I. ACKNOWLEDGEMENTS
This Office Action addresses U.S. Application No. 18/571001 (“’001 Application” or “instant application”). Based upon a review of the instant application, the actual filing date of the instant application is December 15, 2023.
This action is being issued following Applicant’s response of 2/02/2026 which included 1) claim amendments and 2) arguments.
II. STATUS OF CLAIMS
Claims 1-20 were filed with the application. The preliminary amendment of 11/13/2024 amended claims 1, 3, 4, 6-8, 10-13, 16, and 17 and canceled claims 18-20. The amendment of 2/02/2026 cancels claims 6 and 17, amends claims 1, 8, and 13. Therefore, as of the date of this Office Action, the status of the claims is:
a. Claim 1-5, and 7-16 (“Pending Claims”).
b. Claim 1-5 and 7-16 are examined (“Examined Claims”)
III. PRIORITY AND CONTINUING DATA
The ‘001 application is a national stage entry of PCT/US2022/034001, filed 6/17/2022, which claims the benefit of provisional applications 63/279038, filed 11/12/2021 and 63/212564, filed 6/18/2021. Because the earliest possible effective filing date is after March 16, 2013, the first to file provision of the AIA , apply to this proceeding.
IV. SPECIFICATION OBJECTIONS
The specification is objected to as the first paragraph of the disclosure does not list the PCT application in the priority chain.
V. REJECTIONS UNDER 5 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.
Claims 1-5 and 7-16 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 is rejected for several reasons. First, the claim is directed to determining the efficacy of a prescription based treatment but does not have a step of determining the efficacy. The claim does include a step of determining if a condition … is improving. However, Applicant should tie this step to the efficacy. Second, it is unclear whether the task to which the feedback the level of attention is regarding is related to the movement data, as the movement data is not specified to be captured relative to a task. Third, it is unclear whether the level of attention is the same thing as whether the subject is on-task or off-task, and hence, the claim does not actually determine whether the subject is on-task or off-task. Fourth, in lines 22-23, the claim mentions determining whether a condition of a subject that impedes the subject’s ability to concentrate is improving. However, there is no previous mention of diagnosing or identifying or otherwise finding this condition. Is helpful or unhelpful fidgeting the condition? Fifth, there is no antecedent basis for the prescription in line 23, as it was previously referred to as a prescription based treatment. Sixth, it is unclear whether the method includes the step of administering the prescription, as there is no positive step of administering a prescription to the subject. Seventh, there is no antecedent basis for the pre-prescription” in the claim, since there is no step of applying the prescription, the timing of the measurement relative to the prescription is undeterminable. Further, claim covers a situation where all the measurements are made after the prescription is applied. Eighth, it is unclear what the further categorized movement data refers to, Applicant should refer to the movement data characterized and fidgeting or non-fidgeting and then the movement data categorized and helpful or unhelpful fidgeting, for clarity.
Claim 2 is rejected in that it is unclear what the “movement data” refers to , as multiple types of movement data have been recited. While it appears that it refers to the movement data mentioned in line 6, for clarify, Applicant should be more specific..
Claim 4 is rejected in that it is unclear what the relationship between he subcategories of fidgeting data recited in claim 4 and the helpful and non-helpful fidgeting movement already recited in claim 1 is.
Claim 8 is rejected for several reasons. First, the claim is directed to determining the efficacy of a prescription based treatment but does not have a step of determining the efficacy. The claim does include a step of determining if a condition … is improving. However, Applicant should tie this step to the efficacy. Second, , in lines 24-25, the claim mentions determining whether a condition of a subject that impedes the subject’s ability to concentrate is improving. However, there is no previous mention of diagnosing or identifying or otherwise finding this condition. Is helpful or unhelpful fidgeting the condition? Third, there is no antecedent basis for the prescription in line 23, as it was previously referred to as a prescription based treatment. Fourth, it is unclear whether the method includes the step of administering the prescription, as there is no positive step of administering a prescription to the subject. Fifth, there is no antecedent basis for the pre-prescription” in the claim, since there is no step of applying the prescription, the timing of the measurement relative to the prescription is undeterminable. Further, claim covers a situation where all the measurements are made after the prescription is applied. Sixth, it is unclear what the further categorized movement data refers to, Applicant should refer to the movement data characterized and fidgeting or non-fidgeting and then the movement data categorized and helpful or unhelpful fidgeting, for clarity.
Claim 9 is rejected in that it is unclear what the “movement data” refers to , as multiple types of movement data have been recited. While it appears that it refers to the movement data mentioned in line 6, for clarify, Applicant should be more specific..
Claim 13 is rejected for several reasons. First, the claim is directed to a system for determining the efficacy of a prescription based treatment but does not have a step of determining the efficacy. The claim does include a step of determining if a condition … is improving. However, Applicant should tie this step to the efficacy. Second, it is unclear whether the task to which the feedback the level of attention is regarding is related to the movement data, as the movement data is not specified to be captured relative to a task. Third, it is unclear whether the level of attention is the same thing as whether the subject is on-task or off-task, and hence, the claim does not actually determine whether the subject is on-task or off-task. Fourth, in lines 27-28, the claim mentions determining whether a condition of a subject that impedes the subject’s ability to concentrate is improving. However, there is no previous mention of diagnosing or identifying or otherwise finding this condition. Is helpful or unhelpful fidgeting the condition? Fifth, there is no antecedent basis for the prescription in line 23, as it was previously referred to as a prescription based treatment. Sixth, it is unclear what the further categorized movement data refers to, Applicant should refer to the movement data characterized and fidgeting or non-fidgeting and then the movement data categorized and helpful or unhelpful fidgeting, for clarity.
Claim 14 is rejected in that it is unclear what the “movement data” refers to , as multiple types of movement data have been recited. While it appears that it refers to the movement data mentioned in line 6, for clarify, Applicant should be more specific..
Claim 16 is rejected in that it is unclear what the relationship between he subcategories of fidgeting data recited in claim 4 and the helpful and non-helpful fidgeting movement already recited in claim 13 is.
Claims 3, 5, 7, 10-12, and 15 are rejected as being dependent on a rejected base claim.
Clarification is required.
VI. REJECTIONS UNDER 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 1-5 and 7-16 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more (See MPEP 2106.04(a)).
Claim 1 recites the limitations:
Receiving movement data …
Categorizing movement data as associated with fidgeting movement or non-fidgeting movement …
Receiving feedback from the subject …
Correlating the feedback … with movement data that is labelled as fidgeting movement …
Categorizing movement data … as unhelpful or helpful fidgeting movement …
Determining if a condition of the subject that impedes the subject’s ability to concentrate is improving once the patient has been treated with the prescription by comparing the categorized and/or further categorized movement data after prescription, when medicated with the categorized and/or further characterized movement data pre-prescription
The first step in the 101 analysis, step 1 in MPEP 2106, is whether the claimed invention is in one of the 4 statutory classes of invention. Here, the claim is drawn to a method of identifying fidgeting, which is one of the 4 statutory classes of invention. Hence, step 1 is satisfied.
The next step in the analysis, step 2A prong one, is whether the claim is directed to judicial exception, i.e. a law of nature, a natural phenomenon, or an abstract idea. The correlating, categorizing and determining by comparing the data steps amount to a mathematical process... Alternatively, the determining step alone is a mathematical process. Mathematical processes are recognized as judicial exceptions that recite an abstract idea. See MPEP 2164
In Step 2A, prong two of the analysis, the claim is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim has several additional elements. The accelerometer and gyroscope are both structure recited at a high level of generality and therefore do not integrate the claim into a practical application. In addition, the AI model is also recited at a high level of generality. The receiving steps are merely a data gathering step, which is pre-solution activity. Further, the correlate step and the categorizing steps are simply pre-solution activity, Therefore, the additional elements and steps do not integrate the claim into a practical application. As such, the answer to step 2A, prong 2, is no.
The final step of the analysis, step 2B, where the claim is evaluated to determine whether the recited additional elements amount to significantly more than the judicial exception. Here, the additional steps and structure are simply well-understood, routine, and conventional processing steps and structure. Hence, the step does not recite an inventive concept.
As such, claim 1 is directed to an abstract idea and is not patent eligible.
As to claims 2-5 and 7, the claims do not add anything that changes the analysis and hence, are also drawn to an abstract idea recite additional mathematical features of the process 6 and 8, and therefore are still drawn to a judicial exception.
Claim 8 has the additional steps receiving user input .. correlating time of user input with the time of movement data and further categorizing the data. The receiving step is insignificant pre-solution activity, and the other two steps are merely part of the algorithm. Hence, claim 8, and claims 9-12 are drawn to a judicial exception.
Claims 13-16 are directed to an abstract idea for the same reasons claims 1-7 are.
VII. ALLOWABLE SUBJECT MATTER
Claims 1-5 and 7-16 would be allowable if the 101 and 112 rejections were overcome.
Claims 1-5, and 7-16 define over the art of record in that none of the art receives feedback from the user on a level of attention on a task, correlates the feedback with data labelled as fidgeting and categorizes the fidgeting as helpful or unhelpful based on the subject being on task or off task from the user feedback
VIII. ANSWER TO ARGUMENTS
Applicant has asserted that amending the claim to recite a method of determining efficacy of a prescription-based treatment makes the claim statutory. This argument fails for several reasons. First, the treatment is a generic treatment. See MPEP 2106.04(d)(2) and July2024 Subject Matter Example 49, noting that applying a generic drug is not sufficient to make a claim statutory. Second, since the claims have no step of actually administering the drug, the administration is not tied to any of the measurements or calculations to integrate the calculations into a practical application. As such, the 101 rejection s hereby maintained.
IX. CONCLUSION
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 ROBERT L NASSER whose telephone number is (571)272-4731. The examiner can normally be reached M-F 8-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Kosowski can be reached at (571) 272-3744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT L NASSER/ Primary Examiner, Art Unit 3992