DETAILED ACTION
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 .
Applicant’s amendments filed 12/30/2025 have been entered.
Claims 24-44 are pending. Claims 43-44 have been added in the amendments filed 12/30/2025.
The outstanding rejection under 35 USC 112 is withdrawn in view of the amendments filed 12/30/2025.
Election/Restrictions
Newly submitted claims 43-44 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The social behavioral condition being treated was presented as anxiety. The newly added claims are directed to the treatment of autism spectrum disorders and social phobia. These conditions are patentably distinct from anxiety. They involve in different medical treatments, symptoms, and diagnostic criteria. Searching all of the disorders recited in the claims would impose undue burden to the examiner.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 43-44 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 24-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weston et al., Depression Anxiety, 2020;37:1261-1279 (from IDS filed 1/6/2026), Gasser et al., Journal of Psychopharmacology 2015, Vol. 29(1) 57–68 in view of Polito et al., PLoS ONE (2019) 14(2): e0211023 and Anderson et al., Harm Reduction Journal, 2019;16:43 (from IDS filed 8/19/2024).
Weston et al. teaches the use of LSD, in various dosages (50-350µg) for treating anxiety (see page 1265, Table 1).
Gasser et al. teaches the administration of 200 µg of LSD improves anxiety of life-threatening illness (see page 64, col. 2, Discussion Section; also page 58, Materials and methods Section).
Gasser et al. does not expressly teach the herein claimed dosage or the dosing regimen of LSD.
Polito et al. teaches “People follow a variety of different schedules when microdosing, sometimes taking a dose each day but much more frequently interspersing dosing days with rest days. One common schedule is to microdose every three days. The idea behind this regimen is that there may be a residual effect from each microdose that lasts one to two days afterwards. Most popular press stories on microdosing have mentioned this three day cycle.” (see 2/26, third paragraph).
Anderson et al. teaches the benefits of using microdosing of psychedelic such as LSD include reduced anxiety, improved mood, and social benefits (see page 4 of 10, Fig. 1; page 7 of 10, col. 1, second paragraph to col. 2, first paragraph).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed dosing regimen in the method of treating neuropsychiatric condition such as anxiety.
One of ordinary skill in the art would have been motivated to employ the herein claimed dosing regimen in the method of treating neuropsychiatric condition such as anxiety. It is well-known in the art for patient to take a dose of LSD and then wait a few days and then take a second dose. The reason for such dosing regimen is well-known that there may be a residual effect from each microdose that lasts one to two days afterwards. Therefore, employing the dosing regimen would be reasonably expected to be effective in treating anxiety.
Furthermore, the optimization of result effect parameters (e.g., dosage range) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As anyone of ordinary skill in the art will appreciate, preferred dosages are merely exemplary and serve as useful guideposts for the physician. There are, however, many reasons for varying dosages, including by orders of magnitude; for instance, an extremely heavy patient or one having an unusually severe infection would require a correspondingly higher dosage; or in the case of patients having renal or hepatic impairment, the required dosage would be much lower. For these and other self-evident reasons and since the cited prior art teaches a range of dosage encompassing that of recited in the claims, prima facie obviousness exists.
Response to Arguments
Applicant’s arguments with respect to claim(s) 24-42 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAN MING R HUI/ Primary Examiner, Art Unit 1627
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