DETAILED ACTION
This office action is in response to the communication received on January 16, 2026 concerning application No. 18/851,884 filed on September 27, 2024.
Claims 1-20 are currently pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Examiner notes that the objection to the specification regarding the length of the abstract was not addressed. Therefore the specification objection stands.
Applicant's arguments filed 01/16/2026 regarding the 35 USC 101 rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 101 rejection of claim 17 previously set forth.
Applicant’s arguments with respect to claim(s) 1 and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
For the same reasons as above claim 2-9, 12, and 14-17 stand rejected in view of the prior art.
Applicant's arguments filed 01/16/2026 regarding the 35 USC 103 rejection of claims 10-11 have been fully considered. Applicant’s arguments overcome the 35 USC 103 rejection of claims 10-11 previously set forth.
Specification
The abstract of the disclosure is objected to because the Abstract exceeds 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6, line 2, “the plurality of echoes” should read “the plurality of ultrasound echoes”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-6, 8-9, 12-15, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Matsumura (US 20110040187, as cited in Applicant’s 09/27/2024 IDS) in view of Fish et al. (WO2017182344A1, hereinafter Fish).
Regarding claim 1, Matsumura teaches a computer-implemented method ([0065] and [0125] disclose an apparatus shown in fig. 1 for implementing a method shown in fig. 5) for generating an ultrasound device interaction indicator representative of an orientation of an ultrasound device relative to a subject ([0118]-[0119] discloses generating a pressure distribution image which is considered an interaction indicator representative of an orientation of the ultrasound device relative to the subject. Also see [0087] and [0120]-[0125]), the computer-implemented method comprising:
obtaining, at an input interface, one or more characteristics of an acoustically translucent standoff layer between a surface of the ultrasound device and skin of the subject ([0081] “An identification sign (ID) indicating the type of the elastic coupler 20 which has been attached to the probe 1 is input from the control interface unit 19 to the pressurizing-state calculator 33 by an operator”. The elastic coupler 20 is considered the acoustically translucent standoff layer);
obtaining, at the input interface, an ultrasound signal from the ultrasound device, wherein the ultrasound signal is representative of a plurality of ultrasound echoes received by the ultrasound device from different depths for each of one or more scan lines ([0066]-[0068] discloses the ultrasound probe transmit and receives echo signals. [0091] discloses receiving a B mode image from the ultrasonic transmitter/receiver);
processing the ultrasound signal to determine a measure of deformation of the acoustically translucent standoff layer ([0085] “The coupler pressurization evaluation unit 36 obtains a thickness detection value in the pressurized state of the elastic coupler 20 and calculates the thickness change with respect to the initial thickness in the initial state. The thickness change in this case corresponds to a total distortion amount (sum of the distortion amounts) of the contact surface of the elastic coupler 20 from the initial state”); and
processing the measure of deformation and the one or more characteristics of the acoustically translucent standoff layer to generate the ultrasound device interaction indicator that is representative of the orientation of the ultrasound device relative to the subject ([0087] “The pressurizing-state image constructing unit 38 constructs a pressurizing-state image in order to cause the image display 9 to display the absolute pressure output from the pressure converter 37. The pressurizing-state image is at least one of a numerical value of the absolute pressure, a graph of the temporal change, a bar chart, and the like and is converted into color image data by the color scan converter 14”. The pressurizing state image is considered the generated ultrasound device interaction indicator).
Matsumara does not specifically teach the ultrasound device interaction indicator represents the orientation angle of the ultrasound device relative to the subject.
However,
Fish in a similar field of endeavor generating an ultrasound device interaction indicator that represent the orientation angle of the ultrasound device relative to the subject (pg. 13, lines 1-12 disclose the ultrasound probe includes a flexible compressible layer that allows the transducer to conform to a surface of the subject. Pg. 15, lines 23-31 disclose providing an indication of the orientation of the ultrasound transducer based on the amount of compression experiences by the flexible layer. Fig. 7 further shows the orientation of the transducer based on the amount of compression of the layer 60 is an orientation angle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound device interaction indicator of Matsumara to include an orientation angle of the ultrasound device in order to have a system that generates more accurate control signals of the ultrasound device, as recognized by Fish (pg. 4, line 8-15).
Regarding claim 2, Matsumura in view of Fish teaches the method of claim 1, as set forth above. Matsumura further teaches the ultrasound device interaction indicator is further representative of a force or pressure exerted by the ultrasound device on the subject ([0087] and [0114] disclose the indicator is representative of a pressure exerted by the device on a subject).
Regarding claim 3, Matsumura in view of Fish teaches the method of claim 1, as set forth above. Matsumura further teaches the one or more characteristics of the acoustically translucent standoff layer comprise a thickness in a zero-force state, a thickness at a predefined non-zero compression force or pressure, and/or an elastic modulus ([0022] and [0101] discloses the elastic coupler (standoff layer) comprises at least an elastic modulus).
Regarding claim 4, Matsumura in view of Fish teaches the method of claim 3, as set forth above. Matsumura further teaches the one or more characteristics of the acoustically translucent standoff layer further comprises a hysteresis behavior ([0081] further discloses the identification of the elastic coupler being input includes the elasticity property of the coupler which corresponds to a hysteresis behavior).
Regarding claim 5, Matsumura in view of Fish teaches the method of claim 1, as set forth above. Matsumura further teaches identifying the plurality of ultrasound echoes from each of the one or more scan lines in the ultrasound signal ([0068] discloses creating RF signal data based on the reflected echo signals for the entire plane (scan lines). The echoes used for creating the RF signal data are considered the identified plurality of ultrasound echoes);
processing, for each scan line, the plurality of ultrasound echoes from the scan line to determine a depth of a distal surface of the acoustically translucent standoff layer, wherein the distal surface of the acoustically translucent standoff layer is distal to the ultrasound device ([0114] discloses identifying the boundary between the elastic coupler 20 and the test object 100 using the RF signal which is then used for determining the thickness distribution. The boundary is considered the distal surface of the standoff layer. The thickness distribution is considered the depth. Fig. 5 shows the boundary between the coupler and the test object is distal to the ultrasound device); and
processing the depth of the distal surface for each of the one or more scan lines to determine the measure of deformation ([0114]-[0115] discloses using the thickness distribution to determine the change in thickness (deformation)).
Regarding claim 6, Matsumura in view of Fish teaches the method of claim 5, as set forth above. Matsumura further teaches processing the plurality of echoes from the scan line to identify an echo for which a signal intensity value first exceeds an intensity threshold ([0092] discloses detecting the RF signal which has an intensity that a exceeds a pre-set threshold); and selecting a depth of the identified echo as the depth of the distal surface ([0114] discloses using the thickness distribution (depth) determined for the RF signal as the thickness distribution for the boundary between the elastic coupler 20 and the test object 100).
Regarding claim 8, Matsumura in view of Fish teaches the method of claim 1, as set forth above. Matsumura further teaches generating the ultrasound device interaction indicator by selecting one of a plurality of predetermined ultrasound device interaction indicators ([0087] discloses the pressurizing-state image (interaction indicator) is selected from a plurality of predefined indicators).
Regarding claim 9, Matsumura in view of Fish teaches the method of claim 2, as set forth above. Matsumura further teaches the ultrasound device interaction indicator is a numerical value of the force or pressure exerted by the ultrasound device on the subject ([0087] and [0114] disclose the indicator is representative of a numerical value of the pressure/force exerted by the device on a subject).
Regarding claim 12, Matsumura in view of Fish teaches a processing system configured to carry out the method according to claim 1 ([0065] and fig. 1 of Matsumara discloses the ultrasonic diagnostic apparatus which includes electronic circuitry for performing the method of claim 1 as set forth above).
Regarding claim 13, Matsumura teaches a system for providing an ultrasound device interaction indicator ([0065] and fig. 1 disclose an ultrasonic diagnostic apparatus according an example of the invention which as previously discussed provides an ultrasound device interaction indicator), the system comprising:
an ultrasound device configured to transmit and receive ultrasound, and to generate an ultrasound signal representative of a plurality of received ultrasound from different depths for each of one or more scan lines ([0066]-[0068] and [0093] disclose transmitting and receiving a plurality of echo signals from the subject from different depths);
an acoustically translucent standoff layer positioned between a surface of the ultrasound device and skin of a subject ([0078] and [0080] disclose elastic coupler 20 (acoustically translucent standoff layer) positioned between a surface of the ultrasound device and the subjects skin);
the processing system (the electronic circuitry of the system shown in fig. 1) comprising an input interface (control interface unit 19 in fig. 1), the processing system configured to:
obtain, at the input interface, one or more characteristics of the acoustically translucent standoff layer between the surface of the ultrasound device and the skin of the subject ([0081] “An identification sign (ID) indicating the type of the elastic coupler 20 which has been attached to the probe 1 is input from the control interface unit 19 to the pressurizing-state calculator 33 by an operator”. The elastic coupler 20 is considered the acoustically translucent standoff layer);
obtain, at the input interface, an ultrasound signal from the ultrasound device, wherein the ultrasound signal is representative of a plurality of ultrasound echoes received by the ultrasound device from different depths for each of one or more scan lines ([0066]-[0068] discloses the ultrasound probe transmit and receives echo signals. [0091] discloses receiving a B mode image from the ultrasonic transmitter/receiver);
process the ultrasound signal to determine a measure of deformation of the acoustically translucent standoff layer ([0085] “The coupler pressurization evaluation unit 36 obtains a thickness detection value in the pressurized state of the elastic coupler 20 and calculates the thickness change with respect to the initial thickness in the initial state. The thickness change in this case corresponds to a total distortion amount (sum of the distortion amounts) of the contact surface of the elastic coupler 20 from the initial state”); and
process the measure of deformation and the one or more characteristics of the acoustically translucent standoff layer to generate the ultrasound device interaction indicator that is representative of the orientation of the ultrasound device relative to the subject ([0087] “The pressurizing-state image constructing unit 38 constructs a pressurizing-state image in order to cause the image display 9 to display the absolute pressure output from the pressure converter 37. The pressurizing-state image is at least one of a numerical value of the absolute pressure, a graph of the temporal change, a bar chart, and the like and is converted into color image data by the color scan converter 14”. The pressurizing state image is considered the generated ultrasound device interaction indicator).
Matsumara does not specifically teach the ultrasound device interaction indicator represents the orientation angle of the ultrasound device relative to the subject.
However,
Fish in a similar field of endeavor generating an ultrasound device interaction indicator that represent the orientation angle of the ultrasound device relative to the subject (pg. 13, lines 1-12 disclose the ultrasound probe includes a flexible compressible layer that allows the transducer to conform to a surface of the subject. Pg. 15, lines 23-31 disclose providing an indication of the orientation of the ultrasound transducer based on the amount of compression experiences by the flexible layer. Fig. 7 further shows the orientation of the transducer based on the amount of compression of the layer 60 is an orientation angle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound device interaction indicator of Matsumara to include an orientation angle of the ultrasound device in order to have a system that generates more accurate control signals of the ultrasound device, as recognized by Fish (pg. 4, line 8-15).
Regarding claim 14, Matsumura in view of Fish teaches the system of claim 13, as set forth above. Matsumura further teaches the acoustically translucent standoff layer comprises an aqueous gel ([0078] discloses the elastic coupler comprises an aqueous gel).
Regarding claim 15, Matsumura in view of Fish teaches the system of claim 13, as set forth above. Matsumura further teaches the acoustically translucent standoff layer comprises a coupling for fastening the acoustically translucent standoff layer to the ultrasound device ([0079] discloses the elastic coupler 20 comprises an attachment tool for attaching the elastic coupler to the ultrasound probe).
Regarding claim 17, Matsumura in view of Fish teaches a computer program product comprising computer program code which, when executed on a computer device having a processing system ([0065]-[0066] and figs. 1-5 of Matsumara disclose an ultrasonic diagnostic apparatus for performing the functions of the invention/method. The part of the apparatus in fig. 1 that contains the instructions for performing the process of the invention/method is considered the computer program product comprising computer program code), cause the processing system to perform the steps of the method according to claim 1 (as discussed above the apparatus of fig. 1 performs the steps of the method in claim 1).
Regarding claim 18, Matsumura in view of Fish teaches the system of claim 13, as set forth above. Matsumura further teaches the ultrasound device interaction indicator is further representative of a force or pressure exerted by the ultrasound device on the subject ([0087] and [0114] disclose the indicator is representative of a pressure exerted by the device on a subject).
Regarding claim 19, Matsumura in view of Fish teaches the system of claim 13, as set forth above. Matsumura further teaches the one or more characteristics of the acoustically translucent standoff layer comprise a thickness in a zero-force state, a thickness at a predefined non-zero compression force or pressure, and/or an elastic modulus ([0022] and [0101] discloses the elastic coupler (standoff layer) comprises at least an elastic modulus).
Regarding claim 20, Matsumura in view of Fish teaches the system of claim 13, as set forth above. Matsumura further teaches the measure of deformation comprises at least one of an axial strain or a deformed thickness of the acoustically translucent standoff layer (Abstract discloses obtaining the thickness of the elastic coupler in the pressurized (deformed) state).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsumura in view of Fish as applied to claim 1 above, and further in view of Jimenez Gonzalez et al. (US 20220330919, hereinafter Jimenez).
Regarding claim 7, Matsumura in view of Fish teaches the method of claim 1, as set forth above. Matsumura further teaches processing the ultrasound signal to generate an image comprising at least part of the acoustically translucent standoff layer ([0091] and fig. 6 disclose generating an image comprising the elastic coupler 20).
Matsumura in view of Fish does not specifically teach performing a cross-correlation of the generated image with a reference image to determine the measure of deformation.
However,
Jimenez in a similar field of endeavor teaches performing a cross-correlation of the generated image with a reference image to determine the measure of deformation ([0072] discloses calculating the deformation of the soft solid using cross-correlation which [0010] discloses includes comparing different images, where the image that is used for comparison is considered the reference image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the deformation determination of Matsumura in view of Fish for the cross-correlation method of Chen because it amounts to simple substitution of one known element for another to obtain the predictable results of calculating the deformation.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsumura in view of Fish as applied to claim 13 above, and further in view of Prologo et al. (US 20220133381, hereinafter Prologo).
Regarding claim 16, Matsumura in view of Fish teaches the method of claim 13, as set forth above. Matsumura in view of Fish does not specifically teach a thickness of the acoustically translucent standoff layer is selected according to a target imaging anatomy.
However,
Prologo in a similar field of endeavor teaches a thickness of the acoustically translucent standoff layer is selected according to a target imaging anatomy ([0127] “the gel and hydrogels can be applied in varying thicknesses based upon the anatomy/size of the target structure”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the thickness of the acoustically translucent standoff layer be selected according to a target imaging anatomy of Prologo to the system of Matsumara in view of Fish to allow for the predictable results of ensuring the acoustically translucent standoff layer can withstand the amount of pressure that is needed to be applied in order to properly image the target anatomy, thereby increasing the likelihood of success for the procedure.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 11 is allowed.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record fails to reasonably teach or in combination render obvious the following limitations when the claims taken as a whole to include, “obtaining. at an input interface, one or more characteristics of the acoustically translucent standoff layer; obtaining, at the input interface, an ultrasound signal from the ultrasound device, wherein the ultrasound signal is representative of a plurality of ultrasound echoes received by the ultrasound device from different depths for each of one or more scan lines; processing the ultrasound signal to determine a measure of deformation of the acoustically translucent standoff layer; and processing the one or more characteristics of the acoustically translucent standoff layer and the ultrasound signal to determine a measure of strain hysteresis of the acoustically translucent standoff layer; and, in response to a determination that the measure of strain hysteresis exceeds a predetermined hysteresis threshold: generating an indication that the acoustically translucent standoff layer needs replacing; and outputting, at an output interface, the indication that the acoustically translucent standoff layer needs replacing”.
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.
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798
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