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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/23/2025 has been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Invention I, Claims 1-5 in the reply filed on 06/19/2026 is acknowledged. Claims 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claims 1-5 are objected to because of the following informalities:
In claim 1, “…wherein the hardware processor, acquires…, extracts,… and outputs…” should be “…wherein the hardware processor is configured to, acquire…, extract,… and output…”.
In claims 2-5, “the hardware processor extracts…” should be “the hardware processor is further configured to extract…”.
In claim 5, “tracks…, and extracts…” should be “track…, and extract…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites a judicial exception (abstract idea). The “acquires…”, “extracts…”, and “outputs…” steps do not specify how to acquire a plurality of images, extract an image from the plurality of images, and output the extracted image. The physician can print and view images of target tissue, and select one of the printed images using their mind and a pen (see MPEP 2106, section III, step 2A of subject matter eligibility test flowchart). This judicial exception is not integrated into a practical application because the step in the claim can be considered as processes that can be performed in the human mind (see MPEP 2106.04(a)(2)(III)).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because no details are given surrounding the step (see MPEP 2106, section III, step 2B of subject matter eligibility test flowchart). Therefore, the claim is not eligible subject matter under 35 US.C. 101.
General system elements (i.e., processor, probe) related to the insignificant extra solution activity steps that do not integrate the abstract idea into a practical application as it does not impose any meaningful limits on practicing the abstract idea.
Claim 2 recites a judicial exception (abstract idea). The “extracts an image region…” step does not specify how to extract an image region. The physician can draw on or around a region of the printed image using their mind and a pen (see MPEP 2106, section III, step 2A of subject matter eligibility test flowchart). This judicial exception is not integrated into a practical application because the step in the claim can be considered as processes that can be performed in the human mind (see MPEP 2106.04(a)(2)(III)).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because no details are given surrounding the step (see MPEP 2106, section III, step 2B of subject matter eligibility test flowchart). Therefore, the claim is not eligible subject matter under 35 US.C. 101.
General system elements (i.e., processor) related to the insignificant extra solution activity steps that do not integrate the abstract idea into a practical application as it does not impose any meaningful limits on practicing the abstract idea.
Claim 3 recites a judicial exception (abstract idea). The “extracts…a frame including the image region that has a highest average brightness…” step does not specify how to extract frame including the image region that has a highest average brightness. The physician can draw on or around a region of the printed images, and select the printed image with the brightest region using their mind and a pen (see MPEP 2106, section III, step 2A of subject matter eligibility test flowchart). This judicial exception is not integrated into a practical application because the step in the claim can be considered as processes that can be performed in the human mind (see MPEP 2106.04(a)(2)(III)).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because no details are given surrounding the step (see MPEP 2106, section III, step 2B of subject matter eligibility test flowchart). Therefore, the claim is not eligible subject matter under 35 US.C. 101.
General system elements (i.e., processor) related to the insignificant extra solution activity steps that do not integrate the abstract idea into a practical application as it does not impose any meaningful limits on practicing the abstract idea.
Claim 4 recites a judicial exception (abstract idea). The “extracts…a first frame…”, “extracts…a second frame…”, “cuts out the second image region…”, and “synthesizes…” steps do not specify how to extract frames including the image regions that has a highest average brightness, cut out a region from an extracted frame, and synthesize the cut out region with the first frame. The physician can print and view images, draw on or around regions of the printed images, select the printed images with the brightest regions, cut out (via scissors) the brightest region from the one of the selected printed image, and glue (via glue stick) the cut out region to one of the other selected printed image using their mind and a pen (see MPEP 2106, section III, step 2A of subject matter eligibility test flowchart). This judicial exception is not integrated into a practical application because the step in the claim can be considered as processes that can be performed in the human mind (see MPEP 2106.04(a)(2)(III)).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because no details are given surrounding the step (see MPEP 2106, section III, step 2B of subject matter eligibility test flowchart). Therefore, the claim is not eligible subject matter under 35 US.C. 101.
General system elements (i.e., processor) related to the insignificant extra solution activity steps that do not integrate the abstract idea into a practical application as it does not impose any meaningful limits on practicing the abstract idea.
Claim 5 recites a judicial exception (abstract idea). The “extracts a continuous lumen…”, “tracks a depth…”, and “extracts the frame…having a shallowest depth…” steps do not specify how to extract a lumen, track a depth, and extract a frame having the shallowest depth. The physician can print and view images of lumen, draw on or around the lumen in the printed images, measure (via a ruler) the depth of the lumen in each printed image, and select a printed image with the shallowest depth using their mind and a pen (see MPEP 2106, section III, step 2A of subject matter eligibility test flowchart). This judicial exception is not integrated into a practical application because the step in the claim can be considered as processes that can be performed in the human mind (see MPEP 2106.04(a)(2)(III)).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because no details are given surrounding the step (see MPEP 2106, section III, step 2B of subject matter eligibility test flowchart). Therefore, the claim is not eligible subject matter under 35 US.C. 101.
General system elements (i.e., processor) related to the insignificant extra solution activity steps that do not integrate the abstract idea into a practical application as it does not impose any meaningful limits on practicing the abstract idea.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (US 20240029245 A1, published January 25, 2024), hereinafter referred to as Xu.
Regarding claim 1, Xu teaches an ultrasonic diagnostic apparatus (Fig. 2, ultrasound system 200)
that transmits an ultrasound wave into a subject (see para. 0037 – “The system 200 comprises an array transducer probe 4 which has a transducer array 6 for transmitting ultrasound waves…”),
that receives the ultrasound wave reflected off a target tissue in the subject to obtain a reception signal (see para. 0037 – “The system 200 comprises an array transducer probe 4 which has a transducer array 6 for…receiving echo information.”; see para. 0044 – “Upon receiving the backscattered echo signals from the subject, the received signals undergo receive beamforming…”), and
that outputs an ultrasound image of the target tissue based on the reception signal (see para. 0045 – “For each line (or sub-aperture), the total received signal, used to form an associated line of the final ultrasound image…”), the ultrasonic diagnostic apparatus comprising:
a hardware processor (Fig. 1, processor 102), wherein the hardware processor,
acquires a plurality of frames of the ultrasound image when an angle of an ultrasound probe is changed by a tilt-shift operation of the ultrasound probe (see para. 0068 – “Turning now back to FIG. 1, and the functionality of the processor 102, as noted above, the processor 102 is caused in step i) to obtain a sequence of ultrasound images of the rectus abdominis muscles, the sequence of ultrasound images having been obtained using an ultrasound transducer tilted at different angles to the surface of the skin [tilt shift operation] of the subject (e.g. patient) and thus having different angles of ingress of the ultrasound waves into the skin.”),
extracts a standard frame including the ultrasound image in a case where the ultrasound probe and the target tissue are orthogonal to each other from the plurality of acquired frames (see para. 0079 – “By taking a sequence of ultrasound images at different angles of tilt, the image in which the probe was correctly or optimally angled (e.g. close/closest to 90 degrees) [probe and target tissue orthogonal to each other] may thus be selected as the image frame in which the boundary [target tissue] is clearest.”; see para. 0080 – “The clearest image generally corresponds the image in which the surface of the muscle (e.g. the muscle fibres which appear as the upper/lower boundaries of two separated rectus abdominis muscles) appears brightest and narrowest (sharpest).”), and
outputs the extracted standard frame (Fig. 2; see para. 0065 – “Output data from the quantification processor is coupled to a graphics processor 36 for the reproduction of measurement graphics and values with the image [includes selected image] on the display 40…”).
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Shimizu et al. (US 20230222760 A1, published July 13, 2023), hereinafter referred to as Shimizu.
Regarding claim 2, Xu teaches all of the elements disclosed in claim 1 above.
Xu teaches extracting an image region (see para. 0097 – “This may involve determining the location of the surface of the rectus abdominis muscles [image region] in the selected image data.”), but does not explicitly teach extracting an image region in which a brightness correlation value between image regions included in each of the plurality of frames is equal to or smaller than a threshold value.
Whereas, Shimizu, in an analogous field of endeavor, teaches wherein the hardware processor extracts an image region in which a brightness correlation value between image regions included in each of the plurality of frames is equal to or smaller than a threshold value (see para. 0090 – “Specifically, it is known that both the spatiotemporal feature a (correlation coefficient between frame images) and the spatiotemporal feature b (ratio between luminance average of neighboring pixels and luminance dispersion of neighboring pixels) are relatively small in the blood flow region. Therefore, in the present embodiment, the control unit 41 determines a region where both of the spatiotemporal features a and b fall below a predetermined threshold value as a blood flow region.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified extracting an image region, as disclosed in Xu, by extracting an image region based on a brightness correlation value being equal to or smaller than a threshold value, as disclosed in Shimizu. One of ordinary skill in the art would have been motivated to make this modification in order to generate a tissue characterization map including the blood flow region and non-blood flow regions, as taught in Shimizu (see para. 0090).
Furthermore, regarding claim 3, Xu further teaches wherein the hardware processor extracts, as the standard frame, a frame including the image region that has a highest average brightness from the extracted image region (Fig. 5B; see para. 0083 – “…select ultrasound image data from the sequence of ultrasound images comprises the processor being caused to select the ultrasound image data having a maximum average intensity [highest average brightness].”).
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Okamura et al. (US 20160135781 A1, published August 14, 2023), hereinafter referred to as Okamura.
Regarding claim 1, Xu teaches all of the elements disclosed in claim 1 above.
Xu teaches extracting, as the standard frame, a frame including the image region that has a highest average brightness from the extracted image region (Fig. 5B; see para. 0083 – “…select ultrasound image data from the sequence of ultrasound images comprises the processor being caused to select the ultrasound image data having a maximum average intensity [highest average brightness].”), but does not explicitly teach extracting a first frame including the first image region and a second frame including the second image region to synthesize the first frame and second frame.
Whereas, Okamura, in an analogous field of endeavor, teaches wherein,
in a case in which each of the plurality of frames includes at least a first image region and a second image region (Fig. 3, group of second ultrasound images α1-α5 (plurality of frames) including tissue T (first image) and needle 1b (second image region)),
the hardware processor extracts, from the plurality of frames, a first frame including the first image region having a highest average brightness among the first image regions as the standard frame (Fig. 3; see para. 0074 – “As explained above, according to the first embodiment, the first ultrasound image [first frame], which is the subject-body image, is generated by performing the first scanning process that is optimal [i.e., optimal brightness of tissue] for observing the tissue [target tissue T as first image region] in the subject's body.”), and
the hardware processor extracts, from the plurality of frames, a second frame including the second image region having the highest average brightness among the second image regions (Fig. 5; see para. 0068 – “…so that the selecting unit 18 b selects a third ultrasound image [second frame] out of the group of second ultrasound images (step S104). More specifically, the selecting unit 18 b determines the image having the maximum frequency of appearance of pixels each having a brightness level equal to or higher than the predetermined threshold value, out of the group of second ultrasound images.”),
cuts out the second image region from the second frame (Fig. 4; see para. 0069 – “After that, the extracting unit 18 c extracts a puncture needle area [second image region] from the third ultrasound image [second frame], so that the image generating unit 14 generates a needle image based on the puncture needle area extracted by the extracting unit 18 c (step S105).”), and
synthesizes the cut out second image region with the first image region of the first frame (Fig. 5; see para. 0069 – “Subsequently, the image synthesizing unit 16 generates a synthesized image by synthesizing together the first ultrasound image [includes target site T as first image region] and the needle image (step S106) [cut out second image region]. As a result, a synthesized image corresponding to one frame has been generated.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified extracting, as the standard frame, a frame including the image region that has a highest average brightness from the extracted image region, as disclosed in Xu, by also extracting a first frame including the first image region and a second frame including the second image region to synthesize the first frame and second frame, as disclosed in Okamura. One of ordinary skill in the art would have been motivated to make this modification in order to display the synthesized image in which the visibility of both the tissue in the subject's body and the puncture needle is improved, so it is possible to enhance safety and the precision level of the puncture process and thus to aid the operator who performs the puncture process, as taught in Okamura (see para. 0074).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Narrow et al. (US 20250073398 A1, published March 6, 2025 with a priority date of September 5, 2023) and Sato (US 20140015933 A1, published January 16, 2014), hereinafter referred to as Narrow and Sato, respectively.
Regarding claim 5, Xu teaches all of the elements disclosed in claim 1 above.
Xu teaches extracting an image region, but does not explicitly teach extracting a continuous lumen region in predetermined frames in which a brightness difference is within a threshold value.
Whereas, Narrow, in an analogous field of endeavor, teaches wherein the hardware processor
extracts a continuous lumen region in predetermined frames in which a brightness difference is within a threshold value among the plurality of frames (Fig. 4A; see para. 0058 – “The 3D ultrasound probe can capture a series of transverse ultrasound images similar to this figure, where each transverse ultrasound image is taken at a different transverse plane spaced apart along the longitudinal direction with respect to the blood vessel. The processor can process each transverse ultrasound image using a deep learning image segmentation model to identify the blood vessel lumen in the image. In this figure, the blood vessel lumen is outlined by an oval 310.”),
tracks a depth of the extracted lumen region in the plurality of frames (see para. 0049 – “After identifying the blood vessel lumen in each of the transverse ultrasound images, the processor can also be programmed to provide assistance to a technician who is cannulating the blood vessel…The processor can also be programmed to provide additional information to the technician, such as blood vessel lumen diameter and depth.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified extracting an image region, as disclosed in Xu, by extracting a continuous lumen region in predetermined frames in which a brightness difference is within a threshold value, as disclosed in Narrow. One of ordinary skill in the art would have been motivated to make this modification in order to have the user know how far to insert the needle before the needle comes into contact with the vessel, as taught in Narrow (see para. 0072).
Xu in view of Narrow teaches selecting an image and tracking the depth of lumen, but does not explicitly teach selecting an image with the shallowest depth.
Whereas, Sato, in an analogous field of endeavor, teaches extracting the frame including the lumen region having a shallowest depth as the standard frame from the plurality of frames (see para. 0095 – “For example, an image with the shallowest or deepest depth of field may be selected as the image to be firstly displayed.”; see para. 0104 – “FIG. 8A shows an example of an image with the shallowest depth of field, that is, the image at the reference position 6 in FIG. 9.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified selecting an image and tracking the depth of lumen, as disclosed in Xu in view of Narrow, by selecting an image with the shallowest depth, as disclosed in Sato. One of ordinary skill in the art would have been motivated to make this modification in order to display images selected starting from the one with the shallowest depth of field and continuing to the ones with successively deeper depths of field, as taught in Sato (see para. 0103).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Yim et al. (US 20160335742 A1, published November 17, 2016) discloses generating a plurality of medical images, selecting images from the plurality of medical images, and generating a panoramic image by synthesizing the selected images.
Arai (US 20210169454 A1, published June 10, 2021) discloses respectively generating ultrasonic images corresponding to the respective positions based on the received signal; stitching the ultrasonic images at the respective positions to generate a stitched image.
Kamiyama et al. (US 20150379700 A1, published December 31, 2015) discloses a graph where the horizontal axis indicates a frame number, and the vertical axis indicates an index based on Doppler data of the frame.
Kamiyama et al. (US 20210093302 A1, published April 1, 2021) discloses displaying a color image representing the size of a 3D region.
Kondoh (US 20140371593 A1, published December 18, 2014) discloses selecting a frame corresponding to the bifurcation point of the vessel.
Halmann et al. (US 20220061813 A1, published March 3, 2022) discloses hen a panoramic view is displayed, the highest scoring frame for each rib space is selected and spliced with the other highest scoring frames, forming a composite image of portions of a plurality of images acquired at different times during the lung ultrasound protocol.
Naito et al. (US 20190307515 A1, published October 10, 2019) discloses the controller causes the image processor to synthesize the partial needle images and the B mode image data in one frame to generate composite ultrasound image data in one frame.
Oishi (US 20110245652 A1, published October 6, 2011) discloses it is judged whether or not a correlation coefficient of a voxel exceeds an effective threshold for each voxel of a profile of correlation coefficient.
Ebata et al. (US 20210353261 A1, published November 18, 2021) discloses selecting a frame where the diameter of the bladder region is maximized.
Nishiura (US 20210212660 A1, published July 15, 2021) discloses selecting a plurality of frames that satisfy at least one predetermined condition of interest.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.C./Examiner, Art Unit 3798
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