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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 16-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishelevich US 2017/0246481 alone or further in view Mason et al US 2010/0280118 or Cohen-Armon et al US 2013/0203801
Regarding claim 16, 23, and 31 Mishelevich teaches a method of improving addiction to an addictive behavior or addictive chemical substance in a patient using a focused ultrasound signal (or TMS, tDC -seeTable 17 Part VI) delivered to at least one of a frontal cortex, an anterior cingulate, an insula, or a nucleus accumbens to improve the patient's addiction. See paras. [0073] - [0078], Table 2, Part VI: Addiction VI., para. [0253], para. [0365], Table 4 paras. [0487]- [0499], paras. [0502]-[0503], Fig. 13, paras [0526]-[0527], 0532} [0538] Table 11 VI Table 17 VI, paras. [0559] and [0573] and fig. 19 and para. [0422] which shows the arrangement for treating addiction. The applications of treatment are to a specific patient.
Mishelevich does not explicitly teach obtaining a measurement of the “specific” patient’s “specific” baseline craving level or teach obtaining a craving level measurement during cue exposure prior to treatment and comparing the level measured during cue exposure to the level of baseline and using the comparison to determine the treatment based upon the comparison. However, such a comparison is obvious particularly when the levels are the same when there is no cue reactivity for the chosen cue. No treatment is to be applied because the Mishelevich method is for treat cue reactivity (See Cohen-Armon et al US2013/0203801 for the term cue-reactivity) to reduce it via neuromodulation and when there is no cue reactivity there is no treatment for it.
Additionally, when a treatment is applied for treating the addictive behavior the use of feedback to enhance the reduction of the patient’s level of craving can be relative or be on a numerical scale of the craving. See "Guided Feedback" paras. [0201] -[0210] for treatments based on feedback based upon a numerical scale para.[0201] that is established to evaluate the feedback. The numerical scale would be based upon the highest craving level, that is the craving level during cue exposure prior to treatment versus the level of where craving at its lowest value, which is at baseline where the craving reactivity is low due to the effective neuromodulation.
The relationship also provides information as to the difference in craving level due to the exposure of the cue and provides information so as to decide stimulation parameters that would be used during treatment and additionally provides a range of craving level to establish the effectiveness of the treatment based upon where the feedback craving level falls within the numerical scale of craving level for a particular cue, which would be obvious since Mishelevich teaches the use of such a scale.
While the examiner considers the word “specific” with respect to the patient, the patient’s baseline craving as now used in the claims to be met by Mishelevich in that any treatment for a patient in Mishelevich will be a specific treatment, for a specific patient based upon the cues specific to the patient that trigger cue reactivity in that patient. Even though a group of people may share that specific cue it is still specific to the patient treated if it is what triggers cue reactivity for the addiction. However, Mason additionally teaches the use of cue of the smell of the patient’s favorite alcoholic beverage, which would be “specific” to that patient or Cohen-Armon et al US 2013/0203801 which teaches cue reactivity to whine glasses. It would have been obvious to have modified Mishelevich to use other cues that are more specific to a particular person as taught by Mason and Cohen-Armon.
For claims 17, 24, the treatment involves focused ultrasound.
For claims 18, 19, 25 and 26 an example of addictive behavior is compulsive
sexual behavior See table 11, part XXII explicit visual or audio sexual behavior. See para. [210] for video gaming.
For claims 20 and 27, see para [0210], drug craving.
For claims 22 and 30, as noted above the cue can be odor (chemical) or auditory
or visual See table 11, part XXII (compulsive sexual behavior)
For claims 31-32, the treatment steps are similar to claim 16 but adds improving mood, anxiety and cognitive functions including impulse control and
self-regulation which are all elements associative with the improvement of self-control needed for overcoming addiction behavior and thus are inherent or obvious outcomes for successful treatment.
For claims 33-35 see Table 2 Part VI and Table 21 for the treatment of obesity via craving of food.
For claims 21, 28-29, although Mishelevich does not mention the addictive chemical substances included in claims 21, 28-29, those substances comprise some of the most common chemical substance addictions and would have been obvious at the time of Applicant's invention to have included in the Mishelevich treatment methods using focused ultrasound transcranial applications. Cohen-Armon and Mason deal with alcohol addictions.
Response to Arguments
Applicant's arguments filed 9-29-2025 have been fully considered but they are not persuasive over the newly applied art and grounds of rejection. See new grounds of rejection above including Cohen-Armon and Mason deal with alcohol addictions.
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.
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/MARK W. BOCKELMAN/ Primary Examiner, Art Unit 3792