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 .
This is the first action on the merits.
Claims 1, 2, 7, 8, 11-16, 21, 28, 30, 37-40 and 44-46 are pending and claims 1, 2, 7, 8, and 11 are under examination. Claims 12-16, 21, 28, 30, 37-40 and 44-46 are currently withdrawn based on the species election and the restriction requirement.
Election/Restrictions
Applicant's election without traverse of Group (I) in the reply filed on November 10, 2025 is acknowledged. Group (I), drawn to the compounds in claim 1, igobaine analogues, embraced by claims 1, 2, 7, 8 and 11-13 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant elects the following species:
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, and indicates claims 1, 2, 7, 8 and 11 read on said species. The elected species was not found during the search, and therefore, the search was expanded.
Specification
The abstract of the disclosure is objected to because Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
Correction is required. See MPEP § 608.01(b).
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mash et al. (Life Sciences, 1995, 57(3), PL 45-50).
The reference teaches the following species:
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, see PL-48. Thus, claims 1 is anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 2, 7 and 8 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Mash et al. (Life Sciences, 1995, 57(3), PL 45-50).
The present application claims compounds of the following general formula, wherein X1= H, R1= H or methyl, R2= OCH3, H or methyl, R3= H of methyl, R4= H or methyl, Y1= H or methyl, Y2= H or methyl, Z1= ethyl and Z2= H of methyl:
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.
The Mash reference teaches the following species, wherein X1= H, R1= H or methyl, R2= OCH3, H or methyl, R3= H of methyl, R4= H or methyl, Y1= H or methyl, Y2= H or methyl, Z1= ethyl and Z2= H of methyl:
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, which is ibogaine, wherein ibogaine and ibogaine’s N-methyl (at X1) derivative have been specifically excluded by proviso by name.
Any methylated derivative at R1, R3, R4, Y1, Y2 and/or Z2 is rendered obvious by the Mash reference since a hydrogen is considered a homologue of methyl. Since a methyl group is considered a homolog of hydrogen these compounds are considered equivalent. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Moving the methoxy on the phenyl ring of ibogaine to any of R1, R3 or R4 is also obvious based on the positional isomer rationale presented above.
The Mash reference further teaches the species presented in the 102 rejection above. Again, any methylated derivative at R1, R3, R4, Y1, Y2 and/or Z2 is rendered obvious by the Mash reference since a hydrogen is considered a homologue of methyl. Moving the hydroxy on the phenyl ring of noribogaine to any of R1, R3 or R4 is also obvious based on the positional isomer rationale presented above.
Thus, the present claims are rendered obvious over Mash et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624