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 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 51-52 and 54 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. Limitation adjusting parameter is unclear. It is unclear because since claim 1 claim improving the patient's post-traumatic stress disorder. There is no reason to adjust parameter if the treatment improves the disorder. As see in the specification the ultrasound treatment could result in improvement, or has no effect or condition become worst.
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.
Claims 41-47 and 51-54 are rejected under 35 U.S.C. 103 as being unpatentable over Tyler (US 2012/0289869) and in view of Meloni et al. (US 2015/0306136).
Addressing claim 41, Tyler discloses a method of improving post-traumatic stress disorder (PTSD) in a patient in need thereof comprising:
administering ultrasound therapy to the patient improving the patient's post-traumatic stress disorder (see [0077], [0092], [0115] and Fig. 1A).
Tyler does not disclose exposing the patient to a cue linked to the patient's trauma to trigger or intensify symptoms of the patient's PTSD and the administering preceded or accompanied by exposure to the cue. Meloni discloses exposing the patient to a cue linked to the patient's trauma to trigger or intensify symptoms of the patient's PTSD and the administering preceded or accompanied by exposure to the cue (see [0028] and [0176]; Tyler administering treatment is ultrasound treatment). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tyler to have exposing the patient to a cue linked to the patient's trauma to trigger or intensify symptoms of the patient's PTSD and the administering preceded or accompanied by during or before exposure to the cue as taught by Meloni because this provoke a high-anxiety and help trained to develop an altered response to said stimulus (see [0022], [0053], [0143] and [0195], 1).
Addressing claims 42-47 and 51-54, Tyler discloses:
addressing claim 42, wherein administering the ultrasound therapy comprises administering a focused ultrasound signal to a neural target site comprising the amygdala, the prefrontal cortex, the hippocampus, basal nuclei, sensory thalamic nuclei, nucleus accumbens, the internal capsule, or combinations thereof (see [0079-0080]).
addressing claim 43, wherein the neural target site comprises a lateral nucleus of the amygdala (see [0079-0080]).
addressing claim 44, wherein the neural target site is the ventromedial prefrontal cortex (see [0079-0080]; choosing one of the brain target regions only require routine skill in the art and depend on physician choice).
addressing claim 45, wherein the neural target site is the basolateral complex of the amygdala (see [0093-0094).
addressing claim 46, wherein the neural target site comprises the infralimbic region of the medial prefrontal cortex (see [0079-0080] and [0093-0094]; choosing one of the brain target regions only require routine skill in the art and depend on physician choice).
addressing claim 47, wherein the neural target site comprises the ventral internal capsule (see [0079-0080] and [0093-0094]; choosing one of the brain target regions only require routine skill in the art and depend on physician choice).
addressing claim 51, further comprising adjusting the ultrasound therapy by increasing the frequency, duration, intensity, sonication duration, pulse width, sonication dose, number of sonication elements, or a combination thereof of a focused ultrasound signal (see [0096]; adjustment by increase or decrease depend on feedback).
addressing claim 52, further comprising adjusting the ultrasound therapy by decreasing the frequency, duration, intensity, sonication duration, pulse width, sonication dose, number of sonication elements, or a combination thereof of a focused ultrasound signal (see [0096]; adjustment by increase or decrease depend on feedback).
addressing claim 53, wherein the cue is a visual cue, an auditory cue, a tactile cue, an olfactory cue, a gustatory cue, an introception cue, or combinations thereof (see [0010], [0028] and [0176]; a cue would be either visual cue or an auditory cue or a tactile cue or an olfactory cue or a gustatory cue or an introception cue.
addressing claim 54, comprising: measuring a first set of one or more wellness-related parameters during or immediately after the ultrasound therapy; measuring a second set of one or more wellness-related parameters more than five hours after the ultrasound therapy; and adjusting at least one parameter associated with the ultrasound therapy according to the first set of wellness-related parameters and the second set of wellness-related parameters (see [0049] and Fig. 5; adjustments or changes may be made in response to feedback information received from the subject wearer; examiner interpreted the claim limitation according to applicant’s specification paragraph [0090] and Fig. 1; basically the feedback is collect and adjust the treatment according to feedback; paragraph [0090] does not disclose first and second set of measurement of wellness (feedback); the paragraph basically only discloses that one can get the feedback immediately after treatment or at a later time like 5 hours or 5 days; the paragraph also only discloses adjust base on feedback (wellness-related parameters) not on first and second set of wellness-related parameters).
Response to Arguments
Applicant’s arguments with respect to claim(s) 41-47 and 51-54 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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