in advance and the time and the variation is made consistent within the range that is predetermined to be indicative of measurement accuracy[validity] after the pressure applied on the specimen from the probe is instantaneously increased to a certain pressure value), detected by a pressure sensor of the ultrasonic device also having the ultrasonic probe, falls into a preset pressure range ([0034]-[0063] the pressure applied on the specimen from the probe is instantaneously increased to a certain pressure value held for a certain time period).
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 determination of a validity of the at least one viscosity parameter of the region of interest according to whether a pressure signal between the ultrasonic probe and the target object, detected by a pressure sensor, falls into a preset pressure range 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 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).
Regarding claim 16, Osaka, in view if Liu and Oikawa, substantially discloses all the limitations of the claimed invention, specifically, Liu discloses further comprising:
the ultrasonic image that is generated based on* the first ultrasonic echo signal while displaying the at least one elasticity parameter and the at least one 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”); and specifically, Oikawa discloses
wherein the at least one elasticity parameter and the at least one viscosity parameter of the region of interest are displayed in the ultrasonic ([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).
*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
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.
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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 M RAYMOND/Supervisory Patent Examiner, Art Unit 3798