DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group I, claims 1-11 and 30 the reply filed on 12/10/2025 is acknowledged.
Claims 12-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025. The species election has been withdrawn.
INFORMATION DISCLOSURE STATEMENT
2. No Information Disclosure Statement has been submitted for review.
OBJECTION
3. Claim 9 is objected to because of the following informalities: Claim 9 recites undefined acronyms DMT and 5-MeO-DMT. Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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 1-11 and 30 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 1 recites (absolute value) and the parenthesis make it unclear if the limitation is part of the claim or not. It is suggested to remove the parenthesis. The dependent claims do not cure the deficiency of claim 1.
Claim Rejections - 35 USC § 102
5. 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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kuar et al. (US 2022/0151945).
Kuar et al. (US 2022/0151945) (hereinafter Kuar et al.) disclose solid lipid nanoparticles with lipid matrix comprising at least one biocompatible lipid forming a generally spherical particle containing curcumin. The particles have a coat of surfactant (para 0222). The particle sizes are 20-80 nm (abstract). The lipid matrix comprises at least two distinct biocompatible lipids which include glycerides and fatty acids (para 0027).
Claim Rejections - 35 USC § 103
6. 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.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kuar et al. (US 2022/0151945) in view of Tu et al. (US 2022/0265566).
Kuar et al. has been discussed supra in the 102 and disclose natural surfactants such as soy lecithin (paras 0078, 0079, 108, claims 10-11). Tu et al. (US 2022/0265566) disclose solid lipid nanoparticles and natural surfactants avoid bio toxicity problems and are generally recognized as safe (para 0002). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use natural surfactants in the compositions of Kuar et al. One would have been motivated to do so because it would avoid toxicity problems.
7. Claims 1, 6-7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kuar et al. (US 2022/0151945) in view of Fresu (US 20170368115).
Kuar et al. has been discussed supra and disclose curcumin and the compositions have antioxidant properties but does not disclose spirulina (algae-derived material).
Fresu (US 20170368115) (hereinafter Fresu) discloses spirulina improve the bioavailability of orally administered curcumin and preparations including spirulina containing curcumin have improved bioavailability (abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to incorporate spirulina into the compositions of Kuar et al. One would have been motivated to do so in order to improve bioavailability.
8. Claims 1, 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kuar et al. (US 2022/0151945) in view of Lpeine (US 20220409682).
Kuar et al. has been discussed supra and disclose curcumin and the compositions have antioxidant properties but does not disclose C-phycocyanin.
Lpeine (US 20220409682) (hereinafter Lepine) discloses c-phycocyanin has antioxidant activity (para 0018-1009). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include C-phytocyanin in the compositions of Kuar et al. in order to improve antioxidant properties. "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 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." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
9. Claims 1 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kuar et al. (US 2022/0151945) in view of Chadeayne (US 20190142851).
Kuar et al. has been discussed supra and disclose curcumin and the compositions have antioxidant properties but does not disclose psilocybin. Chadeayne (US 20190142851) (hereinafter Chadeayne) disclose that psilocybin has antioxidant properties (para 0348). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include psilocybin in the compositions of Kuar et al. in order to improve antioxidant properties. "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 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." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
10. Claims 1 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kuar et al. (US 2022/0151945) in view of Pautu et al. “pH-Responsive Lipid Nanocapsules: A Promising Strategy for Improved Resistant Melanoma Cell Internalization”.
Kuar et al. has been discussed supra and does not disclose pH responsive coatings. Pautu et al. disclose that pH-responsive copolymer bearing a lipophilic chain end has been used providing the lipid nanoparticles (LNC) a stealth behavior in physiological conditions and responsiveness to the acid tumor environment (conclusions). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to coat the lipid nanoparticle of Kuar et al. with pH responsive coatings. One would have been motivated to do so because it would provide stealth behavior in physiological conditions and responsiveness to tumor environments.
DOUBLE PATENTING
11. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-11 and 30 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-11 and 30 of copending Application No. 19/093,251. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
CORRESPONDENCE
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615