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 Objections
Claim 1 is objected to because of the following informalities: At line 3 “assay to the subject” should read --assay on the subject--.
Claim 6 is objected to because of the following informalities: The phrase “method of claim 5, the brain disorder…” should read --method of claim 5, wherein the brain disorder--.
Claim 10 is objected to because of the following informalities: The phrase “method of claim 9, the method further comprises…” should read --method of claim 9, wherein the method further comprises--.
Claim 16 is objected to because of the following informalities: The phrase “the computer-aided process comprise the utilization of FASCILE” should read --the computer-aided process comprises utilization of Fast Automated SEEG Electrode Contact Identification and Labeling Ensemble (FASCILE)--.
Claim 20 is objected to because of the following informalities: The phrase “performing ESM to the subject” should read --performing electrical stimulation mapping (ESM) on the subject--.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10, 11, 14-16, 19, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites the limitation “determining a site for the brain surgery”. There is insufficient antecedent basis for this limitation in the claim. It appears that the claim should be amended to be dependent on claim 8 rather than claim 9.
Claim 11 recites the limitation “frequency bands ranging from about 50 - 150 Hz, optionally with 1 Hz step”. It is ambiguous whether the limitation of the 1 Hz step is necessary to meet the claim.
Claim 14 recites the limitation “locating the positions of the electrode contacts”. There is insufficient antecedent basis for this limitation in the claim. Claims 15 and 16 inherit the deficiencies of the base claim.
Claims 19 and 20 recite the limitation “the mapping results”. There is insufficient antecedent basis for this limitation in the claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-10, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arya et al. (“Pre-surgical Language Localization with Visual Naming associated ECoG High-gamma Modulation in Pediatric Drug-resistant Epilepsy”), hereinafter Arya.
Regarding claim 1, Arya recites a method for mapping a functional brain site in a subject, comprising: a) subjecting a subject to a task (Methods, Experimental Protocol and Data Collection paragraph 1); b) performing an intracranial electroencephalography (iEEG) assay to the subject while the subject is performing the task, wherein the iEEG assay comprises multiple stereotactic or subdural electrodes placed at multiple sites within the subject's brain (Methods, Participants, Electrical Cortical Stimulation, Experimental Protocol and Data Collection, Figure 1); c) recording high gamma EEG signals during step (b) at each iEEG electrode (Methods, Experimental Protocol and Data Collection); d) analyzing the high gamma EEG signals to produce a collection of output data parameters (Methods, data analysis); and e) identifying a functional brain site in the subject that is responsible for performing the task based the collection of output data parameters determined in step (d) (Methods, Experimental Protocol and Data Collection, “Hence, we used ECoG HGM during covert naming as an approximation of cortical sites”).
Regarding claim 2, Arya recites a method wherein the subject is a human patient (Abstract, Objective and Methods).
Regarding claim 3, Arya recites a method wherein the subject is a human child (Abstract, Objective).
Regarding claim 5, Arya recites a method wherein the subject has a brain disorder (Abstract, Methods).
Regarding claim 6, Arya recites a method wherein the brain disorder is selected from the group consisting of epilepsy, a brain tumor, and a vascular lesion (Abstract, Methods; Results, paragraph 1).
Regarding claim 7, Arya recites a method wherein the subject is a human patient with drug-resistant epilepsy (DRE) (Abstract, Methods).
Regarding claim 8, Arya recites a method wherein the method is performed to the subject prior to a brain surgery (Methods, Participants).
Regarding claim 9, Arya recites a method wherein the high gamma iEEG signals comprise signals at about 50-150 Hz (Abstract, Methods).
Regarding claim 10, Arya recites a method wherein the method further comprises determining a site for the brain surgery based on the functional brain site identified in step (e) (Discussion, paragraph 1).
Regarding claim 17, Arya recites a method wherein the functional brain site is a language site and the task is visual naming, auditory naming, story listening, or conversational speech (Methods, Experimental Protocol and Data Collection paragraph 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.
Claims 4, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Arya in view of Ruescher et al. (“Somatotopic mapping of natural upper- and lower-extremity movements and speech production with high gamma electrocorticography”), hereinafter Ruescher.
Regarding claim 4, Arya discloses all of the elements of the claim as discussed above except the subject is a human adult. Ruescher teaches a method for mapping functional brain sites wherein the subject is a human adult (Materials and Methods, Patients). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to use an adult patient, as taught by Ruescher, for functional brain mapping in a method similar to that of Arya because high gamma modulation functional mapping requires patient cooperation and compliance for long periods of time, which is difficult to achieve with young patients.
Regarding claim 18, Arya discloses all of the elements of the claim as discussed above except the functional brain site is a motor site and the task is visually-cued hand motor task. Ruescher teaches a method where patients are given everyday motor tasks to perform to map the motor cortex (Materials and Methods, Selection of natural movements and natural speech production events, paragraphs 1 and 2). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have patients perform hand motor tasks to map a patient’s motor cortex, as taught by Ruescher, in a method similar to that of Arya, in order to enable surgeons to accurately and safely treat motor control symptoms in epileptic patients.
Regarding claim 20, Arya discloses all of the elements of the claim as discussed above except a method of performing ESM to the subject and comparing the mapping results obtained with the results from the ESM. Ruescher teaches a method wherein both ESM and high gamma modulation (HGM) are used for functional mapping and the results with HGM are compared to the ESM results (Material and methods, Analysis of specificity and sensitivity of HGM, Results figures 4 and 5). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to perform ESM and compare the results to HGM in order to confirm the accuracy of HGM, as taught by Ruescher, in a method similar to that of Arya, as ESM is a standard diagnostic procedure.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Arya in view of Weiss et al. (US 20210145347 A1), hereinafter Weiss.
Regarding claim 11, Arya discloses all of the elements of the claim as discussed above except the analyzing step (d) comprising calculating time-frequency representations (TFRs) for frequency bands ranging from about 50- 150 Hz, optionally with 1 Hz step. Weiss teaches a method of analyzing high gamma EEG signals from 65 to 250 Hz by generating time-frequency representations ([0012], [0114]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to use a method of EEG analysis involving time frequency representations, like that of Weiss, with a method like that of Arya in order to characterize the properties of the high gamma band oscillations.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Arya in view of Benadi et al. (“Comparison of Interactive and Automatic Segmentation of SEEG Electrodes on CT Postoperative Images: Preliminary Results”), hereinafter Benadi.
Regarding claim 14, Arya discloses all of the elements of the claim as discussed above except the analyzing step (d) comprising locating the positions of the electrode contacts. Benadi teaches a method wherein the electrode contacts are located after implantation (Section 2.2, interactive segmentation). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to use a manual process like that of Benadi with a method like that of Arya to locate the electrode contacts during analysis in order to assess if the electrodes were placed correctly.
Regarding claim 15, Arya discloses all of the elements of the claim as discussed above except that the positions of the electrode contacts are determined by manual process or by computer-aided process. Benadi teaches a method for locating the position of electrode contacts wherein a surgeon locates the contacts on an image and marks them down (Section 2.2, interactive segmentation). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to use a manual process like that of Benadi with a method like that of Arya to accurately locate electrode contacts.
Regarding claim 16, Arya discloses all of the elements of the claim as discussed above except the computer-aided process comprising the utilization of FASCILE. Because claim 15 is in the alternative form "or", the current claim does not include any patentably distinguishing method because the prior art discloses a method of locating the positions of electrode contacts by a manual process.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Arya in view of Maris et al. (“Nonparametric statistical testing of EEG- and MEG-data), hereinafter Maris.
Regarding claim 12, Arya discloses all of the elements of the claim as discussed above except the analyzing step comprising a clustering algorithm. Maris teaches an EEG data analysis method which utilizes clustering (Results, section 3.2.2. multi-sensor analyses). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to use clustering, as taught by Maris, to analyze EEG in a method similar to that of Arya in order to more accurately model functional mapping and remove noisy data.
Regarding claim 13, Arya discloses all of the elements of the claim as discussed above except the clustering algorithm is a Maris-Oostenveld nonparametric permutation-based clustering procedure. Maris teaches a method wherein the clustering algorithm is a Maris-Oostenveld nonparametric permutation-based clustering procedure (Methods, section 2.3). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to use Maris-Oostenveld clustering as taught by Maris, in a method similar to that of Arya, in order to more accurately detect significant effects in large, multi-sensor datasets.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Arya in view of Garcia Molina et al. (US 20110238685 A1), hereinafter Garcia Molina.
Regarding claim 19, Arya discloses all of the elements of the claim as discussed above except comparing the mapping results obtained with a reference database. Garcia Molina teaches a method where mapping results are compared to a reference database of mapped EEG signals ([0015], [0016]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to compare the results of the mapping to a reference database as taught by Garcia Molina, in a method similar to that of Arya, in order to verify that the mapping results are accurate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R UCHITEL whose telephone number is (571) 305-5153. The examiner can normally be reached Mon-Fri from 8:30am – 5:00pm.
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/CHARLES A MARMOR II/ Supervisory Patent Examiner, Art Unit 3791
/EMILY R UCHITEL/Examiner, Art Unit 3791
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