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
Response to Amendment
The amendment filed 2/09/2026 has been entered. Newly amended Claims 1-4 and 6-20 are pending in the application. Applicant’s amendments to the Claims have overcome every 35 USC 112 and 102(a)(1) rejection previously set forth in the Non-Final Office Action mailed 8/11/2025. Claims 7-20 are withdrawn. Claims 1-4 and 6 are examined on the merits herein.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
Applicant argues that Claim 1, as amended, teaches a composition comprising two ibogaine derivatives that are distinct from natural products in that particular derivatives are claimed, the compounds are of certain ratios, and the properties are different from the natural counterpart. First, the elected composition is comprised of noribogaine and ibogaine, both of which are found in nature and not synthetic derivatives. Second, the compounds being isolated from other materials with which they naturally occur is not sufficient to overcome the 35 USC 101 rejection. “The courts have identified the following concepts and products as examples of laws of nature or natural phenomena: isolated DNA, Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 USPQ2d 1972, 1978-79 (2013)” (MPEP 2106.04(b)). Therefore, 95%+ pure ibogaine derivatives, which are natural products in an isolated state, are not significantly more. Regarding mixtures of natural products like the elected composition, “See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature")” (MPEP 2106.04(b)). Third, applicant does not establish that the “properties” of the claimed composition possess markedly different characteristics from those naturally occurring products. Applicant claims a wide variety of first, second, and third derivatives in ratios that span no less than five orders of magnitude. It is not clear on the record that all such embodiments—or any—possess the markedly different characteristics necessary to distinguish the claimed compositions from their naturally occurring counterparts. “If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception” (MPEP 2106.04(c)).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (e.g., an abstract idea enumerated in the 2019 PEG, a law of nature, or a natural phenomenon) exception without significantly more. The claim(s) recite(s) a combination of a first and second ibogaine derivative (and optionally a third), ibogaine and noribogaine as elected.
To determine patentability under 35 USC 101, the Mayo test is employed:
Step 1) Does the claimed invention fall outside of one of the 4 statutory categories (process, machine, manufacture, or composition of matter)? The claims are directed to a composition of matter. We proceed to Step 2a) Prong One.
Step 2a) Prong One: Do the claim(s) recite a judicial exception (an abstract idea enumerated in the 2019 PEG, a law of nature, or a natural phenomenon)? Yes, ibogaine as well as alkaloids and other derivatives thereof are naturally occurring in iboga plants. See Spec, Page 2. Noribogaine is a naturally occurring metabolite. See Spec, Page 3. We proceed to Prong Two.
Step 2a) Prong Two: Do the claim(s) recite additional elements that integrate the exception into a practical application of the exception? No additional element is recited beyond additional ibogaine “derivatives” being present. This judicial exception is not integrated into a practical application because purification is not a practical application or distinguishing from the natural composition. See MPEP 2106.04(c)(II)(A) and MPEP 2106.04(b). “See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature")” We proceed to Step 2b.
Step 2b) Does the claim as a whole amount to significantly more than the judicial exception? I.e. Are there any additional elements (features/limitations/step) recited in the claim beyond the abstract idea? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed combination is found in plants as stated by applicant on Page 4 of the specification:
Within the context of this disclosure, the term "ibogaine derivative" means a molecule that shares a similar core structure to the compound ibogaine, for example, compounds (ibogaine derivates) such as dihydroxyibogamine, dihydrocatharanthine, coronaridine, conopharyngine, conoflorine, catharanthine, iboxygaine, iboluteine, ibogamine, ibogaline, ibogaine, epiibogamine, isovoacangine, isovoacristine, kisantin, montanin, noribogaine, tabernanthine, tubotaiwine, voacristine, voacangine, voaluteine, and voacamine have been identified in plants such as Alstonia boonei, Anacampta spp., Aspidiosperma, Callichilia barteri, Catharanthus roseus, Creoceras, Ervatamia yunnanensis, Ervatamia divaricate, Ervatamia orientalis, Ervatamia officinalis, Murraya koenigii, Peschiera echinate, Pesheria fuchsiae folia, Rejoua, Rhazya stricta, Schzozygia, Stemmadenia, Strychnos angustiflora, Tabernanthe iboga, Tabernanthe Africana, Tabernanthe australis, Tabernanthe catharinensis, Tabernaemontana corymbose, Tabernaemontana divaricate, Tabernaemontana eglandulosa, Tabernaemontana elegans, Tabernaemontana heyneana, Tabernaemontana hilariana, Tabernaemontana holstii, Tabernaemontana johnstonii, Tabernaemontana undulata, Tabernanthe pubescens, Trachelospermum jasminoides, Vinca minor, Voacanga Africana, Voacanga schweinfurthii, and Voacanga globosa.
No other elements beyond additional derivatives are present. Therefore, the combination as claimed is not distinct from those ibogaine derivatives found in nature. Although applicant does claim derivatives and broad ratios, these general limitations do not suggest that the combinations of Claims 1-4 and 6 are in fact distinct from the naturally occurring components whether isolated, combined, in an extract, in their natural state within the bark of iboga plants, or ingested by humans or other animals.
Applicant claims a wide variety of first, second, and third derivatives in ratios that span no less than five orders of magnitude (e.g., 1:100 and 100:1). It is not clear on the record that all such embodiments—or any—possess the markedly different characteristics necessary to distinguish the claimed compositions from their naturally occurring counterparts. “If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception” (MPEP 2106.04(c)).The subject matter as claim is therefore not eligible subject matter under 35 USC 101.
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 (i.e., changing from AIA to pre-AIA ) 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 § 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 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lotsof (WO2008039179).
Lotsof teaches “A composition comprising one or more of ibogaine, ibogamine, 4 tabemanthine, their nontoxic salts and/or the converted principal metabolite noribogaine in a therapeutically effective concentration” (Claim 1). More specifically, Lotsof teaches “a composition comprising one or more of ibogaine…and principal metabolite noribogaine” as elected (Page 1, Field of Invention). Doses of 0.1-25mg/kg are contemplated (Claim 6). The agents can be in a pure form (Page 6). Several derivatives of Claim 6 are unnamed and excluded from the composition (e.g., dihydroxyibogamine).
One of skill in the art seeking to form a composition as described by Lotsof would find it obvious to form a composition comprising ibogaine, noribogaine, and optionally one of the other cited derivatives in amounts as described in the amounts described because Lotsof establishes the general parameters of such a composition. Equal parts ibogaine and noribogaine for example can be deployed in a molar ratio of 1:1 to form a dose of 25mg/kg as described (12.5mg ibogaine and 12.5mg noribogaine, or 8.3mg ibogaine, 8.3 noribogaine, and 8.3 some other named derivative). Regarding broad ratios, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Conclusion
No claim is allowable.
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 extension fee 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 7:30am - 4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
Prosecution Insights