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 .
Election/Restrictions
Applicant’s election of invention I relating to claims 1-10 in the response filed 1/5/2026 is acknowledged.
Applicant was reached out to over phone in regards to an incomplete response to the election of species requirement which resulted in applicant selecting claim 4 to be examined while claims 5-8 are to be withdrawn without traverse.
Claims 1-4 and 9-10 remain pending in the current application.
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 1-4 and 9-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites generating an ADC map. The limitation of generating an ADC map as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting a generic MRI device to generate images nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the MR language, generating an ADC map in the context of this claim encompasses the user manually calculating generating a display of consolidated ADC values directly from MR images. Similarly, the limitation of identifying clusters, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic MR components. For example, but for the MR image language, identifying clusters in the context of this claim encompasses the user manually identifying features from an image. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a processor to perform generation of an ADC map and identifying clusters. The processor in both steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of ranking information based on a determined amount of use) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform both the generation of an ADC map and identifying clusters amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
Dependent claims are rejected as well as they do not provide substantive limitations that would preclude the process from being performed manually by a user as a mental process.
1
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Raj (US 20160300352 A1) in view of Blake (US 20160022375 A1).
Regarding claim 1, Raj teaches A method, comprising receiving a diffusion weight image (DWI) ([abst] Methods and systems for analyzing a medical image of a subject's brain are disclosed; [0060] A medical image may be tomographic. The medical image may be diffusion weighted. A diffusion weighted image may be any image from which a measurement of diffusion within any given imaging voxel can be calculated or observed)
a structural T1 image, or both from a magnetic resonance imaging (MRI) sequence on a patient's brain ([0060] The medical image of the subject's brain may be acquired by any of one several available MRI modalities: T1-weighted, T2-weighted, diffusion weighted, perfusion MRI, etc.)
wherein the patient suffers from drug- resistant mesial temporal epilepsy (mTLE) ([0075] diagnosis may be obtained for one or more of: Alzheimer, frontotemporal dementia, Parkinson's, corticobasal syndrome, semantic dementia, progressive nonfluent aphasia, ALS, epilepsy and more diseases involving neurodegeneration; [0122] We tested the ability of the network diffusion model to capture the cross-sectional pattern of atrophy in a well characterized and stereotyped group of epileptics, called temporal lobe epilepsy with mesial temporal epilepsy (TLS-MTS). We also applied our model to TLE subjects with no visible atrophy on MRI (LTE-no))
and generating an apparent diffusion coefficient (ADC) map of the patient's brain based at least partially upon the DWI, the structural T1 image, or both ([0066] The predicted future disease patterns may be output in a representation selected from the group of a) a ball and stick model overlaid on a connectivity map of the human brain; b) a table; c) a graph; and d) a color-coded surface map of the brain; [0129] MRI-derived atrophy maps).
Raj fails to teach segmenting one or more mesial temporal lobe portions from a remainder of the patient's brain based at least partially upon the ADC map and identifying one or more clusters to be ablated in the one or more mesial temporal lobe portions.
However, Blake teaches segmenting one or more portions based at least partially upon the ADC map ([0006] The processing device may receive cardiac imaging data, segment the cardiac imaging data to identify at least two types of tissue)
and identifying one or more clusters to be ablated in the one or more mesial temporal lobe portions ([0007] cause a mapping system to detect an intracardiac location of an ablation tip of a cardiac ablation catheter, output a cardiac imaging model identifying at least one ablation target to a display, output the intracardiac location of the ablation tip to the display)
Raj and Blake are considered analogous because both disclose methods of analyzing MRI mapping data in order to make medical determinations. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use the segmentation-based method of determining ablation targets disclosed in Blake on the brain data disclosed in Raj in order to facilitate the placement of lesions at optimal target sites and improve the efficacy of the therapy while reducing post-procedure complications (Blake [0004]).
Regarding claim 2, Raj fails to teach the one or more clusters are identified based at least partially upon an intra-cluster ADC similarity, a spatial proximity, or both.
However, Blake teaches the one or more clusters are identified based at least partially upon an intra-cluster ADC similarity, a spatial proximity, or both ([0064] targeted location selection algorithms may include selecting target locations based on the threshold of the accumulated distribution of phase filament locations over time).
Raj and Blake are considered analogous because both disclose methods of analyzing MRI mapping data in order to make medical determinations. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to determine ablation targets based on a proximity or distribution determination in order to facilitate the placement of lesions at optimal target sites and improve the efficacy of the therapy while reducing post-procedure complications (Blake [0004]).
Regarding claim 3, Raj fails to teach determining one or more characteristics of the one or more clusters.
However, Blake teaches determining one or more characteristics of the one or more clusters ([0064] selecting target locations based on the threshold of the accumulated distribution of phase filament locations over time, or selecting target locations based on minimal channel widths that sustain arrhythmic propagation).
Raj and Blake are considered analogous because both disclose methods of analyzing MRI mapping data in order to make medical determinations. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to determine ablation targets based on characteristics including but not limited to proximity or distribution determination in order to facilitate the placement of lesions at optimal target sites and improve the efficacy of the therapy while reducing post-procedure complications (Blake [0004]).
Regarding claim 9, Raj fails to teach determining an ablation volume that includes at least a portion of the one or more clusters, wherein the ablation volume is determined based at least partially upon the characteristics.
However, Blake teaches determining an ablation volume that includes at least a portion of the one or more clusters, wherein the ablation volume is determined based at least partially upon the characteristics ([0064] selecting target locations based on the threshold of the accumulated distribution of phase filament locations over time, or selecting target locations based on minimal channel widths that sustain arrhythmic propagation).
Raj and Blake are considered analogous because both disclose methods of analyzing MRI mapping data in order to make medical determinations. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to determine ablation targets based on characteristics including but not limited to proximity or distribution determination in order to facilitate the placement of lesions at optimal target sites and improve the efficacy of the therapy while reducing post-procedure complications (Blake [0004]).
Regarding claim 10, Raj fails to teach wherein the ablation volume is also determined based at least partially upon: a power of a laser generated by an ablation tool to ablate the ablation volume; a duration that the laser contacts the ablation volume; a location of the ablation tool in the patient's brain; a trajectory of the ablation tool in the patient's brain; or a combination thereof.
However, Blake teaches wherein the ablation volume is also determined based at least partially upon: a power of a laser generated by an ablation tool to ablate the ablation volume ([0101] appropriate parameters for ablation of target treatment site 901 may be determined. For example, wattage, therapy duration, irrigation rate, target site temperature, tip pressure (contact force), etc., may be selected to produce a lesion of an appropriate size to fully ablate target treatment site 901)
Raj and Blake are considered analogous because both disclose methods of analyzing MRI mapping data in order to make medical determinations. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to determine ablation targets based the wattage delivered by an ablation tool in order to facilitate the placement of lesions at optimal target sites and improve the efficacy of the therapy while reducing post-procedure complications (Blake [0004]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Raj in view of Blake as applied to claim 3 above, and further in view of Pascual-Leone (US 20150119689 A1).
Regarding claim 4, Raj as modified fails to teach the characteristics comprise spatial coordinates of the one or more clusters.
However, Pascual-Leone teaches the characteristics comprise spatial coordinates of the one or more clusters ([0009] Once one or more ROIs and/or one or more seed maps are selected, coordinates of one or more stimulation sites may be computed, to identify one or more individual target sites)
Raj as modified and Pascual-Leone are considered analogous because both disclose applications of MRI to determine a course of treatment. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to determine treatment sites through utilization of spatial coordinates in order to represent alterations in brain networks and connectivity (Pascual-Leone [0003]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GABRIEL VICTOR POPESCU/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798