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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/03/25 has been entered.
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 1-25 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 specification insufficiently discloses how ultrasound treatment is determined to be appropriate for the patient to treat a disorder by screening a patient.
No art rejection
Response to Arguments
Applicant's arguments filed 11/03/25 have been fully considered but they are not persuasive. Applicant argues it is clear that the inventors were in possession of the invention for the listed disorders using the claimed predictive model, with the specified output and training and therefore respectfully requested that this rejection be withdrawn. Applicant argues the specification describe predictive model, inputs, outputs and training process in ample detail to demonstrate to one of skill in the art that the inventors were in possession of the claimed invention at the time of filing. Applicant’s argument is not persuasive because the amendment does not address the issue raise by examiner. Examiner raised questions “how does screening for Parkinson make ultrasound appropriate for treatment? Does screening determine that a patient has pain, or addiction or Parkinson then use ultrasound treatment? If the screening indicates the patient don't have pain, addition or Parkinson then don't use ultrasound treatment? Pain, addiction and Parkinson can be treated by many other ways. As see in applicant’s specification paragraph [0065] there are other alternative treatment such as medications, transcranial magnetic stimulation, deep brain stimulation, biologicals, surgical intervention, changes of settings for an existing spinal cord stimulator, behavioral and social intervention, digital intervention via a portable device, mindfulness approaches, social media approaches, a care provider coming to the individual, directing an individual to go to a clinic, emergency room, or hospital, or directing the user to obtain additional testing. The specification does not disclose or provide examples how predictive model determine that ultrasound treatment is appropriate instead of using other treatment. The claims can overcome 112 rejection by having the specification discloses how predictive model determine that ultrasound treatment is appropriate instead of using other treatments and possibly having this information in the claims. Examiner consider “predictive model” to be a black box because the specification does not disclose how predictive model determine that ultrasound treatment is appropriate instead of using other treatments. The specification basically discloses having inputs (extracted features) into the predictive model (black box) then out the outputs that indicate use ultrasound for treatment or other treatments without describe sufficiently how predictive model (black box) able to determine that. The specification only discloses the type of algorithms use for predictive model and train model.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0253840; US 2017/0203103; US 2015/0223877; US 2012/0265547; US 2009/0284378; US 2009/0157058; 2008/0004672; US 2010/0125206 (see [0008] and [0023]; predicting whether ultrasound insonation is likely to be effective in treating the symptoms of small vessel occlusion); US 2019/0307427 (see [0025]) and US 2018/0181704 (see [0189]).
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793