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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 07/24/2026 has been entered.
Status of Claims
In the response filed 07/24/2026, the following occurred: No claims were amended.
Claims 1-19 are currently pending and have been examined.
Claim Rejections – 35 § 112(b)
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 1-19 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 “determining one or more target locations in the precision functional mapping data using the computer system, wherein the one or more target locations indicate locations to which neuromodulation should be delivered”. It is unclear how determination is made by the computer system in determining one or more target locations in the precision functional mapping data, wherein the one or more target locations indicate locations to which neuromodulation should be delivered. Is the determination of the one or more target locations in the precision functional mapping data being performed using an algorithm or a formula? Claim 1 is therefore found to be indefinite, because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. All dependent claims, namely claims 2-19, are rejected for at least the same reason.
Claim 1 recites “generating target localization data by localizing the one or more target locations relative to the brain of the subject”. It is unclear how target localization data by localizing the one or more target locations relative to the brain of the subject, is generated. Is the generation of the target localization data by localizing the one or more target locations relative to the brain of the subject performed using an algorithm or a formula? Claim 1 is therefore found to be indefinite, because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. All dependent claims, namely claims 2-19, are rejected for at least the same reason.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-19: Step 1
Claims 1-19 are drawn to a method for planning, guiding, or monitoring a delivery of neuromodulation to a subject’s brain (i.e. method), which is within the four statutory categories (i.e. process).
Claims 1-19: Step 2A Prong One
Claim 1 recites a method for planning, guiding, or monitoring a delivery of neuromodulation to a subject’s brain, the method comprising: (a) accessing precision functional mapping data with a computer system; (b) determining one or more target locations in the precision functional mapping data using the computer system, wherein the one or more target locations indicate locations to which neuromodulation should be delivered; (c) generating target localization data by localizing the one or more target locations relative to the brain of the subject; and (d) outputting target localization data with the computer system.
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing personal behavior by manually following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. But for the recitation of generic computer components, these limitations encompass a user receiving attribute data associated with a user, (a) accessing precision functional mapping data; (b) determining one or more target locations in the precision functional mapping data, wherein the one or more target locations indicate locations to which neuromodulation should be delivered; (c) generating target localization data by localizing the one or more target locations relative to the brain of the subject; and (d) outputting target localization data. These steps could be carried out manually by a user following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity.
Claims 2-19 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. Claim 2 further defines outputting the target localization data. Claim 3 further defines receiving feedback data from the subject. Claim 4 further defines updating the neuromodulation settings. Claim 5 further defines receiving feedback data from the subject and inputting the feedback data. Claim 6 further defines generating a report that indicates a neuromodulation treatment plan. Claim 7 further defines neuromodulation setting for delivering neuromodulation. Claim 8 further defines generating a report that indicates an image-based guidance. Claim 9 further defines generating the report. Claim 10 further defines generating the composite image data. Claim 11 further defines generating a report that indicates monitoring delivery of neuromodulation. Claims 12 and 13 further define precision functional mapping data. Claims 14 and 17 further define the one or more target locations. Claims 15 and 16 further define the brainordinates. Claim 18 further defines determining the one or more target locations. Claim 19 further defines the condition. Therefore, these claims are similarly drawn to Certain Methods of Organizing Human Activity.
Claims 1-19: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas along with insignificant, extra-solution data gathering activity, and adding limitations similar to adding the words “apply it” to the abstract idea. Claim 1 recites the additional elements that the computer-implemented system comprises one or more processing devices, and the user using the electromechanical machine.
Claims 1-19, directly or indirectly, recite the following generic computer components: “computer system,” which are similar to adding the words “apply it” to the abstract idea. The written description discloses that the recited computer components encompass generic components including “in some embodiments, computing device 1350 can include a processor 1402, a display 1404, one or more inputs 1406, one or more communication systems 1408, and/or memory 1410. In some embodiments, processor 1402 can be any suitable hardware processor or combination of processors, such as a central processing unit (“CPU”), a graphics processing unit (“GPU”), and so on“ (see at least Paragraph [0081]), and “As used herein in the context of computer implementation, unless otherwise specified or limited, the terms “component,” “system,” “module,” “framework,” and the like are intended to encompass part or all of computer-related systems that include hardware, software, a combination of hardware and software, or software in execution. For example, a component may be, but is not limited to being, a processor device, a process being executed (or executable) by a processor device, an object, an executable, a thread of execution, a computer program, or a computer” (see at least Paragraph [0092]). Although the additional elements limits the identified judicial exceptions, this type of limitation merely confines the use of the abstract idea to a particular technological environment, and thus fails to add an inventive concept to the claims. See MPEP 2106.05 (h). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 “merely include[ing] instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Claims 1-19: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”). As explained above, the generic computer components and machine learning are at best the equivalent of merely adding the words “apply it” to the judicial exception.
Receiving and transmitting data over a network (i.e. receiving and communicating data or signals) has been recognized as well-understood, routine, and conventional activity of a general-purpose computer (see MPEP 2106.05(d) and buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014)).
Gathering and analyzing information using conventional techniques and displaying the result has also been found to be insufficient to show an improvement to technology, (see MPEP 2106.05(a) and TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48).
Insignificant, extra solution, data gathering activity has been found to not amount to significantly more than an abstract idea (see MPEP 2106.05(g) and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)). Therefore, the high-level recitation of an output of results also fails to include additional elements that are sufficient to amount to significantly more than the judicial exception.
Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
The most remarkable prior art of record is as follows:
Hermosillo et al.: U.S. Patent Application Publication U.S. 2023/0115330 A1, Functional Magnetic Resonance Imaging Brain Mapping And Neuromodulation Guidance And Monitoring Based Thereon
Grado et al.: U.S. Patent U.S. 12,214,201 B2, Method For Adaptive Control Of A Medical Device Using Bayesian Optimization
Pepin et al.: U.S. Patent Application Publication U.S. 2021/0052900 A1, Neuromodulation Therapy Simulator
Lynch et al., Precision mapping and transcranial magnetic stimulation of individual-specific functional brain networks in humans, STAR Protocols, Volume 4, Issue 1, 2023, 10218, ISSN 2666-1667, https://doi.org/10.1016/j.xpro.2023.102118. (https://www.sciencedirect.com/science/article/pii/S266616672300076X)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joy Chng whose telephone number is 571.270.7897. The examiner can normally be reached on Monday-Friday, 9:00am-5:00pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, JASON DUNHAM can be reached on 571.272.8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866.217.9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Joy Chng/
Primary Examiner, Art Unit 3686
Prosecution Insights