DETAILED ACTION
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/30/2026 has been entered.
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 .
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 25, 28-29, 33-35, 38-39, 43 and 45-54 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.
Claim 25 recites “provide an intensity of stimulation to manage the one or more symptoms to the wearable device based on the sensed one or more symptoms” in line “g),” but lacks detail in the specification and is potentially new matter. The specification fails to teach, explicitly or otherwise, that the intensity of stimulation is managed without a severity score. In other words, the specification fails to teach how it could provide an intensity of stimulation with only the sensed symptoms. Additionally, without such teachings it is unclear how the invention would then incorporate the stimulating element. Same issue is seen in claim 39. Clarification required.
Claims 28, 45, and 48 recite the use of “artificial intelligence”, but the specification is devoid of details regarding machine learning. The specification merely recites the use of a machine learning algorithm, but fails to provide details and the composition of the algorithm, e.g., specific formula.
Claims not listed are rejected by virtue of claim dependency.
Examiner’s Note
Due to the amendments, and subsequent change in scope of the claims, allowable subject matter cannot be noted because of the rejections noted above. As such, the limitations previously indicated as not taught or suggested by the prior art is no longer applicable. Furthermore, the scope of the claims are unclear due to the removal of the severity score and machine learning.
It is further noted, the claimed invention now merely claims assessing a patient based on meeting a single threshold, which is highly prevalent in the art and seen throughout the prior art of record.
Response to Arguments
Applicant’s arguments filed 12/12/2025, with respect to 35 U.S.C. 103 rejections have been fully considered and are persuasive. The prior art rejection has been withdrawn.
Applicant contends that claims 28 was amended to overcome the 35 U.S.C. 112(a) rejection regarding the machine learning limitation, on page 8 of the Remarks. The amendments however, are not sufficient because they merely recite the language in the specification. The specification lacks details on how the inputs are used with an algorithm that receives the input and calculates the output. The specification must have specific details on the machine learning process that include more than just the inputs and the output.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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