DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 06 July 2026 have been fully considered but they are not persuasive.
With respect to 101 rejection, applicant argues that claim is amended to recite the dynamic image is generated by an imaging apparatus by irradiating the subjection with radiation, accordingly, dynamic image is of an actual subject and allows indication of blood flow detect and 101 rejection should be withdrawn.
However, the examiner respectfully disagrees.
The amended limitation of “the hardware processor obtains the dynamic image of a subject that is generated by an imaging apparatus by irradiating the subject with radiation” falls into data gathering and is a form of a pre-solution insignificant activity. With respect to inventive concept under step 2B, the limitation is evaluated whether the limitation is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. The examiner submits “Nagatsuka” (US2023/0067560) teaches radiographic imaging system generating dynamic images wherein dynamic imaging using conventional radiographic imaging apparatus ([0191]), thus generating dynamic image by irradiating radiation to a subject, is performed by conventional radiographic imaging apparatus, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
Therefore, 101 rejection is proper and maintained. The examiner has modified 101 rejection in view of amendment.
With respect to 103 rejection, applicant argues that amended limitation is not taught by combination of Shimamura 967, Moult and Shimamura 665 because (1) Moult does not compare a quantitative value of an area with abnormal pixel values to an area of an entire processing region and (2) Shimamura 665 does not compare an area of a signal decrease region to an area of an entire processing region in the dynamic image (page 7).
However, the examiner respectfully disagrees.
Moult was cited for detecting and comparing abnormal pixel values to determine a blood flow defect region and further teaches in analyzing blood flow in images, the quantitative value is an area (area of abnormal features [0097]) but does not further teach that the second threshold is a ratio between an area of the signal decrease region and an area of an entire processing region in the dynamic image.
Shimamura 665 was cited for disclosing comparing an area of signal decrease (which is affected area) to an area of an entire processing region. The examiner submits that Shimamura 665 teaches using “a ratio” of affected region over whole region in evaluating blood flow condition, specifically, the ratio of the integrated value of the blood flow amount in each region to the integrated value of the blood flow characteristics amount in the entire lung field calculated ([0162]).
Shimamura 665 discloses dynamic analysis image of lung, wherein the ratio of affected region over whole lung and determining characteristic amounts relating to the area of affected and whole area wherein the characteristic amounts can include a blood flow ([0082]-[0083]), and specifically can include blood flow increase and decrease (pixel value decreases [0108]), and can include ratio integrated blood flow characteristic amount in the region to the integrated value of the blood flow characteristic amount in the entire lung is calculated ([0162]), thus reads on claimed ratio between area of the signal decrease (blood flow characteristic amount in the region) and an entire processing region (entire lung), this makes it possible to grasp to some extent whether or not the blood flow distribution in the upper, middle, and lower lung fields is normal ([0162]). The examiner submits that in order to determine whether ratio is normal, it includes comparing its ratio to a threshold of the ratio.
Therefore, rejection is proper and maintained and the rejection is modified in view of amendment.
Regarding to new claims 11-12, claims 11-12 are rejected under 101 and claim 11 is further rejected under 103.
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 and 3-12 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 dynamic analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
“perform dynamic analysis on a dynamic image,”
“when a pixel of the dynamic analysis image has a signal value less than or equal to a first threshold, [the hardware processor] detects the pixel as a signal decrease region that indicates a decrease in a blood flow value, and [the hardware processor] compares a quantitative value of the detected signal decrease region or a quantitative value of a non-signal decrease region with a second threshold, the non-signal decrease region being other than the signal decrease region, and based on the comparison, determines whether a blood flow defect is present.”
Wherein the quantitative value is an area, and the second threshold is a ratio between an area of the signal decrease region and an area of an entire processing region in the dynamic image.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind and mathematical concepts as it is regarding a concept relating to the analyzing the image and determining presence of a blood defect by observing a region with decrease in blood flow using comparison.
These actions fall under the Mental Processes and the Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations using a formula and definition to determine measurements.” A human, such as a surgeon can observe the dynamic analysis image of blood flow changes in the images, and based on the observation, one can determine region of blood flow decrease by observing signal value less than the reference and compare the region/area of signal decrease and compare the area to second threshold and make judgement whether a blood flow defect is present by using mental framework. In addition, area of region can be calculated by number of pixels and using area formula of pixel (square) and calculating a ratio between an area of signal decrease region over entire region of the dynamic image according to definition of a ratio. Thus, a surgeon can perform 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 and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“the hardware processor obtains the dynamic image of a subject that is generated by an imaging apparatus by irradiating the subjection with radiation,”
“the dynamic analysis comprising a hardware processor,”
“the hardware processor generates a dynamic analysis image for measuring a blood flow, based on signal value of pixels constituting the dynamic image.”
Obtaining image with irradiation and generating a dynamic analysis image is data gathering and is a form of a pre-solution insignificant activity. The steps of obtaining the dynamic image and generating a dynamic analysis image, comparing quantitative value are performed in order to gather data for the recited mental process step and are necessary precursor for all uses of the recited abstract idea since no dynamic analysis and comparison of area can be carried out without first gathering necessary image data. The use of a hardware processor for performing mental framework of comparison, observation and determination are recited with high generality, and specification does not provide special algorithms performed by hardware and processor is invoked merely as a tool to perform the abstract steps and does not add meaningful limitations, and thus, does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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 - The claim recites the following additional elements:
“the hardware processor obtains the dynamic image of a subject that is generated by an imaging apparatus by irradiating the subjection with radiation,”
“the dynamic analysis comprising a hardware processor,”
“the hardware processor generates a dynamic analysis image for measuring a blood flow, based on signal value of pixels constituting the dynamic image.”
This element of “generating dynamic image by an imaging apparatus by irradiating the subject with radiation” represents well-understood, routine and conventional activity because US2023/0067560 “Nagatsuka” teaches radiographic imaging system generating dynamic images using conventional radiographic imaging apparatus ([0191]), thus generating dynamic image by irradiating radiation to a subject, is performed by conventional radiographic imaging apparatus, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
The element of hardware is described as controller, processor such as a CPU performing calculations and control and a memory, and a personal computer ([0026] and [0031]), which is commercially available product and thus, hardware processor is well-understood and conventional activity, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 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: Statutory Category: Yes - The claims recite a dynamic analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
“the quantitative value is an area,”
“[the second threshold is set for each of the divided regions], based on a ratio between an area of the signal decrease region and an area of an entire processing region in the dynamic image”
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation performing mathematical calculation as area and ratio of area of signals to an entire area in the image are mathematical relationship and can be determined using formula for area and ratio can be determined by dividing region of interest over whole area. Specifically, a surgeon can calculate by observing the area in the image with comparison to threshold and can determine the ratio of the area over whole area by using mental framework of calculation. 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 mathematical concept of abstract idea.
The claim further recites the limitations:
“a processing region in the dynamic image is divided into multiple divided regions”
“the second threshold is set for each of the divided regions”
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 analyzing the image and dividing image into multiple divided regions and assigning threshold value for the region. Specifically, a surgeon can observe the dynamic analysis image of blood flow changes in the images and determine to divide into plurality of regions and assign threshold value to the region by using mental framework. The dynamic analysis can be performed in mental framework using opinion, observation by looking at the image, comparison, and judgement. 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 recite further limitations.
The use of a hardware processor for performing mathematical concepts and mental framework, and does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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.
The element of hardware is described as controller, processor such as a CPU performing calculations and control and a memory, and a personal computer ([0026] and [0031]), which is commercially available product and thus, hardware processor is well-understood and conventional activity, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
For these reasons, there is no inventive concept in the claim. In light of the 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 dynamic analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
“the dynamic image [is expressed] in multiple tones of color according to the signal values of the pixels constituting the dynamic analysis image,” and
“The first threshold is set to a predetermined tone of color according to the multiple tones, the predetermined tone corresponding to a blood flow defect.”
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in mind as it recites assigning different tones of colors to the pixels by comparing values of the pixels and determining which color would fill the pixel, which can all performed in human mental framework, by observing the value of the pixels, and selecting a color for the value of the pixel, and coloring the pixel with selected color which represents a blood flow defect.
These actions fall under the Mental Process concepts categories defined in MPEP 2106.04 (A) (2) as “concepts performed in human mind (including observation, evaluation, judgement and opinion).” A human, a surgeon can could mentally perform tasks of observing the pixel values of given image, comparing the value of the pixels to known condition value for blood flow defect, and based on the comparison, determine that the pixel represents a blood defect condition and assign the pixel with designated color for the condition. 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 of abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“the dynamic analysis image is expressed in multiple tones of color according to signal value of the pixels constituting the dynamic analysis image”
Generating a dynamic analysis image with multiple tones of color is data gathering and is a form of a pre-solution insignificant activity. The use of a hardware processor for expressing image with multiple tones of color, and performing mental framework of comparison, observation and determination are recited with high generality and specification does not provide special algorithms performed by hardware and processor is invoked merely as a tool to perform the abstract steps and does not add meaningful limitations, and thus, does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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. The element of hardware is described as controller, processor such as a CPU performing calculations and control and a memory, and a personal computer ([0026] and [0031]), which is commercially available product and thus, hardware processor is well-understood and conventional activity, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
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 dynamic analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
“corrects a variation in the generated dynamic image caused by different imaging conditions in imaging and the first threshold is set, based on the dynamic analysis image on which the correction of variation is performed.”
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 analyzing the image and correcting the images to be used due to imaging condition. Specifically, a surgeon can observe the dynamic analysis image of blood flow changes in the images and determine some images or region of images to be excluded for analysis due to movement of patient during imaging and can set threshold for the images that are selected for further analysis. These dynamic analysis can be performed in mental framework using opinion, observation by looking at the image, comparison, and judgement. 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 hardware processor corrects”
The use of a hardware processor for correcting the image, and performing mental framework of comparison, observation and determination are recited with high generality and specification does not provide special algorithms performed by hardware and processor is invoked merely as a tool to perform the abstract steps and does not add meaningful limitations, and thus, does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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. The element of hardware is described as controller, processor such as a CPU performing calculations and control and a memory, and a personal computer ([0026] and [0031]), which is commercially available product and thus, hardware processor is well-understood and conventional activity, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
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 dynamic analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
“a processing region in the dynamic image is divided into multiple divided regions according to a distance from a predetermined reference position”
“different first thresholds are set to the respective divided region”
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 analyzing the image and dividing region into multiple image using a reference point in the image, such as an edge of the organ in the image. Specifically, a surgeon can observe the dynamic analysis image, and determine to divide into plurality of regions and setting threshold value for each of the region by using mental framework. The dynamic analysis can be performed in mental framework using opinion, observation by looking at the image, comparison, and judgement. 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 recite further limitations. This claim is therefore directed to an abstract idea.
The use of a hardware processor for expressing image with multiple tones of color, and performing mental framework of comparison, observation and determination are recited with high generality and specification does not provide special algorithms performed by hardware and processor is invoked merely as a tool to perform the abstract steps and does not add meaningful limitations, and thus, does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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. The element of hardware is described as controller, processor such as a CPU performing calculations and control and a memory, and a personal computer ([0026] and [0031]), which is commercially available product and thus, hardware processor is well-understood and conventional activity, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
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: Statutory Category: Yes - The claims recite a dynamic analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
“when determining that a blood flow defect is present in the dynamic analysis image, [the hardware processor] outputs determination information on the blood flow defect.”
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 analyzing the image and determining the presence of blood defect, and outputting the finding. Specifically, a surgeon can observe the dynamic analysis image, and determine a blood defect presence by judgement, and announce (by pen, computer, or in-person) to a colleague or patient the result by using mental framework. The dynamic analysis can be performed in mental framework using opinion, observation by looking at the image, comparison, and judgement. The outputting the result can be done by in-person communication and written form. 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 further recites “hardware processor.”
The use of a hardware processor for outputting the result and performing mental framework of comparison, observation and determination are recited with high generality and specification does not provide special algorithms performed by hardware and processor is invoked merely as a tool to perform the abstract steps and does not add meaningful limitations, and thus, does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the claim further recites “hardware processor.”
The element of hardware is described as controller, processor such as a CPU performing calculations and control and a memory, and a personal computer ([0026] and [0031]), which is commercially available product and thus, hardware processor is well-understood and conventional activity, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
For these reasons, there is no inventive concept in the claim. In light of the 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: Statutory Category: Yes - The claims recite a dynamic analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
“colors the signal decrease region in the dynamic analysis image with a color different from a color of the non-signal decrease region”
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 assigning different colors to region with signal changes. Specifically, a surgeon can observe the dynamic analysis image, and determine to assign blue to signal decrease regions while assign red to signal increase regions by using mental framework. The dynamic analysis can be performed in mental framework using opinion, observation by looking at the image, comparison, and judgement. 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 further recites “hardware processor.”
The use of a hardware processor for outputting the result and performing mental framework of comparison, observation and determination are recited with high generality and specification does not provide special algorithms performed by hardware and processor is invoked merely as a tool to perform the abstract steps and does not add meaningful limitations, and thus, does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the claim further recites “hardware processor.”
The element of hardware is described as controller, processor such as a CPU performing calculations and control and a memory, and a personal computer ([0026] and [0031]), which is commercially available product and thus, hardware processor is well-understood and conventional activity, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
For these reasons, there is no inventive concept in the claim. In light of the 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 dynamic analysis method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
“performing dynamic analysis on a dynamic image,”
“when a pixel of the dynamic analysis image has a signal value less than or equal to a first threshold, detecting the pixel as a signal decrease region that indicates a decrease in a blood flow value, and
comparing a quantitative value of the detected signal decrease region or a quantitative value of a non-signal decrease region with a second threshold, the non-signal decrease region being other than the signal decrease region, and based on the comparison, determines whether a blood flow defect is present.”
Wherein the quantitative value is an area, and the second threshold is a ratio between an area of the signal decrease region and an area of an entire processing region in the dynamic image.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind and mathematical concepts as it is regarding a concept relating to the analyzing the image and determining presence of a blood defect by observing a region with decrease in blood flow using comparison.
These actions fall under the Mental Processes and the Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations using a formula and definition to determine measurements.” A human, such as a surgeon can observe the dynamic analysis image of blood flow changes in the images, and based on the observation, one can determine region of blood flow decrease by observing signal value less than the reference and compare the region/area of signal decrease and compare the area to second threshold and make judgement whether a blood flow defect is present by using mental framework. In addition, area of region can be calculated by number of pixels and using area formula of pixel (square) and calculating a ratio between an area of signal decrease region over entire region of the dynamic image according to definition of a ratio. Thus, a surgeon can perform 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 and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“obtaining the dynamic image of a subject that is generated by an imaging apparatus by irradiating the subjection with radiation,”
“generating a dynamic analysis image for measuring a blood flow, based on signal value of pixels constituting the dynamic image.”
Obtaining image with irradiation and generating a dynamic analysis image is data gathering and is a form of a pre-solution insignificant activity. The steps of obtaining the dynamic image and generating a dynamic analysis image, comparing quantitative value are performed in order to gather data for the recited mental process step and are necessary precursor for all uses of the recited abstract idea since no dynamic analysis and comparison of area can be carried out without first gathering necessary image data. The use of a hardware processor for performing mental framework of comparison, observation and determination are recited with high generality, and specification does not provide special algorithms performed by hardware and processor is invoked merely as a tool to perform the abstract steps and does not add meaningful limitations, and thus, does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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 - The claim recites the following additional elements:
“obtaining the dynamic image of a subject that is generated by an imaging apparatus by irradiating the subjection with radiation,”
“generating a dynamic analysis image for measuring a blood flow, based on signal value of pixels constituting the dynamic image.”
This element of “generating dynamic image by an imaging apparatus by irradiating the subject with radiation” represents well-understood, routine and conventional activity because US2023/0067560 “Nagatsuka” teaches radiographic imaging system generating dynamic images using conventional radiographic imaging apparatus ([0191]), thus generating dynamic image by irradiating radiation to a subject, is performed by conventional radiographic imaging apparatus, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
Per specification, the element of hardware for generating dynamic image is described as controller, processor such as a CPU performing calculations and control and a memory, and a personal computer ([0026] and [0031]), which is commercially available product and thus, hardware processor is well-understood and conventional activity, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
For these reasons, there is no inventive concept in the claim. In light of the above, claim 9 is ineligible.
Claim 10 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 non-transitory computer-readable storage medium storing a program for a computer of a dynamic analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
“performing dynamic analysis on a dynamic image,”
“when a pixel of the dynamic analysis image has a signal value less than or equal to a first threshold, detecting the pixel as a signal decrease region that indicates a decrease in a blood flow value, and
comparing a quantitative value of the detected signal decrease region or a quantitative value of a non-signal decrease region with a second threshold, the non-signal decrease region being other than the signal decrease region, and based on the comparison, determines whether a blood flow defect is present.”
Wherein the quantitative value is an area, and the second threshold is a ratio between an area of the signal decrease region and an area of an entire processing region in the dynamic image.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind and mathematical concepts as it is regarding a concept relating to the analyzing the image and determining presence of a blood defect by observing a region with decrease in blood flow using comparison.
These actions fall under the Mental Processes and the Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations using a formula and definition to determine measurements.” A human, such as a surgeon can observe the dynamic analysis image of blood flow changes in the images, and based on the observation, one can determine region of blood flow decrease by observing signal value less than the reference and compare the region/area of signal decrease and compare the area to second threshold and make judgement whether a blood flow defect is present by using mental framework. In addition, area of region can be calculated by number of pixels and using area formula of pixel (square) and calculating a ratio between an area of signal decrease region over entire region of the dynamic image according to definition of a ratio. Thus, a surgeon can perform 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 and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“obtain the dynamic image of a subject that is generated by an imaging apparatus by irradiating the subjection with radiation,”
“generate a dynamic analysis image for measuring a blood flow, based on signal value of pixels constituting the dynamic image.”
Obtaining image with irradiation and generating a dynamic analysis image is data gathering and is a form of a pre-solution insignificant activity. The steps of obtaining the dynamic image and generating a dynamic analysis image, comparing quantitative value are performed in order to gather data for the recited mental process step and are necessary precursor for all uses of the recited abstract idea since no dynamic analysis and comparison of area can be carried out without first gathering necessary image data. The use of a hardware processor, computer-readable storage medium storing program for performing mental framework of comparison, observation and determination are recited with high generality, and specification does not provide special algorithms performed by hardware and processor is invoked merely as a tool to perform the abstract steps and does not add meaningful limitations, and thus, does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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 - The claim recites the following additional elements:
“obtain the dynamic image of a subject that is generated by an imaging apparatus by irradiating the subjection with radiation,”
“generate a dynamic analysis image for measuring a blood flow, based on signal value of pixels constituting the dynamic image.”
This element of “generating dynamic image by an imaging apparatus by irradiating the subject with radiation” represents well-understood, routine and conventional activity because US2023/0067560 “Nagatsuka” teaches radiographic imaging system generating dynamic images using conventional radiographic imaging apparatus ([0191]), thus generating dynamic image by irradiating radiation to a subject, is performed by conventional radiographic imaging apparatus, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
Per specification, the element of hardware for generating dynamic image is described as controller, processor such as a CPU performing calculations and control and a memory such as hard disk drive, and a personal computer ([0026], [0031] and [0035]), which is commercially available product and thus, hardware processor is well-understood and conventional activity, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
For these reasons, there is no inventive concept in the claim. In light of the above, claim 10 is ineligible.
Claims 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a dynamic analysis apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
Of claim 11, [the hardware processor generates the dynamic analysis image] by calculating a difference between a signal value of each pixel in a reference frame of the dynamic image and a signal value of each corresponding pixel in other frames of the dynamic image
Of claim 12, wherein [the hardware processor performs dynamic analysis processing on the dynamic image before generating the dynamic analysis image] by calculating a correction value based on spatial direction feature quantities and gain values
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind and mathematical concepts as it is regarding a concept relating to calculating a difference between two pixel values, which is a definition of subtraction, and calculating correction value based on spatial direction feature quantities and gain values, which calculates minimum value or maximum value ([0046]) and the gain values (threshold values) are calculated by visually checking blood flow of sites of the spatial direction feature ([0047]).
These actions fall under the Mental Processes and the Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations using a formula and definition to determine measurements.” A human, such as a surgeon can observe the dynamic analysis image of blood flow changes in the images, and based on the observation, one can determine a difference between two pixels of two images, by subtracting each pixel value from corresponding pixel of the other image using definition of subtraction. Moreover, one can process the image, by calculating a correction value by calculating minimum value of the feature (ROI) and setting gain values by visually checking blood flow sites in the image ([0047]). The specification provides mathematical equation to follow to obtain a correction value ([0047] equation (1)). Thus, a surgeon can perform 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 in calculating and processing the data using mathematical equation and formula. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
Of claim 11, [the hardware processor generates the dynamic analysis image]
Of claim 12, wherein [the hardware processor performs dynamic analysis processing on the dynamic image before generating the dynamic analysis image]
Obtaining image with irradiation and generating a dynamic analysis image and hardware performing dynamic analysis processing on the dynamic image before generating the dynamic analysis image is data gathering and is a form of a pre-solution insignificant activity. The steps of obtaining the dynamic image and generating a dynamic analysis image, processing the image by calculating values are performed in order to gather data for the recited mental process step and are necessary precursor for all uses of the recited abstract idea since no dynamic analysis and comparison of area can be carried out without first gathering necessary image data. The use of a hardware processor, computer-readable storage medium storing program for performing mental framework of comparison, observation and determination are recited with high generality, and specification does not provide special algorithms performed by hardware and processor is invoked merely as a tool to perform the abstract steps and does not add meaningful limitations, and thus, does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
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 - The claim recites the following additional elements:
Of claim 11, [the hardware processor generates the dynamic analysis image]
Of claim 12, wherein [the hardware processor performs dynamic analysis processing on the dynamic image before generating the dynamic analysis image]
This element of “generating dynamic image by an imaging apparatus by irradiating the subject with radiation” represents well-understood, routine and conventional activity because US2023/0067560 “Nagatsuka” teaches radiographic imaging system generating dynamic images using conventional radiographic imaging apparatus ([0191]), thus generating dynamic image by irradiating radiation to a subject, is performed by conventional radiographic imaging apparatus, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
Per specification, the element of hardware for generating dynamic image is described as controller, processor such as a CPU performing calculations and control and a memory such as hard disk drive, and a personal computer ([0026], [0031] and [0035]), which is commercially available product and thus, hardware processor is well-understood and conventional activity, making the limitation to be well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
For these reasons, there is no inventive concept in the claim. In light of the above, claims 11-12 are ineligible.
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 3 and 9-10 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 3 recites “an area” and it is not definite whether applicant intends to recite new and distinct area from recited “an area” in claim 1.
Claims 9-10 recite “obtaining the dynamic image of a subject” and it is not definite whether it refers to same and previously recited “A subject” or intends to recite new and distinct subject.
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.
Claims 1, 4-5, 7-8, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over “Shimamura,” US 2020/0034964 (hereinafter Shimamura) and “Moult et al.,” US 2018/0315194 (hereinafter Moult), and “Shimamura et al.,” US 2020/0327665 (hereinafter Shimamura 665).
Regarding to claim 1, Shimamura teaches a dynamic analysis apparatus configured to perform dynamic analysis on a dynamic image the dynamic analysis apparatus comprising a hardware processor (analysis apparatus includes a hardware processor [0094]), wherein:
The hardware processor obtains the dynamic image of a subject that is generated by an imaging apparatus by irradiating the subject with radiation (dynamic imaging that irradiates the object with pulsed radiation [0067]-[0070]),
the hardware processor generates a dynamic analysis image for measuring a blood flow, based on signal values of pixels constituting the dynamic image (blood flow analysis image [0254]),
Shimamura does not further explicitly disclose when a pixel of the dynamic analysis image has a signal value less than or equal to a first threshold, the hardware processor detects the pixel as a signal decrease region that indicates a decrease in a blood flow value, and the hardware processor compares a quantitative value of the detected signal decrease region or a quantitative value of a non-signal decrease region with a second threshold, the non-signal decrease region being other than the signal decrease region, and based on the comparison, determines whether a blood flow defect is present and wherein the quantitative value is an area and the second threshold is a ratio between an area of the signal decrease and an area of an entire processing region in the dynamic image.
However, in the analogous field of endeavor in angiographic imaging blood flow analysis, Moult teaches when a pixel of the dynamic analysis image has a signal value less than or equal to a first threshold, the hardware processor detects the pixel as a signal decrease region that indicates a decrease in a blood flow value (analyzing images, including pixel values are evaluated for abnormal condition, images are analyzed for information of blood flow, pixel values are determined to be abnormal based on comparisons to predefined thresholds, [0097]) and the hardware processor compares a quantitative value of the detected signal decrease region or a quantitative value of a non-signal decrease region with a second threshold, the non-signal decrease region being other than the signal decrease region, and based on the comparison, determines whether a blood flow defect is present (analyzing images, area of the abnormal features by comparing identified pixels collectively, and blood flow can be determined to be region of decreased blood flow when regions whose pixels values are lower than expected normal state [0097]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify dynamic analysis image as taught by Shimamura to incorporate teaching of Moult, since detecting abnormal state by analyzing images with areas by comparing pixels where the blood flow decrease regions are identified using comparison was well known in the art as taught by Moult. One of ordinary skill in the art could have combined the elements as claimed by Shimamura with no change in their respective functions, determining a region with decrease blood flow by thresholding, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to detect abnormal area in blood flow ([0097]), and there was reasonable expectation of success.
Moult further teaches in analyzing blood flow in images, the quantitative value is an area (area of abnormal features [0097]), but does not further teach that the second threshold is a ratio between an area of the signal decrease region and an area of an entire processing region in the dynamic image.
However, in the analogous field of endeavor in dynamic image analysis, Shimamura 665 discloses dynamic analysis image of lung, wherein the ratio of affected region over whole lung and determining characteristic amounts relating to the area of affected and whole area wherein the characteristic amounts can include a blood flow ([0082]-[0083]), and specifically can include blood flow increase and decrease (pixel value decreases [0108]), and can include ratio integrated blood flow characteristic amount in the region to the integrated value of the blood flow characteristic amount in the entire lung is calculated ([0162]), thus reads on claimed ratio between area of the signal decrease (blood flow characteristic amount in the region) and an entire processing region (entire lung), this makes it possible to grasp to some extent whether or not the blood flow distribution in the upper, middle, and lower lung fields is normal ([0162]). The examiner submits that in order to determine whether ratio is normal, it includes comparing its ratio to a threshold of the ratio. Since, Moult teaches comparing area, it can incorporate ratio of area and compare ratio of area to arrive at the claimed invention.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify dynamic image as taught by Shimamura to incorporate teaching of Shimamura 665, since ratio of blood flow change in the region over entire region was well known in the art as taught by Shimamura 665. One of ordinary skill in the art could have combined the elements as claimed by Shimamura with no change in their respective functions, configuring its blood flow to be determined as a ratio, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide local blood flow characteristic amount to the entire lung ([0162]), and there was reasonable expectation of success.
Regarding to claims 4-5, Shimamura, Moult, and Shimamura 665 together teach all limitations of claim 1 as discussed above.
Shimamura further teaches following limitations:
Of claim 4, the dynamic analysis image is expressed in multiple tones of color according to the signal values of the pixels constituting the dynamic analysis image (decreasing blood flow region expressed in cold color such as blue [0317]), and the first threshold is set to a predetermined tone of color among the multiple tones (Blood flow change matches its corresponding color, the predetermined tone corresponding to a blood flow defect (decreasing blood flow with cold color, increasing blood flow with warm color [0317]).
Of claim 5, the hardware processor corrects a variation in the generated dynamic analysis image caused by different imaging conditions in imaging, and the first threshold is set, based on the dynamic analysis image on which the correction of the variation is performed (imaging condition such as movement caused by body motion [0127], blood flow analysis image components other than a change in blood flow volume has been removed to correctly recognize the change in blood flow volume for appropriate diagnosis [0155])
Regarding to claim 7, Shimamura, Moult, and Shimamura 665 together teach all limitations of claim 1 as discussed above.
Moult further teaches wherein when determining that a blood flow defect is present in the dynamic analysis image, the hardware processor outputs determination information on the blood flow defect (outputs of images used to compute number, which is used to grade a level of ocular disease based on abnormal value/feature ([0097]).
Regarding to claim 8, Shimamura, Moult, and Shimamura 665 together teach all limitations of claim 7 as discussed above.
Shimamura further teaches wherein the hardware processor colors the signal decrease region in the dynamic analysis image with a color different from a color of the non-signal decrease region and outputs the colored dynamic analysis image ([0299], [0303], and region Ar1 with decrease in blood flow volume expressed in blue while region Ar2 with an increasing blood flow volume expressed in red [0317]).
Regarding to claim 11, Shimamura, Moult, and Shimamura 665 together teach all limitations of claim 1 as discussed above.
Shimamura 665 further teaches following limitations:
Of claim 11, the hardware processor generates the dynamic analysis image by calculating a difference between a signal value of each pixel in a reference frame of the dynamic image and a signal value of each corresponding pixel in other frames of the dynamic image ( a difference value between the pixel value and the corresponding pixel of the reference image is obtained [0128]; temporal changes of the blood in ROI obtained, difference in logarithm of the pixel values at two different times, between pixel values of each frame and pixel values of the pixels in the reference image [0166]-[0168])
Regarding to claim 9, Shimamura teaches a dynamic analysis method of performing dynamic analysis on a dynamic image obtained by irradiating a subject with radiation ([0067]-[0070]), the method comprising:
Obtaining the dynamic image of a subject that is generated by an imaging apparatus by irradiating the subject with radiation ([0067]-[0070])
generating a dynamic analysis image for measuring a blood flow, based on signal values of pixels constituting the dynamic image (blood flow analysis image [0254]),
Shimamura does not further explicitly disclose when a pixel of the dynamic analysis image has a signal value less than or equal to a first threshold, the hardware processor detects the pixel as a signal decrease region that indicates a decrease in a blood flow value, and the hardware processor compares a quantitative value of the detected signal decrease region or a quantitative value of a non-signal decrease region with a second threshold, the non-signal decrease region being other than the signal decrease region, and based on the comparison, determines whether a blood flow defect is present.
However, in the analogous field of endeavor in angiographic imaging blood flow analysis, Moult teaches when a pixel of the dynamic analysis image has a signal value less than or equal to a first threshold, the hardware processor detects the pixel as a signal decrease region that indicates a decrease in a blood flow value (analyzing images, including pixel values are evaluated for abnormal condition, images are analyzed for information of blood flow, pixel values are determined to be abnormal based on comparisons to predefined thresholds, [0097]) and the hardware processor compares a quantitative value of the detected signal decrease region or a quantitative value of a non-signal decrease region with a second threshold, the non-signal decrease region being other than the signal decrease region, and based on the comparison, determines whether a blood flow defect is present (analyzing images, area of the abnormal features by comparing identified pixels collectively, and blood flow can be determined to be region of decreased blood flow when regions whose pixels values are lower than expected normal state [0097]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify dynamic analysis image as taught by Shimamura to incorporate teaching of Moult, since detecting abnormal state by analyzing images with areas by comparing pixels where the blood flow decrease regions are identified using comparison was well known in the art as taught by Moult. One of ordinary skill in the art could have combined the elements as claimed by Shimamura with no change in their respective functions, determining a region with decrease blood flow by thresholding, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to detect abnormal area in blood flow ([0097]), and there was reasonable expectation of success.
Moult further teaches in analyzing blood flow in images, the quantitative value is an area (area of abnormal features [0097]), but does not further teach that the second threshold is a ratio between an area of the signal decrease region and an area of an entire processing region in the dynamic image.
However, in the analogous field of endeavor in dynamic image analysis, Shimamura 665 discloses dynamic analysis image of lung, wherein the ratio of affected region over whole lung and determining characteristic amounts relating to the area of affected and whole area wherein the characteristic amounts can include a blood flow ([0082]-[0083]), and specifically can include blood flow increase and decrease (pixel value decreases [0108]), and can include ratio integrated blood flow characteristic amount in the region to the integrated value of the blood flow characteristic amount in the entire lung is calculated ([0162]), thus reads on claimed ratio between area of the signal decrease (blood flow characteristic amount in the region) and an entire processing region (entire lung), this makes it possible to grasp to some extent whether or not the blood flow distribution in the upper, middle, and lower lung fields is normal ([0162]). The examiner submits that in order to determine whether ratio is normal, it includes comparing its ratio to a threshold of the ratio. Since, Moult teaches comparing area, it can incorporate ratio of area and compare ratio of area to arrive at the claimed invention.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify dynamic image as taught by Shimamura to incorporate teaching of Shimamura 665, since ratio of blood flow change in the region over entire region was well known in the art as taught by Shimamura 665. One of ordinary skill in the art could have combined the elements as claimed by Shimamura with no change in their respective functions, configuring its blood flow to be determined as a ratio, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide local blood flow characteristic amount to the entire lung ([0162]), and there was reasonable expectation of success.
Regarding to claim 10, Shimamura teaches a non-transitory computer-readable storage medium storing a program for a computer (a computer reads the system program [0107]) of a dynamic analysis apparatus configured to perform dynamic analysis on a dynamic image obtained by irradiating a subject with radiation ([0067]-[0070]), the program causing the computer (claim 12) to:
Obtain the dynamic image of a subject that is generated by an imaging apparatus by irradiating the subject with radiation ([0067]-[0070])
generate a dynamic analysis image for measuring a blood flow, based on signal values of pixels constituting the dynamic image (blood flow analysis image [0254]),
Shimamura does not further explicitly disclose when a pixel of the dynamic analysis image has a signal value less than or equal to a first threshold, the hardware processor detects the pixel as a signal decrease region that indicates a decrease in a blood flow value, and the hardware processor compares a quantitative value of the detected signal decrease region or a quantitative value of a non-signal decrease region with a second threshold, the non-signal decrease region being other than the signal decrease region, and based on the comparison, determines whether a blood flow defect is present.
However, in the analogous field of endeavor in angiographic imaging blood flow analysis, Moult teaches when a pixel of the dynamic analysis image has a signal value less than or equal to a first threshold, the hardware processor detects the pixel as a signal decrease region that indicates a decrease in a blood flow value (analyzing images, including pixel values are evaluated for abnormal condition, images are analyzed for information of blood flow, pixel values are determined to be abnormal based on comparisons to predefined thresholds, [0097]) and the hardware processor compares a quantitative value of the detected signal decrease region or a quantitative value of a non-signal decrease region with a second threshold, the non-signal decrease region being other than the signal decrease region, and based on the comparison, determines whether a blood flow defect is present (analyzing images, area of the abnormal features by comparing identified pixels collectively, and blood flow can be determined to be region of decreased blood flow when regions whose pixels values are lower than expected normal state [0097]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify dynamic analysis image as taught by Shimamura to incorporate teaching of Moult, since detecting abnormal state by analyzing images with areas by comparing pixels where the blood flow decrease regions are identified using comparison was well known in the art as taught by Moult. One of ordinary skill in the art could have combined the elements as claimed by Shimamura with no change in their respective functions, determining a region with decrease blood flow by thresholding, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to detect abnormal area in blood flow ([0097]), and there was reasonable expectation of success.
Moult further teaches in analyzing blood flow in images, the quantitative value is an area (area of abnormal features [0097]), but does not further teach that the second threshold is a ratio between an area of the signal decrease region and an area of an entire processing region in the dynamic image.
However, in the analogous field of endeavor in dynamic image analysis, Shimamura 665 discloses dynamic analysis image of lung, wherein the ratio of affected region over whole lung and determining characteristic amounts relating to the area of affected and whole area wherein the characteristic amounts can include a blood flow ([0082]-[0083]), and specifically can include blood flow increase and decrease (pixel value decreases [0108]), and can include ratio integrated blood flow characteristic amount in the region to the integrated value of the blood flow characteristic amount in the entire lung is calculated ([0162]), thus reads on claimed ratio between area of the signal decrease (blood flow characteristic amount in the region) and an entire processing region (entire lung), this makes it possible to grasp to some extent whether or not the blood flow distribution in the upper, middle, and lower lung fields is normal ([0162]). The examiner submits that in order to determine whether ratio is normal, it includes comparing its ratio to a threshold of the ratio. Since, Moult teaches comparing area, it can incorporate ratio of area and compare ratio of area to arrive at the claimed invention.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify dynamic image as taught by Shimamura to incorporate teaching of Shimamura 665, since ratio of blood flow change in the region over entire region was well known in the art as taught by Shimamura 665. One of ordinary skill in the art could have combined the elements as claimed by Shimamura with no change in their respective functions, configuring its blood flow to be determined as a ratio, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide local blood flow characteristic amount to the entire lung ([0162]), and there was reasonable expectation of success.
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Shimamura, Moult, and Shimamura 665 as applied to claim 1 above, and further in view of “Muraoka et al.,” US 2013/0156267 (hereinafter Muraoka).
Regarding to claims 3 and 6, Shimamura, Moult and Shimamura 665 together teach all limitations of claim 1 as discussed above.
Shimamura 665 teaches dynamic analysis with following limitations:
Of claim 3, a processing region in the dynamic image is divided into multiple divided regions (left and right lung field regions may be divided into three equal parts in the upper, middle, and lower power [0162]), the quantitative value is an area (blood flow characteristics amount in each of the six divided regions to the integrated value of the blood flow characteristics amount in the entire lung field [0163]), and the second threshold is set based on a ratio between an area of the signal decrease region in the divided region and an area of the entire region ([0082]-[0083], [0108], and [0162]).
Of claim 6, a processing region in the dynamic image is divided into multiple divided regions according to a distance from a predetermined reference position ([0162], distance from the endpoints to regions [0217])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify dynamic image as taught by Shimamura to incorporate teaching of Shimamura 665, since dividing regions into multiple sub-regions was well known in the art as taught by Shimamura 665. One of ordinary skill in the art could have combined the elements as claimed by Shimamura with no change in their respective functions, dividing target in the image into multiple subregions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide local blood flow characteristics within the lung ([0217]), and there was reasonable expectation of success.
Shimamura 665 do not further disclose threshold value is set for each of the regions, based on a ratio between an area of the signal decrease region in the region and an area of the entire region, but does not teach threshold value is set for each of the regions.
However, in the analogous field of endeavor in dynamic analysis image, Muraoka teaches dynamic analysis image wherein the second threshold value is set for each of the divided regions ([0199] and [0204], [0206]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify subregions in the image as taught by Shimamura 665 to incorporate teaching of Muraoka, since threshold setting for each of the regions was well known in the art as taught by Muraoka. One of ordinary skill in the art could have combined the elements as claimed by Shimamura 665 with no change in their respective functions, configuring the threshold for abnormality for each subregion, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide abnormal/disorder determination for each subregion ([0204]), and there was reasonable expectation of success.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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