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 .
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) 6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tonomura et al. (WO 2011/034005) in view of Park et al. (US Pub No. 2015/0148674). Note that the below rejection relies on the machine-generated English translation of Tonomura et al..
With regards to claim 6, Tonomura et al. disclose a tissue elasticity measurement device, wherein the tissue elasticity measurement device comprises a control host (56) of medical imaging and an elasticity measurement probe (12) (pg. 3, first-second paragraphs, referring to the ultrasonic diagnostic apparatus (100) including an ultrasonic probe (12) that is used to acquire signals which are used to generate elasticity frame data; pg. 3, 4th paragraph, referring to the control unit (56) which is composed of a CPU, etc.);
the elasticity measurement probe (12) is configured to transmits a first ultrasonic signal to a tissue in a measurement area (pg. 2, last paragraph-pg. 3, first paragraph, referring to the ultrasonic probe (12) that transmits an ultrasonic wave and is of the ultrasonic diagnostic apparatus which generates a tomographic image “and generates an elastic image…”; Figure 1), wherein the control host performs ultrasonic scanning by controlling N ultrasonic array elements (“plurality of ultrasonic transducers”/”large number of transducers”, and thus there is N [positive integer’ number of ultrasonic array elements) on the elasticity measurement probe (12) to form at least one imaging line of the first ultrasonic signal, wherein N is a positive integer (pg. 1, last line-pg. 2, first paragraph, referring to the ultrasonic probe having a plurality of ultrasonic transducers, wherein the tomographic image is generated based on the echo signal; pg. 2, last paragraph-pg. 3, first paragraph, referring to the ultrasonic probe which performs ultrasonic scanning (i.e. “an ultrasonic wave that is transmitted to the subject via the ultrasonic probe 12 at time intervals”) and the transmitting unit and the ultrasonic transmission/reception control unit (17) that controls the transmitting unit (14); pg. 3, second to last paragraph, referring to the ultrasonic probe (12) being formed by arranging a large number of transducers in a strip shape and performing beam scanning mechanically or electronically; pg. 4, second paragraph, referring to the transmitting unit (14) generating a transmission pulse for generating an ultrasonic wave by driving the ultrasonic probe (12) and has a convergence point of the ultrasonic wave transmitted by the built-in transmission phasing/adding unit; Figure 1);
the control host is configured to track a measurement value (i.e. distance between the two tracked points corresponding to the at least one imaging line) of the at least one imaging line of the first ultrasonic signal (pg. 6, last paragraph-pg. 7, first paragraph, referring to tracking two points on the tomographic image, wherein a distance between the two points is measured while changing the position of the tracking point according to the tissue displacement [which occurs over time] in which the two tracking points are set, wherein two points define a line and/or the distance between the two points is representative of a line in an image (i.e. “tomographic image”) which is generated from at least one imaging line of the first ultrasonic signal, and thus the tracked “two points” and/or the tracked “distance between the two points” corresponds to the tracked “measurement value of the at least one imaging line”);
the control host is further configured to determine, according to the at least one imaging line at a plurality of time points, a motion state (i.e. “rate of change in the distance between the two points”, wherein a change in distance/position over time (i.e. “rate of change”) is representative of a motion state of the imaging line (i.e. “two points”/”distance”)) of each imaging line of the at least one imaging line [note that there may be a single/only one imaging line] (pg. 6 last paragraph-pg. 7, first paragraph, referring to tracking the two points, wherein the distance between the two points is measured while changing the position of the tracking point according to the tissue displacement in which the two tracking points are set and “When the rate of change in the distance [i.e. motion state] between the two points is greater than a preset threshold, it is possible to determine that the compression state of the subject on the tomographic surface of the subject is appropriate”; pg. 3, first paragraph, referring to the ultrasonic wave is transmitted to the subject via the ultrasonic probe (12) at time intervals and wherein the receiving unit (16) receives a time-series reflected echo signal generated from the subject; pg. 6, 4th-5th paragraphs, referring to the frame evaluation data “in time series”),
wherein the motion state (i.e. compression state which is represented by a rate of change in the distance) is characterized by a plurality of motion parameters (i.e. rate of change acquired over time, thus providing a plurality of rate of changes values), the control host determines values of the plurality of motion parameters of each imaging line of the at least one imaging line according to the measurement value (i.e. distance between the two tracked points) at the plurality of time points, when the values of the motion parameters meet corresponding a preset condition (i.e. preset threshold), it is determined that the motion state meets the preset condition (pg. 6, 4th-5th paragraphs, referring to the time series images being stored in the cine memory (48), wherein the frame selection unit (50) uses the frame evaluation data stored in the cine memory (48) as analysis frame data and determines whether or not the compression state on the tissue on the tomographic plane of the subject is appropriate, and therefore the motion state (i.e. compression state is appropriate or not) is characterized by a plurality of motion parameters (i.e. rate of change acquired over time due to the analysis being performed on time series data (i.e. plurality of frames acquired over time)); pg. 6, last paragraph-pg. 7, first paragraph, referring to tracking the rate of change in the distance between the two points and when the rate of change between the two points is greater than a preset threshold (i.e. preset conditions), then it is possible to determine that the compression state of the subject on the tomographic surface of the subject is appropriate, and therefore the plurality of motion parameters (i.e. rate of change in the distance which is acquired for a plurality of time-serial images/frames, and thus each rate of change measurement corresponds to a motion parameter) are compared to the preset condition to determine that the motion state meets the preset condition); and
the control host is further configured to select a position of the at least one imaging line with the motion state meeting the preset condition to determine one or more measurement positions of tissue elasticity measurement (pg. 6, 5th paragraph, referring to determining whether or not the compression state on the tissue on the tomographic plane of the subject is appropriate, and selecting a plurality of elastic frame data in an appropriate compressed state as elastic frame data for analysis; pg. 6, last paragraph -pg. 7, first paragraph, referring to determining the compression state is appropriate when the rate of change in the distance between the two points is greater than a preset threshold, wherein the corresponding selected frames would be associated with a temporal position and/or compression depth position with an imaging line (i.e. “two points”/”distance”) with a motion state (i.e. rate of change in the distance) meeting a preset condition (i.e. “greater than a preset threshold”); pg. 10, 2nd-3rd full paragraphs, referring to determining whether or not the applying of the ultrasound probe 12 to the subject is or is not appropriate, wherein, if it is determined that the compression state of the tissue is not appropriate, this is displayed so that the examiner can recognize that the way of applying the ultrasonic probe 12 to the subject, which is associated with a measurement position, is not or is appropriate by looking at the display, and thus, an appropriate (or not appropriate) position for a measurement position associated with the positioning of the ultrasonic probe is determined),
the elasticity measurement probe is further configured to perform a tissue elasticity measurement (pg. 3, first paragraph-second paragraphs; pg. 5, 1st-3rd paragraphs, referring to the ultrasound probe (12) which is used to collect signals which are used to perform tissue elasticity measurements (i.e. strain amount, etc.)),
wherein tissue elasticity measurements at the one or more measurement positions is obtained in order to provide an accurate diagnosis (Abstract; pg. 6, 5th paragraph; pg. 10, 2nd-3rd full paragraphs, referring to determining whether or not the compression state on the tissue on the tomographic plane of the subject is appropriate/adequate, and thereby selecting a plurality of elastic frame data in an appropriate compressed state as elastic frame data for analysis in order to determine accurate disease stage classification results of elastic images).
With regards to the limitation directed to “an elastic parameter is obtained to diagnose a degree of tissue fibrosis”, the limitation is directed to an intended use or manner of operating the claimed device/apparatus. Note that claim 1 does not positively set forth that a specific structure/element of the claimed device/apparatus is configured to obtain an elastic parameter to diagnose a degree of tissue fibrosis. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the device/control host of Tonomura et al. is capable of being used to perform additional steps, including obtaining an elastic parameter which could be used to diagnose a degree of tissue fibrosis, Tonomura et al. meet the above limitations.
However, though Tonomura et al. do disclose that tissue elasticity measurements at the one or more measurement positions is obtained in order to provide an accurate diagnosis (see above), Tonomura et al. do not specifically disclose that obtaining the accurate tissue elasticity measurements/diagnosis comprises having the control host be further configured to control the elasticity measurement probe to perform the tissue elasticity measurement at the one or more measurement positions.
Park et al. disclose a method and ultrasound apparatus for providing an ultrasound elastography image, which change a transmission position of an ultrasound signal used to push an object on the basis of a user input or a region of interest (ROI), thereby increasing an accuracy of an elastography image when a pressure is not equally applied (Abstract; paragraphs [0009]-[0012], [0072], [0091], [0097]). When it is determined that an elastography image of a region on a moving path of the first ultrasound signal or an elastography image of a region under a generation position of a shear wave is low in accuracy, the ultrasound apparatus may change the transmission position of the first ultrasound signal and a new elastography image of the object is acquired (paragraphs [0096]-[0106]; paragraphs [0119]-[0122], note that the ultrasound apparatus/probe of Park et al. is therefore controlled to perform the tissue elasticity measurement (i.e. elastography image measurement) at a measurement position that does not correspond to a low accuracy; Figures 5, 7).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the obtaining the accurate tissue elasticity measurements/diagnosis of Tonomura et al. comprise having the control host be further configured to control the elasticity measurement probe to perform the tissue elasticity measurement at the one or more measurement positions, as taught by Park et al., in order to increase an accuracy of an elastography image when pressure/compression is not equally applied (paragraphs [0009]-[0012]).
With regards to claim 10, Tonomura et al. disclose that before the elasticity measurement probe transmits a first ultrasonic signal to a tissue in a measurement area, the control host is further configured to control R ultrasonic array elements on the elasticity measurement probe to transmit a third ultrasonic signal to the tissue in the measurement area and to collect an echo signal of the third ultrasonic signal, so as to determine a position of the measurement area, wherein R is a positive integer (pg. 1, last line-pg. 2, first paragraph, referring to the ultrasonic probe having a plurality of ultrasonic transducers, wherein the tomographic image is generated based on the echo signal; pg. 2, last paragraph-pg. 3, first paragraph, referring to the ultrasonic probe which performs ultrasonic scanning (i.e. “an ultrasonic wave that is transmitted to the subject via the ultrasonic probe 12 at time intervals”) and the transmitting unit and the ultrasonic transmission/reception control unit (17) that controls the transmitting unit (14); pg. 3, second to last paragraph, referring to the ultrasonic probe (12) being formed by arranging a large number of transducers in a strip shape and performing beam scanning mechanically or electronically; pg. 4, second paragraph, referring to the transmitting unit (14) generating a transmission pulse for generating an ultrasonic wave by driving the ultrasonic probe (12) and has a convergence point of the ultrasonic wave transmitted by the built-in transmission phasing/adding unit; pg. 6, 4th paragraph-6th paragraph, referring to a plurality of frame data/time-serial images being acquired, wherein each frame/image is a result of the transmission of an ultrasonic signal, and therefore the “third ultrasonic signal” can be associated with an initial acquired image and the “first ultrasonic signal” can be associated with the next acquired image, such that the third ultrasonic signal is transmitted before the probe transmits the first ultrasonic signal; further, note that the acquired tomographic images would provide the ability to determine a position of the measurement area as the image would include the measurement area; Figure 1).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tonomura et al. in view of Park et al. as applied to claim 6 above, and further in view of Carlini et al. (US Pub No. 2017/0340310).
With regards to claim 9, as discussed above, the above combined references meet the limitations of claim 6. Further, Tonomura et al. disclose that the control host is further configured to control M ultrasonic array elements on the elasticity measurement probe to transmit a second ultrasonic signal at a selected position and to collect an echo signal of the second ultrasonic signal; and the echo signal of the second ultrasonic signal is processed, wherein M is a positive integer (pg. 1, last line-pg. 2, first paragraph, referring to the ultrasonic probe having a plurality of ultrasonic transducers, wherein the tomographic image is generated based on the echo signal; pg. 2, last paragraph-pg. 3, first paragraph, referring to the ultrasonic probe which performs ultrasonic scanning (i.e. “an ultrasonic wave that is transmitted to the subject via the ultrasonic probe 12 at time intervals”) and the transmitting unit and the ultrasonic transmission/reception control unit (17) that controls the transmitting unit (14); pg. 3, second to last paragraph, referring to the ultrasonic probe (12) being formed by arranging a large number of transducers in a strip shape and performing beam scanning mechanically or electronically; pg. 4, second paragraph, referring to the transmitting unit (14) generating a transmission pulse for generating an ultrasonic wave by driving the ultrasonic probe (12) and has a convergence point of the ultrasonic wave transmitted by the built-in transmission phasing/adding unit; pg. 6, 4th paragraph-6th paragraph, referring to a plurality of frame data/time-serial images being acquired, wherein each frame/image is a result of the transmission of an ultrasonic signal, and therefore the “second ultrasonic signal” can be associated with a second image that is acquired; Figure 1).
However, the above combined references do not specifically disclose that the control host is further configured to transmit shear waves to the tissue in the measurement area.
Carlini et al. disclose a method for quantifying the elasticity of a material by ultrasounds, comprising the generation of one acoustic disturbance ultrasound beam (10) for the excitation point (1) for generating a shear wave (11) and measuring the shear wave (11) at a plurality of lines of sight placed in a region of interest (2) at different predetermined distances from the first excitation point (1) (Abstract; paragraphs [0013], Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the control host of the above combined references be further configured to transmit shear waves to the tissue in the measurement area, as taught by Carlini et al., in order to provide an additional, alternative technique for quantifying elasticity of material (Abstract).
Response to Arguments
Applicant's arguments filed November 24, 2025 have been fully considered but they are not persuasive.
With regards to claim 6, Applicant argues that Tonomura’s teachings are confined to temporal filtering and provide zero motivation for a person of ordinary skill in the art to consider, let alone implement, the spatial position selection required by claim 6.
However, as set forth in the above rejection, Tonomura do disclose in pg. 6, 5th paragraph and in pg. 10, 2nd-3rd full paragraphs determining whether or not the compression state on the tissue on the tomographic plane of the subject is appropriate/adequate, and thereby selecting a plurality of elastic frame data in an appropriate compressed state as elastic frame data for analysis in order to determine accurate disease stage classification results of elastic images. Tonomura further discloses in pg. 10, 2nd-3rd full paragraphs determining whether or not the applying of the ultrasound probe 12 to the subject is or is not appropriate, wherein, if it is determined that the compression state of the tissue is not appropriate, this is displayed so that the examiner can recognize that the way of applying the ultrasonic probe 12 to the subject, which is associated with a measurement position, is not or is appropriate by looking at the display, and thus, an appropriate (or not appropriate) position for a measurement position associated with the positioning of the ultrasonic probe is determined. It is clear that the tissue elasticity measurements at the one or more measurement positions is obtained in order to provide an “accurate” diagnosis. Examiner emphasizes that the measurement positions therefore correspond to positions associated with accurate elasticity measurements. Though Tonomura may be silent with regards to controlling the elasticity measurement probe to perform the tissue elasticity measurement at the one or more measurement positions [which is disclosed by Tonomura to correspond to positions associated with “accurate” elasticity measurements], it is Park that is relied upon for providing the teaching and motivation for having the control host of Tonomura be further configured to control the elasticity measurement probe to perform the tissue elasticity measurement at the one or more measurement positions, specifically in order to increase an accuracy of an elastography image when pressure/compression is not equally applied (paragraphs [0009]-[0012]). Applicant’s argument that the combination of Tonomura and Park does not meet the claim because Tonomura does not provide the “motivation” to implement the spatial position selection is not persuasive as it is Park that provides the motivation for further modifying Tonomura to meet the spatial position selection limitation (i.e. controlling the elasticity measurement probe to perform the tissue elasticity measurement at the one or more measurement positions).
Applicant further argues that a person of ordinary skill in the art would lack motivation to combine solutions directed at “data quality”, as addressed by Tonomura, and “signal path” problems, as addressed by Park, to solve a distinct and unaddressed problem of “physiological motion interference”, as addressed by claim 6.
However, though claim 6 does refer to determining a motion state and determining motion parameters, claim 6 does not include any mention of “physiological motion interference”. As such, Applicant’s above argument is moot.
Applicant further argues that Park’s position control is an “obstacle avoidance” mechanism whereas the position selection in claim 6 is a “stability-seeking” mechanism. Applicant asserts that Park’s teachings on avoiding static obstacles cannot be fairly extended to suggest the dynamic optimization required by claim 6.
However, claim 6 makes no mention that the invention analyzes “dynamic physiological signals”. Though claim 6 does refer to determining a motion state and determining motion parameters, claim 6 does not further clarify that the motion state/motion parameters are associated with any type of “physiological” signal. Examiner notes that claim 6 is rejected under the combination of Tonomura and Park, wherein both Tonomura and Park are concerned with determining measurement positions associated with accurate data and therefore it would be reasonable to one of ordinary skill in the art to modify Tonomura in view of the teachings of Park.
Applicant additionally argues Park’s “local avoidance” logic is directed to solving isolated, static geometric problems, whereas the “global screening” logic of claim 6 is designed to address pervasive, dynamic physiological interference. Applicant asserts that extending Park’s “patch-work” solution for specific obstacles into the systematic, real-time dynamic quality assessment and management of the entire detection area as required by claim 6 would not have been obvious to a person of ordinary skill in the art.
However, Examiner emphasizes that claim 6 is rejected under the combination of Tonomura in view of Park, wherein Park is solely relied upon to teach having the control host be further configured to control the elasticity measurement probe to perform the tissue elasticity measurements at the one or more measurement positions. Examiner emphasizes that the above rejection is not suggesting adopting Park’s method for obstacle detection, but rather the rejection relies upon Park’s teaching of having the ultrasound apparatus change the position of the first ultrasound signal and acquiring a new elastography image of the object at the new position when a region is low in accuracy at the current position (paragraphs [0096]-[0106], [0119]-[0122]; Figures 5, 7). The ultrasound apparatus/probe of Park is therefor controlled to perform the tissue elasticity measurement at a measurement position that does not correspond to a low accuracy, wherein the rejection relies upon this teaching to further modify Tonomura to meet claim 6. Applicant’s argument is therefore unpersuasive.
The claims therefore remain rejected under the previously applied prior art.
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 KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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, Pascal Bui-Pho can be reached at (571) 272-2714. 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.
/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798