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 .
Specification
The abstract of the disclosure is objected to because legalese, claim language is used. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent claim 1 and analogous independent claims 12-13, recite, for example, the following abstract idea: “…acquire a position of an ultrasound probe…”, falls within mental process, as one can visually consider the position of the probe with respect to the examinees’ breast. Limitation, “…in a case…perform control switching…” can be considered an additional element. The claim as a whole can also be interpreted as just the abstract idea of acquiring the position limitation since the “…perform control of switching…” is a contingent limitation.
The judicial exceptions are not integrated into a “practical application” as defined by the Subject Matter Eligibility Analysis documented in Federal Register 84(4), issued on 07 January 2019, and MPEP § 2106. The limitations of “…wherein the processor is configured to…”, simply represent implementing the abstract ideas with a computer. MPEP § 2106.05(f) notes that “using a computer as a tool to perform the abstract idea” is not sufficient to integrate a judicial exception into a practical application as interpreted by the court(s). Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972) “held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle and Intellectual Ventures LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.” Intellectual Ventures additionally established that if a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category of abstract ideas unless the step(s) cannot be practically performed in the mind. Therefore, a positive recitation of the associated computer would not necessarily result in patent eligible subject matter.
The dependent claims 2,5, 11 and 14 do not sufficiently link the subject matter to a practical application or recite element(s) which constitute significantly more than the abstract ideas identified. The depending claims are directed to additional limitations which encompass abstract ideas consistent with those identified above that are well-understood, routine and/or conventional activity.
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 1-14 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.
Regarding claims 1-2 and 12-13, the phrase "in a case" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 4, limitation “…the switching condition is a case in which capturing of an ultrasound image via the ultrasound probe is not performed on the specific region.”, is unclear in correlation to the preceding limitation that sets the specific region to be irradiated. The metes and bounds of the claim are unclear.
Regarding claim 5, it is unclear the connection, if any, of the “switching condition is a case” with respect to the condition “in a case” of claim 1. It is unclear if the switching condition requires to meet one or both of the conditions or if the predetermined switching condition of claim 1 is now the condition of claim 5 or something else. The metes and bounds of the claim are unclear.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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, 3-8 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okamura et. al. (U.S. 20080249415, October 9, 2008)(hereinafter, “Okamura”).
Regarding Claim 1, Okamura teaches: A medical imaging apparatus (Fig. 1, mammographic diagnosis apparatus, [0027]) comprising:
a processor (“The central control unit 50 is a central processing device…” [0043]), wherein the processor is configured to:
acquire a position of an ultrasound probe that emits an ultrasound beam toward a breast of an examinee, which is in a compressed state via a compression plate (“At the time of acquisition of a compressed breast image…the central control unit 50 transmits the compression thickness of the compressed/fixed breast, the position of an ultrasonic probe 62, provided on the upper paddle 35a, on the detection surface of the flat panel detector 40, and the like to the ultrasonic diagnosis apparatus 6…the position of the ultrasonic probe 62, provided on the upper paddle 35a, on the detection surface of the flat panel detector 40 can be acquired by providing a sensor or the like, which detects the position of the ultrasonic probe 62, in the opening portion 350 of the upper paddle 35a.” [0043]); and
in a case in which the position of the ultrasound probe in a direction orthogonal to a side surface of the compression plate on a chest wall side is equal to or smaller than a predetermined distance from the side surface and a predetermined switching condition is satisfied, perform control of switching to a steer mode or a trapezoidal mode in which an emission direction of the ultrasound beam is directed toward the chest wall side (“The compression paddle control unit 37 measures the compression thickness of the compressed/fixed breast…and sends out the resultant data to the central control unit 50.” [0037]; “When executing the above compressed breast image reconstruction processing, this apparatus executes ultrasonic scanning so as to distribute scanning lines fanwise [trapezoidal] as shown in FIG. 4. This facilitates the occurrence of ultrasonic reflection in the compression unit 35 and allows wide-area ultrasonic imaging along the surface direction of the compression unit 35.” [0071]. See Fig. 4).
Regarding Claim 3, Okamura teaches the claim limitations as noted above.
Okamura further teaches: wherein the processor is configured to control a scanning mechanism that performs scanning using the ultrasound probe on the compression plate, and the switching condition is a case in which an instruction to stop capturing of an ultrasound image via the ultrasound probe is not received (“The input device 64 has various types of switches, buttons, a trackball, a mouse, a keyboard, and the like which are used to input, to the apparatus body 61, various types of instructions and conditions, an instruction to set a region of interest (ROI), various types of image quality condition setting instructions, and the like from an operator. When, for example, the operator operates the end button or FREEZE button of the input device 64, the transmission/reception of ultrasonic waves is terminated, and the ultrasonic diagnosis apparatus is set in a pause state.” [0048]).
Regarding Claim 4, Okamura teaches the claim limitations as noted above.
Okamura further teaches: wherein the processor is configured to: set a specific region to be irradiated with the ultrasound beam based on a radiation image captured by emitting radiation to the breast of the examinee; and control a scanning mechanism that performs scanning using the ultrasound probe on the compression plate, and the switching condition is a case in which capturing of an ultrasound image via the ultrasound probe is not performed on the specific region (“The input device 64 is connected to the apparatus body 61. The input device 64 has various types of switches, buttons, a trackball, a mouse, a keyboard, and the like which are used to input, to the apparatus body 61, various types of instructions and conditions, an instruction to set a region of interest (ROI), various types of image quality condition setting instructions, and the like from an operator. When, for example, the operator operates the end button or FREEZE button of the input device 64, the transmission/reception of ultrasonic waves is terminated, and the ultrasonic diagnosis apparatus is set in a pause state.” [0048]; “…when the ultrasonic image P is divided into a plurality of layers in the depth direction with the distance between the upper and lower paddles 35a and 35b being represented by L, an image can be reconstructed by using small image areas including echo signals exhibiting two or three reflections of ultrasonic waves by the compression unit 35 in such a manner that the real areas R1, R2, R3, R4, and R5 are respectively replaced by the small image areas P5, P6, P7, P8, and P9. Performing image reconstruction upon selecting small image areas in accordance with the number of reflections by the compression unit 35 can reconstruct an image by using reflected waves exhibiting similar degrees of attenuation and improve image quality. In addition, for example, with regard to an area outside the real area R4 or R5, image reconstruction can be implemented by using a small image area below the virtual image lower paddle 35b'.” [0067]).
Regarding Claim 5, Okamura teaches the claim limitations as noted above.
Okamura further teaches: wherein the switching condition is a case in which an instruction to stop capturing of an ultrasound image via the ultrasound probe is not received (“The input device 64 has various types of switches, buttons, a trackball, a mouse, a keyboard, and the like which are used to input, to the apparatus body 61, various types of instructions and conditions, an instruction to set a region of interest (ROI), various types of image quality condition setting instructions, and the like from an operator. When, for example, the operator operates the end button or FREEZE button of the input device 64, the transmission/reception of ultrasonic waves is terminated, and the ultrasonic diagnosis apparatus is set in a pause state.” [0048]).
Regarding Claim 6, Okamura teaches the claim limitations as noted above.
Okamura further teaches: wherein the compression plate includes a guide member that guides the ultrasound probe such that a longitudinal direction of the ultrasound probe is a direction orthogonal to a chest wall (“The compression paddle control unit 37 measures the compression thickness of the compressed/fixed breast (i.e., the distance between the upper and lower paddles 35a and 35b) and sends out the resultant data to the central control unit 50.” [0037]; “The image combining unit 77 combines the image received from the image generating unit 75 with character information of various types of parameters, scale marks, and the like, and outputs the resultant signal as a video signal to the monitor 63.” [0058]; “This positional association can be implemented by providing a position sensor in the opening portion 350 of the compression unit 35 or the ultrasonic probe 62 itself and specifying the position of the ultrasonic probe 62 on the flat panel detector 40. At this time, as shown in FIG. 8, it is preferable to indicate the position of the ultrasonic image on the mammographic image (or the position of the mammographic image on the ultrasonic image) in advance and, when the operator clicks the position as needed, automatically display the ultrasonic image (or the mammographic image) corresponding to the position simultaneously with the mammographic image (or the ultrasonic image) or selectively.” [0070]; “When executing the above compressed breast image reconstruction processing, this apparatus executes ultrasonic scanning so as to distribute scanning lines fanwise [trapezoidal] as shown in FIG. 4. This facilitates the occurrence of ultrasonic reflection in the compression unit 35 and allows wide-area ultrasonic imaging along the surface direction of the compression unit 35.” [0071]. See Figs. 4 and 8).
Regarding Claim 7, Okamura teaches the claim limitations as noted above.
Okamura further teaches: wherein the processor is configured to control a scanning mechanism that performs scanning using the ultrasound probe on the compression plate such that the scanning using the ultrasound probe is performed on the compression plate in a state in which a longitudinal direction of the ultrasound probe is in the direction orthogonal to the side surface of the ultrasound probe on the chest wall side (“The compression paddle control unit 37 measures the compression thickness of the compressed/fixed breast (i.e., the distance between the upper and lower paddles 35a and 35b) and sends out the resultant data to the central control unit 50.” [0037]; “When executing the above compressed breast image reconstruction processing, this apparatus executes ultrasonic scanning so as to distribute scanning lines fanwise [trapezoidal] as shown in FIG. 4. This facilitates the occurrence of ultrasonic reflection in the compression unit 35 and allows wide-area ultrasonic imaging along the surface direction of the compression unit 35.” [0071]. See Fig. 4).
Regarding Claim 8, Okamura teaches the claim limitations as noted above.
Okamura further teaches: wherein an acoustic matching material is provided between the ultrasound probe and the compression plate (“The ultrasonic probe 62 includes a plurality of piezoelectric transducers which generate ultrasonic waves on the basis of driving signals from the apparatus body 61 and convert reflected waves from a subject to be examined into electrical signals, a matching layer provided for the piezoelectric transducers, a backing member which prevents ultrasonic waves from propagating backward from the piezoelectric transducers…” [0047]).
Regarding Claim 11, Okamura teaches the claim limitations as noted above.
Okamura further teaches: wherein the processor is configured to display, in a distinguishable manner on a display unit, a first imaging region imaged in a state in which the emission direction of the ultrasound beam is a normal direction and a second imaging region imaged in the steer mode or the trapezoidal mode in which the emission direction of the ultrasound beam is inclined, and display, on the display unit, a captured ultrasound image (“The control processor 78 reads out control programs for image generation/display and the like from the internal storage unit 79, maps them in its internal memory, and executes computation/control and the like associated with various types of processing. The control processor 78 also implements an ultrasonic scan function of distributing scanning lines fanwise and the compressed breast image reconstruction function by mapping dedicated programs in the memory.” [0059]; “After the execution of the compressed breast image reconstruction processing, the central control unit 50 or the image combining unit 77 positionally associates the reconstructed compressed breast image with the mammographic image. This positional association can be implemented by providing a position sensor in the opening portion 350 of the compression unit 35 or the ultrasonic probe 62 itself and specifying the position of the ultrasonic probe 62 on the flat panel detector 40. At this time, as shown in FIG. 8, it is preferable to indicate the position of the ultrasonic image on the mammographic image (or the position of the mammographic image on the ultrasonic image) in advance and, when the operator clicks the position as needed, automatically display the ultrasonic image…corresponding to the position simultaneously with the mammographic image (or the ultrasonic image) or selectively” [0070]).
Regarding Claim 12, Okamura teaches: A medical imaging method comprising:
via a computer, acquiring a position of an ultrasound probe that emits an ultrasound beam toward a breast of an examinee, which is in a compressed state via a compression plate (“The central control unit 50 is a central processing device…” [0043]); and
performing, in a case in which the position of the ultrasound probe in a direction orthogonal to a side surface of the compression plate on a chest wall side is equal to or smaller than a predetermined distance from the side surface and a predetermined switching condition is satisfied, control of switching to a steer mode or a trapezoidal mode in which an emission direction of the ultrasound beam is directed toward the chest wall side (“The compression paddle control unit 37 measures the compression thickness of the compressed/fixed breast (i.e., the distance between the upper and lower paddles 35a and 35b) and sends out the resultant data to the central control unit 50.” [0037]; “When executing the above compressed breast image reconstruction processing, this apparatus executes ultrasonic scanning so as to distribute scanning lines fanwise [trapezoidal] as shown in FIG. 4. This facilitates the occurrence of ultrasonic reflection in the compression unit 35 and allows wide-area ultrasonic imaging along the surface direction of the compression unit 35.” [0071]. See Fig. 4).
Regarding Claim 13, Okamura teaches: A non-transitory computer-readable storage medium storing a medical imaging program causing a computer to execute a process (“The control processor 78 reads out control programs for image generation/display and the like from the internal storage unit 79, maps them in its internal memory, and executes computation/control and the like associated with various types of processing.” [0059]) comprising:
acquiring a position of an ultrasound probe that emits an ultrasound beam toward a breast of an examinee, which is in a compressed state via a compression plate (“At the time of acquisition of a compressed breast image…the central control unit 50 transmits the compression thickness of the compressed/fixed breast, the position of an ultrasonic probe 62, provided on the upper paddle 35a, on the detection surface of the flat panel detector 40, and the like to the ultrasonic diagnosis apparatus 6…the position of the ultrasonic probe 62, provided on the upper paddle 35a, on the detection surface of the flat panel detector 40 can be acquired by providing a sensor or the like, which detects the position of the ultrasonic probe 62, in the opening portion 350 of the upper paddle 35a.” [0043]); and
performing, in a case in which the position of the ultrasound probe in a direction orthogonal to a side surface of the compression plate on a chest wall side is equal to or smaller than a predetermined distance from the side surface and a predetermined switching condition is satisfied, control of switching to a steer mode or a trapezoidal mode in which an emission direction of the ultrasound beam is directed toward the chest wall side (“The compression paddle control unit 37 measures the compression thickness of the compressed/fixed breast…and sends out the resultant data to the central control unit 50.” [0037]; “When executing the above compressed breast image reconstruction processing, this apparatus executes ultrasonic scanning so as to distribute scanning lines fanwise [trapezoidal] as shown in FIG. 4. This facilitates the occurrence of ultrasonic reflection in the compression unit 35 and allows wide-area ultrasonic imaging along the surface direction of the compression unit 35.” [0071]. See Fig. 4).
Regarding Claim 14, Okamura teaches: A medical imaging system (Fig. 1, mammographic diagnosis apparatus, [0027]) comprising:
a mammography apparatus that captures a radiation image by detecting radiation, which is emitted from a radiation source and is transmitted through a breast of an examinee, via a radiation detector (“As shown in FIG. 1, the ultrasonic diagnosis apparatus 6 comprises an apparatus body 61, an ultrasonic probe 62, a monitor 63, and an input device 64... The ultrasonic probe 62 includes a plurality of piezoelectric transducers which generate ultrasonic waves on the basis of driving signals from the apparatus body 61 and convert reflected waves from a subject to be examined into electrical signals, a matching layer provided for the piezoelectric transducers, a backing member which prevents ultrasonic waves from propagating backward from the piezoelectric transducers, and the like. When an ultrasonic wave is transmitted from the ultrasonic probe 62 to a subject P to be examined, the transmitted ultrasonic wave is sequentially reflected by a discontinuity surface of acoustic impedance of internal body tissue, and is received as an echo signal by the ultrasonic probe 62. ” [0046-0047]);
an ultrasound probe that emits an ultrasound beam to the breast of the examinee (“The ultrasonic probe 62 includes a plurality of piezoelectric transducers which generate ultrasonic waves on the basis of driving signals from the apparatus body 61 and convert reflected waves from a subject to be examined into electrical signals, a matching layer provided for the piezoelectric transducers, a backing member which prevents ultrasonic waves from propagating backward from the piezoelectric transducers…” [0047]);
and the medical imaging apparatus according to claim 1, this incoproates limitations from claim 1 and accordingly the previously disclosed rejections are applied.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Okumara in view of Arai et. al. (U.S. 20170281124, October 5, 2017)(hereinafter, “Arai”).
Regarding Claim 2, Okamura teaches the claim limitations as noted above.
wherein, in a case in which an inclination angle of the ultrasound beam emitted in the steer mode or the trapezoidal mode is denoted by θ, a depth of the breast to be observed is denoted by a, and a distance between the ultrasound probe and the compression plate is denoted by b, the predetermined distance is a distance represented by tanθ × (a+b).
with regards to an angle of the ultrasonic beam Okumara further teaches: “The internal storage unit 79 stores transmission/reception conditions, a control program for executing image generation/display processing, diagnosis information (a patient ID, findings by a doctor, and the like), a diagnosis protocol, the scanning line angle information of the probe, the position information of the probe, a body mark generation program, a dedicated program for implementing the compressed breast image reconstruction function, and other data.” [0060]; “…the angle of an ultrasonic scanning line can be arbitrarily changed. Although there is no specific limitation on how the angle is changed, an arbitrary value or a preset value can be artificially selected on the basis of the size of a breast of a patient, the width and length of a compression paddle, a distance L between upper and lower paddles 35a and 35b, and the like.” [0096].
Arai in the field of breast imaging systems teaches: “FIG. 15 shows a front view when a state, in which the compression plate 32 compresses the breast N with the acoustic matching member 50 interposed between the compression plate 32 and the breast N, is viewed from the direction of the nipple of the breast N and a side view when the state is viewed from the side surface of the subject.” [0126]; “…the acoustic matching member 78 preferably has high adhesion to the breast N, and the upper acoustic matching member 80 preferably has high lubricity in order to move the ultrasound probe 36 smoothly. Therefore, the static friction coefficient of the acoustic matching member 78 is larger than the static friction coefficient of the upper acoustic matching member 80.” [0164]. See Figs. 15-25.
From the combination of references one of ordinary skill in the art can obtain the inclination angle to be represented by tanθ × (a+b) since the probe in both references are moving at distances between the probe and compression plate and consider the breast information. Computation of the angle using the specific equation provided would be obvious to try for obtaining “…breast image reconstruction function, and other data. (Okumara, [0096]). Furthermore, it has been held that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Regarding Claims 9 and 10, Okamura teaches the claim limitations as noted above.
wherein a thickness of the acoustic matching material is 1 mm or larger and 10 mm or smaller; wherein a thickness of the acoustic matching material is larger as a distance to the chest wall is smaller.
Okumra teaches acoustic matching material: “The ultrasonic probe 62 includes a plurality of piezoelectric transducers which generate ultrasonic waves on the basis of driving signals from the apparatus body 61 and convert reflected waves from a subject to be examined into electrical signals, a matching layer provided for the piezoelectric transducers, a backing member which prevents ultrasonic waves from propagating backward from the piezoelectric transducers…” [0047].
Okumara does not teach the thickness information.
Arai in the field of breast imaging systems teaches: “…the acoustic matching member 50 is provided between the compression plate 32 and the breast N, and an upper acoustic matching member 60 is provided on the upper surface of the compression plate 32. In the case of capturing an ultrasound image, the control unit 40 causes the probe moving mechanism 38 to move the ultrasound probe 36 along the upper surface of the compression plate 32 in a state in which the upper acoustic matching member 60 is provided.” [0116]; “As shown in FIG. 13, the thickness of the upper acoustic matching member 60 in the Z-axis direction is smaller than the thickness of the acoustic matching member 50 in the Z-axis direction. As a specific example of the thickness of the acoustic matching member 50 in the Z-axis direction, 1 mm or more can be mentioned.” [0118]. See Fig. 13.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the acoustic matching material in Okumara is 1 mm or larger and 10 mm or smaller; wherein a thickness of the acoustic matching material is larger as a distance to the chest wall is smaller as taught in Arai to “…function as a lubricant in the movement of the ultrasound probe 36 and a function of reducing an acoustic impedance mismatch on the contact surface between the compression plate 32 and the ultrasound probe 36.” (Arai, [0117]), “The acoustic matching member 50 preferably has high adhesion to the breast N, and the upper acoustic matching member 60 preferably has high lubricity in order to move the ultrasound probe 36 smoothly.” (Arai, [0119]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Manak et. al. U.S. 20140135623 teaches a mammographic-imaging system for identification and diagnosis.
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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798