DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 05/19/2026 have been fully considered but they are not persuasive.
Rejections under 35 USC 101 have been withdrawn.
Regarding the amendments to claims 1, 16, & 17, the combination of Pelissier and Caluser has been maintained. Pelissier teaches that, for each organ to be imaged in the protocol, the user is prompted to acquire the image. Although the form that this prompt takes is not disclosed, Caluser teaches providing a guide marker to the user to guide them to acquiring each peripheral anatomical site. Examiner asserts that one having ordinary skill in the art would understand that a guide marker can be displayed to guide the user to acquiring each peripheral anatomical site in the protocol.
Claim Objections
Claim 14 is objected to because of the following informalities: “the plurality of peripheral anatomical site include” should read –the plurality of peripheral anatomical sites includes--.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
Rejections under 35 USC 101 have been withdrawn in response to Applicant’s amendments filed 05/19/2026.
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.
Claims 1-6, 9, & 15-16 rejected under 35 U.S.C. 103 as being unpatentable over Pelissier (US 2010/0049050) in view of Caluser (US 2009/0124906).
Regarding claim 1, Pelissier teaches an ultrasound diagnostic apparatus comprising:
an ultrasound probe (ultrasound transducer 14, [0038]);
a display (display 20, [0022]);
a memory (data store 31, [0036]) configured to store (block 43, [0068]) a detection order (sequence of ultrasound images, [0048]) in which the plurality of peripheral anatomical sites are to be detected ([0048]); and
a processor (protocol controller 30, [0023] & [0025]).
However, Pelissier fails to disclose: a memory configured to store, for a target anatomical site, a plurality of peripheral anatomical sites effective to detect the target anatomical site; and a processor configured to: cause the display to display a first guide marker for guiding a user to operate the ultrasound so as to detect a current peripheral anatomical site among the plurality of peripheral anatomical sites in accordance with the detection order; while the first guide marker is displayed, repeatedly transmit an ultrasound beam from the ultrasound probe to a subject and acquire ultrasound images; perform image analysis on each of the acquired ultrasound images to determine whether the current peripheral anatomical site is recognized in the acquired ultrasound image; in response to recognizing the current peripheral anatomical site in the acquired ultrasound image, update the displayed first guide marker to a guide marker for detecting a next peripheral anatomical site in accordance with the detection order; when a last peripheral anatomical site among the plurality of peripheral anatomical sites in the detection order is recognized in the acquired ultrasound image, cause the display to display a target guide marker for guiding the user to control at least one of a movement direction, an orientation, or an inclination so as to detect the target anatomical site based on a relative positional relationship between the recognized last peripheral anatomical site and the target anatomical site; and perform image analysis on an ultrasound image acquired while the target guide marker is displayed to detect the target anatomical site.
Caluser teaches:
a memory (memory, [0049]) configured to store, for a target anatomical site (target anatomical site, [0049]), a plurality of peripheral anatomical sites (anatomical reference points, [0049]) effective to detect the target anatomical site ([0020]-[0021]); and
Paragraphs [0020]-[0021] teach that different anatomical reference points (nipple, umbilicus, thyroid cartilage) can be used to detect different targets (breast, liver, neck).
a processor (software application, [0019]) configured to:
cause the display (display 24, [0036]) to display a first guide marker (continuous ultrasound probe position and orientation display, [0019]) for guiding a user to operate the ultrasound probe so as to detect a current peripheral anatomical site among the plurality of peripheral anatomical sites in accordance with the detection order ([0022]-[0023] & Claim 24);
while the first guide marker is displayed, repeatedly transmit an ultrasound beam from the ultrasound probe to a subject and acquire ultrasound images ([0020]-[0021]);
perform image analysis on each of the acquired ultrasound images to determine whether the current peripheral anatomical site is recognized in the acquired ultrasound image ([0020]-[0021] & [0049], Claim 24);
when a last peripheral anatomical site among the plurality of peripheral anatomical sites in the detection order is recognized in the acquired ultrasound image, cause the display to display a target guide marker for guiding the user to control at least one of a movement direction (transducer position, [0022]), an orientation, or an inclination (orientation help, [0020]) so as to detect the target anatomical site based on a relative positional relationship between the recognized last peripheral anatomical site and the target anatomical site ([0049] & Claim 24); and
Paragraph [0049] & Claim 24 teach that the determination of the target site is made in relation to the anatomical reference points. Because of this, the system must be able to determine when all of the anatomical reference points have been captured in order to determine the position of the target site. Determining that all the anatomical reference points have been captured comprises determining that a last anatomical reference point has been captured. Thus, regardless of the detection order, the system is able to determine which reference point is the last reference point, as the condition of capturing “all” reference points is only satisfied once the last reference point is captured.
Additionally, [0020] teaches that any anatomical reference can be selected for guidance. Thus, the guidance to a peripheral site and the guidance to the target site would function identically.
perform image analysis on an ultrasound image acquired while the target guide marker is displayed to detect the target anatomical site ([0020]-[0021] & [0049], Claim 24).
Regarding the limitation “in response to recognizing the current peripheral anatomical site in the acquired ultrasound image, update the displayed first guide marker to a guide marker for detecting a next peripheral anatomical site in accordance with the detection order”, Examiner asserts that combined Pelissier and Caluser teach the full scope of the limitation. Pelissier teaches sequentially acquiring peripheral anatomical sites ([0048]), and Caluser teaches guidinga user to acquire the peripheral anatomical sites ([0022]-[0023]). Examiner asserts that one having ordinary skill in the art would understand that a new guidance marker can be provided for each successive peripheral anatomical site.
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 Pelissier to include: a memory configured to store, for a target anatomical site, a plurality of peripheral anatomical sites effective to detect the target anatomical site; and a processor configured to: cause the display to display a first guide marker for guiding a user to operate the ultrasound so as to detect a current peripheral anatomical site among the plurality of peripheral anatomical sites in accordance with the detection order; while the first guide marker is displayed, repeatedly transmit an ultrasound beam from the ultrasound probe to a subject and acquire ultrasound images; perform image analysis on each of the acquired ultrasound images to determine whether the current peripheral anatomical site is recognized in the acquired ultrasound image; in response to recognizing the current peripheral anatomical site in the acquired ultrasound image, update the displayed first guide marker to a guide marker for detecting a next peripheral anatomical site in accordance with the detection order; when a last peripheral anatomical site among the plurality of peripheral anatomical sites in the detection order is recognized in the acquired ultrasound image, cause the display to display a target guide marker for guiding the user to control at least one of a movement direction, an orientation, or an inclination so as to detect the target anatomical site based on a relative positional relationship between the recognized last peripheral anatomical site and the target anatomical site; and perform image analysis on an ultrasound image acquired while the target guide marker is displayed to detect the target anatomical site, as taught by Caluser. Detecting a peripheral anatomical site and providing guidance to detect a target anatomical site can help verify that the ultrasound probe is obtaining image data at the correct location and can assist the user in doing so. This can result in a more effective procedure with higher quality ultrasound images.
Regarding claim 2, Pelissier in view of Caluser teach the ultrasound diagnostic apparatus according to claim 1, and Pelissier further teaches that the processor is further configured to cause the display to sequentially display guidance (prompt, [0048]) for detecting the plurality of peripheral anatomical sites in accordance with the detection order ([0048]) based on the relative positional relationship between the plurality of peripheral anatomical sites ([0101] & Figures 6A-D), and to update a displayed guidance in response to recognition, by the image analysis, of a peripheral anatomical site corresponding to the displayed guidance ([0048]).
Because the prompts are displayed in relation to a sequence of ultrasound images, it is assumed that a new prompt will be displayed for the user to capture each image.
Caluser further teaches that the guidance is a guide marker ([0019]).
Regarding claims 3-6, Pelissier in view of Caluser teach the ultrasound diagnostic apparatus according to claim 2, and Pelissier further teaches that the processor is further configured to guide the user to operate the ultrasound probe so as to change the detection order and detect the plurality of peripheral anatomical sites in the changed detection order ([0069]) based on the recognition result obtained by the image analysis ([0116]), the correction information input by the user (altered parameter values, [0079] & [0088]; measurement control, [0109]), and the relative positional relationship between the plurality of peripheral anatomical sites ([0101] & Figures A-D).
According to [0069], the user can be prompted to choose between two or more protocols. Because these protocols are distinct, they must either comprise different steps or a different arrangement of steps. Either way, the selection of protocols provides a way to change the detection order.
Modified Pelissier teaches that the plurality of sites comprises a plurality of peripheral anatomical sites (Caluser, [0021]).
Regarding claim 9, Pelissier in view of Caluser teach the ultrasound diagnostic apparatus according to claim 1, and Pelissier further teaches a monitor (display 20, [0048]), wherein the display is the monitor ([0048]).
Caluser further teaches that the processor is further configured to display on the monitor the first guide marker and the target guide marker provided to the user to operate the ultrasound probe ([0019]-[0020]).
As discussed in the rejection of claim 1, since any anatomical reference can be selected, the first guide marker and target guide marker would function identically.
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 Pelissier such that the processor is further configured to display on the monitor the first guide marker and the target guide marker provided to the user to operate the ultrasound probe, as taught by Caluser. This allows the user to place the probe in the exact correct position and orientation, increasing the quality of the image and effectiveness of the scan.
Regarding claim 15, Pelissier in view of Caluser teach the ultrasound diagnostic apparatus according to claim 1, and Pelissier further teaches that the processor is connected to the ultrasound probe via a network (ethernet or other network connection 62A, [0073]-[0074]).
Claim 16 is rejected for similar reasons to claim 1.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, as applied to claim 2, above, in further view of Rothberg (US 2017/0360403).
Regarding claim 7, Pelissier in view of Caluser teach the ultrasound diagnostic apparatus according to claim 2.
However, Pelissier in view of Caluser fail to disclose that the processor is further configured to recognize an imaged anatomical site of the subject based on subject information concerning a state of the subject, which is input by the user.
Rothberg teaches that the processor is further configured to recognize an imaged anatomical site of the subject based on subject information (medical information about the subject, [0087]) concerning a state of the subject ([0087]), which is input by the user ([0250]).
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 Pelissier and Caluser such that the processor is further configured to recognize an imaged anatomical site of the subject based on subject information concerning a state of the subject, which is input by the user, as taught by Rothberg. Because the relative positions or sizes of various anatomical structures may vary based on a patient’s age, height, weight, sex, etc., inputting this information about the patient can increase the accuracy of locating these anatomical structures.
Claim 8 is rejected for similar reasons to claim 7.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, as applied to claim 9, above, in further view of Chono (US 2015/0320399).
Regarding claim 10, Pelissier in view of Caluser teach the ultrasound diagnostic apparatus according to claim 9.
However, Pelissier in view of Caluser fail to disclose that the processor is further configured to generate a contour of a peripheral anatomical site recognized by the image analysis, display on the monitor the ultrasound image, and display on the monitor the contour of the recognized peripheral anatomical site superimposed on the ultrasound image.
Chono teaches that the processor (measurement position computation unit 110, [0081]) is further configured to generate a contour (contour line 352, [0081]) of a peripheral anatomical site (cardiac wall, [0081]) recognized by the image analysis, display on the monitor (display unit 132, [0083]) the ultrasound image (image 302, [0083]), and display on the monitor the contour of the recognized peripheral anatomical site superimposed on the ultrasound image ([0081] & [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 taught by Pelissier and Caluser such that the processor is further configured to generate a contour of a peripheral anatomical site recognized by the image analysis, display on the monitor the ultrasound image, and display on the monitor the contour of the recognized peripheral anatomical site superimposed on the ultrasound image, as taught by Chono. Generating a contour of the peripheral anatomical site allows the user to quickly and effectively understand positional information of an image, allowing for diagnostic decisions to be made with more confidence and accuracy.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, as applied to claim 1, above, in further view of Ishikawa (US 2011/0246129).
Regarding claim 11, Pelissier in view of Caluser teach the ultrasound diagnostic apparatus according to claim 1.
However, Pelissier in view of Caluser fail to disclose a speaker configured to generate audio, wherein the processor is further configured to guide the user to operate the ultrasound probe by generating audio from the speaker.
Ishikawa teaches a speaker (sound presentation section, [0126]) configured to generate audio ([0126]), wherein the processor is further configured to guide the user to operate the ultrasound probe by generating audio from the speaker ([0126]).
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 Pelissier and Caluser to include a speaker configured to generate audio, wherein the processor is further configured to guide the user to operate the ultrasound probe by generating audio from the speaker, as taught by Ishikawa. This allows the user to follow guidance from the processor without having to look at a display screen.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, as applied to claim 1, above, in further view of Parthasarathy (US 2016/0143621).
Regarding claim 12, Pelissier in view of Caluser teach the ultrasound diagnostic apparatus according to claim 1, and Caluser further teaches identifying the target anatomical site ([0021]) and the plurality of peripheral anatomical sites ([0049] & Claim 24).
Combined Pelissier and Caluser teach updating the displayed guide marker so as to sequentially guide the user to detect the plurality of peripheral anatomical sites (See rejection of claim 2).
However, Pelissier in view of Caluser fail to disclose that the target anatomical site is a common bile duct, and the plurality of peripheral anatomical sites includes a short-axis view of a portal vein, a long-axis view of a gallbladder, and a long-axis view of the portal vein, and wherein the processor is configured to detect the short-axis view of the portal vein, the long-axis view of the gallbladder, the long-axis view of the portal vein, and then the common bile duct by image analysis of B-mode ultrasound images without switching to Doppler measurement.
Parthasarathy teaches imaging a common bile duct, a portal vein, and a gallbladder ([0067]), and wherein the processor is configured to detect the portal vein, gallbladder, and common bile duct by image analysis of B-mode ultrasound images without switching to Doppler measurement ([0067]).
Regarding the views of each anatomical site, the claimed views are well-known in the art for each claimed anatomical site. Examiner asserts that one having ordinary skill in the art would understand that the processor can guide the user to obtaining a standard view. Additionally, Pelissier teaches that the order of the acquisition can be changed in any order.
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 ability to identify the target anatomical site and the plurality of peripheral anatomical sites taught by Caluser such that a common bile duct is identified as the target anatomical site and a portal vein and a gallbladder are identified as the peripheral anatomical sites, and wherein the processor is configured to detect the portal vein, gallbladder, and common bile duct by image analysis of B-mode ultrasound images without switching to Doppler measurement, as taught by Parthasarathy. Locating and imaging the common bile duct is a necessary step when attempting to diagnose gallstones or a blockage of the bile duct.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, as applied to claim 1, above, in further view of Zilberstein (US 2005/0266074).
Regarding claim 13, Pelissier in view of Caluser teach the ultrasound diagnostic apparatus according to claim 1, and Caluser further teaches identifying the target anatomical site ([0021]) and the plurality of peripheral anatomical sites ([0049] & Claim 24).
Combined Pelissier and Caluser teach updating the displayed guide marker so as to sequentially guide the user to detect the plurality of peripheral anatomical sites (See rejection of claim 2).
However, Pelissier in view of Caluser fail to disclose that the target anatomical site is an appendix, and the plurality of peripheral anatomical sites include a short-axis view of an ascending colon, a long-axis view of a cecum, and a long-axis view of an ileum, and wherein the processor is configured to detect the short-axis view of the ascending colon, the long-axis view of the cecum, the long-axis view of the ileum, and then a long-axis view of the appendix.
Zilberstein teaches imaging an appendix, an ascending colon, a cecum, and an ileum ([0101]-[0102]), and wherein the processor is configured to detect the ascending colon, cecum, ileum, and appendix ([0101]-[0102]).
Regarding the views of each anatomical site, the claimed views are well-known in the art for each claimed anatomical site. Examiner asserts that one having ordinary skill in the art would understand that the processor can guide the user to obtaining a standard view. Additionally, Pelissier teaches that the order of the acquisition can be changed in any order.
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 ability to identify the target anatomical site and the plurality of peripheral anatomical sites taught by Caluser such that an appendix is identified as the target anatomical site and an ascending colon, a cecum, and an ileum are identified as the peripheral anatomical sites, and wherein the processor is configured to detect the ascending colon, cecum, ileum, and appendix, as taught by Zilberstein. Locating and imaging the appendix is a necessary step when attempting to diagnose appendicitis.
Claims 14 & 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, as applied to claim 1, above, in further view of Narouze (US 2010/0204568).
Regarding claim 14, Pelissier in view of Caluser teach the ultrasound diagnostic apparatus according to claim 1, and Caluser further teaches identifying the target anatomical site ([0021]) and the plurality of peripheral anatomical sites ([0049] & Claim 24).
Combined Pelissier and Caluser teach updating the displayed guide marker so as to sequentially guide the user to detect the plurality of peripheral anatomical sites (See rejection of claim 2).
However, Pelissier in view of Caluser fail to disclose that the target anatomical site includes at least one of a nerve root of a fifth cervical vertebra or a nerve root of a seventh cervical vertebra, and the plurality of peripheral anatomical sites include a long-axis view of a nerve root of a sixth cervical vertebra, and wherein, in response to recognizing the long-axis view of the nerve root of the sixth cervical vertebra, the processor detects the nerve root of the fifth cervical vertebra toward a head side of the subject or the nerve root of the seventh cervical vertebra toward a torso side of the subject.
Narouze teaches imaging a nerve root of a fifth cervical vertebra ([0042]) and a nerve root of a seventh cervical vertebra ([0042] & [0045]) and a long-axis view ([0014] & Figure 5B) nerve root of a sixth cervical vertebra ([0042]), and wherein, in response to recognizing the nerve root of the sixth cervical vertebra ([0042]), the processor detects the nerve root of the seventh cervical vertebra toward a torso side of the subject ([0042]).
Regarding the views of each anatomical site, the claimed views are well-known in the art for each claimed anatomical site. Examiner asserts that one having ordinary skill in the art would understand that the processor can guide the user to obtaining a standard view. Additionally, Pelissier teaches that the order of the acquisition can be changed in any order.
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 ability to identify the target anatomical site and the plurality of peripheral anatomical sites taught by Caluser such that a nerve root of a fifth cervical vertebra and a nerve root of a seventh cervical vertebra are identified as the target anatomical site and a nerve root of a sixth cervical vertebra is identified as the peripheral anatomical sites, and wherein, in response to recognizing the nerve root of the sixth cervical vertebra, the processor detects the nerve root of the seventh cervical vertebra toward a torso side of the subject, as taught by Narouze. As stated by [0043]-[0044] of Narouze, locating and imaging nerve roots of the cervical vertebrae is a necessary step when treating complex regional pain syndrome (CRPS).
Regarding claim 20, Pelissier in view of Caluser and Narouze teach the ultrasound diagnostic apparatus according to claim 14, and Narouze further teaches that the processor is further configured to perform image analysis to detect a shape of a transverse process existing around a detected nerve root ([0045]), and determine whether the detected nerve root is the nerve root of the seventh cervical vertebra based on the detected shape of the transverse process (“The level of C7 48 can be identified by the characteristic shape of the transverse process”, [0045]).
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 Pelissier and Caluser such that the processor is further configured to perform image analysis to detect a shape of a transverse process existing around a detected nerve root, and determine whether the detected nerve root is the nerve root of the seventh cervical vertebra based on the detected shape of the transverse process, as taught by Narouze. Per [0042] of Narouze, the C7 has known relative locations to various nerves and arteries. Thus, the C7 can be used as a landmark when locating these nerves or arteries to diagnose and injury.
Regarding claim 21, Pelissier in view of Caluser and Narouze teach the ultrasound diagnostic apparatus according to claim 14, and Narouze further teaches that the processor is configured to recognize the nerve root of the sixth cervical vertebra based on detection of a vertebral artery depicted together with the nerve root (“enabling visualization of both bony structures (i.e., C6…) and vascular structures (i.e., the vertebral artery 46)”, [0042]).
Per [0014], Figure 5B depicts a long-axis view of the vertebrae. Both the nerve root and vertebral artery would be present in this view. Nevertheless, the claimed view is well-known in the art, and Examiner asserts that one having ordinary skill in the art would understand that the processor can recognize a standard view.
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 Pelissier and Caluser such that the processor is configured to recognize the nerve root of the sixth cervical vertebra based on detection of a vertebral artery depicted together with the nerve root, as taught by Narouze. This allows the nerve root of the sixth cervical vertebra to function as a reference to the vertebral artery in order to diagnose an injury to the vertebral artery.
Claims 17 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, in further view of Gono (US 2009/0023991) and Avendi (US 2019/0355149).
Regarding claim 17, Pelissier teaches an ultrasound diagnostic apparatus comprising:
an ultrasound probe (ultrasound transducer 14, [0038]);
a monitor (display 20, [0022]);
a memory (data store 31, [0036] & [0047]) configured to store (block 43, [0068]): a plurality of peripheral anatomical sites (various internal organs of a subject, [0048]), and a determined detection order (sequence of ultrasound images, [0048]) in which the plurality of anatomical sites (various internal organs of a subject, [0048]) are detected sequentially ([0048]) based on a relative positional relationship between the plurality of peripheral anatomical sites ([0101] & Figures 6A-D), set in advance ([0048], [0101], & [0115]); and
Paragraph [0101] teaches “a sequence of steps that may be provided for a specific protocol” and details several protocols, such as scans of the right upper quadrant, subxiphoid area, left upper quadrant, suprapubic area, and liver. Paragraph [0115] also teaches scanning the liver or the heart. It is expected that different protocols can be set for different patients. Additionally, as a protocol, it is expected that the probe can be navigated from one organ to another, highlighting the positional relationship between the sites.
a processor (programmable data processor, [0035]) configured to: read out from the memory, upon input by a user, the determined detection order ([0048]), transmit an ultrasound beam from the ultrasound probe to a subject ([0039]-[0040]) to acquire ultrasound images (image 21, [0042]), cause the monitor to display the ultrasound images ([0035]), and cause the monitor to display guidance to the user ([0048] & [0099]).
However, Pelissier fails to disclose: the memory is configured to store a plurality of target anatomical sites, wherein the plurality of peripheral anatomical sites have a relative positional relationship to at least one of the plurality of target anatomical sites, wherein the plurality of sites comprises a plurality of peripheral anatomical sites; and the processor is configured to: read out from the memory, upon input by a user, the at least one of the plurality of target anatomical sites, and perform image analysis on the ultrasound images to determine whether the current peripheral anatomical site is recognized.
Caluser teaches:
the memory is configured to store a plurality of target anatomical sites (liver, neck, etc., [0021]), wherein the plurality of peripheral anatomical sites (umbilicus, thyroid cartilage, etc., [0021]) have a relative positional relationship to at least one of the plurality of target anatomical sites ([0021]), wherein the plurality of sites comprises a plurality of peripheral anatomical sites ([0020]-[0021]); and
the processor (software, [0049]) is configured to: read out from the memory (memory, [0049]), upon input by a user ([0049]), the at least one of the plurality of target anatomical sites ([0049]), and perform image analysis on the ultrasound images to determine whether the current peripheral anatomical site is recognized ([0020]-[0021] & [0049], Claim 24).
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 Pelissier such that the memory is configured to store a plurality of target anatomical sites, wherein the plurality of peripheral anatomical sites have a relative positional relationship to at least one of the plurality of target anatomical sites, wherein the plurality of sites comprises a plurality of peripheral anatomical sites; and the processor is configured to: read out from the memory, upon input by a user, the at least one of the plurality of target anatomical sites, and perform image analysis on the ultrasound images to determine whether the current peripheral anatomical site is recognized, as taught by Caluser. Using a plurality of peripheral anatomical sites ensures that each target anatomical site in the detection order uses a peripheral anatomical site during its detection. This ensures a more accurate detection of each target anatomical site.
However, Pelissier in view of Caluser fail to disclose that the guidance includes a name of a current peripheral anatomical site in accordance with the determined detection order, and update the guidance to guidance including a name of a next peripheral anatomical site in accordance with the determined detection order in response to recognizing the current peripheral anatomical site in the ultrasound images.
Gono teaches that the guidance includes a name of a current peripheral anatomical site (name of an observation target region, Claim 7) in accordance with the determined detection order (step S8, [0266]; step S4’, [0268]; Figure 30), and update the guidance to guidance including a name of a next peripheral anatomical site in accordance with the determined detection order in response to recognizing the current peripheral anatomical site in the ultrasound images (step S8, [0266]; step S4’, [0268]; Figure 30).
Claim 7 states that the coefficient may be the name of an observation target region, with [0246] teaching that the observed region may be a living body mucosa or epithelia, relating to an anatomical site. Figure 30 & [0266] detail step S8, in which, based on what is observed in the image, the system automatically switches the coefficient. Step S4’, in Figure 30 & [0268], teaches that the coefficient is displayed. Figure 30 fits into Figure 27, which is an iterative flowchart. Thus, the system cycles through anatomical sites; once a site is recognized in an image, the system automatically updates to the next anatomical site, all while displaying the name of the anatomical site to the user.
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 Pelissier and Caluser such that the guidance includes a name of a current peripheral anatomical site in accordance with the determined detection order, and update the guidance to guidance including a name of a next peripheral anatomical site in accordance with the determined detection order in response to recognizing the current peripheral anatomical site in the ultrasound images, as taught by Gono. Displaying the name of the anatomical sites to be captured provides context to the imaging sequence, allowing the user to better understand the imaging procedure through which they are being guided.
However, Pelissier, Caluser, and Gono fail to disclose causing, after a last peripheral anatomical site among the plurality of peripheral anatomical sites has been recognized, the monitor to display guidance including a name of the target anatomical site.
Avendi teaches causing, after a last peripheral anatomical site among the plurality of peripheral anatomical sites has been recognized, the monitor (display 20, [0057]) to display guidance including name of the target anatomical site ([0070]-[0071] & Figures 11-14).
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 Pelissier, Caluser, and Gono to include causing, after a last peripheral anatomical site among the plurality of peripheral anatomical sites has been recognized, the monitor to display guidance including a name of the target anatomical site, as taught by a Avendi. This confirms to the user, based on the recognized peripheral anatomical sites, that the target anatomical site is the correct detection object.
Regarding claim 19, Pelissier, Caluser, Gono, and Avendi teach the ultrasound diagnostic apparatus according to claim 17, and Pelissier further teaches:
an input device (user interface 32, [0037]);
wherein the processor is further configured to change the detection order, upon input through the input device ([0069]).
According to [0069], the user can be prompted to choose between two or more protocols. Because these protocols are distinct, they must either comprise different steps or a different arrangement of steps. Either way, the selection of protocols provides a way to change the detection order.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, Gono, and Avendi, as applied to claim 17, above, in further view of Gauthier (US 2017/0007207).
Regarding claim 18, Pelissier, Caluser, Gono, and Avendi teach the ultrasound diagnostic apparatus according to claim 17, and Pelissier further teaches:
an input device (user interface 32, [0037]);
wherein the processor is further configured to edit the detection order, upon input through the input device ([0068]).
However, Pelissier, Caluser, and Gono, and Avendi fail to disclose that editing the detection order comprises skipping a step of an imaging sequence.
Gauthier teaches skipping a step of an imaging sequence ([0024]).
Paragraph [0024] states “The number N of image planes being acquired can also be changed in real-time during imaging”. By acquiring fewer image planes, the steps of acquiring these image planes will be skipped. Additionally, the ability to do so in real-time gives the user the determination of which image planes will be skipped.
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 Pelissier to include skipping a step of an imaging sequence, as taught by Gauthier. If an anatomical site is too difficult or time-consuming to acquire, the ability to skip its acquisition ensures that the progress of the imaging sequence is not inhibited.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights