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 12/23/2025 have been fully considered but they are not persuasive.
The rejections under 35 USC 101 have been upheld. Although the generation of an ultrasound image cannot be performed in the mind, Examiner asserts that the steps of identifying the peripheral sites and detection order and detecting the peripheral and target sites can be performed mentally. Regarding the limitation of performing image analysis to detect and recognize an anatomical site, this can amount to looking at an image and recognizing parts of the image. Though, as Applicant argues, the invention comprises a practical application, these steps can still be performed mentally.
Applicant argues, see Applicant’s arguments pages 15-17, that the references do not teach detecting the target site based on its relative positional relationship to the peripheral sites. Examiner upholds that Caluser teaches this limitation. Paragraphs [0020]-[0021] & [0049] of Caluser teach that a positional relationship between the peripheral reference and target is known. Examiner further asserts that a positional relationship must be known between a peripheral site and target site in order for the use of peripheral sites to be effective. Pelissier teaches that a user can be guided to multiple sites, and, therefore, the combination of Pelissier and Caluser would result in the user being guided to detect multiple peripheral sites in order to detect the target site.
Applicant argues, see Applicant’s arguments pages 17-18, that the references do not teach that a unique plurality of peripheral sites is set for each patient. Newly-found reference of Robinson has been introduced to teach the limitation. Robinson teaches that each scan can have a set of unique reference points.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 5-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: YES -The claims recite an ultrasound diagnostic apparatus and a method for controlling an ultrasound diagnostic apparatus, and, therefore, are an apparatus and method.
Step 2A, Prong 1, Judicial Exception: YES -Claims 1 & 18 recite the limitations “identify[ing] the plurality of peripheral anatomical sites effective to detect the input target anatomical site, uniquely set for the first subject by referring to the input identification information”, “identify[ing] the detection order uniquely set for the first subject by referring to the input identification information”, “guid[ing] a user to operate the ultrasound probe so as to detect the plurality of peripheral anatomical sites according to the detection order”, “perform[ing] image analysis on the acquired ultrasound image to detect an imaged anatomical site of the subject and recognize a type of the imaged anatomical site”, and “guid[ing] the user to operate the ultrasound probe so as to detect the target anatomical site when the type of the imaged anatomical site is recognized as a last peripheral anatomical site among the plurality of peripheral anatomical sites in the detection order”. These limitations comprise method steps that, under their broadest reasonable interpretation, cover performance of the limitations in the mind, and nothing in the claim element precludes the step from practically being performed in the mind. Thus, the claims recite a mental process.
Step 2A, Prong 2, Integrated into Practical Application: No -Claim 1 recites additional elements such as “transmit an ultrasound beam from the ultrasound probe to the first subject to acquire an ultrasound image”. Claims 18 recites additional elements such as “acquiring an ultrasound image on the basis of a reception signal generated by transmission and reception of an ultrasound beam from an ultrasound probe to a subject”.
Claims 2 & 10 are drawn to guiding the user to detect the sites which further recites additional elements that are extra solution activity, and the guiding steps are further directed to the abstract which can be performed via mental steps. Claims 3 & 5-7 are drawn to guiding the user to skip detection or change the detection order of the sites which are further directed to the abstract which can be performed via mental steps. Claims 8-9 are drawn to recognizing a site which is further directed to the abstract which can be performed via mental steps. Claim 11 is drawn to displaying guidance which does not add significantly more than the abstract idea because displaying guidance is just outputting results. Claim 12 is drawn to generating a contour which is further directed to the abstract which can be performed via mental steps, and displaying a contour of the site which does not add significantly more than the abstract idea because displaying guidance is just outputting results. Claim 13 is drawn to providing audio guidance is further directed to the abstract which can be performed via mental steps. Claims 14-17 are drawn to defining the target anatomical site and peripheral anatomical site which constitute additional elements, and they recite an insignificant pre-extra solution activity of data gathering. Because the claims are recited at a high level of generality, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea to integrate the judicial exception into a practical application. Thus, the claims are directed to an abstract idea.
Step 2B, Inventive Concept: No -The additional elements amount to no more than a means for gathering data. The gathering of data cannot integrate a judicial exception into a practical application or provide an inventive concept. Because the acquiring step remains an insignificant pre-extra solution activity, the additional elements, either considered individually or as a whole, do not claim substantially more than the judicial exception and therefore does not confer an inventive concept. There is no inventive concept in the claim, and thus, it is ineligible.
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 1-3, 5-7, 11, & 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Pelissier (US 2010/0049050) in view of Caluser (US 2009/0124906), Robinson (US 2016/0155247), and Urabe (US 2017/0100098).
Regarding claim 1, Pelissier teaches an ultrasound diagnostic apparatus comprising:
an ultrasound probe (ultrasound transducer 14, [0038]);
a memory (data store 31, [0036]) configured to: store (block 43, [0068]) a first plurality of peripheral anatomical sites (various internal organs of a subject, [0048]) for a first subject among a plurality of subjects and a second plurality of peripheral anatomical sites ([0048] & [0101]) for a second subject among the plurality of subjects, the first plurality of peripheral anatomical sites being different from the second plurality of peripheral anatomical sites ([0101] & [0115]), and a first detection order (sequence of ultrasound images, [0048]) in which the first plurality of anatomical sites (various internal organs of a subject, [0048]) are detected sequentially ([0048]) and the second detection order ([0101]) in which a second plurality of peripheral anatomical sites are detected sequentially ([0048], [0101], & [0115]), the first detection order being different from the second detection order ([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. Because each protocol comprises acquiring images of various internal organs of the subject, per [0048], each protocol would comprise different organs based on the focus of the current scan. Protocols comprising different peripheral anatomical sites would have different detection orders. Additionally, it is expected that different protocols can be performed on different patients.
a processor (protocol controller 30, [0023] & [0035]) configured to: identify the first detection order uniquely set for a first subject (block 45, [0069]) and transmit an ultrasound beam from the ultrasound probe to a subject ([0039]-[0040]) to acquire an ultrasound image (image 21, [0042]).
However, Pelissier fails to disclose a memory configured to store: a target anatomical site input by a user, wherein the plurality of peripheral anatomical sites is effective to detect the target anatomical site based on a relative positional relationship between the plurality of peripheral anatomical sites and the target anatomical site; and a processor configured to: identify the first plurality of peripheral anatomical sites effective to detect the input target anatomical site, uniquely set for the first subject, guide the user to operate the ultrasound probe so as to detect the first plurality of peripheral anatomical sites according to the first detection order, perform image analysis on the ultrasound image acquired to detect an imaged anatomical site of the subject and recognize a type of the imaged anatomical site, and display a guide marker to guide the user to control at least one of an orientation of the ultrasound probe and an inclination of the ultrasound probe based on a relative positional relationship between a last peripheral anatomical site and the target anatomical site so as to detect the target anatomical site when the type of the imaged anatomical site is recognized as the last peripheral anatomical site among the first plurality of peripheral anatomical sites in the first detection order, and perform image analysis on the target anatomical site to detect the target anatomical site.
Caluser teaches:
a memory (memory, [0049]) configured to store: a target anatomical site (target anatomical site, [0049]) input by a user ([0049]), wherein the plurality of peripheral anatomical sites (anatomical reference points, [0049]) is effective to detect the target anatomical site ([0020]-[0021]) based on a relative positional relationship between the plurality of peripheral anatomical sites and the target anatomical site ([0020]-[0021] & [0049]); and
Paragraphs [0020]-[0021] teach that different anatomical reference points (nipple, umbilicus, thyroid cartilage) can be used to detect different targets (breast, liver, neck). This supports the claim made above for the rejection under Pelissier that imaging different target anatomical sites comprises acquiring different peripheral anatomical sites.
a processor (software application, [0019]) configured to: identify the first plurality of peripheral anatomical sites effective to detect the input target anatomical site, uniquely set for the first subjects ([0019] & Claim 24), guide the user to operate the ultrasound probe so as to detect the first plurality of peripheral anatomical sites according to the first detection order ([0022]-[0023] & Claim 24), perform image analysis on the ultrasound image acquired to detect an imaged anatomical site of the subject ([0020]-[0021] & [0049], Claim 24) and recognize a type of the imaged anatomical site ([0049] & Claim 24), and display a guide marker (continuous ultrasound probe position and orientation display, [0019]) to guide the user to control at least one of an orientation of the ultrasound probe and an inclination of the ultrasound probe (orientation help, [0020]) so as to detect the target anatomical site when the type of the imaged anatomical site is recognized as the last peripheral anatomical site among the first plurality of peripheral anatomical sites in the first detection order ([0049] & Claim 24), and perform image analysis on the target anatomical site to detect the target anatomical site ([0049] & Claim 1).
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.
Because supplementary calculations are performed with reference to the anatomical references and target pixels, it can be assumed that the processor recognizes the anatomical references. For example, in order to calculate the distance from the anatomical reference, as taught in [0020], the processor must first recognize the anatomical reference and its 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 taught by Pelissier to include a memory configured to store: a target anatomical site input by a user, wherein the plurality of peripheral anatomical sites is effective to detect the target anatomical site based on a relative positional relationship between the plurality of peripheral anatomical sites and the target anatomical site; and a processor configured to: identify the first plurality of peripheral anatomical sites effective to detect the input target anatomical site, uniquely set for the first subject, guide the user to operate the ultrasound probe so as to detect the first plurality of peripheral anatomical sites according to the first detection order, perform image analysis on the ultrasound image acquired to detect an imaged anatomical site of the subject and recognize a type of the imaged anatomical site, and display a guide marker to guide the user to control at least one of an orientation of the ultrasound probe and an inclination of the ultrasound probe based on a relative positional relationship between a last peripheral anatomical site and the target anatomical site so as to detect the target anatomical site when the type of the imaged anatomical site is recognized as the last peripheral anatomical site among the first plurality of peripheral anatomical sites in the first detection order, and perform image analysis on the target anatomical site 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.
However, Pelissier in view of Caluser fail to disclose a second plurality of peripheral anatomical sites effective to detect the target anatomical site.
Robinson teaches a second plurality of peripheral anatomical sites (set of unique reference points, [0079]) effective to detect the target anatomical site (ROI, [0078]).
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 to include a second plurality of peripheral anatomical sites effective to detect the target anatomical site, as taught by Robinson. Per [0113]-[0114] of Robinson, different reference points may be visible in different patient positions and the positions of reference points may change between scans. This would also apply to performing scans of the same target among different patients.
However, Pelissier in view of Caluser and Robinson fail to disclose: a memory configured to store first identification information identifying the first subject to be examined, the first identification information being stored in association with the first plurality of peripheral anatomical sites, and second identification information identifying the second subject, the second identification information being stored in association with the second plurality of peripheral anatomical sites.
Urabe teaches:
a memory (scanning-information storage unit 108, [0079]) configured to store first identification information (patient ID, [0072]) identifying the first subject to be examined ([0072]), the first identification information being stored in association with the first plurality of peripheral anatomical sites ([0072]), and second identification information identifying the second subject, the second identification information being stored in association with the second plurality of peripheral anatomical sites.
Paragraph [0072] teaches that the patient ID comprises examination history and lesion position information. Because the process of Pelissier comprises obtaining multiple peripheral sites, the combination of Pelissier and Urabe would comprise recalling these sites. Additionally, in regards to the second identification information, it is expected that the invention of Urabe can store patient information for more than one patient at a time.
Regarding the limitations that the peripheral anatomical sites and detection order are uniquely set for the first subject based on the first identification information, as is stated above, the peripheral anatomical sites (and, therefore, the detection order) are expected to be set based on what area of the subject is being imaged. This information can be accessed via the patient ID taught by Urabe. Therefore, Examiner asserts that the combinations of Pelissier and Caluser with Urabe respectively teach the limitations of identifying the peripheral anatomical sites and detection order based on the input identification information.
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 Robinson to include: a memory configured to store first identification information identifying the first subject to be examined, the first identification information being stored in association with the first plurality of peripheral anatomical sites, and second identification information identifying the second subject, the second identification information being stored in association with the second plurality of peripheral anatomical sites, as taught by Urabe. By associating the position of an anatomical site with the subject identification information, the time it takes to search for the anatomical site can be drastically reduced in future examinations.
Regarding claim 2, Pelissier in view of Caluser, Robinson, and Urabe teach the ultrasound diagnostic apparatus according to claim 1, and Pelissier further teaches that the processor is further configured to guide the user to operate the ultrasound probe so as to sequentially detect the first plurality of sites in accordance with the first detection order ([0048]).
Regarding claims 3 & 5-7, Pelissier in view of Caluser, Robinson, and Urabe 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 first detection order and detect the first plurality of sites in the changed first detection order ([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.
Modified Pelissier teaches that the plurality of sites comprises a plurality of peripheral anatomical sites (Caluser, [0021]).
Regarding claim 11, Pelissier in view of Caluser, Robinson, and Urabe teach the ultrasound diagnostic apparatus according to claim 1, and Pelissier further teaches comprising a monitor (display 20, [0048]).
Caluser further teaches that the processor is further configured to display on the monitor the guide marker provided to the user to operate the ultrasound probe ([0019]-[0020]).
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 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 17, Pelissier in view of Caluser, Robinson, and Urabe 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]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, Robinson, and Urabe, as applied to claim 5, above, in further view of Rothberg (US 2017/0360403).
Regarding claim 8, Pelissier in view of Caluser, Robinson, and Urabe teach the ultrasound diagnostic apparatus according to claim 2.
However, Pelissier in view of Caluser, Robinson, and Urabe fail to disclose that the processor is further configured to recognize an imaged anatomical site of the first subject based on subject information concerning a state of the first subject, which is input by the user.
Rothberg teaches that the processor is further configured to recognize an imaged anatomical site of the first subject based on subject information (medical information about the subject, [0087]) concerning a state of the first 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, Caluser, Robinson, and Urabe such that the processor is further configured to recognize an imaged anatomical site of the first subject based on subject information concerning a state of the first 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.
Regarding claim 9, Pelissier in view of Caluser, Robinson, and Urabe teach the ultrasound diagnostic apparatus according to claim 5.
However, Pelissier in view of Caluser, Robinson, and Urabe fail to disclose that the processor is further configured to recognize an imaged anatomical site of the first subject based on subject information concerning a state of the first subject, which is input by the user.
Rothberg teaches that the processor is further configured to recognize an imaged anatomical site of the first subject based on subject information (medical information about the subject, [0087]) concerning a state of the first 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, Caluser, Robinson, and Urabe such that the processor is further configured to recognize an imaged anatomical site of the first subject based on subject information concerning a state of the first subject, which is input by the user, which is input by the user through the input unit, 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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, Robinson, and Urabe, as applied to claim 11, above, in further view of Chono (US 2015/0320399).
Regarding claim 12, Pelissier in view of Caluser, Robinson, and Urabe teach the ultrasound diagnostic apparatus according to claim 11, and Caluser teaches determining a last peripheral anatomical site ([0049] & Claim 24).
However, Pelissier in view of Caluser, Robinson, and Urabe fail to disclose that the processor is further configured to generate a contour of the last peripheral anatomical site recognized, and display on the monitor the ultrasound image acquired, and displayed on the monitor the contour of the last 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 the last peripheral anatomical site (cardiac wall, [0081]) recognized, and display on the monitor (display unit 132, [0083]) the ultrasound image (image 302, [0083]) acquired, and displayed on the monitor the contour of the last peripheral anatomical site superimposed on the ultrasound image ([0081] & [0083]).
Any contour created for a peripheral anatomical site can be created for a last 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 taught by Pelissier, Caluser, Robinson, and Urabe such that the processor is further configured to generate a contour of the last peripheral anatomical site recognized, and display on the monitor the ultrasound image acquired, and displayed on the monitor the contour of the last 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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, Robinson, and Urabe, as applied to claim 1, above, in further view of Ishikawa (US 2011/0246129).
Regarding claim 13, Pelissier in view of Caluser, Robinson, and Urabe teach the ultrasound diagnostic apparatus according to claim 1.
However, Pelissier in view of Caluser, Robinson, and Urabe 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, Caluser, Robinson, and Urabe 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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, Robinson, and Urabe, as applied to claim 1, above, in further view of Parthasarathy (US 2016/0143621).
Regarding claim 14, Pelissier in view of Caluser, Robinson, and Urabe teach the ultrasound diagnostic apparatus according to claim 1, and Caluser further teaches identifying the target anatomical site ([0021]) and last peripheral anatomical site ([0049] & Claim 24).
However, Pelissier in view of Caluser, Robinson, and Urabe fail to disclose imaging a common bile duct, a portal vein, and a gallbladder.
Parthasarathy teaches imaging a common bile duct, a portal vein, and a gallbladder ([0067]).
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 last peripheral anatomical site 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, 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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, Robinson, and Urabe, as applied to claim 1, above, in further view of Zilberstein (US 2005/0266074).
Regarding claim 15, Pelissier in view of Caluser, Robinson, and Urabe teach the ultrasound diagnostic apparatus according to claim 1, and Caluser further teaches identifying the target anatomical site ([0021]) and last peripheral anatomical site ([0049] & Claim 24).
However, Pelissier in view of Caluser, Robinson, and Urabe fail to disclose imaging an appendix, an ascending colon, a cecum, and an ileum.
Zilberstein teaches imaging an appendix, an ascending colon, a cecum, and an ileum ([0101]-[0102]).
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 last peripheral anatomical site 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, as taught by Zilberstein. Locating and imaging the appendix is a necessary step when attempting to diagnose appendicitis.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, Robinson, and Urabe, as applied to claim 1, above, in further view of Narouze (US 2010/0204568).
Regarding claim 16, Pelissier in view of Caluser, Robinson, and Urabe teach the ultrasound diagnostic apparatus according to claim 1, and Caluser further teaches identifying the target anatomical site ([0021]) and last peripheral anatomical site ([0049] & Claim 24).
However, Pelissier in view of Caluser, Robinson, and Urabe fail to disclose imaging a nerve root of a fifth cervical vertebra and a nerve root of a seventh cervical vertebra and a nerve root of a sixth cervical vertebra.
Narouze teaches imaging a nerve root of a fifth cervical vertebra and a nerve root of a seventh cervical vertebra and a nerve root of a sixth cervical vertebra ([0044]).
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 last peripheral anatomical site 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, 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).
Claims 21 & 23 are rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser and Robinson, in further view of Gono (US 2009/0023991) and Avendi (US 2019/0355149).
Regarding claim 21, 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 first plurality of peripheral anatomical sites (various internal organs of a subject, [0048]) for a first subject and a second plurality of peripheral anatomical sites ([0048] & [0101]) for a second subject, the first plurality of peripheral anatomical sites being different from the second plurality of peripheral anatomical sites ([0101] & [0115]), and a first detection order (sequence of ultrasound images, [0048]) in which the first plurality of anatomical sites (various internal organs of a subject, [0048]) are detected sequentially for the first subject ([0048]) and the second detection order ([0101]) in which a second plurality of peripheral anatomical sites are detected sequentially for the second subject ([0048], [0101], & [0115]), set in advance ([0048], [0101], & [0115]), the first detection order being different from the second detection order ([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. Because each protocol comprises acquiring images of various internal organs of the subject, per [0048], each protocol would comprise different organs based on the focus of the current scan. Protocols comprising different peripheral anatomical sites would have different detection orders. Additionally, it is expected that different protocols can be performed on different patients.
a processor (programmable data processor, [0035]) configured to: read out from the memory, upon input by a user indicating the first subject ([0104]), the first plurality of peripheral anatomical sites ([0048]) and the first detection order ([0048]), transmit an ultrasound beam from the ultrasound probe to the first 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]).
Paragraph [0104] teaches that a different set of images may be required based on the user’s sex, age, weight, etc. Indicating the user’s demographics would, thus, change the peripheral anatomical sites and the detection order.
However, Pelissier fails to disclose: the memory is configured to store a plurality of target anatomical sites, wherein the plurality of peripheral anatomical sites is effective to detect a target anatomical site among the plurality of target anatomical sites based on a relative positional relationship between the plurality of peripheral anatomical sites and the target anatomical site; 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.
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]) is effective to detect a target anatomical site among the plurality of target anatomical sites ([0021]) based on a relative positional relationship between the first plurality of peripheral anatomical sites and the target anatomical site; 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]).
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 is effective to detect a target anatomical site among the plurality of target anatomical sites based on a relative positional relationship between the plurality of peripheral anatomical sites and the target anatomical site; 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, 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 a second plurality of peripheral anatomical sites effective to detect the target anatomical site.
Robinson teaches a second plurality of peripheral anatomical sites (set of unique reference points, [0079]) effective to detect the target anatomical site (ROI, [0078]).
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 to include a second plurality of peripheral anatomical sites effective to detect the target anatomical site, as taught by Robinson. Per [0113]-[0114] of Robinson, different reference points may be visible in different patient positions and the positions of reference points may change between scans. This would also apply to performing scans of the same target among different patients.
However, Pelissier in view of Caluser and Robinson fail to disclose that each of the guidance includes a name of the first plurality of peripheral anatomical sites one by one respectively in accordance with the first detection order, wherein the processor updates the display of the name of the next peripheral anatomical site in accordance with the first detection order after successfully detecting the current peripheral anatomical site in ultrasound images.
Gono teaches that each of the guidance includes a name of the first plurality of peripheral anatomical sites (name of an observation target region, Claim 7) one by one respectively in accordance with the first detection order (step S8, [0266]; step S4’, [0268]; Figure 30), wherein the processor updates the display of the name of the next peripheral anatomical site in accordance with the first detection order after successfully detecting the current peripheral anatomical site in 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, Caluser, and Robinson such that each of the guidance includes a name of the first plurality of peripheral anatomical sites one by one respectively in accordance with the first detection order, wherein the processor updates the display of the name of the next peripheral anatomical site in accordance with the first detection order after successfully detecting the current peripheral anatomical site in 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, Robinson, and Gono fail to disclose causing, after all the first plurality of peripheral anatomical sites have been detected, the monitor to display the name of the target anatomical site.
Avendi teaches causing, after all the first plurality of peripheral anatomical sites have been detected, the monitor (display 20, [0057]) to display the 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, Robinson, and Gono to include causing, after all the first plurality of peripheral anatomical sites have been detected, the monitor to display the 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 23, Pelissier, Caluser, Robinson, Gono, and Avendi teach the ultrasound diagnostic apparatus according to claim 21, and Pelissier further teaches:
an input device (user interface 32, [0037]);
wherein the processor is further configured to change the first 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 22 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Caluser, Robinson, Gono, and Avendi, as applied to claim 21, above, in further view of Gauthier (US 2017/0007207).
Regarding claim 22, Pelissier, Caluser, Robinson, Gono, and Avendi teach the ultrasound diagnostic apparatus according to claim 21, 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, Robinson, 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.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798