DETAILED ACTION
Notice of Pre-AIA or AIA Status
Response to Amendment
1. Claims 1, 4 and 5 have been amended as requested in the amendment filed on July 28, 2026. Following the amendment, claims 1 and 3-6 are pending in the instant application.
2. Claims 1 and 3-6 are under examination in the instant office action.
3. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
4. Applicant’s arguments filed on July 28, 2026, have been fully considered but found to be not persuasive for reasons set forth below. New grounds of rejection necessitated by Applicant’s amendment are set forth below as well.
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.
5. Claims 1 and 3-6, as amended, 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.
6. Claim 1 stands vague and indefinite for reciting the limitation “exercise for dementia prevention,” see reasons of record in section 5 of Paper mailed on May 06, 2026.
Applicant traverses the rejection by supplying the definition of the word “exercise” from Merriam Webster dictionary, p. 6 of the Response. While the argument has been fully considered it is not persuasive to overcome the rejection. Briefly, the claimed method is to motivate a subject to perform “exercise for dementia prevention.” Applicant’s position is that the exercise intended by claim 1 encompasses “bodily exertion for the sake of developing and maintaining physical fitness.” The Examiner maintains that since the claim does not contain any reference to any bodily exertion, then it is not obvious what specific exercise is intended the subject of the claimed method to be motivated to perform so to prevent dementia.
7. Next, claim 1, as amended, in step two, specifically requires storing “measurement data” without any reference to what the data are. It appears that the step is intended to repeat practicing the task as described in step one; however, step one does not require measuring any parameter(s) or collecting any data. Moreover, step two refers to data “being acquired in advance by an optical measurement device,” and it is not clear what was measured, what units were used and what optical device was involved.
8. Further, claim 1, as amended, recites the limitation "pre-exercise measurement data and post-exercise measurement data" in step three, and there is insufficient antecedent basis for this limitation within the claim because the term “exercise” is mentioned only within the claim preamble and not as an active step. Also, it is not obvious how step three, which requires the subject to perform the task, relates to step one, when the same subject has already been given the task.
9. Similarly, step four refers to “performing the exercise for dementia prevention” without specifically pointing out what specific “bodily exertion for the sake of developing and maintaining physical fitness” is intended by the claim.
10. Finally, step four, as amended, fails to clearly articulate how presenting an index leads to the motivation of the subject as stated within the claim’s preamble.
Applicant is advised to rewrite claim 1 to better express claimed subject matter.
11. Claim 4 stands rejected for reasons of record in section 9 of Paper mailed on May 06, 2026.
12. Claim 5 stands rejected for reasons of record in section 10 of Paper mailed on May 06, 2026.
13. Claim 3 and 6 are indefinite for being dependent from indefinite claim.
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.
14. Claims 1 and 3-6, as amended, 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 enablement requirement for reasons of record fully explained in section 10 of Paper mailed on May 02, 2022, section 9 of Paper mailed on October 07, 2022, section 14 of Paper mailed on April 28, 2023, section 7 of Paper mailed on October 10, 2023, section 12 of Paper mailed on April 26, 2024, in section 6 of Paper mailed on August 15, 2024 and within the Examiner’s Answer to the Patent Trial and Appeal Board, document of April 04, 2025. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1 and 3-6, as currently presented, are vague and ambiguous for failing to clearly articulate the claimed subject matter, see sections 5-13 earlier. However, by broadest reasonable interpretation, the claims appear to encompass the same method as presented earlier, which is,
A method for indexing cognitive function of a subject for motivating to perform exercise for dementia prevention, comprising: giving, to the subject a task suitable for inducing biological activity related to cognitive function of the brain of the subject, the task consists of cold sensory
stimulation to the subject by applying a cooling agent, arithmetic calculation by the subject by a
display device, memorization of characters by the subject by the display device, or spatial
recognition of a location in a map by the subject by the display device; acquiring measurement data by measuring, by an optical measurement device, a change in a cerebral blood flow of the subject when the task is given to the subject; constructing a regression model in advance based on measurement data of changes in cerebral blood flow in a group of non-demented persons, who are diagnosed by a doctor as being non-demented definitively, acquired in advance when the task has been given to the non- demented persons, and -measurement data of changes in cerebral blood flow in a group of persons with mild cognitive impairment, acquired in advance when the task has been given to the persons with mild cognitive impairment, wherein the constructing the model is performed in advance of indexing cognitive function of the subject; storing the regression model in a storage; acquiring an index indicating the cognitive function of the subject at respective timings before and after exercise interventions for dementia prevention by comparing, by the processor, the measurement data of the subject at respective timings before and after the exercise interventions for dementia prevention with the regression model stored in the storage, wherein the index indicating the cognitive function of the subject is a numerical value indicating the change in the biological activity related to the cognitive function of the subject acquired from the measurement data compared to the regression model or a score obtained by converting the numerical value.
This inventive concept has been fully examined earlier, and the claims have been found not enabled under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. See also the PTAB decision of January 30, 2026.
The full text of the rejection will not be repeated here. The Examiner maintains the same position and claims 1 and 3-6, as amended, are rejected.
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.
15. Claims 1 and 3-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Method claim(s) 1 and 3-6, by broadest reasonable interpretation and consistent with the specification as originally filed, encompass mental steps, abstract ideas and laws of nature by reciting relationship between changes in the levels of cerebral flow and natural process of cognitive activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons that follow.
The subject matter eligibility under 35 U.S.C. 101 of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products) was confirmed by the U.S. Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. , 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. , 132 S. Ct. 1289, 101 USPQ2d 1961 (2012). "[L]aws of nature, natural phenomena, and abstract ideas" are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. (2010). "Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work." Gottschalkv. Benson, 409 U. S. 63, 67 (1972).
In brief, in Prometheus, a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder is the focus. This method comprises a) administering 6-thioguanine to patients and b) determining the level of 6-thioguanine in the patients and c) correlate the level of 6-thioguanine, i.e. a certain level/red blood cells, with the decision whether a need for increase or decrease the amount of 6-thioguanine treatment in said patients.
In Prometheus, the Court found that "[i]f a law of nature is not patentable, neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Additionally, "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law." Flook, 437 U. S., at 590; see also Bilski, 561 U. S., ("[T]he prohibition against patenting abstract ideas 'cannot be circumvented by'.., adding 'insignificant post-solution activity'" (quoting Diehr, supra, at 191-192)).
The Court also summarized their holding by stating "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately."
Thus, if the claim recites or involves a judicial exception, such as a law of nature/natural principle or natural phenomenon (e.g., the law of gravity, F=ma, sunlight, barometric pressure, etc.), and/or something that appears to be a natural product (e.g., a citrus fruit, uranium metal, nucleic acid, protein, etc.), then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself.
In the instant case, based upon an analysis with respect to the claim as a whole, claims 1 and 3-6 are determined to be directed to a judicial exception without significantly more. The rationale for this determination is explained below in view of controlling legal precedent set forth in 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618) dated December 16, 2014 and 2019 Revised Patent Subject Matter Eligibility Guidance (84 FR 50) dated January 07, 2019.
The instant claims 1 and 3-6 encompass a process. (Step 1: Yes).
Next, Step 2, is the two-part analysis from Alice Corp. (also called the Mayo test) to determine whether the claim is directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions). (In Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) the Supreme Court sets forth a two-step test for determining patent eligibility. First, determine if the claims encompass a judicial exception (a natural phenomenon/law of nature/abstract idea). If so, then ask whether the remaining elements/steps, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to ‘“transform the nature of the claim’ into a patent-eligible application.” Id. at 2355 (quoting Mayo, 132 S. Ct. at 1297). Put another way, there must be a further “inventive concept” to take the claim into the realm of patent eligibility. Id. at 2355. In the recent Myriad v Ambry case, the CAFC found claims (drawn to methods comprising obtaining tissue samples, analyzing sequences of cDNA and comparing germline sequences of a gene to wild-type sequences) to encompass the abstract mental processes of ‘comparing’ and ‘analyzing’. Recitation of specific techniques (in Myriad claims 7 and 8 further recited hybridization and PCR) were deemed not “enough” to make the claims patent-eligible since the claims contained no otherwise new process. The elements/steps recited in addition to the judicial exception did nothing more than spell out what practitioners already knew). The instant claims 1 and 3-6 encompass changes in the cerebral flow during cognitive activity, the process that is governed by a law of nature and thus is a judicial exception. The changes in the cerebral flow occur naturally during performance of a cognitive task apart from any human action. The relation between the levels of naturally occurring hemoglobin, which correlate with the change in the cerebral flow, exists in principle and is a consequence of the brain function, entirely natural process, a natural phenomenon, and thus a judicial exception. Furthermore, a process of assigning numerical values and indexes are mental steps, or abstract ideas, also a judicial exception. (Step 2A/1: Yes). Next, prong two of Step 2A requires identifying whether there are additional elements recited in the claim beyond the judicial exception(s) and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration into a practical application” requires an additional element or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such as the claim is more than a drafting effort designed to monopolize the exception. In the instant case, the claims do not recite any additional elements to integrate the judicial exception into a practical application because all the steps of the claimed methods are limited to only those that measure naturally occurring changes in the blood flow during a naturally occurring cognitive process as well as abstract ideas to analyze the results. (Step 2A/2: No).
Finally, claims 1 and 3-6 do not recite any elements, or combinations of elements to ensure that the claim as a whole amounts to significantly more than the judicial exception because the active steps of the claims—measuring the changes in cerebral flow by monitoring the levels of hemoglobin—represent routine steps that read on a well-known fMRI technique. (Step 2B: No).
Thus, for reasons fully explained above, claims 1 and 3-6 do not satisfy the requirement of 35 U.S.C. 101 and are therefore rejected.
Conclusion
16. No claim is allowed.
17. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
August 20, 2026
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