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 .
Acknowledgement is made to Applicant’s response filed 04/07/2026.
Claims 1-10 and 14-27 are pending.
Claims 6, 10, and 14-27 remain withdrawn.
Claims 11-13 are newly cancelled.
Claims 1-5 and 7-9 are currently under consideration to the extent that they read upon Applicant’s elected species.
Withdrawn Rejections
The rejection of claims 11-13 under 35 U.S.C. 103 as being unpatentable over Reanmongkol et al (2007) and Zutavern (US 2,712,018) is withdrawn in view of Applicant’s cancellation of said claims.
Rejections Maintained and Made Again in view of Applicant’s Amendments
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 and 7-9 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Reanmongkol et al (2007) and Zutavern (US 2,712,018).
Reanmongkol teaches a method of extracting Mitragynine comprising leaves of Mitragynine speciosa being dried in hot air oven, powdered, and macerated with methanol for 72 hours, then filtering and evaporating under reduced pressure to obtain a syrupy mass, this mass is then remacerated with methanol twice, filtered and evaporated, wherein the composition is then made alkaline with a solution of ammonia and extracted with portions of chloroform (see entire document, for instance, page 41, right column, paragraph under “Preparation of the methanol and alkaloid extracts from the leaves of M. speciosa”). The composition is then washed with distilled water and dried over anhydrous sodium sulfate and evaporated resulting in an alkaloid extract (see entire document, for instance, page 41, right column, paragraph under “Preparation of the methanol and alkaloid extracts from the leaves of M. speciosa”).
Reanmongkol, while teaching extraction of Mitragynine from Mitragynine speciosa, does not expressly teach the use of calcium hydroxide as an alkaline component or the specific dichloromethane instantly claimed.
Zutavern teaches a process for preparing extracts comprising the use of calcium hydroxide as an extraction liquid and further useful solvents include dichloromethane (methylene chloride) (see entire document, for instance, Example 1 and column 5, lines 52-59).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to utilize calcium hydroxide and dichloromethane as solvents and extraction liquids within the composition of Reanmongkol. One would have been motivated to do so in order to ensure extraction of the components of the Mitragynine speciosa. There would be a reasonable expectation of success since Reanmongkol teaches the use of solvents and extraction liquids, wherein Zutavern teaches similar extraction methods wherein calcium hydroxide and dichloromethane are taught as useful solvents and extraction liquids.
It is noted with regard to the length of the particular steps, that one of ordinary skill would readily optimize the amount of time the composition sets between steps. One would be motivated to optimize the amount of time in order to arrive at a composition with an optimized extraction of Mitragyna speciosa. It is noted that MPEP 2144.05 states: "Generally, 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of time between steps in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of the settling period would have been obvious at the time of Applicant's invention.
It is further noted that Applicant teaches ordered process steps, wherein the prior art teaches the same elements, but does not expressly articulate the exact ordering of the steps. However, absent unexpected results, it would be obvious to optimize and reorder steps in order to arrive at an optimized extraction composition. It is noted that MPEP 2144.04(IV)(C) states that "selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results" (In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946)), and "selection of any order of mixing ingredients is prima facie obvious" (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930)).
Response to Arguments
Applicant argues in the Remarks filed 04/07/2026 that the prior art teaches additional extraction steps and components. Applicant’s arguments are not found persuasive since the instant claims are directed to a process “comprising,” wherein the instant claims are inclusive to additional steps and additional components being present.
Applicant further argues that one of ordinary skill in the art would not have been motivated to utilize the calcium hydroxide or the dichloromethane of Zutavern in the extraction method of Reanmongkol. Appicant’s argument is not found persuasive. Specifically, Reanmongkol teaches the use of solvents and extraction liquids, wherein Zutavern teaches similar extraction methods wherein calcium hydroxide and dichloromethane are taught as useful solvents and extraction liquids.
For at least these reasons, Applicant’s arguments are not found persuasive.
Conclusion
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 TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
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