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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/31/2026 has been entered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-3, 5, 7-18, 20, and 21, are pending and under examination.
Information Disclosure Statement
The IDS dated 03/31/2026 has been considered.
Claim Interpretation
The examiner best understands the “lipophilic carrier” of instant claim 10 to be synonymous with the carrier oils as recited in the instant specification, where oils are lipophilic (see ¶¶ 395-399, 401, 486). Further, any carrier solvent that is lipophilic is interpreted to read on a lipophilic carrier.
Claim Objections
Claim 2 is objected to because of the following informalities: “and” should be removed following “epigallocatechin”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Kava, Matcha, Guayusa, Youpon, Hibiscus, Licorice, and Aloe Vera should be lowercase, as they appear to be common names. Appropriate correction is required.
Claim 8 is objected to because of the following informalities:
Quillaja and Licorice should be lowercase, as they appear to be common names.
The superfluous “and” should be removed in ln 5 following polysorbate 81.
Polyglycerol in line 6 should be lowercase.
Xanthan gum in ln 7 should be lowercase.
The apparent inadvertent repetition of “hydrogenated soybean phosphatidylcholine” in ln 12 should be removed.
Appropriate correction is required.
Claim 18 is objected to because of the following informalities: an inadvertent space was added following “calcium sorbate” and the comma, and should be removed. Appropriate correction is required.
Claim 21 is objected to because of the following informalities:
Niazirin should be lowercase, as the compound appears to be a common name.
The superfluous “and” should be removed following “epigallocatechin.”
Quillaja and Licorice should be lowercase, as they appear to be common names.
The superfluous “and” should be removed following polysorbate 81.
Polyglycerol should be lowercase, as it appears to be a common name.
Xanthan gum should be lowercase, as the compound appears to be a common name.
The apparent inadvertent repetition of “hydrogenated soybean phosphatidylcholine” should be removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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 1-3, 5, 7-18, 20, and 21, 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 the limitation "the aqueous suspension” in line 15. There is insufficient antecedent basis for this limitation in the claim, where there is no previous recitation of an aqueous suspension. For purposes of examination, the limitation is interpreted as the additive.
Claims 2, 3, 5, 7-18, 20, and 21, are also rejected for the same reasons for depending upon rejected claim 1.
Claims 8 and 21 recite “polyglyceryl,” and it is unclear what this component is where polyglyceryl does not appear to be a specific compound or defined class by itself. Further, where the claim uses closed language, is it not clear to the examiner what component reads on “polyglyceryl.”
Claims 8 and 21 recite the limitation “purified components of lecithin…, and cardiolipin,” and it is unclear if the all of the listed components following lecithin to cardiolipin are required to be purified, or only the lecithin, in view of the “and.” If only intending to modify lecithin, “and” should be removed.
Claim 12 recites the limitation "the aqueous suspension” in lines 5 and 7. There is insufficient antecedent basis for this limitation in the claim, where there is no previous recitation of an aqueous suspension. For purposes of examination, the limitation is interpreted as the additive.
Claim 21 recites the limitation "the aqueous suspension". There is insufficient antecedent basis for this limitation in the claim, where there is no previous recitation of an aqueous suspension. For purposes of examination, the limitation is interpreted as the additive.
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 (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 1-3, 5, 8-10, 12-18, 20, and 21, stand rejected under 35 U.S.C. 103 as being unpatentable over Faraci (US 20200037638 A1), in view of Magdassi (US 20110021592 A1), Kesarwani et al (Asian Pac. J Trop Biomed. April 2013 3(4):254-266), Santamaria-Echart et al. (Natural Food Additives, 1 September 2021: 1-17), and Chignola et al (WO 2020104970 A2).
Faraci teaches emulsifying formulations and micellar dispersions that increase the oral bioavailability, absorption, stability, etc., of active ingredients, such as cannabinoids, cannabinoid extract, etc., (i.e., hydrophobic active ingredients), or other active ingredients and a surfactant (abs, ¶ 2). The formulations can be in the form of an additive product, for example a beverage additive (¶ 151). The emulsions can be oil in water emulsions that disperse the non-polar compounds in aqueous liquids, where the dispersed phase is the oil phase and the aqueous phase is the continuous phase (¶ 145). Formulations A6 and A7 comprise tetrahydrocannabinol (THC) extract, medium chain triglycerides (MCT) and/or long chain triglycerides (LCT), Polysorbate 80 at 18 wt%, resulting in particle sizes of 332 nm and 811 nm, respectively (table 4, ¶¶ 121, 122, 143). Viscosity modifying agents can be included, such as guar gum, alginates, etc. (¶ 176). According to Faraci, particle sizes can range from about 50 nm to about 1000 nm (¶ 156). Polysorbate 80 has hydrophilic-lipophilic balance (HLB) or 15 (table 3). Other embodiments use polyethylene glycol as the carrier solvent (tables 3, 5). Cannabidiol or THC extract was solubilized in surfactant and triglyceride, or polyethylene glycol, etc., the solubilized mixture was then dispersed in water (¶ 255). The cannabinoids are derived from Cannabis sativa, Cannabis indica, or Cannabis hybrid plant commonly known as marijuana, the most notable cannabinoid being THC (¶ 4). In some embodiments, the nanoparticles have a Z-average diameter of about 200 nm (¶ 273). The composition may further comprise preservatives, including acetic acid, sorbic acid, sodium benzoate, sodium metabisulfite, etc. (¶ 186).
Faraci, while teaching viscosity modifying agents can be included, including guar gum, etc., Faraci does not teach them specifically added to the aqueous solution, a first plurality of active ingredients in the aqueous solution, nor a third plurality of active ingredients positioned at an interface of the continuous phase and the dispersed phase that causes the net charge instantly claimed.
Magdassi teaches nanoparticles formed from oil in water microemulsions that encapsulate water insoluble actives (abs), where the aqueous phase further comprises re-dispersion aids, including a polymer (¶¶ 29, 68). The polymers include carboxymethyl cellulose, hydroxypropyl methyl cellulose, gum Arabic, etc., and mixtures thereof (¶ 20).
Magdassi does not teach the aqueous solution comprising a first plurality of active ingredients, nor a third plurality of active ingredients positioned at an interface of the continuous phase and the dispersed phase that causes the net charge instantly claimed.
Kesarwani et al teaches bioenhancers of herbal origin to increase the bioavailability of drugs when formulated together with nanoparticles, etc. (abs). The bioenhancers include bile salts (5.1) gallic acid (ch 13 ¶ 21), naringin (10.3), and aloe vera (10.11).
Kesarwani et al do not teach a third plurality of active ingredients positioned at an interface of the continuous phase and the dispersed phase that causes the net charge instantly claimed.
Santamaria-Echarte et al. teaches active substances that act as emulsifiers that are positioned at the interface of the continuous phase and the dispersed phase to assure stable long-term properties (3.2 ¶ 1), reducing interfacial tension and hindering aggregation of the emulsion (3.2 ¶ 1). The active substances include lecithin and Quillaja saponin (1.1 ¶ 9).
Santamaria-Echarte et al. et al do not teach a third plurality of active ingredients positioned at an interface of the continuous phase and the dispersed phase that causes the net charge instantly claimed.
Chignola et al teaches nanoparticles for delivery of lipophilic active ingredients (¶¶ 2, 118), including cannabinoids (¶ 118), that are dispersible in water (¶ 155). In some embodiments, these particles have nanoparticles with a zeta potential of 0-100 mV (¶¶ 28, 169). Zeta potential is an index of magnitude of interaction between colloidal particles used to access the stability of colloidal systems (¶ 170). Zeta potential values higher than 20 mV are good indicators of nanoparticle stability (¶ 323).
Regarding claim 1, Faraci, Magdassi, and Kesarwani et al are considered to be analogous to the claimed invention and they are in the same field of nanoparticle encapsulation of hydrophobic active ingredients. Therefore, one of ordinary skill in the art would have been motivated to have modified Faraci to incorporate the teachings of Magdassi and Kesarwani et al. to include a polymer and an active ingredient in the aqueous phase, as matter of combining prior art elements according to known methods to yield predictable results. One would have been motivated to do so in order to aid in the solubility of the nanoparticles and the bioavailability of the hydrophobic active ingredients.
As the combination of the prior art teaches identical or substantially identical phases, nanoparticle structures, additives, and active agents as fully set in this instant rejection, the functional properties of having at least 5 times higher absorption in-vivo when located inside the one or more nanoparticles compared to when administered in an aqueous solution, appears to be inherent to the composition. See MPEP 2112.01(I).
Regarding the carrier solvent of claims 1 and 16, where embodiments comprising MCT, LCT, and polyethylene glycol, are taught by Faraci, and solubilize the hydrophobic active for dispersion into the aqueous phase, MCT, LCT, and polyethylene glycol read on a “carrier solvent” as instantly claimed.
Regarding the third active ingredient of claims 1, it would have been obvious to include a third active ingredient position at an interface of the continuous phase and the dispersed phase, such as an active substance with emulsifying properties, in order to stabilize the emulsion, reduce interfacial tension and hinder aggregation, as taught by Santamaria-Echart et al.
Regarding the charge imparted by the third active ingredient of claim 1, it would have been obvious select from active agents that impart a net charge that is 20 mV or greater, where charges greater than 20 mV were known to be indicative of good nanoparticle stability, as taught by Chignola et al. Regarding the 10 fold dilution, where charges greater than 20 mV were known to have good nanoparticle stability, it would have been obvious to select actives that impart at least 20 mV of surface charge under any dilution conditions, including 10 fold.
Regarding claims 2 and 3, it would have been obvious to include a bioenhancer to the aqueous phase, such as bile salts, gallic acid, and aloe vera, in order to increase the bioavailability of the active.
Regarding claim 5, where a third active ingredient is made obvious above in order to stabilize the nanoparticles, the limitations are met.
Regarding claims 8, polysorbate 80 is included in the embodiments taught by Faraci above, therefore the limitation is met.
Regarding claim 9, polysorbate 80 has a HLB of 15, thereby meeting the instant limitation.
Regarding claim 10, it would have been obvious to include both MCT and LCT, as taught by Faraci, thereby appearing to read on further comprising a lipophilic carrier. In the embodiments, polysorbate 80 is included at 18 wt% of the nanoparticle, therefore the wt% of the emulsifier in the further lipophilic carrier would be less than 25 wt%, as instantly claimed.
Regarding claim 12, where the combination above makes obvious the claimed composition containing nanoparticle dispersed in aqueous phase, with particle sizes that can range from about 50 nm to about 1000 nm, and with embodiments having a Z-average diameter of about 200 nm, it would have been obvious to formulate particles with a Z-average diameter of about 200 nm.
Further, the functional limitations of the Z-average diameter of the one or more nanoparticles changing less than 20% when the aqueous suspension is incubated at 40°C for four weeks and the Z-average diameter of the one or more nanoparticles changing less than 20% when the aqueous suspension is incubated at 90°C for 30 minutes, appears to be inherent to the formulation, where the formulation has the same components and structure as instantly claimed. MPEP 2112.01(I)
Regarding claim 13, it would have been obvious to include carboxymethyl cellulose, hydroxypropyl methyl cellulose, gum Arabic, and mixtures thereof, as a second polymer, as they are suitable polymers known to improve stability of nanoparticles of the dispersed phase, as taught by Magdassi.
Regarding claim 14, it appears tetrahydrocannabinol extract reads on tetrahydrocannabinol, where it appears that tetrahydrocannabinol is a cannabinoid extract, as taught by Faraci. Even if not, it would have been obvious to select from other cannabinoids as the second active agent, such as cannabidiol, which is taught to be suitable by Faraci.
Regarding claim 15, it would have been obvious to select from gum Arabic as the first polymer, in order to aid in the dispersion of the particles in the emulsion, as taught by Magdassi.
Regarding claim 17, it would have been obvious to formulate the nanoparticles with a Z-average diameter of about 200 nm, as taught by Faraci.
Regarding the functional storage limitations, where the composition comprises the same components, in the same size ranges instantly claimed, the storage properties are inherent to the composition itself. MPEP 2112.01(I).
Regarding claim 18, it would have been obvious to include preservatives including acetic acid, sorbic acid, sodium benzoate, sodium metabisulfite, etc., as taught by Faraci, in order to preserve the components of the additive and extend shelf life.
Regarding claim 20, where the composition as instantly claimed is made obvious above, it appears the functional limitation of having one or more nanoparticles changing by less than or equal to 50% upon pasteurization of the additive, is inherent to the composition itself. See MPEP 2112.01(I).
Regarding claim 21, it would have been obvious to formulate the additive of claim 21 for the same reasons discussed above as applied to each claim limitation.
Response to Arguments
Applicants have not provided any arguments with respect to the prior art rejection in the RCE response dated 03/31/2026. Accordingly, the claims stand rejected for the same reasons above and of record.
Claim 7 stands rejected under 35 U.S.C. 103 as being unpatentable over Faraci (US 20200037638 A1), in view of Magdassi (US 20110021592 A1), Kesarwani et al (Asian Pac. J Trop Biomed. April 2013 3(4):254-266), Santamaria-Echart et al. (Natural Food Additives, 1 September 2021: 1-17), and Chignola et al (WO 2020104970 A2) as applied to claims 1-3, 5, 8-10, 12-18, 20, and 21 above, and further in view of Nushtaeva (Colloids and Surfaces A: Physicochem. Eng. Aspects, 2016, 504, 449–457).
Faraci, Magdassi, Kesarwani et al, Santamaria-Echart et al, and Chingola et al (WO 2020104970 A2) are discussed above but do not teach the third active agents of claim 7.
Nushtaeva teaches it was known to use ground ginger (Zingiber officinale) to stabilize O/W emulsions (abs, 2.1).
It would have been obvious to include Zingiber officinale as the third active ingredient, in order to stabilize the emulsion made obvious above, as taught by Nushtaeva. Further, it would be expected based on the teachings of Santamaria-Echart et al that the Zingiber officinale, an emulsifier, would be positioned at the interface of the continuous phase and the dispersed phase, where emulsifiers were known to have such properties.
Regarding the imparted charge, where the inclusion of Zingiber officinale at the interface of the phases is made obvious above, which is one of the third active agents instantly claimed, it appears that a net charge of 15 mV or higher when the aqueous suspension is diluted at least up to 10 fold with an aqueous fluid, is inherent to the components of the composition comprising Zingiber officinale. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. See MPEP 2112(II). The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Here, while Nushtaeva does not measure the net charge of the emulsions stabilized by Zingiber officinale, the charge imparted by Zingiber officinale is inherent to the active ingredient itself.
Response to Arguments
Applicants have not provided any arguments with respect to the prior art rejection in the RCE response dated 03/31/2026. Accordingly, the claims stand rejected for the same reasons above and of record.
Claim 11 stands rejected under 35 U.S.C. 103 as being unpatentable over Faraci (US 20200037638 A1), in view of Magdassi (US 20110021592 A1), Kesarwani et al (Asian Pac. J Trop Biomed. April 2013 3(4):254-266), Santamaria-Echart et al. (Natural Food Additives, 1 September 2021: 1-17), and Chignola et al (WO 2020104970 A2) as applied to claims 1-3, 5, 8-10, 12-18, 20, and 21 above, and further in view of Waugh (US 20190105261 A1).
The references are discussed above but do not teach wherein the second active ingredient is selected from the group consisting of those of claim 11.
Waugh teaches it was known to formulate nanoparticles encapsulating active agents, which may be one or more of the following: mentha piperita, capsicum, salvia officinalis, etc. (¶¶ 92, 160).
It would have been obvious to modify the combination made obvious above by selecting from other known actives that are suitable for encapsulation in nanoparticles, such as mentha piperita, capsicum, and salvia officinalis, as taught by Waugh, depending on the desired therapeutic effects.
Response to Arguments
Applicants have not provided any arguments with respect to the prior art rejection in the RCE response dated 03/31/2026. Accordingly, the claims stand rejected for the same reasons above and of record.
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.
Claims 1-3, 5, 7-18, 20, and 21, stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/945,011 (reference application), hereinafter referred to as ‘011, in view of Faraci (US 20200037638 A1), Magdassi (US 20110021592 A1), Kesarwani et al (Asian Pac. J Trop Biomed. April 2013 3(4):254-266), Santamaria-Echart et al. (Natural Food Additives, 1 September 2021: 1-17), and Nushtaeva (Colloids and Surfaces A: Physicochem. Eng. Aspects, 2016, 504, 449–457). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of '011 disclose a method of stabilizing active ingredients of plant materials in an aqueous suspension, comprising encapsulating the actives in nanoparticles (claim 1). The nanoparticles comprise polymers selected from those of claim 13 (claim 13). The nanoparticles further comprise the actives of instant claim 2 (claim 15). The plant material includes kava, ginseng, etc., overlapping instant claim 3 (claim 10). The nanoparticles comprise emulsifying agents selected from Quillaja, Tween 80, etc., overlapping instant claim 8 (claim 12). The plant material is selected from Ginko biloba, etc., overlapping instant claim 11 (claim 10). The nanoparticles have a Z-average diameter of instant claims 12 and 17 (claim 1). The nanoparticles further comprise the cannabinoids of instant claim 14 (claim 11). The carrier solvent is medium chain triglycerides, overlapping instant claim 16 (claim 7). The nanoparticles have a net charge that is 15 mV or higher.
'011 is discussed above but does not teach the functional limitation of having 5 times higher absorption in-vivo when inside the nanoparticles compared to when administered in aqueous solution, the first active ingredients of claims 2 and 3 in the aqueous phase, the third active ingredients as instantly claimed, wherein the emulsifying agent is less than 25 wt% of the lipophilic carrier, nor the preservatives of claim 18.
It would have been obvious to include a third active ingredient position at an interface of the continuous phase and the dispersed phase for imparting the net charges instantly claimed, for the same reasons discussed above by Santamaria-Echart et al and Chingola.
Where the claims of recite identical or substantially identical phases, nanoparticle structures, additives, and active agents as those instantly claimed, the functional properties of having at least 5 times higher absorption in-vivo when located inside the one or more nanoparticles compared to when administered in an aqueous solution, appears to be inherent to the composition. See MPEP 2112.01(I).
Regarding claims 2 and 3, it would have been obvious to include a bioenhancer to the aqueous phase, such as bile salts, gallic acid, and aloe vera, as taught by Kesarwani for the same reasons discussed above.
Regarding claim 7, it would have been obvious to include Zingiber officinale as the third active ingredient, as taught by Nushtaeva, for the same reasons discussed above. The charge of Zingiber officinale appears to be inherent to ingredient and the components of the nanoparticles made obvious above, for the same reasons discussed above and of record.
Regarding claim 15, it would have been obvious to select from gum Arabic as the first polymer, in order to aid in the dispersion of the particles in the emulsion, as taught by Magdassi.
It would have been obvious to select from known amounts of emulsifying agents, such as 18 wt%, as taught by Faraci above and for the same reasons.
Regarding claim 18, it would have been obvious to include preservatives including acetic acid, sorbic acid, sodium benzoate, sodium metabisulfite, etc., as taught by Faraci.
It would have been obvious to formulate the nanoparticle suspensions comprising the same actives and emulsifiers instantly claimed, by selected from those disclosed by the claims of ‘011, thus arriving at the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants have not provided any arguments with respect to the double patenting rejections in the RCE response dated 03/31/2026. Accordingly, the claims stand rejected for the same reasons above and of record.
Claims 1-3, 5, 7-18, 20, and 21, stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/944,982 (reference application), hereinafter referred to as ‘982, in view of Faraci (US 20200037638 A1), Kesarwani et al (Asian Pac. J Trop Biomed. April 2013 3(4):254-266), Santamaria-Echart et al. (Natural Food Additives, 1 September 2021: 1-17), Chignola et al (WO 2020104970 A2), and Nushtaeva (Colloids and Surfaces A: Physicochem. Eng. Aspects, 2016, 504, 449–457). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of '982 disclose a method of stabilizing active ingredients in an aqueous suspension comprising nanoparticles comprising an active in a carrier solvent (claim 1). The aqueous suspension further comprises a taurocholic acid, etc., overlapping claim 2 (claim 15) The carrier solvent is medium chain triglycerides, etc., overlapping claim 16 (claim 3). The composition comprises a polymer selected from methyl cellulose, etc., overlapping claim 13 (claim 12). The nanoparticles comprise emulsifying agents overlapping claim 8 (claim 11). The nanoparticles comprise lanolin A, etc. (claim 14). The plant material is selected from kava, etc. (claim 4). The aqueous suspension further comprises the polymers of claim 15 (claim 16). The particles have a Z-average diameter of claim 12 and 17 (claim 9). The nanoparticles further comprise the cannabinoids of claim 14 (claim 10). The nanoparticles further comprise emulsifying agents selected from Quillaja, Tween 80, etc., overlapping claim 8 (claim 11).
The claims of '982 do not teach the functional limitation of having 5 times higher absorption in-vivo when inside the nanoparticles compared to when administered in aqueous solution, the actives of claim 3 in aqueous, the third active ingredients of the instant claims, wherein the emulsifying agent is less than 25 wt% of the lipophilic carrier, nor the preservatives of claim 18.
It would have been obvious to include a third active ingredient position at an interface of the continuous phase and the dispersed phase for imparting the net charges instantly claimed, for the same reasons discussed above by Santamaria-Echart et al and Chingola.
Where the claims of recite identical or substantially identical phases, nanoparticle structures, additives, and active agents as those instantly claimed, the functional properties of having at least 5 times higher absorption in-vivo when located inside the one or more nanoparticles compared to when administered in an aqueous solution, appears to be inherent to the composition. See MPEP 2112.01(I).
Regarding claim 3, it would have been obvious to include a bioenhancer to the aqueous phase, such as aloe vera, as taught by Kesarwani for the same reasons discussed above.
Regarding claim 7, it would have been obvious to include Zingiber officinale as the third active ingredient, as taught by Nushtaeva, for the same reasons discussed above. The charge of Zingiber officinale appears to be inherent to ingredient and the components of the nanoparticles made obvious above, for the same reasons discussed above and of record.
It would have been obvious to select from known amounts of emulsifying agents, such as 18 wt%, as taught by Faraci above and for the same reasons.
Regarding claim 18, it would have been obvious to include preservatives including acetic acid, sorbic acid, sodium benzoate, sodium metabisulfite, etc., as taught by Faraci.
It would have been obvious to formulate the nanoparticle suspensions comprising the same actives and emulsifiers instantly claimed, by selected from those disclosed by the claims of ‘982, thus arriving at the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants have not provided any arguments with respect to the double patenting rejections in the RCE response dated 03/31/2026. Accordingly, the claims stand rejected for the same reasons above and of record.
Claims 1-3, 5, 7-18, 20, and 21, stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/945,010 (reference application), hereinafter referred to as ‘010, in view of Faraci (US 20200037638 A1), Santamaria-Echart et al. (Natural Food Additives, 1 September 2021: 1-17), and Nushtaeva (Colloids and Surfaces A: Physicochem. Eng. Aspects, 2016, 504, 449–457). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of '010 disclose compositions comprising an aqueous suspension comprising a first plurality of active ingredients, and one or more nanoparticles, wherein the nanoparticles comprise a second plurality of active ingredients (claim 1). The nanoparticles solubilize the second active ingredient (i.e., carrier solvent) (claim 1). The Z-average diameter is the same as claim 12 (claim 1). The first polymer is selected from those of claim 15 (claim 6), and claim 13 (claim 10). The second active ingredients are selected from cannabidiol, Ginkgo biloba, etc., overlapping claims 11 and 14 (claims 2, 3). The nanoparticles further comprise emulsifying agents selected from Tween 80, etc., overlapping claim 8 (claim 5). The nanoparticles have a surface charge of 15 mV or higher and is diluted at least 10-fold, overlapping claim 6 (claims 13, 14), wherein the positive charge is generated by emulsifying agents (claim 15). The composition comprises a bioenhancer selected from lanolin A, etc. (claim 18), and taurocholic acid, etc. (claim 19), overlapping claims 2 and 3. The composition comprises a third plurality of active ingredients and a second polymer selected from alginic acid, etc., overlapping claim 15 (claims 7, 8)
The claims of '010 do not disclose the functional limitation of having 5 times higher absorption in-vivo when inside the nanoparticles compared to when administered in aqueous solution, the third active ingredients of the instant claims, the carrier solvent of claim 16, wherein the emulsifying agent is less than 25 wt% of the lipophilic carrier, nor the preservatives of claim 18.
It would have been obvious to include a third active ingredient position at an interface of the continuous phase and the dispersed phase for imparting the net charges instantly claimed, for the same reasons discussed above by Santamaria-Echart et al and Chingola.
Where the claims of recite identical or substantially identical phases, nanoparticle structures, additives, and active agents as those instantly claimed, the functional properties of having at least 5 times higher absorption in-vivo when located inside the one or more nanoparticles compared to when administered in an aqueous solution, appears to be inherent to the composition. See MPEP 2112.01(I).
Regarding claim 7, it would have been obvious to include Zingiber officinale as the third active ingredient, as taught by Nushtaeva, for the same reasons discussed above. The charge of Zingiber officinale appears to be inherent to ingredient and the components of the nanoparticles made obvious above, for the same reasons discussed above and of record.
Regarding claim 16, it would have been obvious to select from known carrier solvents used in nanoparticles, such as medium chain triglycerides, as taught by Faraci.
It would have been obvious to select from known amounts of emulsifying agents, such as 18 wt%, as taught by Faraci above and for the same reasons.
Regarding claim 18, it would have been obvious to include preservatives including acetic acid, sorbic acid, sodium benzoate, sodium metabisulfite, etc., as taught by Faraci.
It would have been obvious to formulate the nanoparticle suspensions comprising the same actives and emulsifiers instantly claimed, by selected from those disclosed by the claims of ‘010, thus arriving at the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants have not provided any arguments with respect to the double patenting rejections in the RCE response dated 03/31/2026. Accordingly, the claims stand rejected for the same reasons above and of record.
Claims 1-3, 5, 7-18, 20, and 21, stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/945,012 (reference application), hereinafter referred to as ‘012, in view of Faraci (US 20200037638 A1), Magdassi (US 20110021592 A1), Kesarwani et al (Asian Pac. J Trop Biomed. April 2013 3(4):254-266), Chignola et al (WO 2020104970 A2), Santamaria-Echart et al. (Natural Food Additives, 1 September 2021: 1-17) and Nushtaeva (Colloids and Surfaces A: Physicochem. Eng. Aspects, 2016, 504, 449–457). Although the claims are not identical they are not patentably distinct because the claims of ‘012 disclose a method of stabilizing active ingredients of plant materials in aqueous suspension, comprising encapsulating one or more active ingredients in nanoparticles, and dispersing the nanoparticles in an aqueous solution (claim 1). The carrier solvent is medium chain triglycerides, overlapping instant claim 16 (claim 15). The plant material is selected from Ginko biloba, ginger root, etc., overlapping instant claim 11 (claim 7). The nanoparticles further comprise cannabinoids selected from cannabidiol, tetrahydrocannabinol, etc., overlapping instant claim 14 (claim 17). The nanoparticles further comprise emulsifying agents selected from Quillaja, tween 80, etc., overlapping instant claim 8 (claim 18). The suspension comprises a second plurality of active ingredients in the aqueous suspension (claim 19). The nanoparticles have a Z-average diameter of instant claim 12 (claim 16).
The claims of ‘012 do not disclose a first polymer, the functional limitation of having 5 times higher absorption in-vivo when inside the nanoparticles compared to when administered in aqueous solution, the actives of claims 2 and 3, a third active agent positioned at the interface of the phases of the instant claims, a second polymer of claim 13, the emulsifying agent is less than 25% by weight of the lipophilic carrier, nor the preservatives of claim 18.
It would have been obvious to include gum Arabic, etc., as a first polymer, for the same reasons discussed above by Magdassi.
It would have been obvious to include a third active ingredient position at an interface of the continuous phase and the dispersed phase for imparting the net charges instantly claimed, for the same reasons discussed above by Santamaria-Echart et al and Chingola.
Where the claims of recite identical or substantially identical phases, nanoparticle structures, additives, and active agents as those instantly claimed, the functional properties of having at least 5 times higher absorption in-vivo when located inside the one or more nanoparticles compared to when administered in an aqueous solution, appears to be inherent to the composition. See MPEP 2112.01(I).
Regarding claims 2 and 3, it would have been obvious to include a bioenhancer to the aqueous phase, such as bile salts, gallic acid, and aloe vera, in order to increase the bioavailability of the active, as taught by Kesarwani, and where ‘012 discloses that an active can be included in the aqueous phase.
Regarding claim 7, it would have been obvious to include Zingiber officinale as the third active ingredient, as taught by Nushtaeva, for the same reasons discussed above. The charge of Zingiber officinale appears to be inherent to ingredient and the components of the nanoparticles made obvious above, for the same reasons discussed above and of record.
Regarding claim 6, it would have been obvious to modify the net charge to be 15 mV or greater, where charges greater than 20 mV are suitable for stable emulsions, as taught by Chignola et al, and for the same reasons discussed above.
Regarding claim 13, it would have been obvious to include carboxymethyl cellulose, hydroxypropyl methyl cellulose, gum Arabic, and mixtures thereof, as a second polymer, as taught by Magdassi for the same reasons discussed above.
It would have been obvious to select from known amounts of emulsifying agents, such as 18 wt%, as taught by Faraci above and for the same reasons.
Regarding claim 18, it would have been obvious to include preservatives including acetic acid, sorbic acid, sodium benzoate, sodium metabisulfite, etc., as taught by Faraci.
It would have been obvious to formulate the nanoparticle suspensions comprising the same actives and emulsifiers instantly claimed, by selected from those disclosed by the claims of ‘012, thus arriving at the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants have not provided any arguments with respect to the double patenting rejections in the RCE response dated 03/31/2026. Accordingly, the claims stand rejected for the same reasons above and of record.
Claims 1-3, 5, 7-18, 20, and 21, stand rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,964,049 B2, hereinafter referred to as ‘049, in view of in view of Faraci (US 20200037638 A1), Kesarwani et al (Asian Pac. J Trop Biomed. April 2013 3(4):254-266), Santamaria-Echart et al. (Natural Food Additives, 1 September 2021: 1-17), Chignola et al (WO 2020104970 A2), and Nushtaeva (Colloids and Surfaces A: Physicochem. Eng. Aspects, 2016, 504, 449–457). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘049 disclose a composition comprising an aqueous solution and a dispersed phase comprising nanoparticles comprising: first active ingredients selected from Ginko biloba, ginger root, lavender, etc., overlapping the actives of instant claims 7 and 11 (claim 1); a lipophilic carrier selected from medium chain triglycerides, long chain triglycerides, etc., overlapping instant claim 16 (claim 1); emulsifying agents selected from Quillaja, tween 80, etc., overlapping instant claim 8 (claim 1). Each particle comprises a second active agent selected from cannabidiol, tetrahydrocannabinol, etc., overlapping instant claim 14 (claim 2). The aqueous solution further comprises a first polymer from those of instant claim 15 (claim 4), a second polymer selected from those of instant claim 13 (claim 5). The composition further comprises gallic acid, etc., overlapping instant claim 2 (claim 9). The particles have a net negative charge that is -15 mV or lower (claim 11). The particles have a Z-average diameter that is the same as instant claim 12 (claim 13).
The claims of ‘049 do not disclose the functional limitation of having 5 times higher absorption in-vivo when inside the nanoparticles compared to when administered in aqueous solution, the actives of claim 3, a third active agent positioned at the interface of the phases of the instant claims, the emulsifying agent is less than 25% by weight of the lipophilic carrier, nor the preservatives of claim 18.
It would have been obvious to include a third active ingredient position at an interface of the continuous phase and the dispersed phase for imparting the net charges instantly claimed, for the same reasons discussed above by Santamaria-Echart et al and Chingola.
Where the claims of recite identical or substantially identical phases, nanoparticle structures, additives, and active agents as those instantly claimed, the functional properties of having at least 5 times higher absorption in-vivo when located inside the one or more nanoparticles compared to when administered in an aqueous solution, appears to be inherent to the composition. See MPEP 2112.01(I).
Regarding the actives of claim 3, it would have been obvious to include aloe vera, as taught by Kesarwani, for the same reasons discussed above.
Regarding claim 6, it would have been obvious to modify the net charge to be 15 mV or greater, where charges greater than 20 mV are suitable for stable emulsions, as taught by Chignola et al, and for the same reasons discussed above.
Regarding claim 7, it would have been obvious to include Zingiber officinale as the third active ingredient, as taught by Nushtaeva, for the same reasons discussed above. The charge of Zingiber officinale appears to be inherent to ingredient and the components of the nanoparticles made obvious above, for the same reasons discussed above and of record.
It would have been obvious to select from known amounts of emulsifying agents, such as 18 wt%, as taught by Faraci above and for the same reasons.
Regarding claim 18, it would have been obvious to include preservatives including acetic acid, sorbic acid, sodium benzoate, sodium metabisulfite, etc., as taught by Faraci.
It would have been obvious to formulate the nanoparticle suspensions comprising the same actives and emulsifiers instantly claimed, by selected from those disclosed by the claims of ‘049, thus arriving at the instantly claimed invention.
Response to Arguments
Applicants have not provided any arguments with respect to the double patenting rejections in the RCE response dated 03/31/2026. Accordingly, the claims stand rejected for the same reasons above and of record.
Double Patenting - Withdrawn
The nonstatutory double patenting over copending application no. 17/945,035 is withdrawn, as the copending application has been abandoned.
Conclusion
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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