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 .
Claim Status
Applicant’s remarks and amendments, filed 19 February 2026 in response to the non-final rejection mailed 20 October 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 19 February 2026 replaces all prior versions and listings of the claims.
Claim 7, 8, and 12 are pending. Claims 14, 15, 17, 33, 40, and 61-72 are canceled by Applicant’s amendment. Claims 7 and 8 remain withdrawn. Claim 12 is amended. Claim 12 is being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments, on page 8 of the reply filed 19 February 2026 with respect to the rejection of Claims 12, 61, 62, and 65-72 on the ground of nonstatutory double patenting over Claims 1, 10, 11, 13, and 14 of US Patent No. 10,555,914 B1 have been fully considered and are WITHDRAWN - The rejection as directed to Claims 61, 62, and 65-72 are withdrawn due to cancellation of the claims, and the rejection of Claim 12 is withdrawn due to the amendment of the claim to limit the solvent to propane-1,3-diol, which is not claimed or contemplated by the ‘914 patent.
Claim Objections
Claims 7 and 8 are objected to for an incomplete listing of the claims. For the manner of making amendments and the required format, see the applicable U.S. regulations, in particular 37 CFR 1.121 and 1.125. One of the requirements for effectively amending claims in a national phase application is a complete listing of all claims ever presented, including the text of all pending and withdrawn claims. The status of every claim in such listing must be indicated after its claim number by one of the following identifiers in a parenthetical expression: (Original), (Currently Amended), (Canceled), (Withdrawn), (Previously Presented), (New), and (Not Entered) (see 37 CFR 1.121(c)). Since Claims 7 and 8 are withdrawn claims, they need to be labeled as such. Appropriate correction is required.
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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.
Claims 12 is rejected under 35 U.S.C. 103 as being unpatentable over Krotov (EP 3459536 A1) in view of Bastin et al. (Org Pro Res Dev, 2000, 427-435), and Kingsley et al. (US 2019/0030170 A1).
The instant claims are as of record, drawn to a container comprising a composition comprising a solvent, a cannabinoid anion, and a cation.
Krotov teaches a composition comprising cannabidiol, tetrahydrocannabinol (THC; e.g., (6aR,10aR)-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-oxide is ionic tetrahydrocannabinol)), and pectins (pharmaceutically acceptable excipient) wherein the composition is prepared by incubating cannabis plant material in an aqueous medium (solvent; liquid phase) comprising salt (solute) under conditions to allow conversion of cannabinoid acids and cannabinoids into the respective cannabinoid salts and/or complexes thereof (e.g., broadly the combination of a cannabinoid anion and cation in solution would inherently form a salt of said cannabinoid anion), and wherein the solvent comprises water and alcohol (Krotov, Claims 1-3, page 4; as required for instant Claim 12). Alcohols that may be used include ethanol, isopropanol, or butanol (Krotov, [0011], page 3; dissolved in a solvent, as required for instant Claim 12).
The difference between the instant claims and the teachings of the primary reference, Krotov, is that although the reference teaches the compound/composition, the primary reference does not explicitly teach the salt as instantly claimed.
Bastin et al. teach various pharmaceutically acceptable salt forms, by class and example (Bastin et al., Table 1, page 428; as required for instant Claim 12), that are frequently developed to enhance aqueous solubility of drug substances, improved physical stability, taste masking, modification of pharmacokinetics, or milling/micronizing of the active ingredient to improve homogeneity (Bastin et al., page 428-429). Additionally, they are also sometimes used to decrease solubility for use in suspension formulations, for taste-masking, or extended release products (Bastin et al., page 428). Bastin et al. teach that, although the choice of salt is governed largely by the acidity or basicity of the ionisable group, safety of the counterion, drug indications, route of administration and the intended dosage form must also be considered. Toxicological and pharmacological implications of the selected salt former must be considered as well as the effects of the parent drug. Salt formers can be subdivided into a number of categories depending upon their functionality and purpose. Some of the most frequently used examples are listed in Table 1 (Bastin et al., page 428; as required for instant Claim 12).
Krotov and Bastin et al. do not teach wherein the composition is within a container or a propane-1,3,-diol solvent.
Kingsley et al. teach aqueous formulations comprising at least one cannabinoid wherein the pH ranges from 3.0 to about 9.0 and optimization of pH increases cannabinoid stability (Kingsley et al., [0063], page 6). The formulations may comprise a solubility-enhancing agent such as a solvent, solvents include, for example, ethanol, glycerin, polyethylene glycols, propylene glycol, poloxomers, and others known to those of ordinary skill in the art (see e.g., instant specification page 11, lines 28-23 and page 12, lines 1-7; Kingsley et al., [0049]; as required for instant Claim 12). Kinsley et al. also disclose a pharmaceutical kit comprising first and second pharmaceutical compositions provided in separate chambers of a container having two or more chambers (container contains second composition; Kingsley et al., [0069], page 6; as required for instant Claim 12).
It would have been obvious to a skilled artisan prior to the effective filing date of the instant application to combine the teachings of Krotov, Bastin et al., and Kingsley et al. to arrive at the instant invention. A skilled artisan would be motivated to have made any salt form, including the sodium, potassium, calcium, or magnesium forms, as Bastin et al. teaches salts forms of pharmaceuticals are routinely synthesizes in the endeavor to alter solubility, increase physical stability, alter the pharmacokinetics of the compound, taste-masking, or increase homogeneity of the active substance in a micronised particle formulation. The skilled artisan would have been motivated to make each salt form, including the sodium, potassium, calcium, or magnesium salts of tetrahydrocannabinol, for the reasons set forth above and those disclosed within the reference, including increasing the solubility of the active pharmaceutical. Additionally, a skilled artisan would be motivated to optimize pH improve cannabinoid stability (Kingsley et al., [0063], page 6) and provide a multi-chambered container which can allow for suspension of a pharmaceutical composition (Kingsley et al., [0065] and [0069], page 6) and could do so with a reasonable expectation of success. Finally, it would be obvious to a skilled artisan to try different short chain alcohol solvents known to said artisan, such as propane-1,3-diol, and a skilled artisan could therefore arrive at the instantly claimed invention.
Additionally, a skilled artisan would have a reasonable expectation for success in making the pharmaceutical salts, including the sodium, potassium, calcium, or magnesium salts of tetrahydrocannabinol, as Bastin et al. teaches salt formation of pharmaceutical compounds is a routine practice of the skilled artisan.
Furthermore, Krotov, Bastin et al., and Kingsley et al. are relied upon for the reasons discussed above. If not expressly taught by Krotov, Bastin et al., or Kingsley et al., based upon the overall beneficial teaching provided by these references with respect to salt selection (instant Claims 12, 61, and 62), cation and solvent molar concentrations and volumes (instant Claims 12, 61, 62, and 66), optimization of container size and amount of composition therein (instant Claim 12), and solvent choice (instant Claim 12) in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., selection and/or optimization of the salt form and concentration and solvent choice), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 12 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of copending Application No. 19/406,561 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘561 Claim 1 discloses a container comprising a chamber wherein the container comprises a composition in the chamber and the composition comprises anionic cannabinoid. The instant Claim 12 is encompassed by this claim, disclosing a container (broadly any container which may comprise a chamber, see e.g., instant specification, page 9, lines 12-18 and Figures 13-18) wherein the container contains a composition comprising a cannabinoid anion which may be comprised within the chamber (see e.g., page 5 descriptions of Figures 13-14). Additionally, the instant claims are recited with a degree of generality relating to the claimed device/structure (the “container” claimed) and the material worked upon thereby (the volume of materials placed therein), that the inclusion of the material or article worked upon by the structure being instantly claimed, does not impart patentability to the claims or patentably distinguish over the reference ‘561 invention as claimed (see MPEP § 2115).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 19 February 2026 have been fully considered but they are not persuasive.
Applicant argues that a “solute” is not a “salt” according to the present claims and that the teachings of Bastin et al. are therefore irrelevant. The composition comprised within the container, however, comprises a solvent, a cation, and an anion. A salt is an ionic compound formed through the chemical bonding of cations and anions, and therefore cations and anions are the components that make up salt (Hollar, 2022, entire document). A solute is something dissolved in a solvent and when a salt is dissolved in a solvent as a solute, and the combination of a cannabinoid anion and cation in solution would inherently form a salt of said cannabinoid anion, as taught by Krotov. While Krotov does not explicitly teach the specific cations and anions of the instant application, it does teach tetrahydrocannabinol (THC; e.g., (6aR,10aR)-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-oxide is ionic tetrahydrocannabinol) which is incubated in an aqueous medium (solvent; liquid phase) comprising salt (solute) under conditions to allow conversion of cannabinoid acids and cannabinoids into the respective cannabinoid salts and/or complexes thereof. Bastin et al. are therefore relied upon to teach the various cations (see e.g., Bastin et al., Table 1, page 428).
Although the primary reference does not teach propane-1,3-diol (does not anticipate), it is still obvious over the prior art because the combination of references discloses that water, ethanol, isopropanol, butanol, glycerin, polyethylene glycols, propylene glycol, poloxomers, and others known to those of ordinary skill in the art. Additionally, the instant specification (page 11, lines 28-23 and page 12, lines 1-7) indicates that the solvents water, ethanol, propylene glycol, propane-1,3-diol, or a sugar alcohol are acceptable alternatives and there is no data showing the criticality of propane-1,3-diol as the solvent for the claimed invention. One of skill in the art is a person knowledgeable in the art of cannabinoid solubilization, and would therefore know the best solvents for use with cannabinoid compounds and would also be aware that propane-1,3-diol is a short chain alcohol like the other named suitable alcohols.
Conclusion
No claims are 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.
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, 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
/AARON J KOSAR/Primary Examiner, Art Unit 1655