DETAILED ACTION
This office action is in response to the communication received on 08/14/2024 concerning application no. 18/722,399 filed on 08/14/2024.
Claims 1-9 are pending.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the features of claims 1, 5-7, and 9 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because:
Fig. 2 show flowcharts without written-in descriptions to indicate the function that is executed in each step.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Claim 7, contains an optional limitation “when the step of placing the support at the predetermined point of the surface of the patient's body is repeated several times in succession, a standard deviation of the position of the surface of the support is less than a deviation in position and a standard deviation of the orientation of the surface of the support is less than a deviation in orientation”. According to MPEP 2111.04, “The broadest reasonable interpretation of a method (or process) claim having contingent limitation acquires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”.
Therefore, the claim element starting with “wherein the predetermined point” and ending with “deviation in orientation” is not required to be performed.
Claim 8, contains an optional limitation “when the probe is held”. According to MPEP 2111.04, “The broadest reasonable interpretation of a method (or process) claim having contingent limitation acquires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”.
Therefore, the claim element starting with “the recorded position” and ending with “the current orientation” is not required to be performed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite for the following reasons:
The claim as a whole is indefinite. The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Recites “the surface of the first object”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the surface of the second object”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the support being configured to receive on a surface of the support the second object by maintaining the second object in a predetermined position and orientation of the second object relative to a fixed reference frame relative to the patient's body”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is attempting to establish that the second object on the support is with respect to a separate fixed frame of reference relative to the patient body or is acting as the separate fixed frame of reference relative to the patient body. If it is the former, it is further unclear if the separate fixed frame of reference is a part of the patient body or another feature that is itself situated with respect to the patient body.
Applicant is encouraged to provide consistent and clear language.
Recites “the second object is maintained in a predetermined position and orientation relative to the reference frame”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “predetermined position and orientation” is the same as the “predetermined position and orientation of the second object relative to a fixed reference frame” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the reference frame”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the reference frame”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “reference frame” is the same as the “fixed reference frame” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “determining the reference frame”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art whether the reference frame is known as the claim earlier establishes that the “the second object is maintained in a predetermined position and orientation relative to the reference frame” or is required to be determined as established in the instant element.
Applicant is encouraged to provide consistent and clear language.
Recites “determining coordinates of at least one first point corresponding to a vertex of a polygon disposed in a first plane transverse to the recorded direction of the probe”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the polygon is representative of. One possible interpretation is the ultrasound image frames. Second possible interpretation is a segmentation. Third possible interpretation is of the coordinate system.
Applicant is encouraged to provide consistent and clear language.
Recites “determining the current position and the current direction of the probe in the reference frame, from the first markers identifiable by another processing of the at least one image”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the relationship is between the current position/direction to the recorded position/direction. That is, the instant claim establishes that the current position/direction is ascertained based on the image. However, a preceding element establishes that the recorded position/direction is determined based on the image. It is unclear if the current position/direction and recorded position/direction are the same or different. If they are the same, it is further unclear why two different terms are used to define the same feature and it is further unclear how it is being determined. That is if it based on the claimed language regarding the current position/direction or based on the claimed language regarding the recorded position/direction. If they are different, it is further unclear how an image captures two different positions and directions of the probe.
Applicant is encouraged to provide consistent and clear language.
Recites “a central area of the polygon”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “central area of the polygon” is the same as the “central area of the polygon” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “a straight line”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “straight line” is the same as the “straight line” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “at least one second point corresponding to the vertex of the polygon disposed in a new second plane transverse to the new current direction of the probe”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art where the polygon, the vertex, and the point are disposed. The preceding claim establishes that is based on a first plane. Then another preceding claim establishes it is based on the second plane. It would be unclear how and where the polygon, the vertex, and the point can be situated in multiple locations.
Applicant is encouraged to provide consistent and clear language.
Recites “a central area”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “central area” is the same as the “central area” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “a straight line”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “straight line” is the same as the “straight line” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the new projection being closer to the projection of the at least one first point than to the projection of the at least one second point, until the at least one second point and the at least one first point coincide”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how the points coincide given that they appear to be situated with respect to the same vertex of a polygon but also the claim appears to establish them to be different. That is, it is unclear what the points’ relationship is to one another. If they are different, it is unclear how they can coincide. If they are the same, it is unclear how the assessment is conducted.
Applicant is encouraged to provide consistent and clear language.
Recites “thus the new current position and the new current direction coincide with the recorded position and the recorded direction, the projection and new projection in augmented reality steps of the at least one second point being produced in real time as the probe is displaced”. This claim element is indefinite. It is unclear if the claimed element is an active step or is an intended use limitation. It would be unclear if the current position/directions is coinciding or not based on the “bringing the probe into a new current position and a new current direction”. It would be unclear to one with ordinary skill in the art what the scope of the claim element is as in its present form, the claim element is grammatically incorrect.
Applicant is encouraged to provide consistent and clear language.
Claim 2 is indefinite for the following reasons:
Recites “the faces of the cube”. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 is indefinite for the following reasons:
Recites “the faces of the second cube”. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 is indefinite for the following reasons:
The claim as a whole is indefinite. The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Recites “the at least one first point comprises four first points each corresponding to four vertices of the polygon disposed in the first plane transverse to the recorded direction of the probe”. This claim element is indefinite. Claim 1 establishes that the at least first point corresponds to the vertex of the polygon. It would be unclear to one with ordinary skill in the art what the relationship of the vertex of the polygon is to the four vertices. It would be further unclear how the four points can be with respect to the vertex of the polygon. The language of the claim requiring four vertices contradicts with the independent claim establishing the vertex of the polygon.
Applicant is encouraged to provide consistent and clear language.
Recites “the at least one second point comprises four second points each corresponding to the four vertices of the polygon disposed in the second plane transverse to the current direction of the probe”. This claim element is indefinite. Claim 1 establishes that the at least first point corresponds to the vertex of the polygon. It would be unclear to one with ordinary skill in the art what the relationship of the vertex of the polygon is to the four vertices. It would be further unclear how the four points can be with respect to the vertex of the polygon. The language of the claim requiring four vertices contradicts with the independent claim establishing the vertex of the polygon.
Applicant is encouraged to provide consistent and clear language.
The claim as a whole is indefinite. This claim element is indefinite. Again, as discussed above, it would be unclear to one with ordinary skill in the art if the first and second points are referring to the same points or different points. If they are the same points, it is unclear how the data capture and processing is being performed. If they are different points, it is unclear how they are occupying the same polygon and its features.
Applicant is encouraged to provide consistent and clear language.
Claim 5 is indefinite for the following reasons:
The claim as a whole is indefinite. The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Recites “a first geometric shape”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “first geometric shape” is the same as the “polygon” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “a first geometric shape is associated with the at least one first point”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the points are associated to the geometric shape or the polygon as established in the claim 1. It is further unclear if the geometric shape and the polygon are different, what their relationship is such that the point is associated to both.
Applicant is encouraged to provide consistent and clear language.
Recites “a second geometric shape”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “second geometric shape” is the same as the “polygon” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “a second geometric shape is associated with the at least one second point”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the points are associated to the geometric shape or the polygon as established in the claim 1. It is further unclear if the geometric shape and the polygon are different, what their relationship is such that the point is associated to both.
Applicant is encouraged to provide consistent and clear language.
Claim 6 is indefinite for the following reasons:
The claim as a whole is indefinite. The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Recites “a straight line segment”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “straight line segment” is the same as the “straight line” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “wherein a straight line segment connecting the at least one first point to the at least one second point is displayed as a function of a distance between the at least one first point and the at least one second point”. This claim element is indefinite. Again, as discussed above, it would be unclear to one with ordinary skill in the art if the first and second points are referring to the same points or different points. The independent claim establishes that they are both coinciding and not together. It is unclear what the relationship is between the points.
Applicant is encouraged to provide consistent and clear language.
Claim 7 is indefinite for the following reasons:
The claim as a whole is indefinite. The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Recites “a position and an orientation”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “position and an orientation” is the same as the “predetermined position and orientation” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the surface of the support disposed at the predetermined point is stable over time, and repeatable”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how a surface of the support is repeatable.
Applicant is encouraged to provide consistent and clear language.
Recites “i.e. when the step of placing the support at the predetermined point of the surface of the patient's body is repeated several times in succession, a standard deviation of the position of the surface of the support is less than a deviation in position and a standard deviation of the orientation of the surface of the support is less than a deviation in orientation”. This claim element is indefinite. It is unclear if the language is actively claimed or not as the term appears to be explanatory but it is unclear if it actually being claimed or not.
Applicant is encouraged to provide consistent and clear language.
Recites “a standard deviation of the position of the surface of the support is less than a deviation in position”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how a standard deviation can be less than a deviation. A standard deviation is “a measure which shows how much variation (such as spread, dispersion, spread,) from the mean exists”.1
Applicant is encouraged to provide consistent and clear language.
Recites “a standard deviation of the orientation of the surface of the support is less than a deviation in orientation”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how a standard deviation can be less than a deviation. A standard deviation is “a measure which shows how much variation (such as spread, dispersion, spread,) from the mean exists”.2
Applicant is encouraged to provide consistent and clear language.
Claim 8 is indefinite for the following reasons:
The claim as a whole is indefinite. The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Recites “a first user”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “first user” is the same as the “user” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the recorded position and the recorded direction of the probe being defined by a first user when the probe is held in the hand of the first user in a current position and according to a current direction”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the relationship is between the current position/direction to the recorded position/direction. That is, the instant claim establishes that the current position/direction and the recorded position/direction are the same. However, claim 1 establishes that the current position/direction and the recorded position/direction to be differing. If they are the same, it is further unclear why two different terms are used to define the same feature and it is further unclear how it is being determined. That is if it based on the claimed language regarding the current position/direction or based on the claimed language regarding the recorded position/direction. If they are different, it is further unclear how an image captures two different positions and directions of the probe as established in claim 1.
Applicant is encouraged to provide consistent and clear language.
Recites “the reference frame”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “reference frame” is the same as the “fixed reference frame” established in the claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the recorded position and the recorded direction of the probe being defined by a first user when the probe is held in the hand of the first user in a current position and according to a current direction, the step of determining the current position and the current direction of the probe in the reference frame, from the second markers identifiable on the at least one image comprising a step of recording the current position of the probe and the current orientation”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the relationship is between the current position/direction to the recorded position/direction. That is, the instant claim establishes that the current position/direction is ascertained based on the image. However, claim 1 establishes that the recorded position/direction is determined based on the image. It is unclear if the current position/direction and recorded position/direction are the same or different. If they are the same, it is further unclear why two different terms are used to define the same feature and it is further unclear how it is being determined. That is if it based on the claimed language regarding the current position/direction or based on the claimed language regarding the recorded position/direction. If they are different, it is further unclear how an image captures two different positions and directions of the probe.
Applicant is encouraged to provide consistent and clear language.
Claim 9 is indefinite for the following reasons:
The claim as a whole is indefinite. The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Recites “the surface of the first object”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the surface of the second object”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the support configured to maintain the second object in a predetermined position and orientation of the second object relative to a fixed reference frame relative to the patient's body”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is attempting to establish that the second object on the support is with respect to a separate fixed frame of reference relative to the patient body or is acting as the separate fixed frame of reference relative to the patient body. If it is the former, it is further unclear if the separate fixed frame of reference is a part of the patient body or another feature that is itself situated with respect to the patient body.
Applicant is encouraged to provide consistent and clear language.
Recites “the support configured to maintain the second object in a predetermined position and orientation of the second object relative to a fixed reference frame relative to the patient's body”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “predetermined position and orientation” is the same as the “predetermined position and orientation of the second object relative to a fixed reference frame” established in the claim 9 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “to display the at least one image acquired by the camera, and to display in the at least one image in augmented reality at least one first point corresponding to a vertex of a polygon disposed in a first plane transverse to a recorded direction of the probe”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the polygon is representative of. One possible interpretation is the ultrasound image frames. Second possible interpretation is a segmentation. Third possible interpretation is of the coordinate system.
Applicant is encouraged to provide consistent and clear language.
Recites “at least one second point corresponding to the vertex of the polygon disposed in a second plane transverse to the current direction of the probe, so that a central area of the polygon is crossed by a straight line parallel to the current direction of the probe and passing through the current position of the probe”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the relationship is between the current position/direction to the recorded position/direction. That is, the instant claim establishes that the current position/direction is ascertained based on the image. However, a preceding element establishes that the recorded position/direction is determined based on the image. It is unclear if the current position/direction and recorded position/direction are the same or different. If they are the same, it is further unclear why two different terms are used to define the same feature and it is further unclear how it is being determined. That is if it based on the claimed language regarding the current position/direction or based on the claimed language regarding the recorded position/direction. If they are different, it is further unclear how an image captures two different positions and directions of the probe.
Applicant is encouraged to provide consistent and clear language.
Recites “a central area of the polygon”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “central area of the polygon” is the same as the “central area of the polygon” established in the claim 9 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “a straight line”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “straight line” is the same as the “straight line” established in the claim 9 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “at least one second point corresponding to the vertex of the polygon disposed in a second plane transverse to the current direction of the probe”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art where the polygon, the vertex, and the point are disposed. The preceding claim establishes that is based on a first plane. Then another preceding claim establishes it is based on the second plane. It would be unclear how and where the polygon, the vertex, and the point can be situated in multiple locations.
Applicant is encouraged to provide consistent and clear language.
Recites “a central area of the polygon”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “central area of the polygon” is the same as the “central area of the polygon” established in the claim 9 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “a straight line”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “straight line” is the same as the “straight line” established in the claim 9 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the user holding the probe in a hand being guided by the display to make the at least one first point coincide with the at least one second point in the at least one displayed image, by displacing the probe to a new current position and a new current direction so as to gradually make the new current position and the new current direction of the probe coincide with the recorded position and the recorded direction of the probe”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how the points coincide given that they appear to be situated with respect to the same vertex of a polygon but also the claim appears to establish them to be different. That is, it is unclear what the points’ relationship is to one another. If they are different, it is unclear how they can coincide. If they are the same, it is unclear how the assessment is conducted.
Applicant is encouraged to provide consistent and clear language.
Recites “the display device being configured to display the at least one image acquired by the camera, and to display in the at least one image in augmented reality at least one first point corresponding to a vertex of a polygon disposed in a first plane transverse to a recorded direction of the probe, so that a central area of the polygon is crossed by a straight line parallel to the recorded direction of the probe and passing through the recorded position of the probe, and to display in the at least one image in augmented reality at least one second point corresponding to the vertex of the polygon disposed in a second plane transverse to the current direction of the probe, so that a central area of the polygon is crossed by a straight line parallel to the current direction of the probe and passing through the current position of the probe, the user holding the probe in a hand being guided by the display to make the at least one first point coincide with the at least one second point in the at least one displayed image, by displacing the probe to a new current position and a new current direction so as to gradually make the new current position and the new current direction of the probe coincide with the recorded position and the recorded direction of the probe”. It would be unclear to one with ordinary skill in the art if the elements are actually being performed or are capable of performance by the system as the claim does not establish processing steps and is rather articulating a display device that is able to display. Given the various rejections noted above due to the substantial lack of clarity, it is unclear what is being actively claim and what is being recited as intended use limitation.
Applicant is encouraged to provide consistent and clear language.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 9, as best understood in light of the 112(b) rejections, is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 9 recites “the user holding the probe”.
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 1-9, as best understood in light of the 112(b) rejections, are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is 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 a method for guiding a user holding in one hand a probe configured for ultrasound observation of a body of a patient and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “determining the reference frame, from the second markers identifiable by processing the at least one image, the recorded position and the recorded direction of the probe being defined in the reference frame; in the reference frame, determining coordinates of at least one first point corresponding to a vertex of a polygon disposed in a first plane transverse to the recorded direction of the probe, such that a central area of the polygon is crossed by a straight line parallel to the recorded direction of the probe and passing through the recorded position of the probe; determining the current position and the current direction of the probe in the reference frame, from the first markers identifiable by another processing of the at least one image; determining coordinates in the reference frame of at least one second point, the at least one second point corresponding to the vertex of the polygon placed in a second plane transverse to the current direction of the probe, so that a central area of the polygon is crossed by a straight line parallel to the current direction of the probe and passing through the current position of the probe: bringing the probe into a new current position and a new current direction so that a new projection in augmented reality of the at least one second point corresponding to the vertex of the polygon disposed in a new second plane transverse to the new current direction of the probe, a central area of the polygon being crossed by a straight line parallel to the new current direction of the probe and passing through the new current position of the probe, the new projection being closer to the projection of the at least one first point than to the projection of the at least one second point, until the at least one second point and the at least one first point coincide, and thus the new current position and the new current direction coincide with the recorded position and the recorded direction, the projection and new projection in augmented reality steps of the at least one second point being produced in real time as the probe is displaced”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the determinations of reference frames, position, orientation, and the points with respect to the probe direction and position over time. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “the probe being provided with a first object secured to the probe, the first object comprising first markers on the surface of the first object, the probe being held in a current position and according to a current direction, a display device configured to receive at least one image acquired by a camera configured to observe in its field the probe, the first object, and a second object comprising second markers on the surface of the second object, the user being guided towards a recorded position and a recorded direction of the probe, the method comprising the following steps: placing a support at a predetermined point of a surface of the patient's body observed with the probe, the support being configured to receive on a surface of the support the second object by maintaining the second object in a predetermined position and orientation of the second object relative to a fixed reference frame relative to the patient's body; placing the second object on the surface of the support, so that the second object is maintained in a predetermined position and orientation relative to the reference frame fixed relative to the patient's body; acquiring at least one image with the camera; displaying the at least one image on the display device; projection, in augmented reality on the at least one displayed image, the at least one first point; projecting, in augmented reality onto the at least one displayed image, the at least one second point”. Collection of the image data and the placement of objects is a data gather step which is a form of a pre-solution insignificant activity. The display and use of AR is a display step that merely amounts to a post-solution insignificant activity.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 is ineligible.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 2 recites the following elements: “wherein the first object is a first cube comprising the first markers on the faces of the cube”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 2 is ineligible.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 3 recites the following elements: “wherein the second object is a second cube comprising the second markers on the faces of the second cube”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 3 is ineligible.
Claim 4 is 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 a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “the at least one first point comprises four first points each corresponding to four vertices of the polygon disposed in the first plane transverse to the recorded direction of the probe, so that the central area of the polygon is crossed by the straight line parallel to the recorded direction of the probe and passing through the recorded position of the probe, and the at least one second point comprises four second points each corresponding to the four vertices of the polygon disposed in the second plane transverse to the current direction of the probe, so that the central area of the polygon is crossed by the straight line parallel to the current direction of the probe and passing through the current position of the probe”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the assessment of points with respect to the probe. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 4 is ineligible.
Claim 5 is 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 a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “a first geometric shape is associated with the at least one first point, the first geometric shape being projected in augmented reality during the projection step, in augmented reality on the at least one displayed image, of the at least one first point, and a second geometric shape is associated with the at least one second point, the second geometric shape being projected in augmented reality during the projection step, in augmented reality on the at least one displayed image, of the at least one second point”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the assessment of geometric shapes. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 5 is ineligible.
Claim 6 is 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 a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein a straight line segment connecting the at least one first point to the at least one second point is displayed as a function of a distance between the at least one first point and the at least one second point”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the assessment of distance between points. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 6 is ineligible.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 7 recites the following elements: “wherein the predetermined point of the surface of the body is predetermined so that a position and an orientation, in the fixed reference frame relative to the patient's body, the surface of the support disposed at the predetermined point is stable over time, and repeatable, i.e. when the step of placing the support at the predetermined point of the surface of the patient's body is repeated several times in succession, a standard deviation of the position of the surface of the support is less than a deviation in position and a standard deviation of the orientation of the surface of the support is less than a deviation in orientation”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 7 is ineligible.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 8 recites the following elements: “the recorded position and the recorded direction of the probe being defined by a first user when the probe is held in the hand of the first user in a current position and according to a current direction, the step of determining the current position and the current direction of the probe in the reference frame, from the second markers identifiable on the at least one image comprising a step of recording the current position of the probe and the current orientation”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 8 is ineligible.
Claim 9 is 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 a system for guiding a user holding in one hand a probe configured for ultrasound observation of a body of a patient and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “at least one first point corresponding to a vertex of a polygon disposed in a first plane transverse to a recorded direction of the probe, so that a central area of the polygon is crossed by a straight line parallel to the recorded direction of the probe and passing through the recorded position of the probe, and to display in the at least one image in augmented reality at least one second point corresponding to the vertex of the polygon disposed in a second plane transverse to the current direction of the probe, so that a central area of the polygon is crossed by a straight line parallel to the current direction of the probe and passing through the current position of the probe, the user holding the probe in a hand being guided by the display to make the at least one first point coincide with the at least one second point in the at least one displayed image, by displacing the probe to a new current position and a new current direction so as to gradually make the new current position and the new current direction of the probe coincide with the recorded position and the recorded direction of the probe”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the determinations of reference frames, position, orientation, and the points with respect to the probe direction and position over time. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “the system comprising the probe provided with a first object secured to the probe, the first object comprising first markers on the surface of the first object, the system also comprising a second object comprising second markers on the surface of the second object, the system comprising a support placed at a predetermined point of the surface of the patient's body observed with the probe, the second object being placed on a surface of the support configured to maintain the second object in a predetermined position and orientation of the second object relative to a fixed reference frame relative to the patient's body, the system further comprising a camera configured to observe in its field the probe, the first object, and the second object, the system comprising a display device configured to receive at least one image acquired by the camera, the display device being configured to display the at least one image acquired by the camera, and to display in the at least one image in augmented reality; ”. Collection of the image data and the placement of objects is a data gather step which is a form of a pre-solution insignificant activity. The display and use of AR is a display step that merely amounts to a post-solution insignificant activity.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 9 is ineligible.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 4-9 are as best understood in light of the 112(b) rejections, rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anthony et al. (PGPUB No. US 2013/0296707).
Regarding claim 1, Anthony teaches a method for guiding a user holding in one hand a probe configured for ultrasound observation of a body of a patient (Paragraph 0006 teaches an ultrasound scanning system includes a graphical user interface that provides visually intuitive feedback to a user to assist the user in properly aligning an ultrasound scanner to a desired acquisition state. In addition to providing pose information, the feedback may direct the user as to a target contact force applied by the ultrasound scanner to a surface undergoing a scan. Fig. 18), the probe being provided with a first object secured to the probe (Paragraph 0031 teaches a frame may include any substantially rigid structure that receives and holds the probe in a fixed position and orientation relative to the frame), the first object comprising first markers on the surface of the first object (Paragraph 0045 teaches the camera may be mounted separate from the ultrasound probe and directed toward an area of use of the ultrasound probe so that the camera can capture images of the ultrasound probe in order to derive pose information directly from images of the ultrasound probe. Paragraph 0031 teaches a frame may include any substantially rigid structure that receives and holds the probe in a fixed position and orientation relative to the frame), the probe being held in a current position and according to a current direction, a display device configured to receive at least one image acquired by a camera configured to observe in its field the probe, the first object, and a second object comprising second markers on the surface of the second object, the user being guided towards a recorded position and a recorded direction of the probe (Paragraph 0140 teaches while such an approach may be used without additional visual elements, the approach may be improved by providing a reference object within the graphical representation 1700 that represents a target pose and/or contact force for an ultrasound probe. For the projected pyramid described above, the reference image may, for example, include a square with an `X` as shown in FIG. 13. By including this reference image, a user of an ultrasound probe may receive an intuitive visual representation of a difference between a target acquisition state and a current acquisition state of an ultrasound probe operated by the user. Figs. 2, 16, and 18. Paragraph 0147 teaches the target pose information may, for example, include at least one of a target position, a target orientation, and a target rotation for the ultrasound probe. The target pose information may be associated with a previous scan, the target pose information being stored in memory in order to guide a user to a previous scan state, or the target pose information may be manually entered by a user in order to guide a user to a manually selected state. More generally, the target pose information may be any useful reference point to which an ultrasound probe might be directed), the method comprising the following steps:
placing a support at a predetermined point of a surface of the patient's body observed with the probe, the support being configured to receive on a surface of the support the second object by maintaining the second object in a predetermined position and orientation of the second object relative to a fixed reference frame relative to the patient's body (Paragraph 0047 teaches the ultrasound probe may be used to capture an ultrasound image of a target through a skin surface. A fiducial marker with predetermined dimensions may be applied to the skin surface of the target that is to be scanned by the ultrasound probe. The fiducial marker may have any desired dimension or shape such as a square, a rectangle, a circle and/or any other regular, irregular, and/or random shape and/or patterns. The fiducial marker may be made of a thin material. Suitable materials include, but are not limited to, any materials that will not obstruct the transducer from obtaining an ultrasound scan of the target. The fiducial marker may be adhered to the skin surface of a target using any suitable methods and/or any suitable adhesives. In another aspect, the fiducial marker may be stamped, inked or otherwise applied to the skin surface using ink or any other suitable, visually identifiable marking material(s). Paragraph 0131 teaches Fig. 10 shows a fiducial marker that may be used with the techniques described above. The fiducial marker 1000 may be applied to a skin surface of a target as a sticker, or using ink or any other suitable marking technique);
placing the second object on the surface of the support, so that the second object is maintained in a predetermined position and orientation relative to the reference frame fixed relative to the patient's body (Paragraph 0047 teaches the ultrasound probe may be used to capture an ultrasound image of a target through a skin surface. A fiducial marker with predetermined dimensions may be applied to the skin surface of the target that is to be scanned by the ultrasound probe. The fiducial marker may have any desired dimension or shape such as a square, a rectangle, a circle and/or any other regular, irregular, and/or random shape and/or patterns. The fiducial marker may be made of a thin material. Suitable materials include, but are not limited to, any materials that will not obstruct the transducer from obtaining an ultrasound scan of the target. The fiducial marker may be adhered to the skin surface of a target using any suitable methods and/or any suitable adhesives. In another aspect, the fiducial marker may be stamped, inked or otherwise applied to the skin surface using ink or any other suitable, visually identifiable marking material(s). Paragraph 0131 teaches Fig. 10 shows a fiducial marker that may be used with the techniques described above. The fiducial marker 1000 may be applied to a skin surface of a target as a sticker, or using ink or any other suitable marking technique);
acquiring at least one image with the camera (Paragraph 0045 teaches the camera may be mounted separate from the ultrasound probe and directed toward an area of use of the ultrasound probe so that the camera can capture images of the ultrasound probe in order to derive pose information directly from images of the ultrasound probe. Paragraph 0122 teaches after the points or other features on the fiducial marker are selected, the corresponding features may be identified for each digital image where the fiducial marker is present. In general, the fiducial marker may be visible in at least one of the plurality of digital images (and not necessarily the first image), although it is also possible to recover camera pose entirely based on features other than the fiducial marker. The planar homography matrix from image i to the previous image may be calculated. The correspondences between consecutive images may be extracted using any suitable technique such as scale-invariant feature transform (SIFT));
determining the reference frame, from the second markers identifiable by processing the at least one image, the recorded position and the recorded direction of the probe being defined in the reference frame (Paragraph 0102 teaches the processor may be programmed to identify one or more predetermined features (such as the fiducial marker and/or other features on the skin surface of the target) and calculate a pose of the handheld ultrasound probe using the one or more predetermined features in an image from the camera. In this manner, a number of camera images, each associated with one of a number of ultrasound images, may be used to align the number of ultrasound images in a world coordinate system. The images, when so aligned, may be combined to obtain a reconstructed volume of the target. Paragraph 0117 teaches once a world coordinate system is established (which may be arbitrarily selected or related to specific elements of the ultrasound system and/or the target), a three-dimensional motion of the handheld ultrasound probe with respect to the skin surface for the digital image may be estimated and the pose may be expressed within the world coordinates);
in the reference frame, determining coordinates of at least one first point corresponding to a vertex of a polygon disposed in a first plane transverse to the recorded direction of the probe, such that a central area of the polygon is crossed by a straight line parallel to the recorded direction of the probe and passing through the recorded position of the probe (Paragraph 0141 teaches Fig. 18depicts a display using a graphical representation during user operation of an ultrasound probe. As described above, the user interface may display a graphical representation containing a reference image and a current image. By seeking to align the current image with the reference image. In a first step, a user may rotate an ultrasound probe along its access, causing a corresponding rotation of the current image as shown in a second, updated instance of the user interface. A user may then increase (or decrease) contact force resulting in corresponding changes to a scale of the current image, as generally depicted in a third instance of the user interface. Finally, a user may pivot the ultrasound probe about a point of contact with a target surface, thus bringing the current image into alignment with the reference image. Paragraph 0142 teaches the system may determine when the ultrasound probe is suitably aligned with a target pose and contact force. This may, for example, be determined based on quantitative data for the pose and contact force stored in the system, or based upon visual analysis of the current image and reference image. Thus, for example, the probe may be considered adequately aligned or "substantially" aligned when the reference image is within three pixels of the current image throughout. The images may be appropriately scaled so that this visual difference of three pixels within the interface correspondence to a suitable physical alignment of the ultrasound probe to a target acquisition state. Paragraph 0143 teaches it will be appreciated that, while a pyramid is depicted, any other suitable graphic may be employed for the reference image and the current image without departing from the scope of this disclosure, provided such images provide useful visual feedback to a user when operating an ultrasound probe to recover a target acquisition state);
displaying the at least one image on the display device (Fig. 18);
projection, in augmented reality on the at least one displayed image, the at least one first point; determining the current position and the current direction of the probe in the reference frame, from the first markers identifiable by another processing of the at least one image (Fig. 18. Paragraph 0148 teaches as shown in step 1906, the process 1900 may include displaying a graphical representation of the target acquisition state relative to the current acquisition state. As described above, the graphical representation may include a first graphic or image corresponding to the target acquisition state and a second graphic or image representing the current acquisition state. The second graphic may be geometrically similar to and superimposed on the first graphic for intuitive user interpretation of the display. One of the images may be scaled, skewed, transformed or the like to provide user feedback to recover an acquisition state. For example, the second graphic may be scaled according to a difference between the current instantaneous contact force and the target instantaneous contact force. The second graphic may also or instead be geometrically transformed according to a difference between the current pose information and the target pose information);
determining coordinates in the reference frame of at least one second point, the at least one second point corresponding to the vertex of the polygon placed in a second plane transverse to the current direction of the probe, so that a central area of the polygon is crossed by a straight line parallel to the current direction of the probe and passing through the current position of the probe (Paragraph 0141 teaches Fig. 18depicts a display using a graphical representation during user operation of an ultrasound probe. As described above, the user interface may display a graphical representation containing a reference image and a current image. By seeking to align the current image with the reference image. In a first step, a user may rotate an ultrasound probe along its access, causing a corresponding rotation of the current image as shown in a second, updated instance of the user interface. A user may then increase (or decrease) contact force resulting in corresponding changes to a scale of the current image, as generally depicted in a third instance of the user interface. Finally, a user may pivot the ultrasound probe about a point of contact with a target surface, thus bringing the current image into alignment with the reference image. Paragraph 0142 teaches the system may determine when the ultrasound probe is suitably aligned with a target pose and contact force. This may, for example, be determined based on quantitative data for the pose and contact force stored in the system, or based upon visual analysis of the current image and reference image. Thus, for example, the probe may be considered adequately aligned or "substantially" aligned when the reference image is within three pixels of the current image throughout. The images may be appropriately scaled so that this visual difference of three pixels within the interface correspondence to a suitable physical alignment of the ultrasound probe to a target acquisition state. Paragraph 0143 teaches it will be appreciated that, while a pyramid is depicted, any other suitable graphic may be employed for the reference image and the current image without departing from the scope of this disclosure, provided such images provide useful visual feedback to a user when operating an ultrasound probe to recover a target acquisition state):
projecting, in augmented reality onto the at least one displayed image, the at least one second point (Fig. 18. Paragraph 0148 teaches as shown in step 1906, the process 1900 may include displaying a graphical representation of the target acquisition state relative to the current acquisition state. As described above, the graphical representation may include a first graphic or image corresponding to the target acquisition state and a second graphic or image representing the current acquisition state. The second graphic may be geometrically similar to and superimposed on the first graphic for intuitive user interpretation of the display. One of the images may be scaled, skewed, transformed or the like to provide user feedback to recover an acquisition state. For example, the second graphic may be scaled according to a difference between the current instantaneous contact force and the target instantaneous contact force. The second graphic may also or instead be geometrically transformed according to a difference between the current pose information and the target pose information);
bringing the probe into a new current position and a new current direction so that a new projection in augmented reality of the at least one second point corresponding to the vertex of the polygon disposed in a new second plane transverse to the new current direction of the probe, a central area of the polygon being crossed by a straight line parallel to the new current direction of the probe and passing through the new current position of the probe, the new projection being closer to the projection of the at least one first point than to the projection of the at least one second point, until the at least one second point and the at least one first point coincide, and thus the new current position and the new current direction coincide with the recorded position and the recorded direction, the projection and new projection in augmented reality steps of the at least one second point being produced in real time as the probe is displaced (Fig. 18. Paragraph 0148 teaches as shown in step 1906, the process 1900 may include displaying a graphical representation of the target acquisition state relative to the current acquisition state. As described above, the graphical representation may include a first graphic or image corresponding to the target acquisition state and a second graphic or image representing the current acquisition state. The second graphic may be geometrically similar to and superimposed on the first graphic for intuitive user interpretation of the display. One of the images may be scaled, skewed, transformed or the like to provide user feedback to recover an acquisition state. For example, the second graphic may be scaled according to a difference between the current instantaneous contact force and the target instantaneous contact force. The second graphic may also or instead be geometrically transformed according to a difference between the current pose information and the target pose information).
Regarding claim 4, Anthony teaches the method in claim 1, as discussed above.
Anthony further teaches a method, wherein:
the at least one first point comprises four first points each corresponding to four vertices of the polygon disposed in the first plane transverse to the recorded direction of the probe, so that the central area of the polygon is crossed by the straight line parallel to the recorded direction of the probe and passing through the recorded position of the probe (Figs. 12-18. Paragraph 0148 teaches as shown in step 1906, the process 1900 may include displaying a graphical representation of the target acquisition state relative to the current acquisition state. As described above, the graphical representation may include a first graphic or image corresponding to the target acquisition state and a second graphic or image representing the current acquisition state. The second graphic may be geometrically similar to and superimposed on the first graphic for intuitive user interpretation of the display. One of the images may be scaled, skewed, transformed or the like to provide user feedback to recover an acquisition state. For example, the second graphic may be scaled according to a difference between the current instantaneous contact force and the target instantaneous contact force. The second graphic may also or instead be geometrically transformed according to a difference between the current pose information and the target pose information), and
the at least one second point comprises four second points each corresponding to the four vertices of the polygon disposed in the second plane transverse to the current direction of the probe, so that the central area of the polygon is crossed by the straight line parallel to the current direction of the probe and passing through the current position of the probe (Figs. 12-18. Paragraph 0148 teaches as shown in step 1906, the process 1900 may include displaying a graphical representation of the target acquisition state relative to the current acquisition state. As described above, the graphical representation may include a first graphic or image corresponding to the target acquisition state and a second graphic or image representing the current acquisition state. The second graphic may be geometrically similar to and superimposed on the first graphic for intuitive user interpretation of the display. One of the images may be scaled, skewed, transformed or the like to provide user feedback to recover an acquisition state. For example, the second graphic may be scaled according to a difference between the current instantaneous contact force and the target instantaneous contact force. The second graphic may also or instead be geometrically transformed according to a difference between the current pose information and the target pose information. Abstract teaches an ultrasound scanning system includes a graphical user interface that provides visually intuitive feedback to a user to assist the user in properly aligning an ultrasound scanner to a desired acquisition state).
Regarding claim 5, Anthony teaches the method in claim 1, as discussed above.
Anthony further teaches a method, wherein:
a first geometric shape is associated with the at least one first point, the first geometric shape being projected in augmented reality during the projection step, in augmented reality on the at least one displayed image, of the at least one first point (Figs. 12-18. Paragraph 0148 teaches as shown in step 1906, the process 1900 may include displaying a graphical representation of the target acquisition state relative to the current acquisition state. As described above, the graphical representation may include a first graphic or image corresponding to the target acquisition state and a second graphic or image representing the current acquisition state. The second graphic may be geometrically similar to and superimposed on the first graphic for intuitive user interpretation of the display. One of the images may be scaled, skewed, transformed or the like to provide user feedback to recover an acquisition state. For example, the second graphic may be scaled according to a difference between the current instantaneous contact force and the target instantaneous contact force. The second graphic may also or instead be geometrically transformed according to a difference between the current pose information and the target pose information), and
a second geometric shape is associated with the at least one second point, the second geometric shape being projected in augmented reality during the projection step, in augmented reality on the at least one displayed image, of the at least one second point (Figs. 12-18. Paragraph 0148 teaches as shown in step 1906, the process 1900 may include displaying a graphical representation of the target acquisition state relative to the current acquisition state. As described above, the graphical representation may include a first graphic or image corresponding to the target acquisition state and a second graphic or image representing the current acquisition state. The second graphic may be geometrically similar to and superimposed on the first graphic for intuitive user interpretation of the display. One of the images may be scaled, skewed, transformed or the like to provide user feedback to recover an acquisition state. For example, the second graphic may be scaled according to a difference between the current instantaneous contact force and the target instantaneous contact force. The second graphic may also or instead be geometrically transformed according to a difference between the current pose information and the target pose information).
Regarding claim 6, Anthony teaches the method in claim 1, as discussed above.
Anthony further teaches a method, wherein a straight line segment connecting the at least one first point to the at least one second point is displayed as a function of a distance between the at least one first point and the at least one second point (Figs. 12-18. Paragraph 0136 teaches the pyramid, which may be a four-sided pyramid or any other shape, may be used as a convenient and intuitive graphical representation for pose information and instantaneous contact force for an ultrasound probe. When viewed from the top (as shown in FIG. 13), the pyramid appears as a square with an X in the middle. As a perspective on the pyramid varies, a two-dimensional projection of the pyramid provides visual information concerning relative pose (position, orientation, and in the case of an ultrasound probe, axial rotation). For example, when rotated about an axis passing through the apex of the pyramid, the resulting projection appears rotated as shown in FIG. 14. In order to resolve any rotational ambiguity associated with a projection that has one or more axes of symmetry, each edge of the graphical representation may be rendered in a different color. Thus for example, a first edge may be rendered in red, a second edge may be rendered in green, and so forth. Any other suitable technique be used to visually encode rotational information so that a unique rotational orientation can be determined. For example, one side may be rendered using a heavier line, or include an "x" across the line, a break in the line, an "s" or other distinguishable feature in the line, or any other visualization to uniquely identify a particular one of the edges).
Regarding claim 7, Anthony teaches the method in claim 1, as discussed above.
Anthony further teaches a method, wherein the predetermined point of the surface of the body is predetermined so that a position and an orientation, in the fixed reference frame relative to the patient's body, the surface of the support disposed at the predetermined point is stable over time, and repeatable, i.e. when the step of placing the support at the predetermined point of the surface of the patient's body is repeated several times in succession, a standard deviation of the position of the surface of the support is less than a deviation in position and a standard deviation of the orientation of the surface of the support is less than a deviation in orientation (Paragraph 0047 teaches the ultrasound probe may be used to capture an ultrasound image of a target through a skin surface. A fiducial marker with predetermined dimensions may be applied to the skin surface of the target that is to be scanned by the ultrasound probe. The fiducial marker may have any desired dimension or shape such as a square, a rectangle, a circle and/or any other regular, irregular, and/or random shape and/or patterns. The fiducial marker may be made of a thin material. Suitable materials include, but are not limited to, any materials that will not obstruct the transducer from obtaining an ultrasound scan of the target. The fiducial marker may be adhered to the skin surface of a target using any suitable methods and/or any suitable adhesives. In another aspect, the fiducial marker may be stamped, inked or otherwise applied to the skin surface using ink or any other suitable, visually identifiable marking material(s). Paragraph 0131 teaches Fig. 10 shows a fiducial marker that may be used with the techniques described above. The fiducial marker 1000 may be applied to a skin surface of a target as a sticker, or using ink or any other suitable marking technique).
Regarding claim 8, Anthony teaches the method in claim 1, as discussed above.
Anthony further teaches a method, the recorded position and the recorded direction of the probe being defined by a first user when the probe is held in the hand of the first user in a current position and according to a current direction, the step of determining the current position and the current direction of the probe in the reference frame, from the second markers identifiable on the at least one image comprising a step of recording the current position of the probe and the current orientation (Fig. 18. Paragraph 0148 teaches as shown in step 1906, the process 1900 may include displaying a graphical representation of the target acquisition state relative to the current acquisition state. As described above, the graphical representation may include a first graphic or image corresponding to the target acquisition state and a second graphic or image representing the current acquisition state. The second graphic may be geometrically similar to and superimposed on the first graphic for intuitive user interpretation of the display. One of the images may be scaled, skewed, transformed or the like to provide user feedback to recover an acquisition state. For example, the second graphic may be scaled according to a difference between the current instantaneous contact force and the target instantaneous contact force. The second graphic may also or instead be geometrically transformed according to a difference between the current pose information and the target pose information).
Regarding claim 9, Anthony teaches a system for guiding a user holding in one hand a probe configured for ultrasound observation of a body of a patient, the system comprising the probe provided with a first object secured to the probe, the first object comprising first markers on the surface of the first object, the system also comprising a second object comprising second markers on the surface of the second object, the system comprising a support placed at a predetermined point of the surface of the patient's body observed with the probe, the second object being placed on a surface of the support configured to maintain the second object in a predetermined position and orientation of the second object relative to a fixed reference frame relative to the patient's body, the system further comprising a camera configured to observe in its field the probe, the first object, and the second object, the system comprising a display device configured to receive at least one image acquired by the camera, the display device being configured to display the at least one image acquired by the camera, and to display in the at least one image in augmented reality at least one first point corresponding to a vertex of a polygon disposed in a first plane transverse to a recorded direction of the probe, so that a central area of the polygon is crossed by a straight line parallel to the recorded direction of the probe and passing through the recorded position of the probe, and to display in the at least one image in augmented reality at least one second point corresponding to the vertex of the polygon disposed in a second plane transverse to the current direction of the probe, so that a central area of the polygon is crossed by a straight line parallel to the current direction of the probe and passing through the current position of the probe, the user holding the probe in a hand being guided by the display to make the at least one first point coincide with the at least one second point in the at least one displayed image, by displacing the probe to a new current position and a new current direction so as to gradually make the new current position and the new current direction of the probe coincide with the recorded position and the recorded direction of the probe (Paragraph 0006 teaches an ultrasound scanning system includes a graphical user interface that provides visually intuitive feedback to a user to assist the user in properly aligning an ultrasound scanner to a desired acquisition state. In addition to providing pose information, the feedback may direct the user as to a target contact force applied by the ultrasound scanner to a surface undergoing a scan. Fig. 18. Paragraph 0045 teaches the camera may be mounted separate from the ultrasound probe and directed toward an area of use of the ultrasound probe so that the camera can capture images of the ultrasound probe in order to derive pose information directly from images of the ultrasound probe. Paragraph 0031 teaches a frame may include any substantially rigid structure that receives and holds the probe in a fixed position and orientation relative to the frame. Paragraph 0140 teaches while such an approach may be used without additional visual elements, the approach may be improved by providing a reference object within the graphical representation 1700 that represents a target pose and/or contact force for an ultrasound probe. For the projected pyramid described above, the reference image may, for example, include a square with an `X` as shown in FIG. 13. By including this reference image, a user of an ultrasound probe may receive an intuitive visual representation of a difference between a target acquisition state and a current acquisition state of an ultrasound probe operated by the user. Figs. 2, 16, and 18. Paragraph 0147 teaches the target pose information may, for example, include at least one of a target position, a target orientation, and a target rotation for the ultrasound probe. The target pose information may be associated with a previous scan, the target pose information being stored in memory in order to guide a user to a previous scan state, or the target pose information may be manually entered by a user in order to guide a user to a manually selected state. More generally, the target pose information may be any useful reference point to which an ultrasound probe might be directed. Paragraph 0047 teaches the ultrasound probe may be used to capture an ultrasound image of a target through a skin surface. A fiducial marker with predetermined dimensions may be applied to the skin surface of the target that is to be scanned by the ultrasound probe. The fiducial marker may have any desired dimension or shape such as a square, a rectangle, a circle and/or any other regular, irregular, and/or random shape and/or patterns. The fiducial marker may be made of a thin material. Suitable materials include, but are not limited to, any materials that will not obstruct the transducer from obtaining an ultrasound scan of the target. The fiducial marker may be adhered to the skin surface of a target using any suitable methods and/or any suitable adhesives. In another aspect, the fiducial marker may be stamped, inked or otherwise applied to the skin surface using ink or any other suitable, visually identifiable marking material(s). Paragraph 0131 teaches Fig. 10 shows a fiducial marker that may be used with the techniques described above. The fiducial marker 1000 may be applied to a skin surface of a target as a sticker, or using ink or any other suitable marking technique. Paragraph 0122 teaches after the points or other features on the fiducial marker are selected, the corresponding features may be identified for each digital image where the fiducial marker is present. In general, the fiducial marker may be visible in at least one of the plurality of digital images (and not necessarily the first image), although it is also possible to recover camera pose entirely based on features other than the fiducial marker. The planar homography matrix from image i to the previous image may be calculated. The correspondences between consecutive images may be extracted using any suitable technique such as scale-invariant feature transform (SIFT). Paragraph 0102 teaches the processor may be programmed to identify one or more predetermined features (such as the fiducial marker and/or other features on the skin surface of the target) and calculate a pose of the handheld ultrasound probe using the one or more predetermined features in an image from the camera. In this manner, a number of camera images, each associated with one of a number of ultrasound images, may be used to align the number of ultrasound images in a world coordinate system. The images, when so aligned, may be combined to obtain a reconstructed volume of the target. Paragraph 0117 teaches once a world coordinate system is established (which may be arbitrarily selected or related to specific elements of the ultrasound system and/or the target), a three-dimensional motion of the handheld ultrasound probe with respect to the skin surface for the digital image may be estimated and the pose may be expressed within the world coordinates. Paragraph 0141 teaches Fig. 18depicts a display using a graphical representation during user operation of an ultrasound probe. As described above, the user interface may display a graphical representation containing a reference image and a current image. By seeking to align the current image with the reference image. In a first step, a user may rotate an ultrasound probe along its access, causing a corresponding rotation of the current image as shown in a second, updated instance of the user interface. A user may then increase (or decrease) contact force resulting in corresponding changes to a scale of the current image, as generally depicted in a third instance of the user interface. Finally, a user may pivot the ultrasound probe about a point of contact with a target surface, thus bringing the current image into alignment with the reference image. Paragraph 0142 teaches the system may determine when the ultrasound probe is suitably aligned with a target pose and contact force. This may, for example, be determined based on quantitative data for the pose and contact force stored in the system, or based upon visual analysis of the current image and reference image. Thus, for example, the probe may be considered adequately aligned or "substantially" aligned when the reference image is within three pixels of the current image throughout. The images may be appropriately scaled so that this visual difference of three pixels within the interface correspondence to a suitable physical alignment of the ultrasound probe to a target acquisition state. Paragraph 0143 teaches it will be appreciated that, while a pyramid is depicted, any other suitable graphic may be employed for the reference image and the current image without departing from the scope of this disclosure, provided such images provide useful visual feedback to a user when operating an ultrasound probe to recover a target acquisition state. Fig. 18. Paragraph 0148 teaches as shown in step 1906, the process 1900 may include displaying a graphical representation of the target acquisition state relative to the current acquisition state. As described above, the graphical representation may include a first graphic or image corresponding to the target acquisition state and a second graphic or image representing the current acquisition state. The second graphic may be geometrically similar to and superimposed on the first graphic for intuitive user interpretation of the display. One of the images may be scaled, skewed, transformed or the like to provide user feedback to recover an acquisition state. For example, the second graphic may be scaled according to a difference between the current instantaneous contact force and the target instantaneous contact force. The second graphic may also or instead be geometrically transformed according to a difference between the current pose information and the target pose information. Abstract teaches an ultrasound scanning system includes a graphical user interface that provides visually intuitive feedback to a user to assist the user in properly aligning an ultrasound scanner to a desired acquisition state).
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.
Claims 2-3 are, as best understood in light of the 112(b) rejections, rejected under 35 U.S.C. 103 as being unpatentable over Anthony et al. (PGPUB No. US 2013/0296707) in view of Wang et al. (PGPUB No. US 2016/0166333).
Regarding claim 2, Anthony teaches the method in claim 1, as discussed above.
However, Anthony is silent regarding a method, wherein the first object is a first cube comprising the first markers on the faces of the cube.
In an analogous imaging field of endeavor, regarding position tracking for ultrasound imaging, Wang teaches a method, wherein the first object is a first cube comprising the first markers on the faces of the cube (Paragraph 0187 teaches the surfaces of the fiducial marker cube may include a highly distinctive QR code pattern with unique patterned surfaces which may include alternating designs).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Anthony with Wang’s teaching of tracking based on QR codes. This modified method would allow the user to improve several clinical applications and procedures (Paragraphs 0014-15 of Wang). Furthermore, the modification results in a trackable pattern that is highly distinctive (Paragraph 0187 of Wang).
Regarding claim 3, Anthony teaches the method in claim 1, as discussed above.
However, Anthony is silent regarding a method, wherein the second object is a second cube comprising the second markers on the faces of the second cube.
In an analogous imaging field of endeavor, regarding position tracking for ultrasound imaging, Wang teaches a method, wherein the second object is a second cube comprising the second markers on the faces of the second cube (Paragraph 0187 teaches the surfaces of the fiducial marker cube may include a highly distinctive QR code pattern with unique patterned surfaces which may include alternating designs).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Anthony with Wang’s teaching of tracking based on QR codes. This modified method would allow the user to improve several clinical applications and procedures (Paragraphs 0014-15 of Wang). Furthermore, the modification results in a trackable pattern that is highly distinctive (Paragraph 0187 of Wang).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ishikawa et al. (PGPUB No. US 2014/0037168): Teaches alignment with respect to vertices for ultrasound imaging.
Boctor et al. (PGPUB No. US 2013/0218024): Teaches the tracking of an ultrasound probe position and orientation.
Southworth et al. (PGPUB No. US 2022/0354462): Teaches the tracking of an ultrasound probe position and orientation.
Shekhar et al. (PGPUB No. US 2009/0161938): Teaches alignment with respect to vertices for ultrasound imaging.
Rothberg et al. (PGPUB No. US 2013/0116561): Teaches alignment with respect to vertices for ultrasound imaging.
McLaughlin et al. (PGPUB No. US 2022/0117582): Teaches the tracking of an ultrasound probe and consideration of a polygon.
Shekhar et al. (PGPUB No. US 2020/0197102): Teaches tracking based on a QR code.
Kadoury et al. (PGPUB No. US 2014/0193053): Teaches alignment with respect to vertices for ultrasound imaging.
Shirazian et al. (PGPUB No. US 2020/0161004): Teaches alignment with respect to vertices for ultrasound imaging.
Vincent et al. (PGPUB No. US 2012/0070051): Teaches ultrasound probe tracking and imaging with respect a target.
Wen et al. (PGPUB No. US 2017/0245837): Teaches alignment with respect to points for ultrasound imaging.
Mahfouz (PGPUB No. US 2017/0367766): Teaches the tracking of an ultrasound probe position and orientation and alignment with respect to vertices for ultrasound imaging.
Mahfouz (PGPUB No. US 2017/0347991): Teaches the tracking of an ultrasound probe position and orientation and alignment with respect to vertices for ultrasound imaging.
Mahfouz et al. (PGPUB No. US 2013/0144135): Teaches the tracking of an ultrasound probe position and orientation and alignment with respect to vertices for ultrasound imaging.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADIL PARTAP S VIRK whose telephone number is (571)272-8569. The examiner can normally be reached Mon-Fri 8-5.
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, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1 Link: https://byjus.com/maths/standard-deviation/
2 Link: https://byjus.com/maths/standard-deviation/
Prosecution Insights