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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/24/2026 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I, claims 66-74 and 76-84, and the species of claim 76(d) in the reply filed on 08/24/2026 is acknowledged. The traversal is on the ground(s) that there is no search burden. This is not found persuasive because there is no argument as to why there would be no search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 75, 77-79 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/24/2026.
Claim Objections
Claims 69-71 are objected to because of the following informalities:
Claims 69-71 are missing periods at the end of each claim.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 66-74, 76, 80 and 84 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US11970446 to Protzko (effectively filed 01 Apr 2022).
Protzko teaches mesembrine besylate salt pattern 1 and its XRPD peaks with d-spacing at Table 3.10 (Col. 43-44):
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689
624
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329
624
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The highlighted XRPD peaks and their corresponding d-spacings lie within +/- 0.2 the values of claims 66, 68-69, 72-73, 76 and 80. Note that some claimed peaks are anticipated by multiple prior art peaks; each anticipatory peak is highlighted in the interest of compact prosecution.
With respect to claim 67, Col. 18 lines 60-67 of Protzko discuss that the (-) isomer occurs naturally and that the mesembrine of the present invention may occur as the cis-isomer. Given that reference to “mesembrine” in the art is generally interpreted as referring to the naturally occurring (-) isomer, and that XRPD data matches, a PHOSITA would reasonably interpret the pattern of the prior art as that of the naturally occurring (-) isomer.
With respect to claims 70-71, Table 3.6 shows TGA/DSC values lying within those of the instant claims:
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414
677
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Note that “about” of claim 71 can be construed so that the prior art values are encompassed by the claim. Furthermore, differences in data can be attributed to experimental parameters and/or sample impurities (see for example Ethanol 0.37 wt % in Table 3.6). Additionally, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A product and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical crystal form, the physical properties such as endothermic events applicant discloses and/or claims are necessarily present. See MPEP § 2112.01.
With respect to claims 74 and 84, hydration studies were performed at Col. 38-39 indicating dissolution of the besylate salt pattern 1 in water, a pharmaceutically acceptable excipient.
Conclusion
Claims 66-74, 76, 80 and 84 are rejected.
Claims 69-71 are objected to.
Claims 75, 77-79, 81-83 and 85 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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