DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claim(s) 1-3, 6-16, and 19-20 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
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. The determination of the region of interest can be performed by observing scanning data and selecting two region of interest. 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. 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: “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 scanning data is data gathering and is a form of a pre-solution insignificant activity. The use of magnetic resonance imaging 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. For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 is ineligible.
Claims 2-3 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.
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. 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 2-3 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.
Claim 8 recites the following elements: “wherein the magnetic resonance imaging comprises structural magnetic resonance imaging of the bran and/or task-based functional MRI and/or resting state functional MRI. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 8 is ineligible.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a 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
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. The determination of the region of interest can be performed by observing scanning data and selecting two region of interest. 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. 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:
“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. ”
“a processing unit,” “an anomaly detection unit,” and “a target identification unit”
Acquiring scanning data is data gathering and is a form of a pre-solution insignificant activity. The use of magnetic resonance imaging does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
Use of processor to perform the judicial exception is recited at a high-level generality (i.e. as a generic processor performing a generic computer function of determining region of interest and based on the judgement, determining a target) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 9 is ineligible.
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.
Claims 10-11 recite the following 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.”
The use of processor, a storage device and a computer readable storage medium are recited with high generality of genetic computer element performing the judicial exception set forth in claim 1, and does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception. These pre and post-solution insignificant activities does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of 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:
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
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. The determination of the region of interest can be performed by observing scanning data and selecting two region of interest. 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. 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: “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 scanning data is data gathering and is a form of a pre-solution insignificant activity. The use of magnetic resonance imaging 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. 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.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 12 rejection.
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. 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 14-15 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.
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. 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 14-15 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.
Claim 20 recites the following elements: “wherein the magnetic resonance imaging comprises structural magnetic resonance imaging of the bran and/or task-based functional MRI and/or resting state functional MRI. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 20 is ineligible.
Claims 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 11 currently recites “A computer readable storage medium.”
The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called computer-readable storage medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01.
A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments maybe amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. 101 by adding the limitation “non-transitory” (e.g. a non-transitory computer readable storage medium) to the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 8-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-15, and 17 of U.S. Patent No. 12,193,784. Although the claims at issue are not identical, they are not patentably distinct from each other because claims are not patentably distinct from each other for the following reasons.
Instant Application 18/574,323
Claims-12/27/2023
U.S. Patent No. 12,193,784
1. A method for target identification, comprising:
acquiring scanning data of a subject, wherein the scanning data comprise the data acquired from
magnetic resonance imaging of the brain of the subject;
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; and determining a target based on the at least one abnormal region of interest.
2. The method according to claim 1, wherein determining the at least two regions of interest of the
subject based on the scanning data, comprises:
determining the at least two regions of interest of the subject based on a volume standard brain
template according to the scanning data.
3. The method according to claim 1, wherein determining the at least two regions of interest of the
subject based on the scanning data, comprises:
determining the at least two regions of interest of the subject based on a cortical standard brain
template according to the scanning data.
4. The method according to claim 1, 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 the at least two regions of interest based on a brain region template of a standard brain and the brain connectivity matrix.
8. The method according to claim 1, wherein 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.
9. A target identification device, comprising:
a data acquisition unit, configured to acquire scanning data of the subject, wherein the scanning data
comprise data acquired from magnetic resonance imaging of the brain of the subject;
a processing unit, configured to determine at least two regions of interest of the subject based on the
scanning data;
an anomaly detection unit, configured to determine at least one abnormal region of interest in the at
least two regions of interest based on a predetermined anomaly detection rule; and
a target identification unit, configured to determine a target based on the at least one anomaly region
of interest.
10. An electronic apparatus, comprising:
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.
11. 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.
12. (Currently Amended) A neuromodulation apparatus, configured to make neuromodulation on a target of a subject in accordance with a preset neuromodulation solution; wherein the target is determined by a method for target identification, comprising:
acquiring scanning data of a subject, wherein the scanning data comprise the data acquired from magnetic resonance imaging of a brain of the subject;
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; and
determining a target based on the at least one abnormal region of interest.
13. (Original) The apparatus according to claim 12, 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 neuromodulation;
and photobiomodulation therapy.
14. (New) The neuromodulation apparatus according to claim 12, wherein determining the at least two regions of interest of the subject based on the scanning data, comprises:
determining the at least two regions of interest of the subject based on a volume standard brain template according to the scanning data.
15. (New) The neuromodulation apparatus according to claim 12, wherein determining the at least two regions of interest of the subject based on the scanning data, comprises:
determining the at least two regions of interest of the subject based on a cortical standard brain template according to the scanning data.
16. (New) The neuromodulation apparatus according to claim 12, 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 the at least two regions of interest based on a brain region template of a standard brain and the brain connectivity matrix.
1. A method of target identification, comprising:
acquiring scanning data of a subject, wherein the scanning data comprise data acquired from magnetic resonance imaging of a brain of the subject;
determining at least two brain regions of the subject based on the scanning data, each brain region comprising at least one voxel, wherein each brain region is composed of voxels with the same function;
determining at least one target brain region corresponding to a disease type in the at least two brain regions based on the disease type of the subject; and determining a target located in the at least one target brain region according to a predetermined target identification rule.
2. (Original) The method according to claim 1, wherein determining the at least two brain
regions of the subject based on the scanning data comprises:
determining the at least two brain regions of the subject based on the scanning data based
on a volumetric standard brain template.
3. (Original) The method according to claim 1, wherein determining the at least two brain regions of the subject based on the scanning data comprises:
determining at least two brain regions of the subject based on the scanning data based on a cortical standard brain template.
4. (Original) The method according to claim 1, wherein determining the at least two brain regions of the subject based on the scanning data, each brain region comprising at least one voxel, comprises:
determining a connectivity between each two voxels in the scanning data to form a brain connectivity matrix corresponding to the scanning data; and forming the at least two brain regions based on a brain region template for a standard brain and the brain connectivity matrix.
8. (Original) The method according to claim 1, wherein the determining the target located
in the at least one target brain region based on the predetermined target identification rule
comprises:
determining a structural subdivision of the brain in which the target is located based on the disease type;
determining an intersection of the at least one target brain regions with the brain structural subdivision; and
determining the target in the intersection.
9. (Original) The method according to claim 1, wherein the magnetic resonance imaging comprises: structural magnetic resonance imaging, and/or task-based functional magnetic resonance imaging, and/or resting state functional magnetic resonance imaging.
10. A target identification device, comprising:
a data acquisition circuit, configured to acquire a scanning data of a subject, the scanning data comprising data acquired from magnetic resonance imaging of the subject's brain;
a processor, configured to determine at least two brain regions of the subject from the scanning data, each brain region comprises at least one voxel, wherein each
brain region is composed of voxels with the same function;
the processor is further configured to determine at least one target brain region corresponding to a disease type in the at least two brain regions based on the disease type
of the subject; and
a target determining unit, configured to determine a target located in the at least one target brain region according to a predetermined target identification rule.
11. An electronic apparatus, comprising:
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.
12. A non-transitory 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.
13. A neuromodulation apparatus, configured to make neuromodulation on a target of a subject in accordance with a preset neuromodulation solution; wherein the target is determined by a method of target identification, comprising:
acquiring scanning data of a subject, wherein the scanning data comprise data acquired from magnetic resonance imaging of a brain of the subject;
determining at least two brain regions of the subject based on the scanning data, each brain region comprising at least one voxel, wherein each brain region is composed of voxels with the same function;
determining at least one target brain region corresponding to a disease type in the at least two brain regions based on the disease type of the subject; and determining a target located in the at least one target brain region according to a predetermined target identification rule.
14. (Original) The apparatus according to claim 13, 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 neuromodulation;
and photobiomodulation therapy.
15. (Previously Presented) The neuromodulation apparatus according to claim 13,
wherein determining the at least two brain regions of the subject based on the scanning data
comprises:
determining the at least two brain regions of the subject based on the scanning data based on a volumetric standard brain template.
16. (Previously Presented) The neuromodulation apparatus according to claim 13,
wherein determining the at least two brain regions of the subject based on the scanning data comprises:
determining at least two brain regions of the subject based on the scanning data based on a cortical standard brain template.
17. (Previously Presented) The neuromodulation apparatus according to claim 13,
wherein determining the at least two brain regions of the subject based on the scanning data,
each brain region comprising at least one voxel, comprises:
determining a connectivity between each two voxels in the scanning data to form a brain connectivity matrix corresponding to the scanning data; and
forming the at least two brain regions based on a brain region template for a standard brain and the brain connectivity matrix.
Regarding to claim(s) 1-4 and 8-16, patented claim(s) 1-4, 8-15 and 17 set(s) forth the above-underlined limitations.
Claim 1 of instant application recites “abnormal region of interest” while patented claim 1 recites “target brain region corresponding to a disease type,” and patented claim 1 recites “a target identification rule” while claim 1 under examination recites “anomaly detection rule,” essentially these two limitations are equivalent in such that region of interest that is diseased/abnormal and determining target according to a predetermined target/anomaly identification/detection rule.
Patented claim 1 further recites “each brain region comprising at least one voxel, wherein each brain region composed of voxels with the same function,” and “two brain regions based on the disease type of the subject.”
The claim under examination is not patentably distinct from the patented claim, since claim under examination recites “abnormal” is generic to “disease type,” species claimed in patented claim 1. Species in the patented claim anticipates the claimed genus in the application being examined and therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub0genus should the genus issue as a patent after the species or sub-genus.
Regarding to claim 2, patented claim 2 set forth the underlined limitations.
Regarding to claim 3, patented claim 3 set forth the underlined limitations.
Regarding to claim 4, patented claim 4 set forth the underlined limitations.
Regarding to claim 8, patented claim 9 set forth the underlined limitations.
Claim 9 of instant application recites “abnormal region of interest,” “data acquisition unit,” and “processing unit” while patented claim 10 recites “target brain region corresponding to a disease type,” “data acquisition circuit,” and “processor,” and patented claim 10 recites “a target identification rule” while claim 9 under examination recites “anomaly detection rule,” essentially these two limitations are equivalent in such that region of interest that is diseased/abnormal and determining target according to a predetermined target/anomaly identification/detection rule.
Patented claim 10 further recites “each brain region comprising at least one voxel, wherein each brain region composed of voxels with the same function,” and “two brain regions based on the disease type of the subject.”
The claim under examination is not patentably distinct from the patented claim, since claim under examination recites “abnormal” is generic to “disease type,” species claimed in patented claim 10. Species in the patented claim anticipates the claimed genus in the application being examined and therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub0genus should the genus issue as a patent after the species or sub-genus.
Patented claim 10 further recites “each brain region comprising at least one voxel, wherein each brain region composed of voxels with the same function,” and “two brain regions based on the disease type of the subject.”
Regarding to claim 10, patented claim 11 set forth the underlined limitations.
Regarding to claim 11, patented claim 12 set forth the underlined limitations.
Claim 12 of instant application recites “abnormal region of interest” while patented claim 13 recites “target brain region corresponding to a disease type,” and patented claim 13 recites “a target identification rule” while claim 12 under examination recites “anomaly detection rule,” essentially these two limitations are equivalent in such that region of interest that is diseased/abnormal and determining target according to a predetermined target/anomaly identification/detection rule.
Patented claim 13 further recites “each brain region comprising at least one voxel, wherein each brain region composed of voxels with the same function,” and “two brain regions based on the disease type of the subject.”
The claim under examination is not patentably distinct from the patented claim, since claim under examination recites “abnormal” is generic to “disease type,” species claimed in patented claim 13. Species in the patented claim anticipates the claimed genus in the application being examined and therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub0genus should the genus issue as a patent after the species or sub-genus.
Regarding to claim 13, patented claim 14 set forth the underlined limitations.
Regarding to claim 14, patented claim 15 set forth the underlined limitations.
Regarding to claim 15, patented claim 16 set forth the underlined limitations.
Regarding to claim 16, patented claim 17 set forth the underlined limitations.
Claims 6-7 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-8 and 19 of U.S. Patent No. 12,193,784 in view of “Pascual- Leone et al.,” US 2015/0119689 (hereinafter Pascual-Leone).
Instant Application 18/574,323
Claims-12/27/2023
U.S. Patent No. 12,193,784
6.(Currently Amended) The method according to claim 1, wherein determining a target based on the at least one abnormal region of interest comprises: 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, and 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.
7. The method according to claim 1, wherein determining the target based on the at least one
abnormal region of interest comprises:
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 the target region of
interest, and determining the target based on a position of the target region of interest.
18.(New) The neuromodulation apparatus according to claim 12, wherein determining a target based on the at least one abnormal region of interest comprises: 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, and 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.
6. (Original) The method according to claim 1, wherein determining the target located in the at least one target brain region according to the predetermined target identification rule comprises:
determining a central location of the at least one target brain region as the targets.
7. (Original) The method according to claim 1, wherein the determining the target located
in the at least one target brain region based on the predetermined target identification rule
comprises: determining a region with a central position of the at least one target brain region as a spherical center and a predetermined target radius range as a target region of interest, and identifying a position of the target region of interest as the target.
8. (Original) The method according to claim 1, wherein the determining the target located in the at least one target brain region based on the predetermined target identification rule comprises:
determining a structural subdivision of the brain in which the target is located based on the disease type;
determining an intersection of the at least one target brain regions with the brain structural subdivision; and
determining the target in the intersection.
19. (Previously Presented) The neuromodulation apparatus according to claim 13, wherein determining the target located in the at least one target brain region according to the predetermined target identification rule comprises:
determining a central location of the at least one target brain region as the targets.
20. (Previously Presented) The neuromodulation apparatus according to claim 13, wherein the determining the target located in the at least one target brain region based on the
predetermined target identification rule comprises:
determining a region with a central position of the at least one target brain region as a spherical center and a predetermined target radius range as a target region of interest, and identifying a position of the target region of interest as the target.
Regarding to claim 6, patented claim 6 and 7 set forth the underlined limitations.
Patented claim does not set forth the further limitations of claim 6 under examination of “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, 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.”
In the analogous MRI analysis of brain field of endeavor, Pascual-Leone makes obvious the limitations set forth above as follows.
determining whether the at least one abnormal region of interest is located in a modulation brain region or not (ROI may comprise a seed in the subgenual cingulate cortex or in any other region of the brain [0008]);
if the at least one abnormal region of interest is located in the modulation brain region (ROI in the subgenual cingulate cortex [0030]), 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 (one or more ROIs in the subgenual cingulate [0054]), and 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 (ROI in the subgenual cingulate cortex based on a 10 mm sphere centered on the coordinates [0160]);
if the at least one abnormal region of interest is not located in the modulation brain region ([0008]; other brain regions used as ROIs [0094]), 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 (target sites identified based on the functional connectivity analysis, one or more regions exhibiting the anticorrelation with the ROI that is above a threshold may be selected as target site [0072]; ideal stimulation target, i.e. node with strongest anticorrelation was selected based on functional connectivity results [0172]; one or more regions exhibiting the anticorrelation with the ROI that is above a threshold may be selected as target stimulation sties [0072]); 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 (optimal target was selected for various radius spheres [0186]).
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 the method as taught by patented claim(s) 6-7 to be as claimed in the instant application, since such limitations were well known in the art as made obvious by Pascual-Leone. One of ordinary skill in the art could have combined the elements as claimed by known methods (e.g. observing the ROI region in brain and determining desired connectivity in the ROI) with no change in their respective functions, 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 ideal stimulation target based on the functional connectivity results ([0172]), and there was reasonable expectation of success.
Regarding to claim 7, patented claim 8 set forth the underlined limitations.
Patented claim 8 does not set forth the further limitations of claim 7 under examination of “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.
In the analogous MRI analysis of brain field of endeavor, Pascual-Leone makes obvious the limitations set forth above as follows.
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 (selecting target based on one or more regions exhibiting anticorrelation with the ROI that is above a threshold [0072]; ideal stimulation target is a node (thus, is read on claimed intersection) with the strongest anticorrelation on functional connectivity results [0172]); 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 (region of interest generated by 25 mm radius spheres centered on the coordinates for BA9, BA46 [0066])
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 the method as taught by patented claim(s) 6-7 to be as claimed in the instant application, since such limitations were well known in the art as made obvious by Pascual-Leone. One of ordinary skill in the art could have combined the elements as claimed by known methods (e.g. observing the ROI region in brain and determining desired connectivity in the ROI) with no change in their respective functions, 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 ideal stimulation target based on the functional connectivity results ([0172]), and there was reasonable expectation of success.
Regarding to claim 18, patented claims 19-20 set forth the above-underlined limitations.
Patented claims 19-20 do not set forth the further limitations of claim 18 under examination of “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, 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.”
In the analogous MRI analysis of brain field of endeavor, Pascual-Leone makes obvious the limitations set forth above as follows.
determining whether the at least one abnormal region of interest is located in a modulation brain region or not (ROI may comprise a seed in the subgenual cingulate cortex or in any other region of the brain [0008]);
if the at least one abnormal region of interest is located in the modulation brain region (ROI in the subgenual cingulate cortex [0030]), 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 (one or more ROIs in the subgenual cingulate [0054]), and 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 (ROI in the subgenual cingulate cortex based on a 10 mm sphere centered on the coordinates [0160]);
if the at least one abnormal region of interest is not located in the modulation brain region ([0008]; other brain regions used as ROIs [0094]), 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 (target sites identified based on the functional connectivity analysis, one or more regions exhibiting the anticorrelation with the ROI that is above a threshold may be selected as target site [0072]; ideal stimulation target, i.e. node with strongest anticorrelation was selected based on functional connectivity results [0172]; one or more regions exhibiting the anticorrelation with the ROI that is above a threshold may be selected as target stimulation sties [0072]); 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 (optimal target was selected for various radius spheres [0186]).
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 the method as taught by patented claim(s) 19-20 to be as claimed in the instant application, since such limitations were well known in the art as made obvious by Pascual-Leone. One of ordinary skill in the art could have combined the elements as claimed by known methods (e.g. observing the ROI region in brain and determining desired connectivity in the ROI) with no change in their respective functions, 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 ideal stimulation target based on the functional connectivity results ([0172]), and there was reasonable expectation of success.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a data acquisition unit,” “a processing unit,” “an anomaly detection unit,” and “a target identification unit” in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
In the specification, the paragraph provides structure for performing the limitations as follows.
[0278] The units described in the present disclosure may be implemented by software or hardware. The described units may also be provided in a processor, which may be described as: a processor includes a scanning data acquisition unit, a setting unit, a processing unit, and a target identification unit. The names of the units do not constitute a limitation on the units themselves in some way.
Therefore, for a purpose of examination, “a data acquisition unit,” “a processing unit,” “an anomaly detection unit,” and “a target identification unit” will be interpreted as a processor and equivalent thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6-15, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Pascual-Leone et al.,” US 2015/0119689 (hereinafter Pascual-Leone).
Regarding to claim 1, Matsuda teaches a method for target identification, comprising:
acquiring scanning data of a subject, wherein the scanning data comprise the data acquired from magnetic resonance imaging of a brain of the subject (MRI system [0059]; structural MRI image and resting state fMRI imaging data [0059]);
determining at least two regions of interest of the subject based on the scanning data (one or ROIs selected [0063]; two regions of interests were identified [0160]);
determining at least one abnormal region of interest in the at least two regions of interest in accordance with a predetermined anomaly detection rule (target site identified by functional connectivity analysis that one or more regions exhibiting anticorrelation with the ROI that is above threshold is selected as target stimulation site [0072]; abnormality in brain networks and connectivity [0245]); and
determining a target based on the at least one abnormal region of interest (as a result of processing of fMRI data using computing device, one or more individual target sites may be identified [0084])
Regarding to claims 2-3, 6-8, and 10-11, Pascual-Leone teaches all limitations of claim 1 as set forth above.
Pascual-Leone further teaches following limitations:
Of claim 2, wherein determining the at least two regions of interest of the subject based on the scanning data, comprises: determining the at least two regions of interest of the subject based on a volume standard brain template according to the scanning data (cortical region templates [0160], standard Harvard/Oxford grey matter template [0161]).
Of claim 3, wherein determining the at least two regions of interest of the subject based on the scanning data, comprises: determining the at least two regions of interest of the subject based on a cortical standard brain template according to the scanning data (cortical template [0065]; 3D templates for sites along the cortex [0090]).
Of claim 6, wherein determining a target based on the at least one abnormal region of interest comprises:
determining whether the at least one abnormal region of interest is located in a modulation brain region or not (ROI may comprise a seed in the subgenual cingulate cortex or in any other region of the brain [0008]);
if the at least one abnormal region of interest is located in the modulation brain region (ROI in the subgenual cingulate cortex [0030]), 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 (one or more ROIs in the subgenual cingulate [0054]), and 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 (ROI in the subgenual cingulate cortex based on a 10 mm sphere centered on the coordinates [0160]);
if the at least one abnormal region of interest is not located in the modulation brain region ([0008]; other brain regions used as ROIs [0094]), 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 (target sites identified based on the functional connectivity analysis, one or more regions exhibiting the anticorrelation with the ROI that is above a threshold may be selected as target site [0072]; ideal stimulation target, i.e. node with strongest anticorrelation was selected based on functional connectivity results [0172]; one or more regions exhibiting the anticorrelation with the ROI that is above a threshold may be selected as target stimulation sties [0072]); 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 (optimal target was selected for various radius spheres [0186]).
Of claim 7, wherein determining the target based on the at least one abnormal region of interest comprises:
determining a brain structure subdivision in which the target is located based on a disease type of the subject (one or more regions of interest may be selected for determining target sites, the ROIs are selected based on the patient’s condition, brain characteristics, diseases and any other suitable factors [0063]);
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 (selecting target based on one or more regions exhibiting anticorrelation with the ROI that is above a threshold [0072]; ideal stimulation target is a node (thus, is read on claimed intersection) with the strongest anticorrelation on functional connectivity results [0172]); 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 (region of interest generated by 25 mm radius spheres centered on the coordinates for BA9, BA46 [0066])
Of claim 8, wherein 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 ([0048] and [0059]).
Of claim 10, an electronic apparatus, comprising: at least one processor (processors [0083]); and a storage device having at least one program stored thereon (memory [0083]), 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 (computer-executable instructions when executed by processors, computing device [0083])
Of claim 11, 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 (computer readable storage medium, program loaded onto computer [0100]).
Regarding to claim 9, Pascual-Leone teaches a target identification device, comprising:
a data acquisition unit (MRI system [0059]), configured to acquire scanning data of a subject, wherein the scanning data comprise data acquired from magnetic resonance imaging of a brain of the subject (structural MRI image and resting state fMRI imaging data [0059]);
a processing unit (processors [0083]), configured to determine at least two regions of interest of the subject based on the scanning data (one or ROIs selected [0063]; two regions of interests were identified [0160]);
an anomaly detection unit (processing fMRI data [0084]), configured to determine at least one abnormal region of interest in the at least two regions of interest based on a predetermined anomaly detection rule (target site identified by functional connectivity analysis that one or more regions exhibiting anticorrelation with the ROI that is above threshold is selected as target stimulation site [0072]; abnormality in brain networks and connectivity [0245]); and
a target identification unit, configured to determine a target based on the at least one anomaly region of interest (as a result of processing of fMRI data using computing device, one or more individual target sites may be identified [0084]).
Regarding to claim 12, Pascual-Leone teaches a neuromodulation apparatus (transcranial magnetic stimulation [0001]), configured to make neuromodulation on a target of a subject in accordance with a preset neuromodulation solution (using TMS to modulate abnormal network interactions [0283]);
wherein the target is determined by a method for target identification, comprising:
acquiring scanning data of a subject, wherein the scanning data comprise the data
acquired from magnetic resonance imaging of a brain of the subject (resting state fMRI imaging data [0059]);
determining at least two regions of interest of the subject based on the scanning data (one or ROIs selected [0063]; two regions of interests were identified [0160]);
determining at least one abnormal region of interest in the at least two regions of interest in accordance with a predetermined anomaly detection rule (target site identified by functional connectivity analysis that one or more regions exhibiting anticorrelation with the ROI that is above threshold is selected as target stimulation site [0072]); and
determining a target based on the at least one abnormal region of interest (as a result of processing of fMRI data using computing device, one or more individual target sites may be identified [0084]).
Regarding to claim 13, Pascual-Leone teaches all limitations of claim 12 as set forth above.
Pascual-Leone further teaches transcranial magnetic stimulation, focused ultrasound, electrode stimulation and other stimulation techniques ([0093]).
Regarding to claims 14-15, Pascual-Leone teaches all limitations of claim 12 as set forth above.
Pascal-Leone further teaches
Of claim 14, wherein determining the at least two regions of interest of the subject based on the scanning data, comprises: determining the at least two regions of interest of the subject based on a volume standard brain template according to the scanning data (cortical region templates [0160], standard Harvard/Oxford grey matter template [0161]).
Of claim 15, wherein determining the at least two regions of interest of the subject based on the scanning data, comprises: determining the at least two regions of interest of the subject based on a cortical standard brain template according to the scanning data (cortical template [0065]; 3D templates for sites along the cortex [0090]).
Regarding to claim 18, Pascual-Leone teaches all limitations of claim 12 as set forth above.
Pascual-Leone further teaches wherein determining a target based on the at least one abnormal region of interest comprises:
determining whether the at least one abnormal region of interest is located in a modulation brain region or not (ROI may comprise a seed in the subgenual cingulate cortex or in any other region of the brain [0008]);
if the at least one abnormal region of interest is located in the modulation brain region (ROI in the subgenual cingulate cortex [0030]), 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 (one or more ROIs in the subgenual cingulate [0054]), and 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 (ROI in the subgenual cingulate cortex based on a 10 mm sphere centered on the coordinates [0160]);
if the at least one abnormal region of interest is not located in the modulation brain region (other ROIs identified [0054]), 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 (functional connectivity analysis with regions exhibiting the anticorrelation with the ROI that is above a threshold selected as target stimulation site [0072]) and which is located in the modulation region as a second target candidate (functional connectivity computed with three seed regions and seed maps to identify candidate targets [0167]); 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 (ideal stimulation target was selected based on functional connectivity results and tested for stimulation field with 6mm sphere and 20 mm sphere [0172]).
Regarding to claim 19, Pascual-Leone teaches all limitations of claim 12 as set forth above.
Pascual-Leone further teaches wherein determining the target based on the at least one abnormal region of interest comprises:
determining a brain structure subdivision in which the target is located based on a disease type of the subject (one or more regions of interest may be selected for determining target sites, the ROIs are selected based on the patient’s condition, brain characteristics, diseases and any other suitable factors [0063]);
determining an intersection (node [0172]) 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 (selecting target based on one or more regions exhibiting anticorrelation with the ROI that is above a threshold [0072]; ideal stimulation target is a node (thus, is read on claimed intersection) with the strongest anticorrelation on functional connectivity results [0172]); 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 (region of interest generated by 25 mm radius spheres centered on the coordinates for BA9, BA46 [0066])
Regarding to claim 20, Pascual-Leone teaches all limitations of claim 12 as set forth above.
Pascual-Leone further teaches wherein 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 (structural images of the patient’s brain along with functional data [0082]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4-5 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Pascual-Leone as applied to claims 1 and 12 above, and further in view of “Greicius et al.,” US 2011/0301431 (hereinafter Greicius).
Regarding to claims 4, Pascual-Leone teaches all limitations of claim 1 as set forth above.
Regarding to claim 4, Pascal-Leone further teaches
determining connectivity between each two voxels in the scanning data to form a brain connectivity corresponding to the scanning data (functional connectivity analysis depend on identification of one or more regions of interest, seeds and reveal a region of interest with other region of the brain show functionally connected [0050]); and
forming the at least two regions of interest based on a brain region template of a standard brain and the brain connectivity matrix (ROIs using functional connectivity [0054]; ROIs using template [0065]-[0066]; after ROI is selected, the functional connectivity analysis is performed [0067]).
Pascual-Leone does not further disclose the brain connectivity is a brain connectivity matrix as claimed.
However, in the analogous field of endeavor in fMRI analysis of brain, Greicius teaches forming a brain connectivity matrix based on the fMRI data ([0029] and [0112]).
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 brain connectivity analysis as taught by Pascual-Leone to incorporate teaching of Greicius, since brain connectivity matrix was well known in the art as taught by Greicius. One of ordinary skill in the art could have combined the elements as claimed by Pascual-Leone with no change in their respective functions, forming brain connectivity matrix based on its fMRI data, 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 visual identification of regions with increased or decreased connectivity ([0029]) and there was reasonable expectation of success.
Regarding to claims 5, Pascual-Leone teach all limitations of claim 1 as set forth above.
Pascual-Leone discloses limitations of 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:
acquiring group brain magnetic resonance data (group level functional connectivity from fcMRI [0017]);
determining a group brain connectivity matrix based on the group brain magnetic resonance data (resting functional connectivity maps for group [0183]);
determining connectivity between each two voxels in the scanning data to form a brain connectivity matrix of the subject corresponding to the scanning data (resting functional connectivity maps individual subjects [0183]); 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 ([0183] and using the maps of group and single subject, optimal targets were selected [0186]).
Pascual-Leone does not further disclose the brain connectivity is a brain connectivity matrix as claimed.
However, in the analogous field of endeavor in fMRI analysis of brain, Greicius teaches forming a brain connectivity matrix based on the group of fMRI data ([0029] and [0112]).
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 brain connectivity analysis as taught by Pascual-Leone to incorporate teaching of Greicius, since brain connectivity matrix was well known in the art as taught by Greicius. One of ordinary skill in the art could have combined the elements as claimed by Pascual-Leone with no change in their respective functions, forming brain connectivity matrix based on its fMRI data, 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 visual identification of regions with increased or decreased connectivity ([0029]) and there was reasonable expectation of success.
Regarding to claims 16-17, Pascual-Leone teach all limitations of claim 12 as set forth above.
Pascal-Leone further teaches following limitations:
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 (fMRI data for functional connectivity analysis involving identifying one or more regions of interest and determining activity of what other regions of the brain correlate with an activity of one or more ROIs [0007]); and forming the at least two regions of interest based on a brain region template of a standard brain and the brain connectivity matrix (two regions of interest defined in a priori, using cortical regions templates [0160]; coordinates identified and serve as optimized TMS targets by computing seed-based functional connectivity with two regions: a priori ROI and subgenual and our effective-ineffective map [0589]).
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:
acquiring group brain magnetic resonance data (resting state functional connectivity maps for the population [0014]; resting state fMRI populations [0048]);
determining a group brain connectivity matrix based on the group brain magnetic resonance data (group functional connectivity [0017]);
determining connectivity between each two voxels in the scanning data to form a brain connectivity matrix of the subject corresponding to the scanning data(single subject functional connectivity map [0014]); 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 (targets generated on the basis of group and individual connectivity analysis [0152]).
Pascual-Leone does not further disclose the brain connectivity is a brain connectivity matrix as claimed.
However, in the analogous field of endeavor in fMRI analysis of brain, Greicius teaches forming a brain connectivity matrix based on the group of fMRI data ([0029] and [0112]).
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 brain connectivity analysis as taught by Pascual-Leone to incorporate teaching of Greicius, since brain connectivity matrix was well known in the art as taught by Greicius. One of ordinary skill in the art could have combined the elements as claimed by Pascual-Leone with no change in their respective functions, forming brain connectivity matrix based on its fMRI data, 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 visual identification of regions with increased or decreased connectivity ([0029]) and there was reasonable expectation of success.
Conclusion
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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