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 .
Response to Arguments
Applicant's arguments filed 06/09/2026 have been fully considered but they are not persuasive.
Applicant argues, see Applicant’s arguments pages 6-8, that Liu does not teach that a blood vessel region overlapping the highlight region gets highlighted while a blood vessel region not overlapping the highlight region does not get highlighted. In the updated rejection of claim 23, Liu is no longer relied upon to teach this limitation—instead, Anand has been cited to read on this limitation. Anand teaches in [0073] that only a blood vessel within the ROI gets highlighted while the rest of the image is depicted in grayscale. Thus, in the event that exactly one blood vessel region overlaps the highlight region, that blood vessel will be highlighted while all other blood vessels not overlapping the highlight region will not be highlighted. Nevertheless, Examiner asserts that this limitation is still taught by Liu. Figure 14 of Liu illustrates a scenario in which anatomical structure 204 does not overlap vertical line 208; no highlighting is applied. However, in Figure 15, when anatomical structure 204 does overlap vertical line 208, segmentation mask 730D is applied to the anatomical structure in its entirety. Likewise, in the claimed scenario in which one blood vessel region overlaps the highlight region, Liu teaches that only that blood vessel, and no other blood vessels, will get highlighted.
Claim Objections
Claims 27-28 are objected to because of the following informalities:
In claim 27, “wherein the processor is further configured to, when” should read –wherein the processor is further configured to: when--.
In claim 28, “wherein the processor is further configured to detect” should read –wherein the processor is further configured to: detect--.
Appropriate correction is required.
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 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.
Claims 23, 29-30, & 32 are rejected under 35 U.S.C. 103 as being unpatentable over Anand (US 2017/0119352) in view of Liu (US 2020/0320695).
Regarding claim 23, Anand teaches an ultrasound diagnostic apparatus configured to display a B-mode ultrasound image that includes a blood vessel of a subject, the diagnostic apparatus comprising:
a monitor (display/monitor 14, [0005]);
a transducer array (linear array of transducers, [0032]);
a transmission and reception circuit that causes the transducer array to transmit an ultrasound beam (pulsed ultrasonic energy, [0004]) toward the subject ([0004]), and processes a reception signal (electronic feedback signal, [0005]) output from the transducer array that has received an ultrasound echo (echoed sound energy, [0004]) from the subject to generate a sound ray signal (signal content, [0004]);
a processor (central processing unit CPU 20, [0005]) configured to:
generate the B-mode ultrasound image based on the sound ray signal generated by the transmission and reception circuit ([0048]); and
Paragraph [0043] teaches an instance in which both color flow Doppler and pulse wave Doppler are used in an exam, where pulse wave Doppler is used to highlight blood flow. Paragraph [0044] teaches an instance where either color flow Doppler or pulse wave Doppler may be used. Thus, the highlighting step does not use color Doppler, and pulse wave Doppler is interchangeable with any further recitation of color flow Doppler.
extract a plurality of blood vessel regions (blood vessels of interest, [0056]) corresponding to cross sections of blood vessels by analyzing the B-mode ultrasound image ([0056]);
display a highlight region (region of interest, [0029], Figure 5);
determine, for each of the plurality of blood vessel regions, whether the blood vessel region overlaps the highlight region ([0073]); and
Paragraph [0073] teaches that a blood vessel within the ROI gets highlighted, while the rest of the image is depicted in grayscale. Thus, there must be a determination of whether a blood vessel is within the ROI before highlighting the blood vessel.
when one blood vessel region among the plurality of blood vessel regions is determined to overlap the highlight region and one or more other blood vessel regions among the plurality of blood vessel regions are determined not to overlap the highlight region, highlight only the one blood vessel region determined to overlap the highlight region in the B-mode ultrasound image displayed on the monitor, without highlighting the one or more other blood vessel regions determined not to overlap the highlight region ([0073]).
However, Anand fails to disclose that the highlight region extends in a depth direction of a center of the B-mode ultrasound image.
Liu teaches that the highlight region (vertical line 208, [0063]) extends in a depth direction of a center of the B-mode ultrasound image (Figures 2-5 & 10-17).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Anand such that the highlight region extends in a depth direction of a center of the B-mode ultrasound image, as taught by Liu. A highlight region of this configuration informs the operator that the probe is sufficiently centered when imaging a target blood vessel.
Regarding claim 29, Anand in view of Liu teach the ultrasound diagnostic apparatus according to claim 23, and Anand further teaches that the processor is further configured to, when the one blood vessel region determined to overlap the highlight region overlaps the highlight region displayed on the monitor, display only a part of the highlight region, which does not overlap the one blood vessel region, on the monitor ([0049] & Figure 5).
In the instant application, this is represented in Figure 8, where the blood vessel region B2 is overlaid on the highlight region R. In the same manner can Anand be applied to this claim. The highlights of the blood vessel regions are overlaid on the ROI, meaning there exist “holes” in the ROI corresponding to the locations of the blood vessel regions. Therefore, only the parts of the ROI that do not contain blood vessel regions are visible in the image. Additionally, it is well-known in the art of visual displays to display objects as layers. Defining the blood vessel to be the top layer allows it to always be displayed unobstructed when overlapping the highlight region.
Regarding claim 30, Anand in view of Liu teach the ultrasound diagnostic apparatus according to claim 23, and Anand further teaches an ultrasound probe (transducer probe 26, [0005]) including the transducer array ([0032]).
Liu further teaches that the processor is further configured to set a placement position of the highlight region on the monitor according to a type of the ultrasound probe ([0045]).
Paragraph [0045] teaches “The vertical line 208…is located halfway along the horizontal dimension of the ultrasound image 202”. Because various ultrasound probes will produce ultrasound images of various sizes and dimensions, the system of Liu must first understand what the horizontal dimension of the ultrasound image is. Thus, the highlight region is placed depending on the type of the ultrasound probe.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Anand such that the processor is further configured to set a placement position of the highlight region on the monitor according to a type of the ultrasound probe, as taught by Liu. In the case of Liu, the system understanding the type of ultrasound probe ensures that the highlight region is properly placed in the center of the image.
Regarding claim 32, Anand in view of Liu teach the ultrasound diagnostic apparatus according to claim 23, and Anand further teaches an ultrasound probe (transducer probe 26, [0005]) including the transducer array ([0032]), wherein the processor is included in an ultrasound diagnostic apparatus main body (portable ultrasound systems 10, [0005], Figures 1A-B), and wherein the monitor and the ultrasound probe are connected to the ultrasound diagnostic main body via a network ([0005] & Figure 2).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Liu, as applied to claim 23, above, in further view of Chen (US 2018/0014810).
Regarding claim 24, Anand in view of Liu teach the ultrasound diagnostic apparatus according to claim 23, and Anand further teaches that the blood vessel region overlaps the highlight region ([0049]).
However, Anand in view of Liu fail to disclose that the processor is further configured to acquire blood vessel information including a diameter of the blood vessel region by analyzing the B-mode ultrasound image, and display the blood vessel information on the monitor.
Chen teaches that the processor is further configured to acquire blood vessel information including a diameter of the blood vessel region by analyzing the B-mode ultrasound image ([0068]), and display the blood vessel information on the monitor ([0068] & Figure 5).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus taught by Anand and Liu such that the processor is further configured to acquire blood vessel information including a diameter of the blood vessel region by analyzing the B-mode ultrasound image, and display the blood vessel information on the monitor, as taught by Chen. By informing the operator of the size of various vessels, the operator can make several clinical decisions, such as determining whether a vessel is large enough from which to draw blood.
Regarding claim 25, Anand in view of Liu and Chen teach the ultrasound diagnostic apparatus according to claim 24, and Chen further teaches that the processor is further configured to acquire information representing whether the blood vessel region belongs to an artery or vein, as the blood vessel information ([0070] & Figure 5).
Paragraph [0070] teaches that the system can identify the inferior vena cava; Figure 5 illustrates that this determination is displayed on the image. Identifying the inferior vena cava comprises determining that the blood vessel region belongs to a vein.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus taught by Anand and Liu such that the processor is further configured to acquire information representing whether the blood vessel region belongs to an artery or vein, as the blood vessel information, as taught by Chen. Because blood is drawn from veins, determining whether a blood vessel region belongs to an artery or vein can further assist the operator in selecting an appropriate vessel from which to draw blood.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Liu and Chen, as applied to claim 24, above, in further view of Toji (US 2015/0164482).
Regarding claim 26, Anand in view of Liu and Chen teach the ultrasound diagnostic apparatus according to claim 24, and Anand further teaches an ultrasound probe (transducer probe 26, [0005]) including the transducer array ([0032]).
However, Anand in view of Liu and Chen fail to disclose that the processor is further configured to detect a motion of the ultrasound probe, determine whether the ultrasound probe is stationary based on the detected motion of the ultrasound probe, and display the blood vessel information on the monitor only when ultrasound probe is determined to be stationary.
Toji teaches that the processor is further configured to detect a motion of the ultrasound probe ([0103]), determine whether the ultrasound probe is stationary based on the detected motion of the ultrasound probe ([0103]), and display the image on the monitor only when ultrasound probe is determined to be stationary ([0103]).
Paragraph [0103] teaches that an image is only recorded when it is determined that the probe is stationary. Therefore, the only images available to be displayed would be those taken while the probe was stationary. Additionally, Chen teaches that the blood vessel information is overlaid on the image. By not recording an image when the probe is not stationary, as taught by Toji, the blood vessel information will consequently not be displayed when the probe is not stationary.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus taught by Anand, Liu, and Chen such that the processor is further configured to detect a motion of the ultrasound probe, determine whether the ultrasound probe is stationary based on the detected motion of the ultrasound probe, and display the blood vessel information on the monitor only when ultrasound probe is determined to be stationary, as taught by Toji. Per [0103] of Toji, motion blurs and artifacts may be present in images taken when the probe is not stationary. Ensuring that the probe is stationary while displaying the image will result in higher quality images.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Liu, as applied to claim 23, above, in further view of Bedi (US 2019/0239848).
Regarding claim 27, Anand in view of Liu teach the ultrasound diagnostic apparatus according to claim 23.
However, Anand in view of Liu fail to disclose that the processor is further configured to: when the one blood vessel region overlaps the highlight region, set an imaging condition such that the one blood vessel region is clearly depicted in the B-mode ultrasound image; and control a generation of the sound ray signal by the transmission and reception circuit and the generation of the B-mode ultrasound image based on the set imaging condition.
Bedi teaches that the processor is further configured to:
when the one blood vessel region overlaps the highlight region, set an imaging condition (frequency, bandwidth, focus, gain, depth, steering angle, and dynamic range, [0053]) such that the one blood vessel region is clearly depicted in the B-mode ultrasound image; and
control the generation of the sound ray signal by the transmission and reception circuit and the generation of the B-mode ultrasound image based on the set imaging condition ([0053]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus taught by Anand and Liu such that the processor is further configured to: when the one blood vessel region overlaps the highlight region, set an imaging conditions such that the one blood vessel region is clearly depicted in the B-mode ultrasound image; and control the generation of the sound ray signal by the transmission and reception circuit and the generation of the B-mode ultrasound image based on the set imaging condition, as taught by Bedi. This ensures that the blood vessels are displayed in their highest possible quality.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Liu, as applied to claim 23, above, in further view of Tepper (US 2014/0011173).
Regarding claim 28, Anand in view of Liu teach the ultrasound diagnostic apparatus according to claim 23.
However, Anand in view of Liu fail to disclose that the processor is further configured to: detect an insertion object inserted into the subject by analyzing the B-mode ultrasound image; estimate an insertion object path of the insertion object based on a trajectory of the insertion object across a plurality of ultrasound images; and highlight the one blood vessel region determined to overlap the highlight region as a blood vessel region into which the insertion object is to be inserted, when the one blood vessel region is determined to overlap the insertion object path.
Tepper teaches that the processor is further configured to:
detect an insertion object (needle, [0154]) inserted into the subject by analyzing the B-mode ultrasound image ([0154]);
estimate an insertion object path (path of the needle, [0154]) of the insertion object based on a trajectory of the insertion object (current trajectory, [0154]) across a plurality of ultrasound images ([0154]); and
highlight the one blood vessel region determined to overlap the highlight region as a blood vessel region into which the insertion object is to be inserted, when the one blood vessel region is determined to overlap the insertion object path ([0157]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Anand and Liu such that the processor is further configured to: detect an insertion object inserted into the subject by analyzing the B-mode ultrasound image; estimate an insertion object path of the insertion object based on a trajectory of the insertion object across a plurality of ultrasound images; and highlight the one blood vessel region determined to overlap the highlight region as a blood vessel region into which the insertion object is to be inserted, when the one blood vessel region is determined to overlap the insertion object path, as taught by Tepper. This allows the operator to track the insertion needle, ensuring that the intended target is penetrated properly.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Liu, as applied to claim 23, above, in further view of Hirayama (US 2017/0281127).
Regarding claim 31, Anand in view of Liu teach the ultrasound diagnostic apparatus according to claim 23, and Anand further teaches an ultrasound probe (transducer probe 26, [0005]) including the transducer array ([0032]).
However, Anand in view of Liu fail to teach that the ultrasound probe includes a housing that holds the transducer array, wherein a guide marker is provided on an outer peripheral portion of the housing, and wherein the processor is further configured to set a placement position of the highlight region on the monitor in association with a placement position of the guide marker in an arrangement direction of a plurality of transducers included in the transducer array.
Hirayama teaches that the ultrasound probe (ultrasound probe 101, [0028]) includes a housing (casing 1, [0034]) that holds the transducer array (piezoelectric element part 5, [0034]), wherein a guide marker (puncture mark 10, [0037], Figures 12-13) is provided on an outer peripheral portion of the housing (Figures 12-13).
Combined Liu and Hirayama teach that the processor is further configured to set a placement position of the highlight region on the monitor (Liu, [0045]) in association with a placement position of the guide marker in an arrangement direction of a plurality of transducers included in the transducer array (Hirayama, [0037]).
Liu teaches that the highlight region is placed in the center of the ultrasound image on the monitor; Hirayama teaches that the guide marker is placed in the center of the ultrasound probe housing. Thus, Examiner asserts that an ultrasound probe combining the teachings of Liu and Hirayama would indicate the position of the highlight region with the guide marker on the housing.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Anand such that the ultrasound probe includes a housing that holds the transducer array, wherein a guide marker is provided on an outer peripheral portion of the housing, and wherein the processor is further configured to set a placement position of the highlight region on the monitor in association with a placement position of the guide marker in an arrangement direction of a plurality of transducers included in the transducer array, as taught by combined Liu and Hirayama. This allows the operator to understand where the highlight region will appear in the image in relation to the probe during the imaging procedure, allowing them to center the probe over the target region without having to reference the monitor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
