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
Applicant’s arguments, filed 8/20/2025 have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 , 4-6, 13-14, and 19-23 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. The recitation “psychedelic drug or entheogen selected from the group consisting of” renders the claim indefinite because it’s unclear if what follows “selected from the group consisting of” limits “psychedelic drug or entheogen” or only limits “entheogen.” Further, claim 1 is directed to a “preformed nano-dimensional drug delivery composition,” however, its dependent claims variously refer to claim 1 as the “composition of claim 1” (claim 2 and 22-23) or “the nano-dimensional compositional structure of claim 1” (claims 4-6, 13-14, 19). It’s unclear why the dependent claims refer to claim 1 using different language. Further, the antecedent basis of “the nano-dimensional compositional structure of claim 1” in claims 4-6, 13-14 and 19 is unclear as claim 1 does not recite a nano-dimensional compositional structure. Regarding claims 20-21, it’s unclear how one can choose between “gums” and “pectin” as pectin is a type of gum. Further regarding claim 19, the claim depends from claim 1, however, claim 1 does not comprise a medicinal mushroom extract. It’s therefore unclear how claim 19, which recites the “composition structure of claim 1 comprising… medical mushroom extract” limits the claim.
Claim Rejections - 35 USC § 102
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 21 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by ES 2401185 T3 to Moodley (document already in record). Moodley teaches a nanoemulsion self-emulsifying drug delivery system (a nano-dimensional self-emulsifying drug delivery compositional structure) (abstract) consisting of: medicinal mushroom extract (page 8, last paragraph), phospholipids (lipids) (page 8, top line 1), chitosan (a polymer) (page 3, last paragraph), cellulose (page 3, last paragraph), mucoadhesive agents (fourth line from bottom), and surfactants (page 5, second full paragraph from bottom).
Claims 1, 4-6, 13-14, 19-20, and 22-23 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 20070281965 A1 to Gant. Gant teaches nanoparticles for rectal, vaginal, buccal, lingual, sublingual, and nasal administration, including nasal inhalation (a nano-dimensional drug delivery compositional structure) (paragraphs 170, 206, and 210-211) consisting of: an entheogen (paragraph 68), phospholipids (a lipid), and polymers consisting of chitosan (paragraph 208), dextrin (paragraphs 211, 217), celluloses (paragraphs 162, 171-173, 177, 204), pectin (paragraph 175), 2-hydroxyethyl methacrylate (paragraph 206), and gum agar, gum arabic, gum karay, locust bean gum, gum tragacanth (gums), surfactants (paragraph 175), stabilizers, complexing agents, cryoprotectants, lyoprectants (chemical stabilizers) (paragraph 189) (at least two ingredients selected from the group consisting of mucoadhesive, permeation enhancers, chemical stabilizers, and surfactants). The particles are prepared by milling to form nanoparticles (paragraph 210). Comparing the art to applicant’s recitation of “self emulsifying,” applicant’s specification defines self-emulsifying at paragraph 81: “The term self-emulsifying drug delivery systems (SEDDS) in this disclosure refers to lipid-based formulations that encompass isotropic mixtures of natural or synthetic oils, solid or liquid surfactants, and co-surfactants.” Gant discloses to lipid-based formulations that encompass isotropic mixtures of natural or synthetic oils, solid or liquid surfactants, and co-surfactants (paragraphs 170, 175, 180, 188, 189, 191, 203, 206, and 209-211) and is therefore fairly a self emulsifying composition, even if the term self-emulsifying is not used in the disclosure. Regarding the intended uses and properties of the claimed nano-dimensional compositional structure recited in claims 4-6, 13, and 19, Gant, as outlined above, teaches administration of the composition by the same routes of administration as presently claimed, and further, the composition of Gant is structurally identical to the present composition. As a composition cannot be separated from its properties, the composition of Gant would possess the same properties as presently claimed. The recitations “wherein the structure is administered across nasal mucosal barriers and enters the blood stream” (claim 4), “wherein the structure is administered from the nasal cavity into the brain by bypassing the blood-brain barrier and enters the blood stream (claim 5), “wherein the structure is administered across nasal dermal and epidermal barriers and enters the blood stream (claim 6), “wherein the structure can deliver a stable, standardized, and precise amount of a psychedilic drug or etheogen, or medicinal medicine for therapy” (claim 13), and “wherein the structure is administered to the gastrointestinal tract, and self-emulsifies, and enters the blood stream” (claim 19) are intended uses of the claimed nano-dimensional composition structure. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the present case, the structure of Gant is identical to the presently claimed structure, and the structure of would therefore be fully capable of performing the intended uses recited in the claims.
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 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.
Claims 1-2,4-6,13-14, 19-20 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over US 20070281965 A1 to Gant in view of US 6350458 to Modi. The relevant portions of Gant are given above. In addition, Gant teaches that the pharmaceutical compositions may be provided in the form of micelles, said micellar dosage forms can be prepared as described in U.S. Pat. No. 6,350,458 (paragraph 182). Further, Gant teaches a particle size distribution of less than 10 microns (paragraph 210).
Modi fails to teach a mean particle size of 25-195 nm.
Modi, cited by Gant as an appropriate means of preparing the particles of Modi in micellular form, teaches particle sizes of 1 to 10 nanometers (col 3, lines 31-32). In Example 1 of Modi, 10 mg of Phospholipon-H (a lipid) and 50 units of insulin (a polymer; 50 units of insulin is the equivalent of 1.1735 mg of insulin, calculated by 50 units x 0.0347 mg/unit = 1.1735 mg) is used, giving a polymer to lipid ratio of 1.1835 mg:10 mg, or 20:2.4 polymer.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the particle size of the particles of Gant to improve delivery of the active agent to the subject. In this way, one would find the particle size of from 25 nm to 190 nm through routine experimentation. The prior art provides sufficient guidance to this end, as Modi teaches the range of less than 10 microns, which overlaps with the present range, and Modi teaches particle sizes of 1 to 10 nanometers, which would point the artisan to lower values within the range of Grant. It would have been further obvious to optimize the lipid to polymer ratio of Gant to improve delivery of the active agent to the subject. “‘[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)” MPEP § 2144.05, II.
Response to Arguments
Applicant’s arguments have been fully considered but are not found persuasive. Applicant makes no arguments except a request for the examiner’s examination. Applicant has not addressed the previous office action or provided a statement or reasoning why they believe the amendments place the claims in condition for allowance. As applicant has made no arguments, 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 PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
September 25, 2025