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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on October 30, 2025 has been entered.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 12, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto et al. (US 5,782,768, hereinafter Hashimoto ‘768) in view of Takimoto et al. (US 2009/0137907, hereinafter Takimoto ‘907).
In re claims 1 and 20, Hashimoto ‘768 teaches an ultrasound diagnostic apparatus comprising:
an ultrasound probe (col. 8, lines 1-19, lines 35-51);
a monitor (col. 8, lines 1-19, lines 35-51, note a CRT display is a monitor); and
a processor configured to detect a position of the ultrasound probe (col. 8, lines 20-30),
acquire an ultrasound image of a subject using the ultrasound probe (col. 8, lines 1-19, lines 35-51),
generate
detect the blood vessel from the
detect a depth from a body surface to the blood vessel of the subject in each position of the blood vessel based on the detected blood vessel (col. 8, lines 1-19, note that x, y, z coordinates are positions, i.e. col. 9, lines 12-29), and
generate a blood vessel image depicting the blood vessel within the subject based on the position of the detected ultrasound probe, the detected blood vessel, and the detected depth, in each position of the blood vessel, where the blood vessel image represents a plan view of the detected blood vessel along a plane perpendicular to a direction along the detected depth (col. 8, lines 1-19, note that x, y, z coordinates are positions, i.e. col. 9, lines 12-44, fig. 5B, note that Hashimoto ‘768’s fig 5A is similar to Applicant’s Fig. 4, and Hashimoto ‘768’s fig. 5B is similar to Applicant’s Fig. 5 with respect to scanning plane and plan view), and
display the blood vessel image on the monitor
Hashimoto ‘768 fails to teach generate three-dimensional ultrasound data of a blood vessel of the subject based on a plurality of frames of the ultrasound images, and display the blood vessel image on the monitor with changing a display form of each position in the blood vessel image on the monitor according to the detected depth corresponding to each position in the blood vessel.
Takimoto ‘907 teaches generate three-dimensional ultrasound data of a blood vessel of the subject based on a plurality of frames of the ultrasound images (abstract, 0046-0050), and display the blood vessel image on the monitor with displaying each position in the blood vessel image on the monitor according to a display form corresponding to the detected depth of the each position in the blood vessel (0082-0083).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Hashimoto ‘768 to include the features of Takimoto ‘907 in order to easily recognize each of the regions.
In re claim 12, Takimoto ‘907 teaches wherein the processor is further configured to generate a three-dimensional ultrasound image corresponding to any location designated by a user for the blood vessel image from the three-dimensional ultrasound data, and display the three-dimensional ultrasound image on the monitor (0046-0050, 0082-0083).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto ‘768 and Takimoto ‘907 in view of Zhang et al.(US 2021/0030486, hereinafter Zhang ‘486).
In re claim 2, Hashimoto ‘768 and Takimoto ‘907 fails to teach further comprising: an optical camera configured to image the ultrasound probe during scanning and the subject, wherein the processor is further configured to display the blood vessel image on the monitor while superimposing the blood vessel image on an optical image captured by the optical camera.
However, Hashimoto ‘768 teaches display ultrasound image of which is the blood vessel image on the monitor col. 9, lines 18-44).
Zhang ‘486 teaches an optical camera configured to image the ultrasound probe during scanning and the subject, wherein the processor is further configured to display the ultrasound acquired (
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Hashimoto ‘768 and Takimoto ‘907 to include the features of Zhang ‘486 in order to allow doctors to see the state of the patient and the affected part existing in front of the doctor's eyes through the camera image displayed on a display of the HMD.
In re claim 3, Zhang ‘486 teaches wherein the processor is further configured to detect the position of the ultrasound probe based on the optical image captured by the optical camera (fig. 1, 24A, 0053-0059, 0061, 0062).
Claim(s) 4-7, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto ‘768, Takimoto ‘907, and/or Zhang ‘486 in view of Bedi et al. (US 2021/0045710, hereinafter Bedi ‘710).
In re claims 4-6, Hashimoto ‘768, Takimoto ‘907, and/or Zhang ‘486 fail to teach wherein the processor is further configured to detect a blood vessel wall and a blood vessel lumen.
Bedi ‘710 teaches wherein the processor is further configured to detect a blood vessel wall and a blood vessel lumen (0041, 0042, 0044-0047, 0085-0087, etc.).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Hashimoto ‘768, Takimoto ‘907, and/or Zhang ‘486 to include the features of Bedi ‘710 in order to identify, from the one or more blood vessels, an artery of interest, and automatically detect spatial boundaries of constituent layers of an arterial wall of the artery of interest, and calculating, via a processor of the ultrasound apparatus, a cross-sectional intima-media area (IMA) of the artery of interest at a first location along a length of the artery of interest.
In re claim 7, Bedi ‘710 teaches wherein the processor is further configured to calculate a thickness of the blood vessel wall or a diameter of the blood vessel lumen based on the blood vessel wall and the blood vessel lumen which are detected (0087, 0177, 0178, 0201, 0214, 0224, 0232, 0233).
In re claim 9, Hashimoto ‘768 teaches wherein the processor is further configured to acquire a B-mode image and a Doppler image, and detect the blood vessel lumen based on the B-mode image and the Doppler image (col. 14, lines 38-53).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto ‘768, Takimoto ‘907, Zhang ‘486, and Bedi ‘710 in view of Imagawa et al. (US 2014/0350350, hereinafter Imagawa ‘350).
In re claim 8, Hashimoto ‘768, Takimoto ‘907, Zhang ‘486, and Bedi ‘710 fail to teach wherein the processor is further configured to detect a location where a spatial change rate of the thickness of the blood vessel wall or the diameter of the blood vessel lumen exceeds a predetermined change rate threshold value, and to display the location on the monitor.
Imagawa ‘350 teaches wherein the processor is further configured to detect a location where a spatial change rate of the thickness of the blood vessel wall or the diameter of the blood vessel lumen exceeds a predetermined change rate threshold value, and to display the location on the monitor (0047-0052).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Hashimoto ‘768, Takimoto ‘907, and Zhang ‘486 to include the features of Bedi ‘710 in order to identify, from the one or more blood vessels, an artery of interest, and automatically detect spatial boundaries of constituent layers of an arterial wall of the artery of interest, and calculating, via a processor of the ultrasound apparatus, a cross-sectional intima-media area (IMA) of the artery of interest at a first location along a length of the artery of interest, and to include the features of Imagawa ‘350 in order to identify planned positions in the respective recommended regions of the target of interest while checking the recommended regions and the unrecommended regions on the image.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto ‘768 and Takimoto ‘907 in view of Ichioka et al. (US 2014/0039316, hereinafter Ichioka ‘316)
In re claim 13, Hashimoto ‘768 and Takimoto ‘907 fail to teach wherein the processor is further configured to calculate a recommended puncture pathway including a recommended puncture direction and a recommended puncture angle with respect to the body surface at a puncture location designated by a user for the blood vessel image from the three-dimensional ultrasound data, and display the recommended puncture pathway on the monitor.
Ichioka ‘316 teaches calculate a recommended puncture pathway including a recommended puncture direction and a recommended puncture angle with respect to the body surface at a puncture location designated by a user for the blood vessel image from the three-dimensional ultrasound data, and display the recommended puncture pathway on the monitor (0069-0076).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Hashimoto ‘768 and Takimoto ‘907 to include the features of Ichioka ‘316 in order to support the accurate insertion of the puncture needle to the target site.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto ‘768 and Takimoto ‘907 in view of Haim et al. (US 2006/0184029, hereinafter Haim ‘029).
In re claim 14, Hashimoto ‘768 and Takimoto ‘907 fail to teach wherein the processor is further configured to determine whether the blood vessel which is detected is an artery or a vein, and generate the blood vessel image in which a depiction form of the blood vessel is changed according to a determination result of whether the blood vessel is the artery or the vein.
Haim ‘029 teaches wherein the processor is further configured to determine whether the blood vessel which is detected is an artery or a vein, and generate the blood vessel image in which a depiction form of the blood vessel is changed according to a determination result of whether the blood vessel is the artery or the vein (0046).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Hashimoto ‘768 and Takimoto ‘907 to include the features of Haim ‘029 in order to detect, recognize and classify of blood vessels with easier visual representation for user.
Claim(s) 13, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto ‘768 and Takimoto ‘907 in view of Mauldin et al. (US 2016/0374644, hereinafter Mauldin ‘644).
In re claim 13, Hashimoto ‘768 and Takimoto ‘907 fails to teach wherein the processor is further configured to calculate a recommended puncture pathway including a recommended puncture direction and a recommended puncture angle with respect to the body surface at a puncture location designated by a user for the blood vessel image from the three-dimensional ultrasound data, and display the recommended puncture pathway on the monitor.
Mauldin ‘644 teaches calculate a recommended puncture pathway including a recommended puncture direction and a recommended puncture angle with respect to the body surface at a puncture location designated by a user for the blood vessel image from the three-dimensional ultrasound data, and display the recommended puncture pathway on the monitor (0100-0102, 0105-0108, 0111, 0112, 0115-0117).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Hashimoto ‘768 and Takimoto ‘907 to include the features of Mauldin ‘644 in order to automate identification of target anatomy, provide an indication of the target mid-line and depth, and provide indication of transducer motion required to align target anatomy with a desired probe and needle insertion path.
In re claim 15, Hashimoto ‘768 and Takimoto ‘907 fail to teach wherein the processor is further configured to detect a nerve bundle from the three-dimensional ultrasound data, and display the nerve bundle which is detected on the monitor.
Mauldin ‘644 teaches wherein the processor is further configured to detect a nerve bundle from the three-dimensional ultrasound data, and display the nerve bundle which is detected on the monitor (0058, 0063, 0071, 0072, 0117).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Hashimoto ‘768 and Takimoto ‘907 to include the features of Mauldin ‘644 in order to automate identification of target anatomy, provide an indication of the target mid-line and depth, and provide indication of transducer motion required to align target anatomy with a desired probe path.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto ‘768, Takimoto ‘907, and/or Zhang ‘486, and Bedi ‘710 in view of Umezawa (US 2017/0055843, hereinafter Umezawa ‘843).
In re claim 16, Hashimoto ‘768, Takimoto ‘907, and/or Zhang ‘486, and Bedi ‘710 fail to teach wherein the processor is further configured to associate positions of a past blood vessel image and of a current blood vessel image with each other; and display, on the monitor, a current location associated with a past finding location on the past blood vessel image while superimposing the current location on the current blood vessel image.
Umezawa ‘843 teaches wherein the processor is further configured to associate positions of a past
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Hashimoto ‘768, Takimoto ‘907, and/or Zhang ‘486 to include the features of Bedi ‘710 in order to identify, from the one or more blood vessels, an artery of interest, and automatically detect spatial boundaries of constituent layers of an arterial wall of the artery of interest, and calculating, via a processor of the ultrasound apparatus, a cross-sectional intima-media area (IMA) of the artery of interest at a first location along a length of the artery of interest, and to include the features of Umezawa ‘843 in order to evaluate the deviation amounts between both images and to determine whether an object state is close to a state obtained at previous measurement.
In re claim 17, Umezawa ‘843 teaches wherein the processor is further configured to display a past finding content and a past ultrasound image corresponding to the current location, which is displayed on the monitor and designated by a user, on the monitor (0095, 0153).
Allowable Subject Matter
Claims 18-19 are 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 12-17, 20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3797