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 .
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.
Current Status of 18/311,744
This Office Action is responsive to the claims of 3 May 2023.
Note that when there is more than one claim-set on file with the same date (as with the instant application), then the later filed claim-set must have claim status identifiers (i.e., “Current Amended”, “Original”, “Previously Presented”, and/or “Canceled”). Currently, none of the claim-sets of 3 May 2023 show claim status identifiers. Please see the enclosed “Notice of Non-Compliant Amendment” form. See also MPEP 714.
Examiner examined the claim-set beginning with “What is claimed is:”
Claims 1-30 have been examined on the merits. The claim status of each claim is assumed “Original” until Applicants update the status of each claim.
Priority
The effective filing date is 17 February 2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3 May 2023, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 5-9, 15-17, and 22-23 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.
Claim 5 recites the limitation "the mixture of organic or mineral acid". There is insufficient antecedent basis for this limitation in the claim.
As drafted, the limitation "the mixture of organic or mineral acid" renders the metes and bounds of claim 5 undefined (hence rendering claim 5 indefinite) since the artisan is not sure where antecedent basis for “organic or mineral acid” is first found in claim 1 (it is found in claim 4). Claim 6 is similarly rejected as indefinite since the claim refers back to rejected claim 5 but does not remedy the rationale underpinning the basis for this rejection. This rejection can be rendered moot by changing the dependency of claim 5 so it depends on claim 4.
Claim 7 contains the Markush limitation “is selected from the group comprising of”…followed by a list of alternative embodiments of acid. However, the “comprising of” language renders the metes and bounds of claim 7 undefined (hence rendering claim 7 indefinite) since it is written as an open-ended list of alternative embodiments; rather, Markush limitations are supposed to be closed-ended alternative embodiments. As written, it is unclear what other alternatives are intended to be encompassed by the claim. A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022). See MPEP 2173.05(h). Claim 8 is similarly rejected as indefinite since the claim refers back to rejected claim 7 but does not remedy the rationale underpinning the basis for this rejection.
This same issue makes claims 9 and 15-17 indefinite (for containing “comprising of” followed by a Markush list of alternative embodiments).
How to render moot these open-ended list of alternatives’ rejections: Please replace “comprising of” with -- consisting of -- in all rejected claims 7-9 and 15-17, above.
Claim 22 recites the limitation "the Mitragynine oxalate salt" of claim 1. There is insufficient antecedent basis for this limitation in the claim.
As drafted, "the Mitragynine oxalate salt" renders the metes and bounds of claim 22 undefined (hence rendering claim 22 indefinite) since the artisan does not know where antecedent basis is first found for "the Mitragynine oxalate salt" within claim 1. Examiner recommends making claim 22 depend from claim 21 to render moot this rejection as claim 21 does contain antecedent basis to "Mitragynine oxalate salt". Claim 23 is indefinite for the same rationale.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-6 and 22-23 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claim 5 contains the limitation "the mixture of organic or mineral acid" not seen in base claim 1. Therefore, dependent claim 5 fails to properly further limit claim 1 and claim 5 is hence rejected under 35 USC 112(d). Claim 6 is similarly rejected under 35 USC 112(d) since it refers back to claim 5 but does not remedy the rationale underpinning the basis for rejecting claim 5. Claim 4 contains “organic or mineral acid”. Hence, this rejection can be remedied by revising claim 5 so that it depends on claim 4.
Dependent claim 22, drawn to the limitation "the Mitragynine oxalate salt", fails to properly further limit base claim 1 since claim 1 is silent as to “oxalate salt”. Hence claim 22 is rejected under 35 USC 112(d). Claim 23 is rejected under 35 USC 112(d) for the same rationale.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 30 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
ACS (American Chemical Society. Chemical Abstract Service. RN 11047-41-9. Entered into STN: 16 November 1984).
The prior art reference ACS teaches the Mitragynine oxalate compound:
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(see enclosed ACS reference).
Furthermore, the limitation “having 72-78% HPLC purity” of the rejected claim 30 is interpreted as an inherent property/function. When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Thus, “having 72%-78% HPLC purity” is also anticipated by the ACS prior art reference. See MPEP 2112.01(I) and (II). This anticipates instant claim 30.
Conclusion
Claims 5-9, 15-17, 22-23, and 30 are not presently allowable as written.
Claims 1-4, 10-14, 18-21, and 24-29 are presently allowable as written.
There is no known prior art reference that either teaches or anticipates a process to purify Mitragynine according to the methods of independent claims 1 and 25.
The reference BOFFA (Boffa, Luisa, et al. “Alkaloid Profiles and Activity in Different Mitragyna speciosa Strains.” Natural Product Communications, Vol. 13 (9), 2018, pp. 1111-1116, referenced in IDS of 3 May 2023), discloses a process of purifying Mitragynine under magnetic stirring at room temperature in a methanol and water mixture. While BOFFA discloses that extraction steps can utilize acidic phases (“Abstract”), one could not immediately envisage the precise order of steps of the instant claims 1 and 25 methods from the BOFFA disclosure.
Moreover, the reference BOFFA is a close art but not a prior art reference since it does not teach, suggest, or anticipate the specific ingredients/reactants used in the specific order of the instant method claims 1 and 25.
Although Mitragynine is naturally occurring (per “Background” section of Specification), the instant claims 1 and 25 and their dependent claims are viewed as subject matter eligible under 35 USC 101 and not naturally occurring due to the order of the steps, and the use of ingredients such as solvents, acids, and alcohol. The order of steps and the use of these ingredients are how the claims 1-30 are “markedly different” from naturally occurring mitragynine. Thus, the claims 1-30 are not viewed as naturally occurring under Revised Step 2A Prong 1 and the analysis quickly follows Pathway B to the ultimate conclusion that claims 1-30 are patent eligible under 35 USC 101. See MPEP 2106.04(c).
The co-pending 18/311,707; 18/311,634; and 18/548,222 are each drawn to distinct subject matter therefore do not constitute a double patent reference against the instant application.
The co-pending 18/311,722 is not drawn to a process of purifying the Mitragynine salt with alcohol as is required by the instant claims 1 and 25, therefore, it is drawn to a distinct process/subject matter and not a double patent reference against the instant application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625