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 12/30/2025 have been fully considered but they are not persuasive.
In light of the amendments, rejections under 35 USC 112 have been withdrawn.
Regarding the amendments to the independent claims, previously-found reference of Tepper has been introduced into the rejections. Tepper teaches highlighting an anatomical structure when it intersects with a trajectory of a needle. Liu teaches highlighting an anatomical structure when it intersects with a highlight region. Although neither reference teaches highlighting the structure when it overlaps both a trajectory and a highlight region. Examiner asserts that one having ordinary skill in the art would understand that a blood vessel region overlapping both the highlight region and insertion object path can be displayed with a different color or brightness than a blood vessel region overlapping one or neither of the highlight region or insertion object path.
Regarding claim 23, newly-found reference of Takimoto has been introduced to teach highlighting blood vessels in a color based on their depths.
Claim Rejections - 35 USC § 112
Rejections under 35 USC 112 have been withdrawn in response to Applicant’s amendments filed 12/30/2025.
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 1, 6, 9, 12, 15, 19, & 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Anand (US 2017/0119352) in view of Tepper (US 2014/0011173) and Liu (US 2020/0320695).
Regarding claim 1, 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 ultrasound image based on the sound ray signal generated by the transmission and reception circuit ([0048]) and display the B-mode ultrasound image on the monitor ([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.
determine a plurality of blood vessel regions (blood vessels of interest, [0056]) of blood vessels including a blood vessel region of the blood vessel in the B-mode ultrasound image corresponding to a cross section of the blood vessel in the B-mode ultrasound image by analyzing the B-mode ultrasound image ([0056]).
However, Anand fails to disclose detecting an insertion object inserted into the subject by analyzing the B-mode ultrasound image, estimating an insertion object path of the insertion object based on a trajectory of the insertion object across a plurality of ultrasound images, and highlighting the blood vessel region in the B-mode ultrasound image displayed on the monitor in a first color or first brightness and the plurality of blood vessel regions other than the blood vessel region in a second color different from the first color or a second brightness different from the first brightness, in response to determining that the plurality of blood vessel regions in the B-mode ultrasound image overlaps the insertion object path of the insertion object on the B-mode ultrasound image.
Tepper teaches detecting an insertion object (needle, [0154]) inserted into the subject by analyzing the B-mode ultrasound image ([0154]), estimating 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 highlighting the blood vessel region in the B-mode ultrasound image displayed on the monitor in a first color or first brightness ([0157]) and the plurality of blood vessel regions other than the blood vessel region in a second color different from the first color or a second brightness different from the first brightness ([0157]), in response to determining that the plurality of blood vessel regions in the B-mode ultrasound image overlaps the insertion object path of the insertion object on the B-mode ultrasound image ([0157]).
Paragraph [0157] teaches that the anatomical feature that intersect the needle trajectory get highlighted. By not highlighting anatomical features that do not intersect the needle trajectory, they are displayed with different colors or brightnesses.
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 to include detecting an insertion object inserted into the subject by analyzing the B-mode ultrasound image, estimating an insertion object path of the insertion object based on a trajectory of the insertion object across a plurality of ultrasound images, and highlighting the blood vessel region in the B-mode ultrasound image displayed on the monitor in a first color or first brightness and the plurality of blood vessel regions other than the blood vessel region in a second color different from the first color or a second brightness different from the first brightness, in response to determining that the plurality of blood vessel regions in the B-mode ultrasound image overlaps the insertion object path of the insertion object on the B-mode ultrasound image, as taught by Tepper. This allows the operator to track the insertion needle, ensuring that the intended target is penetrated properly.
However, Anand in view of Tepper fail to disclose superimposing a highlight region on the B-mode ultrasound image displayed on the monitor, the highlight region having a linear shape extending in a depth direction of a center of the B-mode ultrasound image displayed on the monitor, and highlighting the blood vessel region in the B-mode ultrasound image displayed on the monitor in a first color or first brightness and the plurality of blood vessel regions other than the blood vessel region in a second color different from the first color or a second brightness different from the first brightness, in response to determining that the plurality of blood vessel regions in the B-mode ultrasound image overlaps the highlight region superimposed on the B-mode ultrasound image.
Liu teaches superimposing a highlight region (vertical line 208, [0063]) on the B-mode ultrasound image displayed on the monitor (Figures 2-5 & 10-17), the highlight region having a linear shape extending in a depth direction of a center of the B-mode ultrasound image displayed on the monitor (Figures 2-5 & 10-17), and highlighting (segmentation mask 730D, [0064]) the blood vessel region (anatomical structure 204, [0063]) in the B-mode ultrasound image displayed on the monitor in a first color or first brightness ([0064], Figure 15) and the plurality of blood vessel regions other than the blood vessel region in a second color different from the first color or a second brightness different from the first brightness ([0064], Figure 14), in response to determining that the plurality of blood vessel regions in the B-mode ultrasound image overlaps the highlight region superimposed on the B-mode ultrasound image ([0064], Figures 14-15).
Liu teaches highlighting the anatomical structure if it overlaps the highlight region, and Tepper teaches highlight the anatomical feature if it overlaps the needle trajectory. Examiner asserts that one having ordinary skill in the art would understand that a blood vessel region overlapping both the highlight region and insertion object path can be displayed with a different color or brightness than a blood vessel region overlapping one or neither of the highlight region or insertion object path.
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 Tepper to include superimposing a highlight region on the B-mode ultrasound image displayed on the monitor, the highlight region having a linear shape extending in a depth direction of a center of the B-mode ultrasound image displayed on the monitor, and highlighting the blood vessel region in the B-mode ultrasound image displayed on the monitor in a first color or first brightness and the plurality of blood vessel regions other than the blood vessel region in a second color different from the first color or a second brightness different from the first brightness, in response to determining that the plurality of blood vessel regions in the B-mode ultrasound image overlaps the highlight region superimposed on the B-mode ultrasound image, as taught by Liu. In procedures involving a blood vessel, highlighting the blood vessel region allows the user to easily identify the region of interest.
Regarding claim 6, Anand in view of Tepper and Liu teach the ultrasound diagnostic apparatus according to claim 1, and Anand further teaches the processor is further configured to highlight each of the plurality of blood vessel regions ([0049] & Figure 5), and highlight, among the plurality of blood vessel regions other than the blood vessel region, the blood vessel regions overlapping the highlight region and the blood vessel regions not overlapping the highlight region in different formats (Figure 5 & [0073]).
Figure 5 illustrates that multiple blood vessel regions are highlighted in both light and dark colors. A blood vessel region can be seen up against the right-hand side of the ROI in Figure 5. Because it would be unreasonable to assume that the blood vessel region has a perfectly straight boundary, it can be assumed that part of the blood vessel region lies outside the ROI. Per [0073], anything that lies outside the ROI is depicted in grayscale. Therefore, this teaches that blood vessel region within the ROI in blood vessel region outside the ROI are displayed with different colors.
Regarding claim 9, Anand in view of Tepper and Liu teach the ultrasound diagnostic apparatus according to claim 6, and Anand further teaches the processor is further configured to perform highlighting such that, among the plurality of blood vessel regions other than the blood vessel region, the blood vessel regions overlapping the highlight region and the blood vessel regions not overlapping the highlight region have different colors from each other (Figure 5 & [0073]).
Regarding claim 12, Anand in view of Tepper and Liu teach the ultrasound diagnostic apparatus according to claim 1, and Anand further teaches the processor is further configured to perform highlighting such that the plurality of blood vessel regions have different brightness from each other according to a depth of the blood vessel regions ([0031] & [0041]).
Based on the physics of ultrasound, sound energy dissipates as it travels deeper into tissue. Therefore, echo signals received from more superficial anatomy will have a higher intensity from echo signals received from deeper anatomy. Thus, blood vessel regions will have different intensities (brightness) in the image based on their depth. This is supported in [0031], which teaches that ultrasound echoes are a function of depth, and [0041], which teaches that penetration depth is a limiting factor in ultrasound imaging.
Regarding claim 15, Anand in view of Tepper and Liu teach the ultrasound diagnostic apparatus according to claim 1, and modified Tepper and Liu teach, when a plurality of the blood vessel regions each overlapping the highlight region are determined and the insertion object is detected, perform highlighting such that the blood vessel region overlapping both the highlight region and the insertion object path of the insertion object, and the blood vessel region overlapping only the highlight region have different colors or brightness from each other (See rejection of claim 1).
Regarding claim 19, Anand in view of Tepper and Liu teach the ultrasound diagnostic apparatus according to claim 18, and Anand further teaches the processor is further configured to display only a part of the highlight region, which does not overlap the blood vessel region, on the monitor when the blood vessel region overlaps the highlight region ([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.
Claim 21 is rejected for similar reasons to claim 1. Liu further teaches that the highlight region is displayed on the monitor at a predetermined position (Figures 2-5 & 10-17).
Figures 2-5 & 10-17 depict the vertical line 208 in the same location of the image. It can be assumed that the position of the vertical line is predetermined. Nevertheless, [0051] of Anand teaches that the ROI is located in a default position.
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 Tepper such that the highlight region is displayed on the monitor at a predetermined position, as taught by Liu. This maintains consistency when determining that the blood vessel region overlaps the highlight region.
Claim 22 is rejected for similar reasons to claim 21. Liu further teaches that the at least one highlight region is smaller than the blood vessel region in a lateral direction perpendicular to the depth direction (Figures 14-15).
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 Tepper such that the at least one highlight region is smaller than the blood vessel region in a lateral direction perpendicular to the depth direction, as taught by Liu. This is the expected result of using a linear highlight region.
Claims 2-3, 7-8, 10-11, & 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Tepper and Liu, as applied to claim 1, above, in further view of Chen (US 2018/0014810).
Regarding claim 2, Anand in view of Tepper and Liu teach the ultrasound diagnostic apparatus according to claim 1, and Anand further teaches that the blood vessel region overlaps the highlight region ([0049]).
However, Anand in view of Tepper and 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, Tepper, 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 3, Anand in view of Tepper, Liu, and Chen teach the ultrasound diagnostic apparatus according to claim 2, 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, Tepper, 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 7 is rejected for similar reasons to claim 6.
Claim 8 is rejected for similar reasons to claim 6.
Claim 10 is rejected for similar reasons to claim 9.
Claim 11 is rejected for similar reasons to claim 9.
Claim 13 is rejected for similar reasons to claim 12.
Claim 14 is rejected for similar reasons to claim 12.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Tepper, Liu, and Chen, as applied to claims 2-3, above, in further view of Day (US 2018/0174355) and Nogata (US 2010/0121192).
Regarding claim 4, Anand in view of Tepper, Liu, and Chen teach the ultrasound diagnostic apparatus according to claim 2, and Anand further teaches that the blood vessel region overlaps the highlight region ([0049]).
Chen further teaches that the processor is further configured to highlight the plurality of blood vessel regions other than the blood vessel region on the monitor ([0059] & Figures 4(b) & (c)), and display the blood vessel information acquired in association with the blood vessel region on the monitor ([0068] & Figure 5).
However, Anand in view of Tepper, Liu, and Chen fail to disclose highlighting the plurality of blood vessel regions such that the blood vessel regions other than the blood vessel region have the same color as each other.
Day teaches highlighting the plurality of blood vessel regions such that the blood vessel regions other than the blood vessel region have the same color as each other ([0037]).
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, Tepper, Liu, and Chen to include highlighting the plurality of blood vessel regions such that the blood vessel regions other than the blood vessel region have the same color as each other, as taught by Day. Doing so allows the operator to quickly understand the locations of the blood vessels by looking at the display.
However, Anand in view of Tepper, Liu, Chen, and Day fail to disclose displaying the blood vessel information among the plurality of blood vessel regions.
Nogata teaches displaying the blood vessel information among the plurality of blood vessel regions ([0065] & Figures 8-9).
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, Tepper, Liu, Chen, and Day to include displaying a blood vessel information among the plurality of blood vessel regions, as taught by Nogata. By displaying the diameters of a plurality of blood vessels, the operator can make an informed decision as to which vessel should be selected for a given procedure.
Claim 5 is rejected for similar reasons to claim 4.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Tepper, Liu, and Chen, as applied to claim 2, above, in further view of Toji (US 2015/0164482).
Regarding claim 16, Anand in view of Tepper, Liu, and Chen teach the ultrasound diagnostic apparatus according to claim 2, and Anand further teaches an ultrasound probe (transducer probe 26, [0005]) including the transducer array ([0032]).
However, Anand in view of Tepper, 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 that the ultrasound probe is stationary is determined.
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 that the ultrasound probe is stationary is determined ([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, Tepper, 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 that the ultrasound probe is stationary is determined, 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 17 is rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Tepper and Liu, as applied to claim 1, above, in further view of Bedi (US 2019/0239848).
Regarding claim 17, Anand in view of Tepper and Liu teach the ultrasound diagnostic apparatus according to claim 1.
However, Anand in view of Tepper and Liu fail to disclose that the processor is further configured to, when the blood vessel region overlaps the highlight region, set an imaging condition such that the 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 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 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, Tepper, and Liu such that the processor is further configured to, when the blood vessel region overlaps the highlight region, set an imaging conditions such that the 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 23 is rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Tepper and Liu, as applied to claim 1, above, in further view of Takimoto (US 2009/0137907).
Claim 23 is rejected for similar reasons to claim 1 & 12. Liu further teaches highlighting a whole of the blood vessel region overlapping the highlight region in the B-mode ultrasound image displayed on the monitor (Figures 14-15).
Figure 14 shows anatomical structure 204 at a slight distance away from vertical line 208. Figure 15 shows anatomical structure 204 contacting vertical line 208. When any part of the structure contacts the line, segmentation mask 730D is applied to its entirety.
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 Tepper to include highlighting a whole of the blood vessel region overlapping the highlight region in the B-mode ultrasound image displayed on the monitor, as taught by Liu. Because the highlight region is a line, this allows the intersecting blood vessel to be more easily identifiable, as opposed to highlight only the part of the blood vessel that overlaps the highlight region.
However, Anand in view of Tepper and Liu fail to disclose highlighting such that the plurality of blood vessel regions have different colors from each other according to a depth of the blood vessel regions.
Takimoto teaches highlighting such that the plurality of blood vessel regions (blood vessel regions Vr1 to Vr4, [0083]) have different colors from each other according to a depth of the blood vessel regions ([0083]).
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, Tepper, and Liu to include highlighting such that the plurality of blood vessel regions have different colors from each other according to a depth of the blood vessel regions, as taught by Takimoto. The relative depths of blood vessels is relevant information to a user for procedures involving venipuncture.
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 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 M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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