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 § 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 41-42 and 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Mishelevich (US 2012/0226091) and in view of Borsook et al. (US 2006/0253014).
Addressing claim 41, Mishelevich discloses a method of improving chronic pain in a patient in need thereof comprising:
providing therapy to the patient delivering an ultrasound signal to a neural target site comprising a sensory thalamus lateral, an internal laminar nucleus of the thalamus, an internal capsule, a periaqueductal gray, a periventricular gray, a cingulate cortex, an insula, or combinations thereof (see claims 1-3).
improving the patient’s chronic pain (see abstract and claim 1).
Mishelevich does not priming the patient’s brain for therapy to increase neural activity by exposing the patient to a painful stimulus associated with the chronic pain prior to or during delivering of the ultrasound signal. In the same field of endeavor, which is chronic pain treatment, Borsook discloses priming the patient’s brain for therapy to increase neural activity by exposing the patient to a painful stimulus associated with the chronic pain prior to or during delivering of the therapy (see abstract; [0005], [0017] and [0058]; priming the brain with painful stimuli then take MRI images to identify the target region for therapy; Mishelevich discloses ultrasound stimulation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mishelivich (US 2012/0226091) by priming the patient’s brain by subjecting patient to pain stimulus as taught by Borsook because this allows user to determine target treatment area, provide specific and effective treatment (see abstract and [0058]).
Addressing claims 42 and 48-49, Mishelevich discloses:
addressing claim 42, wherein the cingulate cortex comprises the anterior cingulate cortex (see claim 3).
addressing claim 48, wherein the neural target site is the cingulate cortex (see claim 3).
addressing claim 49, wherein the neural target site is the insula (see claim 3).
Claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Mishelevich (US 2012/0226091), in view of Borsook et al. (US 2006/0253014) and further in view of Mishelevich (US 2014/0343463).
Addressing claims 45-46, Mishelivich (US 2012/0226091) does not disclose wherein the neural target site is the internal capsule and wherein the neural target site is the periaqueductal gray. In the same field of endeavor, Mishelivich (US 2014/0343463) discloses wherein the neural target site is the internal capsule and wherein the neural target site is the periaqueductal gray (see [0064], [0076], claims 4 and 13; the target site is posterior limb of internal capsule (see claim 13); posterior limb of internal capsule is part of the internal capsule). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mishelivich (US 2012/0226091) to target internal capsule and periaqueductal gray as taught by Mishelivich (US 2014/0343463) because stimulate these regions also alleviate pain (see claims 1-4). Also see the prior art made of record and not relied upon is considered pertinent to applicant's disclosure section below regarding stimulate internal capsule to treat pain.
Claims 43-44 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Mishelevich (US 2012/0226091), in view of Borsook et al. (US 2006/0253014) and further in view of Deam (US 2007/0021803).
Addressing claim 47, Mishelevich (US 2012/0226091) does not disclose wherein the neural target site is the sensory thalamus lateral, internal laminar nucleus of the thalamus (examiner interprets as intralaminar nuclei of the thalamus) and the periventricular gray. In the same field of endeavor, Deam discloses wherein the neural target site is the sensory thalamus lateral, internal laminar nucleus of the thalamus and the periventricular gray (see [0010] and [0019]; stimulate the whole thalamus). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mishelivich (US 2012/0226091) to target the sensory thalamus lateral, internal laminar nucleus of the thalamus and the periventricular gray as taught by Deem because stimulate these regions also alleviate pain (see [0019]).
Response to Arguments
Applicant's arguments filed 06/27/26 have been fully considered but they are not persuasive. Applicant argues Borsook does not discloses priming the patient's brain to increase neural activity by exposing the patient to a painful stimulus associated with the chronic pain prior to or during delivery of the therapy. Applicant’s argument is not persuasive because Borsook discloses perform fMRI screening and gene expression studies on test subjects in the presence of a painful stimulus, following analgesic treatment, and/or in the presence of a painful stimulus and analgesic treatment (see [0058]). Presence of a painful stimulus is priming the patient's brain to increase neural activity by exposing the patient to a painful stimulus (increase neural activity is a result of exposing the patient to painful stimulus; fMRI screening enable viewer to see an increase in neural activity). Presence of a painful stimulus and analgesic treatment mean expose the patient to the painful stimulus during the delivery of treatment (deliver analgesic treatment). As examiner stated in the rejection section above the main reference disclose deliver of ultrasound treatment. By imaging the treatment process with the patient expose to painful stimulus one can determine the treatment result and improve the treatment (see [0058], these approaches provide a more complete understanding of the signal transduction mechanisms and the changes in gene expression that accompany both the painful stimuli and analgesic treatment, enabling more specific and effective analgesics to be developed). Applicant argues there is no motivation to combine the references. Applicant’s argument is not persuasive because the motivation reason to combine is provide by Borsook (enable more specific and effective treatment medicines/ methods for treating pain (see [0058])).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0193649 (see [0111]; treat pain by stimulate the internal capsule); US 2006/0004422 (see [0005]; stimulate internal capsule to treat pain); US 2003/0176785 (see [0015]; provide painful stimuli prior to treatment) and “does saphenous pain cause increased in brain neural activity”.
THIS ACTION IS MADE FINAL. 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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