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 .
Remarks
Claims 1-13, filed 04/22/2024, are currently pending and are under consideration.
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 1-13 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 1 recites “energy distribution mapping”. It is unclear what energy distribution is being mapped. For examination purposes, the mapped energy will be understood to be electrical energy.
Claim 8 recites the limitation "the threshold within each network" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-7 and 9-13 are rejected based on their dependency on claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10, 12, and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method for planning, guiding, or monitoring delivery of neuromodulation. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed towards a method, and thus meets the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claim 1 recites a method for planning, guiding, or monitoring delivery of neuromodulation, comprising accessing subject-specific mapping data, determining target locations using a computer system, and generating target localization data.
The limitation of planning, guiding, or monitoring delivery of neuromodulation, as drafted in claims 1-10, 12, and 13, under its broadest reasonable interpretation, covers performance of the limitation in the mind or using pen and paper. For example, planning, guiding, or monitoring delivery of neuromodulation in the context of this claim encompasses a user accessing subject-specific mapping data, determining target locations, and generating target localization data.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
As claimed and understood, the crux of the invention is the data analysis performed in order to generate the target localization data. The step of accessing subject-specific mapping data is considered to be the pre-solution activity of data gathering by no more than routine means. The steps of determining target locations and generating target localization data are considered to be data analysis steps.
The additional element of the computer system is recited at a high level of generality (i.e., as generic computer components for processing data). Specifically, the additional element is generically recited computing elements that perform the steps of gathering, analyzing, and outputting data.
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination is not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional element of a computer system amounts to no more than generically claimed computer components which enable the above-identified abstract idea to be conducted by performing the basic functions of automating mental tasks. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claims 2-10, 12, and 13 depend on claim 1 and recite the same abstract idea as claim 1 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 2-4 (i.e. further describing the data that is used) are further data gathering steps. The additional limitations recited in claims 5-10 (i.e. further describing the analysis performed) are further data analysis steps. The additional elements of claims 12 and 13 (i.e. outputting the data) are data output steps. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
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.
Claims 1-4 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wei et al. (US Patent Application Publication 2024/0260831), hereinafter Wei, further in view of Wagner et al. (US Patent Application Publication 2012/0226200), hereinafter Wagner.
Regarding claim 1, Wei discloses a method for planning, guiding, or monitoring a delivery of neuromodulation to a subject’s brain (e.g. Abstract), the method comprising: (a) accessing subject-specific data with a computer system (e.g. Par. [0084]; Fig. 2: step 201); (b) determining one or more target locations in the subject-specific data using the computer system, wherein the one or more target locations indicate locations to which neuromodulation should be delivered (e.g. Par. [0131]; Fig. 2: step 202, Figs. 3, 4); and (c) generating target localization data by localizing the one or more target locations relative to the brain of the subject, thereby planning, guiding, or monitoring delivery of the neuromodulation to the one or more target locations (e.g. Pars. [0135]; Pars. [0141]-[0144]: determining locations; Pars. [0146]-[0147]; Fig. 2: step 204).
However, Wei fails to specifically disclose wherein the data is energy distribution mapping data. Wagner, in a similar field of endeavor, is directed towards tissue stimulation. Wagner discloses using energy distribution mapping data (e.g. Par. [0063]: the mapping provides energy distribution information).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wei to include the energy distribution mapping data because doing so would allow determination of tissue properties (e.g. Wagner, par. [0063]).
Regarding claim 2, Wei further discloses accessing image data acquired from the subject and generating the subject-specific energy distribution mapping data from the image data (e.g. Par. [0097]).
Regarding claim 3, Wei further discloses wherein the image data comprise structural image data comprising anatomical magnetic resonance images and functional image data (e.g. Par. [0024]).
Regarding claim 4, Wei further discloses wherein the functional image data comprise at least one of subject-specific functional network maps or subject-specific integration zone maps (e.g. Par. [0097]; Par. [0197]; Fig. 3: subject specific mapping).
Regarding claim 11, Wei further discloses determining neuromodulation settings based on the one or more target locations and controlling a neuromodulation device to deliver neuromodulation to the one or more target locations according to the neuromodulation settings (e.g. Par. [0045]; Par. [0150]).
Regarding claim 12, Wei further discloses outputting the target localization data by generating a report that indicates a neuromodulation treatment plan for delivering the neuromodulation to the one or more target locations (e.g. Par. [0153]: the operator or device control the neuromodulation based on the output).
Regarding claim 13, Wei further discloses outputting the target localization data by generating a report that indicates an image-based guidance for delivering neuromodulation to the one or more target locations (e.g. Pars. [0171]-[0172]; Figs. 5, 6: images provided).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Wei et al. (US Patent Application Publication 2024/0260831), hereinafter Wei, further in view of Wagner et al. (US Patent Application Publication 2012/0226200), hereinafter Wagner, as applied to claim 1 above, and further in view of Nummenmaa et al. (US Patent Application Publication 2024/0302420), hereinafter Nummenmaa.
Regarding claim 5, Wei further discloses determining optimal neuromodulation positions from the image data (e.g. Pars. [0135]; Pars. [0141]-[0144]: determining locations; Pars. [0146]-[0147]; Fig. 2: step 204). However, Wei fails to disclose generating simulated electric field data using the optimal neuromodulation positions; calculating an energy distribution across functional networks using the simulated electric field data; and generating the subject-specific energy distribution mapping data based on the calculated energy distribution. Nummenmaa, in a similar field of endeavor, is directed towards determining electric fields of transcranial magnetic stimulation. Nummenmaa discloses generating simulated electric field data, calculating an energy distribution across functional networks using the simulated electric field data, and generating the subject-specific energy distribution mapping data based on the calculated energy distribution (e.g. Pars. [0051]-[0052]; Pars. [0063]-[0064]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wei in view of Wagner to include generating simulated electric fields as taught by Nummenmaa to improve targeting of brain regions for neuromodulation (e.g. Nummenmaa, par. [0046]).
Regarding claim 6, Wei further discloses wherein the optimal neuromodulation positions are determined from the image data by generating a cortical reconstruction from the structural image data and determining an optimal neuromodulation position over the cortical surface reconstruction for each brainordinate in each functional network of the functional image data (e.g. Par. [0097]; Fig. 7).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wei et al. (US Patent Application Publication 2024/0260831), hereinafter Wei, further in view of Wagner et al. (US Patent Application Publication 2012/0226200), hereinafter Wagner, further in view of Nummenmaa et al. (US Patent Application Publication 2024/0302420), hereinafter Nummenmaa, as applied to claim 6 above, and further in view of Liang et al. (US Patent Application Publication 2017/0079538), hereinafter Liang.
Regarding claim 7, Wei fails to disclose wherein the cortical reconstruction is generated based on a finite element model. Liang, in a similar field of endeavor, is directed towards identifying images of brain function. Liang discloses using a finite element model for reconstruction (e.g. Par. [0031]; Par. [0046]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wei in view of Wagner and Nummenmaa to include using a finite element model for reconstruction as taught by Liang because it is a known method for image reconstruction.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wei et al. (US Patent Application Publication 2024/0260831), hereinafter Wei, further in view of Wagner et al. (US Patent Application Publication 2012/0226200), hereinafter Wagner, further in view of Nummenmaa et al. (US Patent Application Publication 2024/0302420), hereinafter Nummenmaa, as applied to claim 5 above, and further in view of Wang et al. (Wang D, et al. Fast computational E-field dosimetry for transcranial magnetic stimulation using adaptive cross approximation and auxiliary dipole method (ACA-ADM). Neuroimage. 2023;267:119850. doi:10.1016/j.neuroimage.2022.119850), hereinafter Wang.
Regarding claim 9, Wei fails to disclose wherein the optimal neuromodulation positions are determined from the image data using an auxiliary dipole method. Wang is directed towards transcranial magnetic stimulation. Wang discloses using an auxiliary dipole method for data analysis (e.g. page 2, left column, first full paragraph: using the auxiliary dipole method to evaluate the efficiency of the stimulation).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wei in view of Wagner and Nummenmaa to include using the auxiliary dipole method as taught by Wang to evaluate the efficiency of the applied stimulation.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wei et al. (US Patent Application Publication 2024/0260831), hereinafter Wei, further in view of Wagner et al. (US Patent Application Publication 2012/0226200), hereinafter Wagner, further in view of Nummenmaa et al. (US Patent Application Publication 2024/0302420), hereinafter Nummenmaa, as applied to claim 5 above, and further in view of Wei et al. (US Patent Application Publication 2024/0335130), hereinafter Wei’130.
Regarding claim 10, Wei further discloses a cortical surface reconstruction generated from the image data (e.g. Par. [0097]). However, Wei fails to disclose projecting the simulated electric field data onto a cortical surface reconstruction. Wei’130, in a similar field of endeavor, is directed towards target identification. Wei’130 discloses projecting the signals onto a cortical surface reconstruction (e.g. Par. [0116]: projecting the data to structural images including reconstructed individual cortical images).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wei in view of Wagner and Nummenmaa to include projecting the data as taught by Wei’130 to process the data to determine target locations.
While there are no prior art rejections for claim 8, it is not indicated as allowable due to the rejections under 35 U.S.C. 101 and 35 U.S.C. 112(b), as explained above.
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 and 11-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, and 8 of copending Application No. 18/642,224 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are directed towards a method for planning, guiding, or monitoring a delivery of neuromodulation to a subject’s brain, which is the same as the claims of copending application 18/642,224.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 1 and 11-13 of the instant application, claims 1, 2, 6, and 8 of the copending application 18/642,224 discloses:
Claim 1. A method for planning, guiding, or monitoring a delivery of neuromodulation to a subject’s brain, the method comprising (claim 1, lines 1-2):
(a) accessing subject-specific energy distribution mapping data with a computer system (claim 1, line 3);
(b) determining one or more target locations in the subject-specific energy distribution mapping data using the computer system, wherein the one or more target locations indicate locations to which neuromodulation should be delivered; and (claim 1, lines 4-6)
(c) generating target localization data by localizing the one or more target locations relative to the brain of the subject, thereby planning, guiding, or monitoring delivery of the neuromodulation to the one or more target locations (claim 1, lines 7-8).
Claim 11. The method of claim 1, further comprising determining neuromodulation settings based on the one or more target locations and controlling a neuromodulation device to deliver neuromodulation to the one or more target locations according to the neuromodulation settings (claim 2).
Claim 12. The method of claim 1, further comprising outputting the target localization data by generating a report that indicates a neuromodulation treatment plan for delivering the neuromodulation to the one or more target locations (claim 6).
Claim 13. The method of claim 1, further comprising outputting the target localization data by generating a report that indicates an image-based guidance for delivering neuromodulation to the one or more target locations (claim 8).
Therefore, claims 1, 2, 6, and 8 of the copending application 18/642,224 anticipate instant claims 1 and 11-13. Therefore, instant claims 1 and 11-13 are not patentable over claims 1, 2, 6, and 8 of the copending application 18/642,224.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ning et al. (US 2023/0211168) is directed towards integrated electric field simulation.
Dosenbach (US 2021/0333343) is directed towards precision functional mapping guided planning.
Pepin et al. (US 2021/0052900) is directed towards a neuromodulation therapy simulator.
Leuthardt et al. (US 2019/0090749) is directed towards a classifier for optimizing a neuromodulation target.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796