DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, 6, 8-10, 16-17, and 20 are objected to because of the following informalities:
In claim 1, line 12, the “identified” should read “specified”.
In claim 6, line 2, “the structure” should read “the predetermined structure”.
In claim 8, line 3, “the human body” should read “a human body”.
In claims 9-10, line 5, “satisfy” should read “satisfying”.
In claim 16, line 5, “an operator” should read “the operator”.
In claim 16, line 7, “a predetermined value” should read “the predetermined value”.
In claim 17, line 4, “the time” should read “a time”.
In claim 20, line 10, the “specified” should read ”identified”.
Appropriate correction is required.
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 8 and 11-17 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 pre-AIA the applicant regards as the invention.
Claim 8 recites "the structure” in line 3. It is unclear whether or not this a reference to the “at least a first structure and a second structure” in claim 7 or the predetermined structure in claim 1. For examination purposes, Examiner of records takes this to be at least the first structure and the second structure.
Claim 13 recites the "second score” in lines 5-6 and 8-9. It is unclear how many scores the applicant is attempting to claim. For examination purposes, Examiner of records takes this to be --a first score--.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1-6 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Deischinger et al (US 20220061798), hereinafter Deischinger, in view of Vega et al (US 20240273726), hereinafter Vega.
Regarding claim 1, Deischinger teaches an ultrasound image generation system (100) (200) for displaying an ultrasound image (300) on a display device (116) (260) (“shown in the screenshot 300 is an ultrasound (e.g., B-Mode) image 310 obtained during ultrasound imaging/examination (e.g., of a fetus).” [0061]), the ultrasound image generation system comprising:
a memory storing instructions (“one or more of the functional blocks (e.g., processors or memories) may be implemented in a single piece of hardware (e.g., a general purpose signal processor or a block of random access memory, hard disk, or the like) or multiple pieces of hardware. Similarly, the programs may be stand-alone programs, may be incorporated as subroutines in an operating system, may be functions in an installed software package” [0015]);
a processor (240) configured to execute the instructions to:
analyze a first ultrasound image (310) of an ultrasound probe (204) (“an ultrasound (e.g., B-Mode) image 310 obtained during ultrasound imaging/examination” [0061]) at a first time (“time” [0061]; a first time on the “time axis” [0061]) to specify a predetermined structure (the “structure captured in the B-Mode” [0061]) (“the signal processor 240 may be trained to identify particular structures … (or types thereof) provided in an ultrasound scan plane,” [0052]; “the processor is further configured to automatically identify the at least one structure of the heart, based on processing of the at least one of the one or more medical images or the imaging data.” [0082] Fig. 2) within an imaging subject (“fetus” [0061]) (“an ultrasound probe 204, …, a RF processor 224, …, a signal processor 240,” [0034]; Fig. 2);
specify a first position (320) in the first ultrasound image of the predetermined structure (“a particular line 320 (referred to hereafter as “analysis line”) through the heart” [0061]; Fig. 3);
output a first area indicator (any vertical line in the “M-mode image 330” [0062] serves as an area indicator, with the vertical line corresponding to the first time being a first area indicator) having an attribute (340) (a position on the vertical axis in the “M-mode image 330” [0062]) corresponding to a first area (the area of the heart in b-mode image 310 at a first time) in the first ultrasound image of the predetermined structure (“the x-axis in the M-mode image 330 represent the time axis, thus allowing for tracking of changes area corresponding to the analysis line 320 through time.” [0061]; Fig. 3);
output a second area indicator (a vertical line in the “M-mode image 330” [0062] corresponding to the second time) having an attribute (340) (a position on the vertical axis in the “M-mode image 330” [0062]) corresponding to a second area (the area of the heart in b-mode image 310 at a second time) in a second ultrasound image (310) at a second time point of the predetermined structure (a second time point corresponds for example to a position of the second caliper 340 in Fig. 3 [0062]) in a manner that a change over time with respect to the first area indicator is recognizable (“A corresponding time motion M-mode image 330 (e.g., “anatomical M-Mode” image as shown in FIG. 3…Thus, the M-mode image 330 represents time-scale (that is time-based) of a cross-sectional area in a body part or structure captured in the B-Mode, and therefore show time-scale based changes or movement in that area. In other words, the x-axis in the M-mode image 330 represent the time axis, thus allowing for tracking of changes area corresponding to the analysis line 320 through time.” [0061]; Fig. 3).
Deischinger does not teach a processor configured to execute the instructions to:
output guide information for instructing an operator who operates the ultrasound probe to move the ultrasound probe to a position where an ultrasound image in which the predetermined structure is displayed more favorably can be obtained, based on the identified first position.
However, in the ultrasound imaging systems field of endeavor, Vega discloses device agnostic systems and methods for acquiring and analyzing images from an ultrasound probe, which is analogous art. Vega teaches a processor configured to execute the instructions to:
output guide information for instructing an operator (“the user” [0113]) who operates the ultrasound probe (“instructions to be displayed” [0113]) to move the ultrasound probe to a position where an ultrasound image in which the predetermined structure is displayed more favorably can be obtained, based on the identified first position (“the computing device computes (e.g., measures) a respective distance between an acquired image in a probe-position space (e.g., a six-dimensional space indicating the (x, y, z) position and rotations in the x-, y-, and z-axis with respect to the 3D model of the anatomical structure of interest) and a predicted plane in a probe-position space that would provide a better image, and determines, based on the computation, a sequence of steps that will guide the user to acquire the better image. In some embodiments, the computing device causes the sequence of steps or instructions to be displayed on a display device that is communicatively connected with the ultrasound probe.” [0113]).
Therefore, based on Vega’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Deischinger to employ a processor configured to execute the instructions to:
output guide information for instructing an operator who operates the ultrasound probe to move the ultrasound probe to a position where an ultrasound image in which the predetermined structure is displayed more favorably can be obtained, based on the identified first position, as taught by Vega, in order to facilitate ultrasonic imaging of the target.
Regarding claim 2, Deischinger modified by Vega teaches the ultrasound image generation system according to claim 1.
Deischinger teaches the display device and the ultrasound probe (Figs. 1-2),
wherein the first area indicator and the second area indicator are displayed simultaneously on the display device (calipers 340 or vertical lines in the “M-mode image 330” [0062] corresponding to the two calipers in Fig. 3); and
wherein the attribute includes any of a shape, coordinate position (“the system user may optimize the quality of the M-mode image 330, such as by carefully selecting the analysis line 320 to run through or bisect a particular structure (e.g., one of the ventricles of the heart), to enable tracking motion of that structure, which allows tracking motion of the heart (vs. time).” [0062]. Note that “motion” causes a change in the coordinate position which is tracked in the M-mode image 330 vs time), luminance, and color of the first area indicator and / or the second area indicator (“two calipers 340 (green and yellow cross) are placed in the M-mode image 330” [0062] Fig. 3).
Regarding claim 3, Deischinger modified by Vega teaches the ultrasound image generation system according to claim 1.
Deischinger does not teach that the processor is further configured to execute the instructions to output, to the display device, a moving direction guide display corresponding to a direction of the second ultrasound probe position with respect to the first ultrasound probe position as at least a part of the guide information.
However, in the ultrasound imaging systems field of endeavor, Vega discloses device agnostic systems and methods for acquiring and analyzing images from an ultrasound probe, which is analogous art. Vega teaches that the processor is further configured to execute the instructions to output, to the display device, a moving direction guide display (1326) corresponding to a direction of the second ultrasound probe position with respect to the first ultrasound probe position as at least a part of the guide information (“the computing device computes (e.g., measures) a respective distance between an acquired image in a probe-position space (e.g., a six-dimensional space indicating the (x, y, z) position and rotations in the x-, y-, and z-axis with respect to the 3D model of the anatomical structure of interest) and a predicted plane in a probe-position space that would provide a better image, and determines, based on the computation, a sequence of steps that will guide the user to acquire the better image. In some embodiments, the computing device causes the sequence of steps or instructions to be displayed on a display device that is communicatively connected with the ultrasound probe.” [0113]; “providing (1326) guidance (e.g., displaying on the user interface, or providing audio guidance feedback) for positioning the first probe device at a different location from a location where the first frame was acquired. For example, the different location has the same x, y, z coordinates but different rotational angles to obtain a third frame of a structure within the anatomical region of interest,” [0166]; Fig. 13C).
Therefore, based on Vega’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Deischinger to employ the processor that is further configured to execute the instructions to output, to the display device, a moving direction guide display corresponding to a direction of the second ultrasound probe position with respect to the first ultrasound probe position as at least a part of the guide information, as taught by Vega, in order to facilitate ultrasonic imaging of the target.
Regarding claim 4, Deischinger modified by Vega teaches the ultrasound image generation system according to claim 1.
Deischinger does not teach that the processor is further configured to execute the instructions to output, to a speaker of the ultrasound image generation system, at least a part of the guide information, a moving direction guide voice corresponding to a direction of the second ultrasound probe position with respect to the first ultrasound probe position.
However, in the ultrasound imaging systems field of endeavor, Vega discloses device agnostic systems and methods for acquiring and analyzing images from an ultrasound probe, which is analogous art. Vega teaches that the processor is further configured to execute the instructions to output, to a speaker of the ultrasound image generation system (“providing audio guidance feedback” [0166]), at least a part of the guide information, a moving direction guide voice corresponding to a direction of the second ultrasound probe position with respect to the first ultrasound probe position (“the computing device computes (e.g., measures) a respective distance between an acquired image in a probe-position space (e.g., a six-dimensional space indicating the (x, y, z) position and rotations in the x-, y-, and z-axis with respect to the 3D model of the anatomical structure of interest) and a predicted plane in a probe-position space that would provide a better image, and determines, based on the computation, a sequence of steps that will guide the user to acquire the better image. In some embodiments, the computing device causes the sequence of steps or instructions to be displayed on a display device that is communicatively connected with the ultrasound probe.” [0113]; “providing (1326) guidance (e.g., displaying on the user interface, or providing audio guidance feedback) for positioning the first probe device at a different location from a location where the first frame was acquired. For example, the different location has the same x, y, z coordinates but different rotational angles to obtain a third frame of a structure within the anatomical region of interest,” [0166]; Fig. 13C).
Therefore, based on Vega’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Deischinger to employ the processor that is further configured to execute the instructions to output, to a speaker of the ultrasound image generation system, at least a part of the guide information, a moving direction guide voice corresponding to a direction of the second ultrasound probe position with respect to the first ultrasound probe position, as taught by Vega, in order to facilitate ultrasonic imaging of the target.
Regarding claim 5, eischinger modified by Vega teaches the ultrasound image generation system according to claim 1, wherein Deischinger teaches that the memory stores a learned model (“the deep neural network(s)”) for specifying the predetermined structure in the imaging subject (the signal processor 240 may be trained to identify particular structures and/or tissues (or types thereof) provided in an ultrasound scan plane, with the training engine 280 training the deep neural network(s) thereof to perform some of the required functions, such as using databases(s) of classified ultrasound images of various structures.” [0052]; “the training engine 280 may be configured to utilize ultrasound images of particular structures to train the signal processor 240 (and/or components thereof, such as the automated heartrate measurement module 242) with respect to the characteristics of the particular structure(s)” [0053] Fig. 2).
Regarding claim 6, Deischinger modified by Vega teaches the ultrasound image generation system according to claim 1, wherein Deischinger teaches that the imaging subject is a human body (“fetus” [0061]), and the structure is an organ of the human body or a portion thereof (“the processor is further configured to automatically identify the at least one structure of the heart, based on processing of the at least one of the one or more medical images or the imaging data.” [0082] Fig. 2).
Regarding claim 18, Deischinger modified by Vega teaches the ultrasound image generation system according to claim 1, wherein Deischinger teaches the first area indicator and the second area indicator (calipers 340 or vertical lines in the “M-mode image 330” [0062] corresponding to the two calipers in Fig. 3) are displayed along a time axis (“the x-axis in the M-mode image 330 represent the time axis, thus allowing for tracking of changes area corresponding to the analysis line 320 through time.” [0061]; Fig. 3).
Regarding claim 19, Deischinger modified by Vega teaches the ultrasound image generation system according to claim 1, wherein Deischinger teaches that the first area indicator and the second area indicator are generated and displayed at a predetermined sampling interval (“The position of the second (right) caliper is then calculated, such as using the heartrate, and set at relative based to the first position, such based on a number of cycles (e.g., 2 cycles), which may be configured in the measure setup. These steps are illustrated and described in more detail with respect to FIGS. 6A-6E, below.” [0072] Fig. 3).
Regarding claim 20, Deischinger teaches a non-transitory computer readable medium storing instructions (“one or more of the functional blocks (e.g., processors or memories) may be implemented in a single piece of hardware (e.g., a general purpose signal processor or a block of random access memory, hard disk, or the like) or multiple pieces of hardware. Similarly, the programs may be stand-alone programs, may be incorporated as subroutines in an operating system, may be functions in an installed software package” [0015])
that, when executed by a processor (240), cause the processor to:
analyze a first ultrasound image (310) of an ultrasound probe (204) (“an ultrasound (e.g., B-Mode) image 310 obtained during ultrasound imaging/examination” [0061]) at a first time (“time” [0061]; a first time on the “time axis” [0061]) to specify a predetermined structure (the “structure captured in the B-Mode” [0061]) (“the signal processor 240 may be trained to identify particular structures … (or types thereof) provided in an ultrasound scan plane,” [0052]; “the processor is further configured to automatically identify the at least one structure of the heart, based on processing of the at least one of the one or more medical images or the imaging data.” [0082] Fig. 2) within an imaging subject (“fetus” [0061]) (“an ultrasound probe 204, …, a RF processor 224, …, a signal processor 240,” [0034]; Fig. 2);
identify a first position (320) in the first ultrasound image of the predetermined structure (“a particular line 320 (referred to hereafter as “analysis line”) through the heart” [0061]; Fig. 3);
output a first area indicator (any vertical line in the “M-mode image 330” [0062] serves as an area indicator, with the vertical line corresponding to the first time being a first area indicator) having an attribute (340) (a position on the vertical axis in the “M-mode image 330” [0062]) corresponding to a first area (the area of the heart in b-mode image 310 at a first time) in the first ultrasound image of the predetermined structure (“the x-axis in the M-mode image 330 represent the time axis, thus allowing for tracking of changes area corresponding to the analysis line 320 through time.” [0061]; Fig. 3);
output a second area indicator (a vertical line in the “M-mode image 330” [0062] corresponding to the second time) having an attribute (340) (a position on the vertical axis in the “M-mode image 330” [0062]) corresponding to a second area (the area of the heart in b-mode image 310 at a second time) in a second ultrasound image (310) at a second time point of the predetermined structure (a second time point corresponds for example to a position of the second caliper 340 in Fig. 3 [0062]) in a manner that a change over time with respect to the first area indicator is recognizable (“A corresponding time motion M-mode image 330 (e.g., “anatomical M-Mode” image as shown in FIG. 3…Thus, the M-mode image 330 represents time-scale (that is time-based) of a cross-sectional area in a body part or structure captured in the B-Mode, and therefore show time-scale based changes or movement in that area. In other words, the x-axis in the M-mode image 330 represent the time axis, thus allowing for tracking of changes area corresponding to the analysis line 320 through time.” [0061]; Fig. 3).
Deischinger does not teach causing the processor to: output guide information for instructing an operator who operates the ultrasound probe to move the ultrasound probe to a position where an ultrasound image in which the predetermined structure is displayed more favorably can be obtained, based on the specified first position.
However, in the ultrasound imaging systems field of endeavor, Vega discloses device agnostic systems and methods for acquiring and analyzing images from an ultrasound probe, which is analogous art. Vega teaches causing the processor to:
output guide information for instructing an operator (“the user” [0113]) who operates the ultrasound probe (“instructions to be displayed” [0113]) to move the ultrasound probe to a position where an ultrasound image in which the predetermined structure is displayed more favorably can be obtained, based on the specified first position (“the computing device computes (e.g., measures) a respective distance between an acquired image in a probe-position space (e.g., a six-dimensional space indicating the (x, y, z) position and rotations in the x-, y-, and z-axis with respect to the 3D model of the anatomical structure of interest) and a predicted plane in a probe-position space that would provide a better image, and determines, based on the computation, a sequence of steps that will guide the user to acquire the better image. In some embodiments, the computing device causes the sequence of steps or instructions to be displayed on a display device that is communicatively connected with the ultrasound probe.” [0113]).
Therefore, based on Vega’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Deischinger to cause a processor to: output guide information for instructing an operator who operates the ultrasound probe to move the ultrasound probe to a position where an ultrasound image in which the predetermined structure is displayed more favorably can be obtained, based on the identified first position, as taught by Vega, in order to facilitate ultrasonic imaging of the target.
Claims 7-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Deischinger and Vega as applied to claim 1, and further in view of Lu et al (US 20240268792), hereinafter Lu.
Regarding claim 7, Deischinger modified by Vega teaches the ultrasound image generation system according to claim 1, wherein Deischinger teaches that based on the workflow being in a process of imaging the first structure, the analyzing the first ultrasound image to identify the predetermined structure in the imaging subject comprises:
analyzing the first ultrasound image to identify the first structure (“identify the relevant structure“ [0067]) and the second structure in the imaging subject (“the signal processor 240 may be trained to identify particular structures … (or types thereof) provided in an ultrasound scan plane” [0052]; “the processor is further configured to automatically identify the at least one structure of the heart,” [0082]);
ignoring the second structure while making the first structure the predetermined structure (“before initiating the automated heartrate measurement, the system user (e.g., ultrasound technician) may still need to focus on or identify the relevant structure before the automatic measurement (e.g., by selecting/setting an analysis line 411, and focus point therein (represent as the two horizontal lines in the analysis line).” [0067]; Fig. 4. Focusing on the relevant structure means ignoring the second structure, that is not relevant).
Deischinger modified by Vega does not teach that the processor is further configured to execute the instructions to:
identify a workflow defining an order in which at least a first structure and a second structure in the imaging subject are to be imaged.
However, in the health monitoring field of endeavor, Lu discloses a remote control system for wireless electrocardiogram monitoring sensor, which is analogous art. Lu teaches that the processor is further configured to execute the instructions to:
identify a workflow (400) defining an order in which at least a first structure and a second structure in the imaging subject are to be imaged (“the workflow 400 includes determining that ultrasound image acquisition of the first anatomical structure is complete, and presenting (416) a suggestion to scan a second anatomical structure using a second set of operating parameters configured for the second anatomical structure. For example, as described in greater detail below, in some embodiments, an operator will perform a series of scans moving from, e.g., the heart to the bladder. The suggestion in this example may be a suggestion to change from device parameters appropriate for heart scans to device parameters appropriate for bladder scans.” [0084]).
Therefore, based on Lu’ teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Deischinger and Vega to employ the processor that is further configured to execute the instructions to: identify a workflow defining an order in which at least a first structure and a second structure in the imaging subject are to be imaged, as taught by Lu, in order to facilitate ultrasound examinations of multiple structures.
Regarding claim 8, Deischinger modified by Vega and Lu teaches the ultrasound image generation system according to claim 7, Deischinger teaches that he structure is an organ of the human body or a portion thereof (“the processor is further configured to automatically identify the at least one structure of the heart, based on processing of the at least one of the one or more medical images or the imaging data.” [0082] Fig. 2).
Regarding claim 11, Deischinger modified by Vega and Lu teaches the ultrasound image generation system according to claim 8, wherein Deischinger teaches that the first area is an area of the predetermined structure (the area of the heart in b-mode image 310 at a first time; Fig. 3).
Allowable Subject Matter
Claims 9-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 12-17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXEI BYKHOVSKI whose telephone number is (571)270-1556. The examiner can normally be reached on Monday-Friday: 8:30am - 5:00pm.
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798
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