DETAILED ACTION
Applicant’s amendment to the claims in the Response filed on 01/23/2026 is acknowledged.
The objection to claims 4-7 is withdrawn in view of Applicant’s amendment to the claims in the Response filed on 01/23/2026. Claims 4-7 were examined on the merits as set forth below.
The rejection of record under 35 U.S.C.§ 102 is maintained and modified in view of Applicant’s amendment to the claims in the Response filed on 01/23/2026 as set forth below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson (US 2020/0030309A1, effective filing date 09/29/2017, prior art of record).
Regarding claims 1-3, Olson teaches treatment of OCD by administering an effective amount of a BOL-148 analog, wherein the subject is human. See the entire document, particularly ¶¶ 0277, 0282, 0286, 0289). Regarding claim 4, Olson teaches oral administration (¶¶ 0078, 0227, 0241).
Accordingly, Olson anticipates the claimed method.
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 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Olson.
As discussed above, claims 1-4 were anticipated by Olson. The reference does not teach the specific dosing schedules recited by claims 5 or 6. However, Olson teaches that the compounds can be administered at any suitable frequency, interval and duration, including every 5 days, in any suitable amount, which can depend on various factors including the weight and age of the subject, state of the disease, etc. (¶¶ 0243-0244). It would have been a matter of routine experimentation using standard laboratory techniques available at the time of filing to determine the optimal dosage and dosing schedule to treat a given subject with OCD according to Olson with a reasonable expectation of success to maximize therapeutic efficacy while minimizing any potential complications or side effects.
Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[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).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Olson as applied to claims 1-4 above, and further in view of Storch et al. (Current Psychiatry Reports, 11:296–301 (2009), hereinafter “Storch”).
As discussed above, claims 1-4 were anticipated by Olson. The reference does not teach that the subject is undergoing psychotherapy. However, Storch teaches psychotherapy for
OCD; in particular, Storch teaches cognitive-behavioral therapy (CBT) with exposure
and response prevention is a first-line intervention for adult and childhood obsessive-compulsive disorder (Abstract). Storch teaches that CBT has higher rates of symptom remission relative to pharmacotherapy alone as well as durability of treatment gains (Introduction).
It would have been prima facie obvious before the effective filing date of the claimed invention to have utilized psychotherapy in combination with BOL-148 in order to advantageously provide both pharmacotherapy and psychotherapy to a subject with a reasonable expectation of success to maximize symptom remission.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments filed 01/23/2025 have been fully considered but they are not persuasive. Applicant’s arguments are discussed to the extent they apply to the current grounds of rejection set forth above.
On page 3 of the Response, Applicant urges that “Olson fails to disclose treating a
subject afflicted with obsessive-compulsive disorder (OCD) as claimed, and the Examiner's
reliance on paragraph [0277] conflates a mere taxonomic classification with operative treatment
disclosure.”
As discussed above, Olson teaches methods of using non-hallucinogenic analogs of psychedelic compounds, including BOL-148, to treat psychiatric disorders, which include “obsessive-compulsive disorder.” (see ¶¶ 0277, 0286; see also ¶¶ 0275-0276). As such, Olson discloses each and every element of the claimed method.
On page 4 of the Response, Applicant urges that “Olson’s operative disclosure consistently excludes OCD. While Olson discloses methods for treating psychiatric disorders with non-hallucinogenic analogs, it consistently and explicitly limits the scope to only three conditions: depression, anxiety, and post-traumatic stress disorder.” As Applicant concedes, Olson discloses treatment of psychiatric disorders with non-hallucinogenic analogs. While, arguendo, depression, anxiety, and post-traumatic stress disorder may be considered genera of psychiatric disorders, Olson clearly discloses OCD as a specific species of psychiatric disorder. Thus, Olson goes beyond “[r]ecognition of OCD’s existence” or “a mere taxonomic classification,” but, rather, discloses OCD as a specific species of psychiatric disorder treatable by non-hallucinogenic analogs.
On pages 4-6 of the Response, Applicant further urges that the “cited passage is a taxonomic classification entirely divorced from Olson’s operative treatment method disclosures” and “provides no disclosure regarding treating OCD with BOL-148, no dosing protocols for OCD, no therapeutic endpoints for OCD treatment, and no working examples demonstrating efficacy against OCD.” Applicant further urges that “Olson's operative disclosure consistently excludes OCD” and fails to “provide enabling disclosure for treating OCD with BOL-148.”
When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005).
Moreover, there is no requirement that a prior art document meet the “how to use” requirement of 35 U.S.C. 112(a) in order to qualify as prior art. See Gleave, 560 F.3d at 1334, 90 USPQ2d at 1237-38; see also In re Schoenwald, 964 F.2d 1122, 1124, 22 USPQ2d 1671, 1673 (Fed. Cir. 1992) (holding that a claimed compound was anticipated even though the prior art reference did not disclose a use for the compound); Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1380-81, 67 USPQ2d 1664, 1670 (Fed. Cir. 2003) (pointing out that actually reducing the invention to practice is not necessary in order for a prior art reference to anticipate); Impax Labs, 468 F.3d at 1382 (stating that "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation")
Here, claim 1 is limited to a “method for treating a subject afflicted with obsessive-compulsive disorder (OCD) comprising administering to the subject a therapeutically effective amount of a BOL-148- based compound.” This method is clearly disclosed by Olson. The instant claims that recite specific dosages and dosing schedules were rendered prima facie obvious by Olson for the reasons set forth above.
Applicant’s remaining arguments were fully considered, but were not found persuasive for the reasons set forth above.
Conclusion
NO CLAIMS ARE ALLOWED
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 THOMAS J VISONE whose telephone number is (571)270-0684. The examiner can normally be reached Monday-Thursday, 8:30 AM to 6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yvonne Eyler can be reached at (571) 272-1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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