DETAILED ACTION
This office action is in response to the communication received on February 12, 2026 concerning application No. 18/966,036 filed on December 2, 2024.
Claims 1-11 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
Applicant's arguments filed 02/12/2026 regarding the claim objections have been fully considered. Applicants arguments overcome the claim objections of claims 5-9 previously set forth. Additionally, the amendments to the claims have been entered and overcome the claim objections of claims 5 and 7 previously set forth. Examiner notes the amendments to the claims have led to further claim objections.
Applicant's arguments filed 02/12/2026 regarding the claim interpretation under 35 USC 112f have been fully considered. The amendments to the claims have been entered and overcome the claim interpretation under 35 USC 112f of claims 1-2 and 4-9 previous set forth.
Applicant's arguments filed 02/12/2026 regarding the prior art rejection have been fully considered but they are not persuasive. In response to the applicant’s arguments on pg. 9 that the prior art fails to teach “recognize, based on an ultrasound image acquired by scanning with an ultrasonic wave using the ultrasonic probe, a scanning cross section scanned with the ultrasonic wave”, examiner respectfully disagrees. As set forth in the previous office action [0057] of Man discloses the processor determines a cut plane (scanning cross section) based on a medical image which represents a cross section of the patient at the cut plane. Applicant argues that Man does not recognize the scanning cross section based on the ultrasound image itself but instead utilizes probe position information to infer the cut plane. However, examiner notes that as the claim is currently written it does not go into detail about how the ultrasound image is being used to recognize the scanning cross section and instead only recites that the recognition is based on an ultrasound image. Therefore the broadest reasonable interpretation of the limitation allows for the ultrasound image to be used in any reasonable capacity to recognize the scanning cross section. Therefore, since Man teaches the position where the medical image was obtained is used for recognizing the cut plane (scanning cross section), the recognition is based on an ultrasound image. For at least these reasons Man teaches the argued limitation recited above.
In response to the applicant’s arguments on pgs. 10-11 that the prior art fails to teach “use an anatomical model in which a correct answer cross section on which ultrasonic examination is to be performed and a correct answer position of the correct answer cross section are registered, to transform a position indicated by the position information acquired by the position sensor into the correct answer position associated with the anatomical model according to a transformation rule”, examiner respectfully disagrees. As set forth in the previous office action [0026] of Man discloses the cross section of the anatomical model (correct answer cross section) is registered with the cut plane which represents the virtual position of the probe (correct answer position) and [0056] discloses at step 830 the processor determines a virtual position of the probe (correct answer position) in the virtual space relative to the anatomical model based on a mapping matrix (transformation rule), where the virtual position in the virtual space corresponds to the physical position of the probe in real space. Applicant argues that “Man does not disclose that the anatomical model pre-registers a correct answer cross section and a corresponding correct answer position for ultrasonic examination…Man relies on geometric coordinate transformation, rather than on any pre-registered reference information defining a correct or expected scanning cross section”. Examiner notes that as the claim is currently written it does not require the anatomical model to pre-register the correct answer cross section and the correct answer position. The claim recites that the correct answer cross section and correct answer position are registered which as discussed above, Man discloses in [0026]. Further the claim does not go into detail about how the anatomical model is used to transform the position into the correct answer position. It only recites that that anatomical model is used in the transformation which as discussed above, Man discloses in [0056]. For at least these reasons Man teaches the argued limitation recited above.
In response to the applicant’s arguments on pg. 11 that the prior art fails to teach “display extraction information related to the ultrasonic examination, which corresponds to the correct answer position on a display”, examiner respectfully disagrees. Applicant argues that “given that Man does not disclose a correct answer position”, Man does not disclose the argued limitation. However, as discussed above Man teaches a correct answer position, therefore Man teaches the argued limitation.
In response to the applicant’s arguments on pgs. 11-12 that the prior art fails to teach “update the transformation rule by using the correct answer position of the correct answer cross section corresponding to the scanning cross section and the position indicated by the position information acquired by the position sensor”, examiner respectfully disagrees. As set forth in the previous office action pg. 8, lines 15-27 and claim 8 of Kruecker disclose the argued limitation. Applicant specifically argues “the update in Kruecker is solely based on coordinate correspondence samples obtained from repositioning a calibration marker at a coordinate system level, and is not guided by any reference information defining a correct or expected scanning cross section”. However, the position of the repositioning location of the probe as discussed in pg. 8, lines 15-27 and shown in fig. 6 represents the correct answer position used for updating the transform matrix (transformation rule). Therefore Kruecker relies upon reference information defining a correct or expected scanning cross section to update the transformation rule. For at least these reasons Kruecker teaches the argued limitation.
Applicant further argues, “even if Man and Kruecker were combined, the combination would merely result in deriving a probe position and performing coordinate system calibration. Such combination would still fail to produce the claimed functionality of updating the transformation rule in a manner guided by correct answer information”. However, as discussed above Man and Kruecker teach the limitations of the claims and as set forth in the previous office action it would have been obvious to combine Man and Kruecker before the effective filing date of the claimed invention, therefore the combination of Man and Kruecker teach claim 1.
For at least these reasons Man in view of Kruecker teach the limitations of claim 1.
In response to applicant’s arguments on pg. 13 that the prior art fails to teach dependent claims 2 and 3, examiner respectfully disagrees. For the same reasons discussed above regarding claim 1, Man in view of Kruecker teach the limitations of claims 2 and 3.
Claim Objections
Claims 4-9 are objected to because of the following informalities:
Claim 8, lines 5-6, “a result of the estimation by the estimation unit” should read “a result of the estimation”. Claim 8 can also be amended similar to claim 9 to use the limitation “estimation result” instead of “a result of the estimation by the estimation unit”.
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) 1-4 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Man et al. (US 20180350064, hereinafter Man) in view of Kruecker et al. (WO2013140315, hereinafter Kruecker).
Regarding claim 1, Man teaches an ultrasound diagnostic apparatus ([0021] discloses a device for performing the processes disclosed in the description. [0024] discloses the processes include ultrasound diagnosis, making the device an ultrasound diagnostic apparatus) comprising:
a position sensor that acquires position information of an ultrasound probe ([0033] “EM wave sensor 815 serves as a position transducer in this context (and maybe referred to as “position transducer” hereinafter), and generates probe position data 320 that indicates the physical position of probe 81 in real space 20”, the EM wave sensor is considered the acquisition unit); and
a processor (the electronic circuitry of the system that carries out data flow 300 shown in fig. 3) configured to:
recognize, based on an ultrasound image acquired by scanning with an ultrasonic wave using the ultrasound probe, a scanning cross section scanned with the ultrasonic wave ([0057] discloses the processor determines a cut plane (scanning cross section) based on a medical image which represents cross section scanned by the probe. [0055] further discloses the ultrasound probe generates the medical image);
use an anatomical model in which a correct answer cross section on which ultrasonic examination is to be performed and a correct answer position of the correct answer cross section are registered ([0026] discloses the cross-section of anatomical model (correct answer cross section) is registered with the cut plane which represents the virtual position of the probe (correct answer position)), to transform a position indicated by the position information acquired by the position sensor into the correct answer position associated with the anatomical model according to a transformation rule ([0056] “At 830, process 800 may involve the processor determining a virtual position (such as virtual position 581 of FIG. 4) of the probe in the virtual space relative to the anatomical model based on the mapping matrix determined in block 810. Specifically, the virtual position as defined in the virtual space corresponds to the physical position of the probe in the real space”, the virtual position corresponds to the correct answer position, and the mapping matrix is the transformation rule);
display extraction information related to the ultrasonic examination, which corresponds to the correct answer position, on a display ([0048] discloses “display image rendering circuit 7806 may also display or generate a 3D image of the anatomical model with the cut plane, as determined by cut plane calculation circuit 7804, identified on the 3D image”. Also see step 850 in [0058]).
Man does not specifically teach updating the transformation rule by using the correct answer position of the correct answer cross section corresponding to the scanning cross section and the position indicated by the position information acquired by the position sensor.
However,
Kruecker in a similar field of endeavor teaches updating a transformation rule by using the correct answer position of the correct answer cross section corresponding to the scanning cross section and the position indicated by the position information acquired by the position sensor (pg. 8, lines 15-27 disclose generating the transform matrix based on the updated data sets representing the positions of the tool. Claim 8 further discloses “the ultrasound tracking transform matrix is updated for each mapping of the image coordinate of the calibration marker (11) within the ultrasound image coordinate system (33) to the corresponding tracking coordinate of the calibration marker (11) within the global spatial coordinate system (21)”. Pg. 4, lines 1-11 disclose the use of EM sensors (position sensor) for tracking).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus disclosed by Man to have update the transformation rule by using the correct answer position of the correct answer cross section corresponding to the scanning cross section and the position indicated by the position information acquired by the position sensor in order to provide more accurate guidance, as recognized by Kruecker (pg. 9, lines 10-15).
Regarding claim 2, Man in view of Kruecker teaches the apparatus of claim 1, as set forth above. Man further teaches the transformation according to the transformation rule is transformation using a transformation matrix ([0056] “At 830, process 800 may involve the processor determining a virtual position (such as virtual position 581 of FIG. 4) of the probe in the virtual space relative to the anatomical model based on the mapping matrix determined in block 810. Specifically, the virtual position as defined in the virtual space corresponds to the physical position of the probe in the real space”, the mapping matrix represents the transformation rule).
Kruecker further teaches the processor updates the transformation matrix by using the position indicated by the position information acquired by the position sensor and the correct answer position of the correct answer cross section (pg. 8, lines 15-27 disclose generating the transform matrix based on the updated data sets representing the positions of the tool. Claim 8 further discloses “the ultrasound tracking transform matrix is updated for each mapping of the image coordinate of the calibration marker (11) within the ultrasound image coordinate system (33) to the corresponding tracking coordinate of the calibration marker (11) within the global spatial coordinate system (21)”).
Regarding claim 3, Man in view of Kruecker teaches the apparatus of claim 1, as set forth above. Man further teaches the correct answer cross section and the correct answer position are registered in the anatomical model for each examination site ([0026] discloses the cross-section of anatomical model (correct answer cross section) is registered with the cut plane which represents the virtual position of the probe (correct answer position)).
Regarding claim 4, Man in view of Kruecker teaches the apparatus of claim 1, as set forth above. Man further teaches setting an anatomical model corresponding to at least one of a body shape or a body position of a subject that serves as a target of the ultrasonic examination, as the anatomical model to be used for the transformation ([0049] “model adjusting circuit 7807 may be configured to customize anatomical model 511 of FIGS. 1-4 or anatomical model 330 of FIG. 6 according to some adjustment parameters”. [0050] “The adjustment parameters may include characteristics of the particular patient, such as gender, height, weight, age, ethnicity, and the like”, the height and weight of the patient at least correspond to body shape. Also see [0031]).
Regarding claim 11, Man in view of Kruecker teaches the apparatus of claim 1, as set forth above. Man further teaches the extraction information includes at least one of information indicating a position of the ultrasound probe (fig. 1 shows the display includes displaying the virtual position 581 of the probe), information indicating an orientation of the ultrasound probe, information indicating a current scanning range with an ultrasonic wave, information indicating a past scanning range with an ultrasonic wave ([0058] discloses the display includes displaying the slice image which represents at least a past scanning range with an ultrasonic wave), or information indicating a non-scanned range.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Man in view of Kruecker as applied to claim 4 above, and further in view of Bohra et al. (US 20250098962, hereinafter Bohra).
Regarding claim 5, Man in view of Kruecker teaches the apparatus of claim 4, as set forth above. Man in view of Kruecker does not specifically teach at least one of the body shape or the body position of the subject is designated by a user, and the processor sets an anatomical model corresponding to the at least one of the body shape or the body position designated by the user, as the anatomical model to be used for the transformation.
However,
Bohra in a similar field of endeavor teaches at least one of the body shape or the body position of the subject is designated by a user ([0015] discloses the size and shape of the user body information is provided by the user), and the processor sets an anatomical model corresponding to the at least one of the body shape or the body position designated by the user, as the anatomical model ([0015] discloses generating the customized anatomical model based on the user provided size and shape information).
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 anatomical model generation of Man in view of Kruecker for the anatomical model generation of Bohra because it amounts to simple substitution of one known element for another to obtain the predictable results of generating the anatomical model.
Regarding claim 6, Man in view of Kruecker teaches the apparatus of claim 4, as set forth above. Man in view of Kruecker does not specifically teach the processor estimates at least one of the body shape or the body position of the subject based on an image generated by imaging the subject with a camera, and sets an anatomical model corresponding to a result of the estimation, as the anatomical model to be used for the transformation.
However,
Bohra in a similar field of endeavor teaches the processor estimates at least one of the body shape or the body position of the subject based on an image generated by imaging the subject with a camera, and sets an anatomical model corresponding to a result of the estimation, as the anatomical model ([0082] discloses using a camera to in order to determine the dimensions of the subject which are used for generating the customized anatomical model. Also see [0025]).
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 anatomical model generation of Man in view of Kruecker for the anatomical model generation of Bohra because it amounts to simple substitution of one known element for another to obtain the predictable results of generating the anatomical model.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Man in view of Kruecker as applied to claim 4 above, and further in view of Pissarenko et al. (US 20240320935, hereinafter Pissarenko).
Regarding claim 7, Man in view of Kruecker teaches the apparatus of claim 4, as set forth above. Man in view of Kruecker does not specifically teach the processor receives subject identification information for identifying the subject, and sets an anatomical model corresponding to the body shape indicated by body shape information linked to the subject identification information, as the anatomical model to be used for the transformation.
However,
Pissarenko in a similar field of endeavor teaches the processor receives subject identification information for identifying the subject, and sets an anatomical model corresponding to the body shape indicated by body shape information linked to the subject identification information, as the anatomical model to be used for the transformation ([0146] discloses the user access the 3D model of the patient based on the patient’s information such as name or unique patient identifier).
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 anatomical model generation of Man in view of Kruecker for the anatomical model generation of Pissarenko because it amounts to simple substitution of one known element for another to obtain the predictable results of generating the anatomical model.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Man in view of Kruecker as applied to claim 4 above, and further in view of Kolen et al. (US 20230334679, hereinafter Kolen).
Regarding claim 8, Man in view of Kruecker teaches the apparatus of claim 4, as set forth above. Man in view of Kruecker does not specifically teach estimating at least one of the body shape or the body position of the subject based on a position of the ultrasound probe, wherein the processor sets an anatomical model corresponding to a result of the estimation by the estimation unit, as the anatomical model to be used for the transformation.
However,
Kolen in a similar field of endeavor teaches estimating at least one of the body shape or the body position of the subject based on a position of the ultrasound probe, wherein the processor sets an anatomical model corresponding to a result of the estimation by the estimation unit, as the anatomical model to be used for the transformation ([0106] “the ultrasound probe comprises an integrated optical shape sensed fiber, the determined location of the ultrasound probe can be used to increase an accuracy of electrode localization performed by the dielectric imaging system. This can, for example, cause the dielectric imaging system to modify the anatomical map based on the highly accurate electrode localization performed by the optical shape sensed fiber”)
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 anatomical model generation of Man in view of Kruecker for the anatomical model generation of Kolen because it amounts to simple substitution of one known element for another to obtain the predictable results of generating the anatomical model.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Man in view of Kruecker as applied to claim 4 above, and further in view of Mahfouz et al. (US 20140221825, hereinafter Mahfouz).
Regarding claim 9, Man in view of Kruecker teaches the apparatus of claim 4, as set forth above. Man in view of Kruecker does not specifically teach estimating at least one of the body shape or the body position of the subject based on the ultrasound image to generate an estimation result, wherein the processor sets an anatomical model corresponding to the estimation result, as the anatomical model to be used for the transformation.
However,
Mahfouz in a similar field of endeavor teaches estimating at least one of the body shape or the body position of the subject based on the ultrasound image to generate an estimation result ([0076] discloses generating contours of the imaging region based on the ultrasound echo as the transducer is moved about the region), wherein the processor sets an anatomical model corresponding to the estimation result, as the anatomical model to be used for the transformation ([0074] “A plurality of bone or other anatomical feature surface contour lines is thereby generated that can be used to generate 3-D images and models of the joint or anatomical feature”).
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 anatomical model generation of Man in view of Kruecker for the anatomical model generation of Mahfouz because it amounts to simple substitution of one known element for another to obtain the predictable results of generating the anatomical model.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Man in view of Kruecker as applied to claim 4 above, and further in view of Samadani et al. (US 20210137605, hereinafter Samadani).
Regarding claim 10, Man in view of Kruecker teaches the apparatus of claim 4, as set forth above. Man in view of Kruecker does not specifically teach in a case in which a change occurs in the body position of the subject, the processor creates a new transformation rule corresponding to the changed body position.
However,
Samadani in a similar field of endeavor teaches in a case in which a change occurs in the body position of the subject, the processor creates a new transformation rule corresponding to the changed body position (Claim 9, “determine a movement of the body of the patient; and if the movement of the body of the patient has exceeded a threshold, update the transformation matrix to generate an updated transformation matrix”. Also see [0075]-[0076]).
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 in a case in which a change occurs in the body position of the subject, the processor creates a new transformation rule corresponding to the changed body position of Samadani to the processor of Man in view of Kruecker to allow for the predictable results of ensuring the most accurate and up to date transformation rule is being used, thereby increasing the accuracy of the output information.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW BEGEMAN whose telephone number is (571)272-4744. The examiner can normally be reached Monday-Thursday 8:30-5:00.
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798