DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12/17/2024 and 4/3/2025 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
Specification
The disclosure is objected to because of the following informalities: prior to allowance, the first paragraph of the specification should be updated to indicate the present status of all applications referred to therein.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The disclosure fails to provide sufficient written description to convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the claimed invention. The claims require a method of electrically stimulating a brain of a subject that includes recording a first level brain activity corresponding to a first brain state, recording a second level brain activity corresponding to a second brain state, determining a different between the recorded first and second levels, determining based on the difference, one or more brain regions that generated electrical activity correspond to the difference, and electrically stimulating the determined one or more brain regions to achieve the second level brain activity. However, the disclosure fails to adequately describe the breadth of the invention and how to determine the aspects of the invention for the different brain activity levels and brain states what are broadly included in “first level brain activity”, “second level brain activity”, “first brain state”, and “second brain state”. Additionally, the disclosure fails to provide adequate written description for how the inventors performed the invention for the broadly recited brain activity levels and brain states, specifically how to stimulate the determined one or more brain regions to achieve the second level brain activity. There are no stimulation parameters provided corresponding to each of the brain activities that would be included in the broad recitation of “second level brain activity”. For at least the reasons given above, the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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 1-20 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 1 recites the limitation "electrically stimulating the determined one or more brain regions to achieve the second level brain activity" in lines 8-9. The metes and bounds of the claim are unclear, as it is unknown if this recitation is requiring merely the intended result of achieving the second level brain activity or if it is requiring some sort of verification of achieving the second level brain activity in order to satisfy the claim limitation. Furthermore, it is unclear if it merely requires achieving the second level brain activity, or if it also requires achieving the second brain state.
Claim 3 recites the limitation "modeling the difference" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "electrically stimulating the determined one or more brain regions to achieve the second level brain activity" in lines 9-10. The metes and bounds of the claim are unclear, as it is unknown if this recitation is requiring merely the intended result of achieving the second level brain activity or if it is requiring some sort of verification of achieving the second level brain activity in order to satisfy the claim limitation. Furthermore, it is unclear if it merely requires achieving the second level brain activity, or if it also requires achieving the second brain state.
Claim 11 recites the limitation "electrically stimulating the determined one or more brain regions to achieve the second level brain activity" in lines 12-13. The metes and bounds of the claim are unclear, as it is unknown if this recitation is requiring merely the intended result of achieving the second level brain activity or if it is requiring some sort of verification of achieving the second level brain activity in order to satisfy the claim limitation. Furthermore, it is unclear if it merely requires achieving the second level brain activity, or if it also requires achieving the second brain state.
Claim 20 recites the limitation "the electrically stimulating controls brain signal patterns" in lines 1-2. The metes and bounds of the claim are unclear as it is unknown what is meant by “controls brain signal patterns” or the breadth of what would be included in such a recitation. Does the electrically stimulating control all brain signal patterns, or merely those associated with the second level brain activity? In what way is “control” used in the context of the claim, as total and complete control as more of an effect?
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1Claims 1-9 are directed to a process and claims 10-20 are directed to a machine.
Step 2A, Prong One
Regarding claims 1, 10, and 11, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper. See MPEP § 2106.04(a)(2)(Ill). The limitation(s) of “determining a different between the recorded first level and the recorded second level”, “determining, based on the difference, one or more brain regions that generated electrical activity corresponding to the difference”, and “modeling the difference to determine one or more brain regions that generated electrical activity correspond to the difference” is/are a process that, as drafted, covers performance of the limitation by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard interpretation. For example, these limitations are nothing more than identifying or calculating a difference between two signals previously obtained. Such would be capable of being performed in a human mind or using a pen and paper because it is either simply observing differences or calculating signal differences using well known techniques.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. In particular, claims 1, 10, and 11 also recite “recording a first level of brain activity of the subject corresponding to a first brain state”, “recording a second level brain activity of the subject corresponding to a second brain state”, and “electrically stimulating the determined one or more brain regions to achieve the second level brain activity”, claims 10 and 11 recite “a non-transitory computer-readable medium having stored therein instructions to cause at least one processor to execute a method”, and claim 11 also recites “at least one electrode” and “at least one processor”. The recording steps amount to nothing more than the pre-solution activity of data gathering. The electrically stimulating step amounts to nothing more than the post-solution activity of treatment that fails to include sufficient detail to integrate the judicial exception into a practical application past merely the generic stimulation. The electrodes, processor, and computer readable medium are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do 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 elements of recording amount to nothing more than mere pre-solution activity of data gathering and post-solution activity of treatment, which does not amount to an inventive concept. The additional elements recited above are well known in the field of electrical stimulation therapy. Moreover, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, is discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984. See MPEP § 2106.05(d). In this case, elements of general computer are being used to implement the abstract idea of .
Regarding dependent claims 2-9 and 12-20, the limitations of claim 2-9 and 12-20 further defines the limitations already indicated as being directed to the abstract idea.
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, 5, 11, 14, 15), (2 and 12), (3 and 13), (6 and 16), (7 and 17), 10, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 10, 27, 29, (28 and 1), respectively, of U.S. Patent No. 11,633,595. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the presently-filed claims.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,208,264. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the presently-filed claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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