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 .
Notice of New Examiner
This case has been transferred to a new examiner for continued examination. Any further communications regarding this case may be directed to the contact information included in the conclusion of this office action.
Examiner’s Comment
Draft proposed examiner’s amendments were communicated to the applicant on 8 July 2026 via a PTO-90 miscellaneous communication, however these examiner’s amendments were denied in a voice mail from Ryan Marshall on 23 July 2026. Applicant requested that an office action be sent.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
Newly submitted Claims 24-28 previously elected Claims 1, 2, and 4-9 do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Elected Claims 1, 2, and 4-9 and new Claims 24-28 lack unity of invention because even though the inventions of these groups require the technical feature of a solid micellar composition comprising micelles of one or more cannabinoid acid and a divalent metal cation, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Donsky et al. (US 2016/0279073 A1). Donsky et al. disclose micelle formulations comprising cannabinoids such as tetrahydrocannabinolic acid and cannabigerolic acid (cannabinoid acid; [0055]) and excipients or carriers such as calcium carbonate and dicalcium phosphate (divalent metal cation; [0065]) which may be in various solid dosage forms ([0064]). The technical feature of a solid micellar composition comprising micelles of one or more cannabinoid acid and a divalent metal cation was therefore known in the art prior to the effective filing date of the instant application and thus is not a special technical feature.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, Claims 24-28 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Status
Applicant’s remarks and amendments, filed 29 January 2026 in response to the non-final rejection mailed 29 July 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 29 January 2026 replaces all prior versions and listings of the claims.
Claims 1, 2, 4-19, and 24-28 are pending. Claims 10-19 and 24-28 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Claims 3 and 20-23 are canceled by Applicant’s amendment. Claims 24-28 are newly added. Claims 1, 4, 5, 7, and 8 are amended. Claims 1, 2, and 4-9 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments, on pages 6-10 of the reply filed 29 January 2026 with respect to the rejection of Claims 1-9 under 35 USC § 103 have been fully considered. The rejections of Claim 1, 2, and 4-9 are withdrawn due to amendment of Claim 1 and the rejection of Claim 3 is withdrawn due to cancellation of the claim.
Specification
The use of the terms “VESIsorb®,” “Prosolv® SMCC 90,” and “Explotab®” (e.g., at [0015] and [0069]), which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 4 is objected to because the phrase “magnesium, calcium, and strontium cations d-block and p-block metal cations” should instead read --magnesium, calcium, strontium, d-block, and p-block metal cations--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
(enablement)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, and 4-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112(a) (AIA ), or 35 U.S.C. 112, first paragraph (pre-AIA ), have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary (see MPEP 2164.01(a)).
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a solid micellar composition comprising micelles of one or more cannabinoid acid and a divalent metal cation wherein the micelles are free of added surfactant and comprise an outer hydrophilic portion and an inner hydrophobic portion. Thus, the claims imply that a cannabinoid acid (e.g., anion) with a divalent metal cation is capable of forming micelles without the presence of a surfactant.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Donsky et al. (US 2016/0279073 A1) disclose micelle formulations comprising cannabinoids such as tetrahydrocannabinolic acid and cannabigerolic acid (cannabinoid acid; [0055]) and excipients or carriers such as calcium carbonate and dicalcium phosphate (divalent metal cation; [0065]) which may be in various solid dosage forms ([0064]). A protocol for making micelles is also disclosed, wherein a cannabinoid or its analog (e.g., cannabinoid acid) and a terpene is dissolved in a water miscible organic solvent and then rapidly injected into distilled water ([0075]).
Piccariello et al. (US 2014/0274936 A1) discloses a coordination complex comprising a cannabinoid and an s-block, d-block, or p-block metal (divalent metal cation; pg. 14, Claims 7 and 10). Cannabinoid acids are not disclosed; however, the coordination complexes are formed via a covalent bond between a metal and an anionic ligand (e.g., a cannabinoid acid is an anionic cannabinoid; [0095]).
The prior art does not disclose that a cannabinoid acid and a divalent metal cation, without an added surfactant, are capable of forming a micelle and thus the art is highly unpredictable in this regard.
(5) The relative skill of those in the art:
The relative skill of those in the art is high, with respect to micelles formed with a surfactant and containing cannabinoids in general. However, making micelles without any added surfactant which contain a cannabinoid acid and a divalent metal cation remains unresolved and beyond the purview of one of skill. Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided details surrounding a method of making solid-state cannabinoid micelles comprising a cannabinoid salt with a monovalent counterion with are emulsified and then precipitated with a divalent metal cation. The solid-state micelle may also contain additional lipids, such as curcumin, within the inner hydrophobic portion (see e.g., [0085]-[0088]). The specification does not provide any working examples wherein a cannabinoid acid and a divalent metal counterion are used to make micelles in the absence of a surfactant, and necessarily excludes cannabinoid salts with a monovalent counterion, which are disclosed as acting as surfactants ([0025]).
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed above and at [0014]-[0015] of the instant specification, and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to determine how to make a micelle formulation without a surfactant comprising a cannabinoid acid and a divalent metal cation.
It is the Examiner’s position that one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation.
Claim Rejections - 35 USC § 112(a)
(written description)
Claims 1, 2, and 4-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a solid micellar composition comprising micelles of one or more cannabinoid acid and a divalent metal cation wherein the micelles are free of added surfactant and comprise an outer hydrophilic portion and an inner hydrophobic portion. Thus, the claims imply that a cannabinoid acid (e.g., anion) with a divalent metal cation is capable of forming micelles without the presence of a surfactant.
The specification, however, only discloses details surrounding a method of making solid-state cannabinoid micelles comprising a cannabinoid salt with a monovalent counterion with are emulsified and then precipitated with a divalent metal cation. The solid-state micelle may also contain additional lipids, such as curcumin, within the inner hydrophobic portion (see e.g., [0085]-[0088]). The specification does not provide any working examples wherein a cannabinoid acid and a divalent metal counterion are used to make micelles in the absence of a surfactant, and necessarily excludes cannabinoid salts with a monovalent counterion, which are disclosed as acting as surfactants ([0025]). Since cannabinoid acids in combination with divalent metal cations are not known in the art, not disclosed by the instant specification, as being able to form micelles, it is concluded that the written description requirement is not satisfied for the claimed composition.
Response to Arguments
Applicant's arguments filed 29 January 2026 have been fully considered but they are not persuasive. Applicant’s arguments with respect to Claims 1, 2, and 4-9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are currently 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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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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.
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/J.L.C./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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