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
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 and selecting brain target location is determined to be appropriate for the patient to treat a disorder by screening a patient. For example, “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. Further, it does not appear, by screening patient for disease then base on well-ness related parameters select the brain target location (claim limitation “selecting a personalized brain target location for focused ultrasound treatment for the patient according to at least one of the plurality of wellness-related parameters when an onset of symptoms has been detected or predicted”). It appears selecting target location is based on images of the brain (see Figs. 8-9).
No art rejection
Response to Arguments
Applicant's arguments filed 04/29/26 have been fully considered but they are not persuasive. Applicant argues the specification disclose predictive model output and training therefore specification provides adequate written description for the claim as currently amended. Applicant argues “the written description requirement may be satisfied if in the knowledge of the art the disclosed function is sufficiently correlated to a particular, known structure”. Applicant’s argument is not persuasive because this is a method claim and examiner does not argue that the specification does not sufficiently disclose a particular known structure. Examiner raises 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. What is the criteria the predictive model use to determine that focused ultrasound is appropriate for patient treatment of the disorder? The specification only discloses the type of algorithms use for predictive model and train model. The specification does however disclose the predictive model predict the particular disease and the disease can be benefit from or can be treated with focus ultrasound. However, applicant does not address the questions examiner raise in the previous rejection in applicant’s remark or claim amendment to overcome the rejection. Does benefit from or can be treated with focus ultrasound mean the model determine focus ultrasound is appropriate for the patient. The claim needs to make this clear. Other alternative treatment such as medications, transcranial magnetic stimulation, deep brain stimulation also benefits or can be use to treat pain, addiction, PTSD, phobias, panic disorders, anxiety, depression, schizophrenia, dementia, Parkinsons' disease, Huntington's disease, obsessive compulsive disorder, or a neurodevelopment disorder. The specification and claims are not sufficiently disclosed what is considered to be appropriate for focus ultrasound use for the patient.
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]); US 2018/0181704 (see [0189]) and US 2013/01847228 (see [0020] and [0047] treat depression with focus ultrasound).
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.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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