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, see pages 16-18, filed 07 July 2026, with respect to double patenting rejection and 102 rejections have been fully considered and are persuasive in view of amendment. The 102 rejections and double patenting rejections of 08 April 2026 has been withdrawn.
Applicant's arguments for 101 rejections filed 07 July 2026 have been fully considered but they are not persuasive. The applicant, in view of amendment, argues that claimed invention is directed to an abstract idea without significantly more. However, the examiner disagrees respectfully. The amended independent claims are directed to abstract idea since they incorporate mental process, mathematical calculations (for determining a group connectivity matrix as previous claim 5), and organizing human activities collectively. The examiner has included detailed explanation of the elements in rejection. The examiner further submits that claims 1, 8, and 12 can be performed by human, using mental framework, mathematical calculations and following set of rules, with mere implementation of those steps in computer. The claims do not recite any active use of the results from calculations to control and/or make changes in practical applications. These elements are claimed in a manner that a physician can obtain MRI image scan data, and making analysis by observing, comparing values of the data, performing mathematical calculations and following set of rules to draw a conclusion.
Therefore, the examiner has maintained 101 rejection and modified 101 rejections in view of amendment (Detailed 101 rejection set forth below).
In view of amendment for claim 9, claim 9 is rejected under 35 USC § 112 (a) for new matter.
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 1-4 and 6-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method for target identification, and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
determining at least two regions of interest of the subject based on the scanning data
determining at least one abnormal region of interest in the at least two regions of interest in accordance with a predetermined anomaly detection rule
determining a target based on the at least one abnormal region of interest
wherein determining at least one abnormal region of interest in the at least two regions of interest in accordance with a predetermined anomaly detection rule, comprises:
determining a group brain connectivity matrix based on the group brain magnetic resonance data;
determining connectivity between each two voxels in the scanning data to form a brain connectivity matrix of the subject corresponding to the scanning data; and determining the at least one abnormal region of interest in accordance with the group brain connectivity matrix and the brain connectivity matrix of the subject;
wherein each brain connectivity matrix of the subject is a diagonal matrix;
obtaining the group brain connectivity matrix comprises option 1 or option 2, option 1: calculating a mean for diagonal matrices of all subjects to obtain a mean matrix, then calculating sequentially the correlation coefficients between each row of diagonal matrix and the corresponding row of the mean matrix to obtain a one-dimensional matrix, and then calculating the mean and standard deviation for the one-dimensional matrix for all subjects to obtain a Corr mean matrix and a Corr std matrix, the Corr mean matrix and the Corr std matrix are the group brain connectivity matrix;
option 2: calculating a mean and standard deviation for diagonal matrices of all subjects to obtain a mean matrix and a standard deviation matrix, the mean matrix and the standard deviation matrix are the group brain connectivity matrix;
obtaining the brain connectivity matrix of the subject comprises option 1 or option 2,
option 1: calculating the average time sequences of all vertices/voxels in each region of interest of the subject, then calculating sequentially correlation coefficients between regions of interest and time sequences of the region of interest to obtain a p fc matrix of the subject, and calculating sequentially the correlation coefficients between each row of the p fc matrix and the corresponding row of the mean matrix to obtain an one-dimensional p corr matrix;
option 2: calculating the average time sequences of all vertices/voxels in each region of interest of the subject, then calculating sequentially correlation coefficients between regions of interest and time sequences of the region of interest to obtain a p fc matrix of the subject;
anomaly detection comprises option 1 or option 2,
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data in the ith row and jth column of the mean matrix, and Big std fc(i,j) is a data in the ith row and jth column of the standard deviation matrix.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind, mathematical calculations, and organizing human activity as it is regarding a concept relating to the determining target by analyzing two regions of interest in the data based on a predetermined anomaly detection rule.
The determination of the region of interest can be performed by observing scanning data and selecting two regions of interest based on set of rules using mental process of combining comparison, analysis, and opinion and judgement. Moreover, a physician can perform observation and analyzing scanning data such as image, make decision from observing whether each region of interest with rules of anomaly detection rule, and draws conclusion that whether ROI is abnormal region and determines that ROI to be target in mental framework. Moreover, obtaining group brain connectivity matrix, the brain connectivity matrix of the subject and anomaly detection can be performed by selecting one of options 1 and 2, and following sequences of mathematical calculations and manipulations using equations and known formula for mean, correlation coefficients, standard deviations, average time sequences of all voxels in each region of interest, performing anomaly detection by plugging in obtained values into the anomaly detection expression, which is a mathematical equation. A physician can perform determining abnormal region of interest by following anomaly detection rule belongs to “following rules or instructions” such as following steps of selection and calculations according to the rule.
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, a mathematical concept-type, and organizing human activit- type abstract idea.
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-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“acquiring scanning data of a subject, wherein the scanning data comprise the data acquired from magnetic resonance imaging of a brain of the subject. ”
“acquiring group brain magnetic resonance data;
Acquiring scanning data of a subject and group brain magnetic resonance data are data gathering and is a form of a pre-solution insignificant activity. The steps of acquiring scanning data (magnetic resonance data) is performed in order to gather data for the recited mental process, mathematical calculations and following rules and is a necessary precursor for all uses of the recited abstract ideas on identifying abnormal regions of the images.
The use of magnetic resonance imaging device to acquire scanning data 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:
“acquiring scanning data of a subject, wherein the scanning data comprise the data acquired from magnetic resonance imaging of a brain of the subject. ”
“acquiring group brain magnetic resonance data;
These elements are evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements. As described in Crozier (US 2017/0354659), measurement or detection in the brain can be done using functional MRI and functional brain network analyses as known in the art, and using known techniques based upon fMRI scanning of human brains ([0026]). Thus, use of scan data from MRI and fMRI for analyzing brain is well-understood, routine and convention.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent 1 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 is ineligible.
Claims 2-4 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 method for target identification, and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
Of claim 2, determining the at least two regions of interest of the subject based on a volume standard brain template according to the scanning data.
Of claim 3, determining the at least two regions of interest of the subject based on a cortical standard brain template according to the scanning data.
Of claim 4, wherein determining the at least two regions of interest of the subject based on the scanning data, comprises determining connectivity between each two voxels in the scanning data to form a brain connectivity matrix corresponding to the scanning data and forming at least two regions of interest based on a brain region template of a standard brain and the brain connectivity matrix.
These limitations, 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 determining ROIs based on mental comparison of brain images to a volume standard brain template/cortical standard brain template. Determining connectivity between tow voxels can be also performed by mental comparison of the values and arranging values in a matrix format that corresponds to voxels in the scanning data. The determination of the region of interest can be performed by observing scanning data and make a comparison analysis with standard template and mentally make a judgement where the ROIs would be located in the scanning data. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claims 2-4 are ineligible.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method for target identification, and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
determining whether the at least one abnormal region of interest is located in a modulation brain region or not
if the at least one abnormal region of interest is located in the modulation brain region, determining a center of the at least one abnormal region of interest as the target or determining a region with the center of the at least one abnormal region of interest as a spherical center, with a predetermined target radius as a first target region of interest, determining the target based on a position of the first target region of interest;
if the at least one abnormal region of interest is not located in the modulation brain region, determining a connectivity of the at least one abnormal region of interest with other regions of interest in the at least two regions of interest, and the region of interest among the other regions of interest having the connectivity with the at least one abnormal region of interest that exceeds a predetermined connectivity threshold and which is located in the modulation region as a second target candidate; and determining a center of the second target candidate as the target, or determining a region with the center of the second target candidate as a spherical center and with the predetermined target radius as a second target region of interest, determining the target based on a position of the second target region of interest.
These limitations, 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 determining target by analyzing two regions of interest in the data based on a predetermined anomaly detection rule. Determining whether ROI is in modulation region or not can be performed by observation of the image and determining in metal frame whether ROI falls within the modulation region. When the ROI is in the modulation region, physician can determine a center of region, by using geometrical property of a center of a circle, and with the predetermined radius, one can determine the target to be circle with predetermined radius from the center of the ROI. This can all be performed by mental observation, using mathematical definition of a circle and one can set radius to cover the ROI and draw a circle with the radius and determine to be target, which can be also performed by drawing a circle in the ROI in the image. Moreover, when the ROI is in other region that the claimed modulation region by observation of the image, physician can determine connectivity of two regions by observing the data upon activation, recognizing two distinct regions, and drawing a line between two regions, and determine the ROI to be target candidate, which can be done by drawing a line in the image showing activation. Subsequently, physician can determine a center of region, by using geometrical property/definition of a center of a circle, and with the predetermined radius, the target can be determined to be circle with predetermined radius from the center of the ROI. This can all be performed by mental observation, using mathematical definition of a circle and radius of the circle, and drawing in the image, in mental framework with aid of pen/paper. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 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 method for target identification, and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
determining a brain structure subdivision in which the target is located based on a disease type of the subject;
determining an intersection of the at least one abnormal region of interest or the region of interest whose connectivity with the abnormal region of interest satisfies a predetermined connectivity threshold condition with the brain structure subdivision as a target candidate; and
determining a center of the target candidate as the target, or, determining a region with the center of the target candidate as a spherical center and with a predetermined target radius as a target region of interest, and determining the target based on a position of the target region of interest
These limitations, 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 determining target by analyzing two regions of interest in the data based on a predetermined anomaly detection rule. Determining a brain subdivision based on the disease type can be done by looking up database (i.e. library, reference) of brain subdivision activation for different types of disease (i.e. brain regions of activation in Alzheimer’s disease, brain regions activated with depression). Once the subdivision is determined, physician can determine an intersection of the determined subdivision with the ROI whose connectivity meets a desired condition, based on observation, comparison of the connectivity, and drawing a conclusion whether condition is met, and draw an intersection line between the subdivision and the ROI with desired connectivity, and conclude that the intersection is a target. The physician can determine a center of region, by using geometrical definition of a center of a circle, and with the predetermined radius, one can determine the target to be circle with predetermined radius from the center of the ROI. This can all be performed by mental observation, using mathematical definition of a circle and radius, and one can set radius to cover the ROI and draw a circle with the radius and determine to be target, which can be also performed by drawing a circle in the ROI in the image with aid of pen/paper. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 7 is ineligible.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim 8 recites additional limitations :
“the magnetic resonance imaging comprises structural magnetic resonance imaging of the brain, and/or task-based functional magnetic resonance imaging and/or, resting state functional magnetic resonance imaging.”
Acquiring scanning data using functional MRI are data gathering and is a form of a pre-solution insignificant activity. The steps of acquiring scanning data (magnetic resonance data) is performed in order to gather data for the recited mental process, mathematical calculations and following rules and is a necessary precursor for all uses of the recited abstract ideas on identifying abnormal regions of the images.
The use of magnetic resonance imaging device to acquire scanning data 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 magnetic resonance imaging comprises structural magnetic resonance imaging of the brain, and/or task-based functional magnetic resonance imaging and/or, resting state functional magnetic resonance imaging.”
These elements are evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements. As described in Crozier (US 2017/0354659), measurement or detection in the brain can be done using functional MRI and functional brain network analyses as known in the art, and using known techniques based upon fMRI scanning of human brains ([0026]), using anatomical imaging and resting fMRI for evaluating brain network connectivity ([0030]) using published method of acquiring resting fMRI data ([0036]), and Resting BOLD fMRI can be collected and processed using software known in the art ([0038]). Thus, use of scan data from MRI and resting fMRI for analyzing brain, namely, brain network connectivity, is well-understood, routine and convention.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent 1 (and their dependent claim 8) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
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 target identification device, and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
Configured to determine at least two regions of interest of the subject based on the scanning data
Configured to determine at least one abnormal region of interest in the at least two regions of interest in accordance with a predetermined anomaly detection rule
Configured to determine a target based on the at least one abnormal region of interest
wherein determining at least one abnormal region of interest in the at least two regions of interest in accordance with a predetermined anomaly detection rule, comprises:
determining a group brain connectivity matrix based on the group brain magnetic resonance data;
determining connectivity between each two voxels in the scanning data to form a brain connectivity matrix of the subject corresponding to the scanning data; and determining the at least one abnormal region of interest in accordance with the group brain connectivity matrix and the brain connectivity matrix of the subject;
wherein each brain connectivity matrix of the subject is a diagonal matrix;
obtaining the group brain connectivity matrix comprises option 1 or option 2, option 1: calculating a mean for diagonal matrices of all subjects to obtain a mean matrix, then calculating sequentially the correlation coefficients between each row of diagonal matrix and the corresponding row of the mean matrix to obtain a one-dimensional matrix, and then calculating the mean and standard deviation for the one-dimensional matrix for all subjects to obtain a Corr mean matrix and a Corr std matrix, the Corr mean matrix and the Corr std matrix are the group brain connectivity matrix;
option 2: calculating a mean and standard deviation for diagonal matrices of all subjects to obtain a mean matrix and a standard deviation matrix, the mean matrix and the standard deviation matrix are the group brain connectivity matrix;
obtaining the brain connectivity matrix of the subject comprises option 1 or option 2,
option 1: calculating the average time sequences of all vertices/voxels in each region of interest of the subject, then calculating sequentially correlation coefficients between regions of interest and time sequences of the region of interest to obtain a p fc matrix of the subject, and calculating sequentially the correlation coefficients between each row of the p fc matrix and the corresponding row of the mean matrix to obtain an one-dimensional p corr matrix;
option 2: calculating the average time sequences of all vertices/voxels in each region of interest of the subject, then calculating sequentially correlation coefficients between regions of interest and time sequences of the region of interest to obtain a p fc matrix of the subject;
anomaly detection comprises option 1 or option 2,
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data in the ith row and jth column of the mean matrix, and Big std fc(i,j) is a data in the ith row and jth column of the standard deviation matrix.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind, mathematical calculations, and organizing human activity as it is regarding a concept relating to the determining target by analyzing two regions of interest in the data based on a predetermined anomaly detection rule.
The determination of the region of interest can be performed by observing scanning data and selecting two regions of interest based on set of rules using mental process of combining comparison, analysis, and opinion and judgement. Moreover, a physician can perform observation and analyzing scanning data such as image, make decision from observing whether each region of interest with rules of anomaly detection rule, and draws conclusion that whether ROI is abnormal region and determines that ROI to be target in mental framework. Moreover, obtaining group brain connectivity matrix, the brain connectivity matrix of the subject and anomaly detection can be performed by selecting one of options 1 and 2, and following sequences of mathematical calculations and manipulations using equations and known formula for mean, correlation coefficients, standard deviations, average time sequences of all voxels in each region of interest, performing anomaly detection by plugging in obtained values into the anomaly detection expression, which is a mathematical equation. A physician can perform determining abnormal region of interest by following anomaly detection rule belongs to “following rules or instructions” such as following steps of selection and calculations according to the rule.
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 9recites a mental process-type, a mathematical concept-type, and organizing human activit- type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“a data acquisition unit configured to acquire scanning data of a subject, wherein the scanning data comprise the data acquired from magnetic resonance imaging of a brain of the subject. ”
“acquiring group brain magnetic resonance data;”
“A processing circuit”
“Anomaly detection circuit”
“A target identification circuit”
Acquiring scanning data of a subject and group brain magnetic resonance data are data gathering and is a form of a pre-solution insignificant activity. The steps of acquiring scanning data (magnetic resonance data) is performed in order to gather data for the recited mental process, mathematical calculations and following rules and is a necessary precursor for all uses of the recited abstract ideas on identifying abnormal regions of the images.
A processing circuit, anomaly detection circuit and a target identification circuit are performed using central processing unit, described in specification ([0275]) as units provided in a processor ([0278]).
The above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process, mathematical calculations and following rules) using rules (e.g., computer instructions) executed by a computer (e.g., processor, computer programming languages as disclosed in specification).
In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 9 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
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:
“acquiring scanning data of a subject, wherein the scanning data comprise the data acquired from magnetic resonance imaging of a brain of the subject. ”
“acquiring group brain magnetic resonance data;
“A processing circuit”
“Anomaly detection circuit”
“A target identification circuit”
These elements are evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements. Per specification, processor is described in general terms, and “conventional procedural programming languages” ([0276]). Moreover, as described in Crozier (US 2017/0354659), measurement or detection in the brain can be done using functional MRI and functional brain network analyses as known in the art, and using known techniques based upon fMRI scanning of human brains ([0026]). Thus, use of processor and scan data from MRI and fMRI for analyzing brain is well-understood, routine and convention.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent 9 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
For these reasons, there is no inventive concept in the claim. In light of the above, claim 9 is ineligible.
Claims 10-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Step 2A, Prong 2, Integrated into Practical Application: No - The claims 10-11 recite the following additional elements:
“at least one processor; and a storage device having at least one program stored thereon, wherein the at least one program, when executed by the at least one processor, causes the at least one processor to execute the method according to claim 1.”
“A computer readable storage medium, having a computer program stored thereon, wherein the computer program, when executed by at least one processor, executes the method according to claim 1.”
A processing circuit, anomaly detection circuit and a target identification circuit are performed using central processing unit, described in specification ([0275]) as units provided in a processor ([0278]) and using conventional programming languages ([0276]).
The above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process, mathematical calculations and following rules) using rules (e.g., computer instructions) executed by a computer (e.g., processor, computer programming languages as disclosed in specification).
In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 9 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
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:
“At least one processor;”
“a storage device having at least one program stored thereon, wherein the at least one program, when executed by the at least one processor, causes the at least one processor to execute the method according to claim 1.”
These elements are evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements. Per specification, processor is described in general terms, and “conventional procedural programming languages” ([0276]). Thus, use of processor for analyzing brain is well-understood, routine and convention.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent 9 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
For these reasons, there is no inventive concept in the claim. In light of the above, claims 10-11 are ineligible.
Claim 12 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 neuromodulation apparatus, and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
Wherein the target is determined by a method for targe identification comprising:
determining at least two regions of interest of the subject based on the scanning data
determining at least one abnormal region of interest in the at least two regions of interest in accordance with a predetermined anomaly detection rule
determining a target based on the at least one abnormal region of interest
wherein determining at least one abnormal region of interest in the at least two regions of interest in accordance with a predetermined anomaly detection rule, comprises:
determining a group brain connectivity matrix based on the group brain magnetic resonance data;
determining connectivity between each two voxels in the scanning data to form a brain connectivity matrix of the subject corresponding to the scanning data; and determining the at least one abnormal region of interest in accordance with the group brain connectivity matrix and the brain connectivity matrix of the subject;
wherein each brain connectivity matrix of the subject is a diagonal matrix;
obtaining the group brain connectivity matrix comprises option 1 or option 2, option 1: calculating a mean for diagonal matrices of all subjects to obtain a mean matrix, then calculating sequentially the correlation coefficients between each row of diagonal matrix and the corresponding row of the mean matrix to obtain a one-dimensional matrix, and then calculating the mean and standard deviation for the one-dimensional matrix for all subjects to obtain a Corr mean matrix and a Corr std matrix, the Corr mean matrix and the Corr std matrix are the group brain connectivity matrix;
option 2: calculating a mean and standard deviation for diagonal matrices of all subjects to obtain a mean matrix and a standard deviation matrix, the mean matrix and the standard deviation matrix are the group brain connectivity matrix;
obtaining the brain connectivity matrix of the subject comprises option 1 or option 2,
option 1: calculating the average time sequences of all vertices/voxels in each region of interest of the subject, then calculating sequentially correlation coefficients between regions of interest and time sequences of the region of interest to obtain a p fc matrix of the subject, and calculating sequentially the correlation coefficients between each row of the p fc matrix and the corresponding row of the mean matrix to obtain an one-dimensional p corr matrix;
option 2: calculating the average time sequences of all vertices/voxels in each region of interest of the subject, then calculating sequentially correlation coefficients between regions of interest and time sequences of the region of interest to obtain a p fc matrix of the subject;
anomaly detection comprises option 1 or option 2,
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data in the ith row and jth column of the mean matrix, and Big std fc(i,j) is a data in the ith row and jth column of the standard deviation matrix.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind, mathematical calculations, and organizing human activity as it is regarding a concept relating to the determining target by analyzing two regions of interest in the data based on a predetermined anomaly detection rule.
The determination of the region of interest can be performed by observing scanning data and selecting two regions of interest based on set of rules using mental process of combining comparison, analysis, and opinion and judgement. Moreover, a physician can perform observation and analyzing scanning data such as image, make decision from observing whether each region of interest with rules of anomaly detection rule, and draws conclusion that whether ROI is abnormal region and determines that ROI to be target in mental framework. Moreover, obtaining group brain connectivity matrix, the brain connectivity matrix of the subject and anomaly detection can be performed by selecting one of options 1 and 2, and following sequences of mathematical calculations and manipulations using equations and known formula for mean, correlation coefficients, standard deviations, average time sequences of all voxels in each region of interest, performing anomaly detection by plugging in obtained values into the anomaly detection expression, which is a mathematical equation. A physician can perform determining abnormal region of interest by following anomaly detection rule belongs to “following rules or instructions” such as following steps of selection and calculations according to the rule.
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, a mathematical concept-type, and organizing human activit- type abstract idea.
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-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“a neuromodulation apparatus configured to make neuromodulation on a target of a subject,”
“acquiring scanning data of a subject, wherein the scanning data comprise the data acquired from magnetic resonance imaging of a brain of the subject. ”
“acquiring group brain magnetic resonance data;
Acquiring scanning data of a subject and group brain magnetic resonance data are data gathering and is a form of a pre-solution insignificant activity. The steps of acquiring scanning data (magnetic resonance data) is performed in order to gather data for the recited mental process, mathematical calculations and following rules and is a necessary precursor for all uses of the recited abstract ideas on identifying abnormal regions of the images. In addition, neuromodulation apparatus is recited in high generality without specific use or controlling the apparatus actively on the based result of anomaly detection.
The use of neuromodulation apparatus and magnetic resonance imaging device to acquire scanning data 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:
“a neuromodulation apparatus configured to make neuromodulation on a target of a subject,”
“acquiring scanning data of a subject, wherein the scanning data comprise the data acquired from magnetic resonance imaging of a brain of the subject. ”
“acquiring group brain magnetic resonance data;
These elements are evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements. As described in Crozier (US 2017/0354659), measurement or detection in the brain can be done using functional MRI and functional brain network analyses as known in the art, and using known techniques based upon fMRI scanning of human brains ([0026]). Thus, use of scan data from MRI and fMRI for analyzing brain is well-understood, routine and convention.
Per specification, neuromodulation apparatus is described as not limited to specific forms of the apparatus ([0219]), which indicates that various neuromodulation apparatuses are widely used. The examiner further submits “Mishelevich” (US 2013/0281890) discloses that ultrasound-based neuromodulation operation using commercially available 1-inch diameter ultrasound transducer with focal spot ([0680]). Thus, neuromodulation apparatus is well-known, routine and conventional in the field of neuromodulation operation.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent 12 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
For these reasons, there is no inventive concept in the claim. In light of the above, claim 12 is ineligible.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Steps 1 and 2A, Judicial Exception are discussed above in the claim 12 rejection.
Steps 2A Prong 2 and 2B: Integration into Practical Application and Invention concepts -No.
Claim 13 recites the following elements: “wherein the preset neuromodulation solution comprises at least one of deep brain electrical stimulation, transcranial electrical stimulation, electroconvulsive therapy, electrical stimulation based on cortical brain electrodes, transcranial magnetic stimulation, focused ultrasound neuromodulation, magnetic resonance guided high-intensity focused ultrasound therapy modulation and photobiomodulation therapy.”
This claim element is a mere list of possible treatments which amounts to a post-solution insignificant activity and is recited without actual treatment is performed to produce an outcome.
Per specification, neuromodulation apparatus is described as not limited to specific forms of the apparatus ([0219]), which indicates that various neuromodulation apparatuses are widely used. The examiner further submits “Mishelevich” (US 2013/0281890) discloses that ultrasound-based neuromodulation operation using commercially available 1-inch diameter ultrasound transducer with focal spot ([0680]). Thus, neuromodulation apparatus is well-known, routine and conventional in the field of neuromodulation operation.
This post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step.
In light of above, claim 13 is ineligible.
Claims 14-17 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 neuromodulation apparatus, and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
Of claim 14, determining the at least two regions of interest of the subject based on a volume standard brain template according to the scanning data.
Of claim 15, determining the at least two regions of interest of the subject based on a cortical standard brain template according to the scanning data.
Of claim 16, wherein determining the at least two regions of interest of the subject based on the scanning data, comprises determining connectivity between each two voxels in the scanning data to form a brain connectivity matrix corresponding to the scanning data and forming at least two regions of interest based on a brain region template of a standard brain and the brain connectivity matrix.
Of claim 17, wherein determining at least one abnormal region of interest in the at least two regions of interest in accordance with a predetermined anomaly detection rule, comprises: Determining a group brain connectivity matrix based on the group brain magnetic resonance data; determining connectivity between each two voxels in the scanning data to form a brain connectivity matrix of the subject corresponding to the scanning data and determining the at least one abnormal region of interest in accordance with the group brain connectivity matrix and the brain connectivity matrix of the subject.
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind, mathematical calculations and organizing human activities as it is regarding a concept relating to the determining ROIs based on mental comparison of brain images to a volume standard brain template/cortical standard brain template. The determination of the region of interest can be performed by observing scanning data and make a comparison analysis with standard template and mentally make a judgement where the ROIs would be located in the scanning data. The elements in claims 16-17 can be performed by following rules of sequence of mathematical calculations, using equations and manipulating data as discussed in claim 13 as set forth above. 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, mathematical concept and organizing human activity type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
“acquiring group brain magnetic resonance data;
Acquiring scanning data of a subject and group brain magnetic resonance data are data gathering and is a form of a pre-solution insignificant activity. The steps of acquiring scanning data (magnetic resonance data) is performed in order to gather data for the recited mental process, mathematical calculations and following rules and is a necessary precursor for all uses of the recited abstract ideas on identifying abnormal regions of the images.
The use of magnetic resonance imaging device to acquire scanning data 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:
“acquiring group brain magnetic resonance data;
These elements are evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements. As described in Crozier (US 2017/0354659), measurement or detection in the brain can be done using functional MRI and functional brain network analyses as known in the art, and using known techniques based upon fMRI scanning of human brains ([0026]). Thus, use of scan data from MRI and fMRI for analyzing brain is well-understood, routine and convention.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent 13 (and their dependent claims 14-17) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
For these reasons, there is no inventive concept in the claim. In light of the above, claims 14-17 are ineligible.
Claim 18 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 neuromodulation apparatus, and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
determining whether the at least one abnormal region of interest is located in a modulation brain region or not
if the at least one abnormal region of interest is located in the modulation brain region, determining a center of the at least one abnormal region of interest as the target or determining a region with the center of the at least one abnormal region of interest as a spherical center, with a predetermined target radius as a first target region of interest, determining the target based on a position of the first target region of interest;
if the at least one abnormal region of interest is not located in the modulation brain region, determining a connectivity of the at least one abnormal region of interest with other regions of interest in the at least two regions of interest, and the region of interest among the other regions of interest having the connectivity with the at least one abnormal region of interest that exceeds a predetermined connectivity threshold and which is located in the modulation region as a second target candidate; and determining a center of the second target candidate as the target, or determining a region with the center of the second target candidate as a spherical center and with the predetermined target radius as a second target region of interest, determining the target based on a position of the second target region of interest.
These limitations, 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 determining target by analyzing two regions of interest in the data based on a predetermined anomaly detection rule. Determining whether ROI is in modulation region or not can be performed by observation of the image and determining in metal frame whether ROI falls within the modulation region. When the ROI is in the modulation region, physician can determine a center of region, by using geometrical property of a center of a circle, and with the predetermined radius, one can determine the target to be circle with predetermined radius from the center of the ROI. This can all be performed by mental observation, using mathematical definition of a circle and one can set radius to cover the ROI and draw a circle with the radius and determine to be target, which can be also performed by drawing a circle in the ROI in the image. Moreover, when the ROI is in other region that the claimed modulation region by observation of the image, physician can determine connectivity of two regions by observing the data upon activation, recognizing two distinct regions, and drawing a line between two regions, and determine the ROI to be target candidate, which can be done by drawing a line in the image showing activation. Subsequently, physician can determine a center of region, by using geometrical property/definition of a center of a circle, and with the predetermined radius, the target can be determined to be circle with predetermined radius from the center of the ROI. This can all be performed by mental observation, using mathematical definition of a circle and radius of the circle, and drawing in the image, in mental framework with aid of pen/paper. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 18 is ineligible.
Claim 19 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 neuromodulation device, and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitations:
determining a brain structure subdivision in which the target is located based on a disease type of the subject;
determining an intersection of the at least one abnormal region of interest or the region of interest whose connectivity with the abnormal region of interest satisfies a predetermined connectivity threshold condition with the brain structure subdivision as a target candidate; and
determining a center of the target candidate as the target, or, determining a region with the center of the target candidate as a spherical center and with a predetermined target radius as a target region of interest, and determining the target based on a position of the target region of interest
These limitations, 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 determining target by analyzing two regions of interest in the data based on a predetermined anomaly detection rule. Determining a brain subdivision based on the disease type can be done by looking up database (i.e. library, reference) of brain subdivision activation for different types of disease (i.e. brain regions of activation in Alzheimer’s disease, brain regions activated with depression). Once the subdivision is determined, physician can determine an intersection of the determined subdivision with the ROI whose connectivity meets a desired condition, based on observation, comparison of the connectivity, and drawing a conclusion whether condition is met, and draw an intersection line between the subdivision and the ROI with desired connectivity, and conclude that the intersection is a target. The physician can determine a center of region, by using geometrical definition of a center of a circle, and with the predetermined radius, one can determine the target to be circle with predetermined radius from the center of the ROI. This can all be performed by mental observation, using mathematical definition of a circle and radius, and one can set radius to cover the ROI and draw a circle with the radius and determine to be target, which can be also performed by drawing a circle in the ROI in the image with aid of pen/paper. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 19 is ineligible.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 12 rejection.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim 20 recites additional limitations :
“the magnetic resonance imaging comprises structural magnetic resonance imaging of the brain, and/or task-based functional magnetic resonance imaging and/or, resting state functional magnetic resonance imaging.”
Acquiring scanning data using functional MRI are data gathering and is a form of a pre-solution insignificant activity. The steps of acquiring scanning data (magnetic resonance data) is performed in order to gather data for the recited mental process, mathematical calculations and following rules and is a necessary precursor for all uses of the recited abstract ideas on identifying abnormal regions of the images.
The use of magnetic resonance imaging device to acquire scanning data 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 magnetic resonance imaging comprises structural magnetic resonance imaging of the brain, and/or task-based functional magnetic resonance imaging and/or, resting state functional magnetic resonance imaging.”
These elements are evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements. As described in Crozier (US 2017/0354659), measurement or detection in the brain can be done using functional MRI and functional brain network analyses as known in the art, and using known techniques based upon fMRI scanning of human brains ([0026]), using anatomical imaging and resting fMRI for evaluating brain network connectivity ([0030]) using published method of acquiring resting fMRI data ([0036]), and Resting BOLD fMRI can be collected and processed using software known in the art ([0038]). Thus, use of scan data from MRI and resting fMRI for analyzing brain, namely, brain network connectivity, is well-understood, routine and convention.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent 12 (and their dependent claim 20) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
For these reasons, there is no inventive concept in the claim. In light of the above, claim 20 is ineligible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amended limitation for claim 9 includes “circuit.” However, the examiner could not find any disclosure in specification for structure, “circuit”. Thus, the specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
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 4 and 16-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4 and 16-17 recite “a brain connectivity matrix” and “a group brain connectivity matrix” and it is not definite whether these terms are different and new from recited “a brain connectivity matrix” and “a group brain connectivity matrix” in claims 1 and 12.
Applicant recommends amending terms with “the or said brain connectivity matrix” and “the or said group brain connectivity matrix.”
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 does not further limit the amended claim 13, rather recites the same limitation, thus fails to further limit the subject matter in claim 13. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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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