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 May 28th, 2026 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Although there is some illegible text in Shellard (Bulletin on Narcotics 1974, 26 (2), 41-55) Table 2, the same portion of text is illegible in the publication, accessible electronically at https://www.unodc.org/unodc/en/data-and-analysis/bulletin/bulletin_1974-01-01_2_page005.html, and is not critical to the analysis of the examiner.
Withdrawal of Objections and Rejections
Applicant’s arguments filed May 28th, 2026, with respect to the objection to the specification have been fully considered and are persuasive. The objection to the specification has been withdrawn. The applicant has submitted amendments to the specification to correct the misspelling of the term “Mitragyna”.
Any rejections not reiterated below are hereby withdrawn.
Pending Objections and Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, and 4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “substantially free” in claim 1 is a relative term which renders the claim indefinite. The term “substantially free” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term "substantially free" renders indefinite the amount of 7-hydroxymitragynine in the instantly claimed composition.
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 and 2 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The rejection was explained in the office actions mailed on December 13, 2024 and April 8, 2026. Applicant's arguments filed May 28th, 2026 have been fully considered but they are not persuasive.
The applicant has imported the following limitations into claim 1: 7-hydroxymitragynine was removed from the group of kratom compounds (recited in claim 1) and the dosage formulation is limited as substantially free from 7-hydroxymitragynine. However, the composition claimed in claim 1 is still a product composed of ingredients found in nature. Characteristics that would markedly differentiate the claimed product from its naturally occurring source material(s) are still not recited in claims 1 or 2. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673
(unclaimed characteristics could not contribute to eligibility; MPEP § 2106.04(c) II B.). Appropriate characteristics can be expressed as the nature-based product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis (MPEP § 2106.04(c) II B.). In the instant case of a
dosage formulation, such characteristic reasonably include the biological activity and palatability of the
composition. The dosage formulation recited in instant claims 1 and 2 does not have the markedly different characteristics necessary to distinguish it from a product of nature; therefore, the rejection of
claims 1 and 2 under 35 U.S.C. 101 is upheld.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1 and 2 remain rejected under 35 U.S.C. 103 as being unpatentable over Kariman (US
20180169172 A1).
Applicant's arguments filed May 28th, 2026 have been fully considered but they are not persuasive. The language of instant claim 1 does not clearly exclude at least trace amounts of 7-hydroxymitragynine from the claimed composition. This exclusion is unclear because the term "substantially free" is not defined by the applicant. Moreover, Kariman recites "at least a trace amount of one or more other of plurality of indole or oxindole alkaloids" (claims 1 and 13), which reads on ajmalicine and isorhynchophylline oxindole (instant claim 1). Therefore, the rejection of instant claims 1 and 2 under 35 U.S.C. 103 over Kariman is maintained.
Claim 4 remains rejected under 35 U.S.C. 103 as being unpatentable over Kariman (US
20180169172 A1).
Applicant's arguments filed May 28th, 2026 have been fully considered but they are not persuasive. The applicant recites "By virtue of its dependency on claim 1, claim 4 is therefore non-obvious over Kariman, at least because Kariman does not teach or suggest a composition substantially free from 7-hydroxymitragynine". This argument is not persuasive for the reasons stated above for maintaining the rejection of instant claim 1 under 35 U.S.C. 103 as being unpatentable over Kariman, noting that the term “substantially free” is not defined by the applicant. The applicant has also not clearly recited why one of skill in the art would include the excipients recited by both Kariman and instant claim 4 only with the inclusion of 7-hydroxymitragynine in the instantly claimed composition. Therefore, the rejection of instant claim 4 under 35 U.S.C. 103 over Kariman is maintained.
Claims 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 20120245190 A1), abbreviated "Li".
Claim 1 recites “A dosage formulation comprising: an active component consisting of two or more kratom compounds selected from the group consisting of Mitragynine, Paynantheine, Speciociliatine, Speciogynine, Ajmalicine, Ciliaphylline, Corynantheidine, Corynoxine A, Corynoxine B, Isomitraphylline, Isorhynchophylline, Mitraphylline, Rhynchophylline, Speciophylline, Speciofoline, Epicatechin, 7- Hydroxyspecioliatine, 9-Hydroxycorynantheidine, Corynoxeine, Isopteropodine, Isorhynchophylline Oxindole, Tetrahydroalstonine, Mitragynine Oxindole B, Mitragynine Oxindole A, and a salt thereof, Claim 2 recites “The dosage formulation of claim 1, further comprising a pharmaceutically acceptable excipient”. Claim 4 recites “The dosage formulation of claim 1, further comprising one or more of a pharmaceutically acceptable excipient, a binder, a stabilizer, a permeation enhancer, a solubilizer, a filler, an extender, a humectant, a disintegrating agent, a solution retarder, an absorption accelerator, a wetting agent an adsorbent, or a lubricant”.
Li recites the technical field of their invention: “The present invention relates to a composition including an autophagy inducing compound. In particular, the present invention relates to a composition including the autophagy inducing compound used to degrade abnormal protein deposit in the nervous system by inducing autophagy and related methods of treatment, such as treating neurodegenerative diseases associated with abnormal protein aggregation and/or deposition and cancer” (paragraph [0002]). Li recites “Aggregate-prone disorders are characterized by the formation of intracellular aggregates in specific tissues” (paragraph [0004]), and provides examples of aggregate prone disorders”: Parkinson’s disease (paragraph [0004]), and “Alzheimer's disease; Huntington’s disease; spinocerebellar ataxia types 1, 2, 3, 6, 7 and 17; spinobullar muscular atrophy; dentatorubral-palli-doluysian atrophy; different forms of dementia that are caused by mutations in the neuronal protein tau; forms of motor neuron disease caused by mutations in superoxide dismutase 1 (SOD1) and forms of peripheral neuropathy caused by mutations in peripheral myelin protein 22 (PMP22)” (paragraph [0005]).
Li recites the utility of isorhynchophylline for the treatment of certain disease by inducing autophagy “The first aspect of the present invention relates to a pharmaceutical composition comprising the compounds of formula (I) (also called Isorhynchophylline (IsoRhy)) and a pharmaceutically acceptable salt thereof, that is used for treatment of diseases that can benefit from degradation of cytoplasmic proteins, organelles or pathogens by inducement of autophagy” (paragraph [0014]; instant claim 1). Li further recites their invention relating to corynoxine and corynoxine B as autophagy inducers: “The present invention also relates to other tetracyclic oxindole alkaloids isolated from Uncaria species including, but not limited to corynoxine (formula II) and corynoxine B (formula III) as autophagy inducers for treating a disease that can benefit from autophagy” (paragraph [0015]; instant claim 1).
Li further recites an embodiment of their invention including an excipient, as broadly understood in the art: “In another embodiment, the composition of the present invention additionally includes a pharmaceutically acceptable carrier, excipient, buffer, stabilizer or other materials known to those skilled in the art to be suitable for administration to living organisms” (paragraph [0058]; instant claims 2 and 4).
Instant claim 1 is distinguished from Li in that Li does not explicitly recite that the active component of their composition is limited to two or more compounds selected from the group recited in instant claim 1, such as isorhynchophylline and corynoxine B. However, it would have been obvious to one of skill in the art to combine isorhynchophylline and corynoxine B as the members of an active component not necessarily comprising any other ingredients, for the purpose of inducing autophagy to treat a disease that can benefit from autophagy, such as Parkinson’s disease (instant claim 1).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients isorhynchophylline and corynoxine B for their known benefit since each is well known in the art for the same purpose, because they are individually thought to possess autophagy-inducing activities. In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). The Supreme Court thus implicitly endorsed the principle, stated in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted), that: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art” (instant claim 1).
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 Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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, Anand Desai can be reached at (571) 272-0947. 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.
/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
Prosecution Insights