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 .
Applicant's election with traverse of Group I, claims 1-7, and 11-14, in the reply filed on 03/12/2026 is acknowledged. Applicants also elect rosmarinic acid as the additional active ingredient or auxiliary active substance. The traversal is on the ground(s) that Nowak (US 20210220278 A1) does not teach or suggest co-loading a mixture of the cannabinoid and polysorbate onto the porous carrier, and merely uses polysorbate as a separate excipient within the formulation. While not agreeing with Applicants’ argument, the examiner notes that Nowak (US 20210220278 A1) is no longer cited in the prior art rejection and Applicants’ arguments with respect to the reference are moot.
Nowak et al (US 20200046787 A1) is newly cited below and teaches magnesium aluminosilicate particles loaded with a mixture of Tween 80 (polyoxyethylene sorbitan monooleate), CBD, and THC, having a particle size meeting the claimed limitations. Thus, the shared technical feature is not a special technical feature and unity is broken.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/12/2026.
Claim Status
Claims 1-14 are pending.
Claims 8-10 are withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim recites “50 to 800 pm,” and it appears the claim was intended to read “50-800 µm,” which was claimed in the 03/19/2024 claim set, and where the instant specification recites “50 to 800 µm” (see pg 2 ln 23-26). Appropriate correction is required.
Claims 2 and 11 are objected to because of the following informalities: “the particle sorbent” should read “the particulate porous sorbet,” in order to be consistent with the terminology used throughout the claims. Appropriate correction is required.
Claim 11 is also objected to because of the following informalities: the claim recites “50 to 200 pm,” and it appears the claim was intended to read “50-200 µm,” which was claimed in the 03/19/2024 claim set, and where the instant specification recites “50 to 800 µm” (see pg 2 ln 23-26). 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.
Claim 5, 6, and 12-14, 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 5 recites “and plant extracts containing these substances, germakrone…”. While the examiner notes that rosmarinic acid was elected as the species of one or more additional active ingredients or auxiliary active substances, the examiner is reading the claim in its entirety for 112(b) issues for purposes of compact prosecution. It is unclear “these substances” are referring to in the claim. For example, are “these substances” the preceding substances, the substances that immediately follow, or any of them. Further, it is unclear if the plant extracts are required to have all of “these substances” or just one.
Claims 6, and 12-14, are also rejected for the same reasons for depending upon rejected claim 5.
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 (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 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.
Claims 1, 2, 7, and 11, are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Nowak et al (US 20200046787 A1, hereinafter “Nowak”), as evidenced by Millapore Sigma (Tween® 80, retrieved 2026).
Nowak discloses cannabinoid compositions comprising particles, wherein the particles comprise one or more cannabinoids, one or more surfactants, and a core, wherein the core comprises a porous bead (abs). In one embodiment, the composition comprises D9-tetrahydrocannabinol (THC) in sesame oil at 14 wt%, cannabidiol (CBD) at 1.4 wt%, Tween 80 at 53 wt% or 26.5 wt%, and Neusilin US2 beads at 33 wt% in a capsule (table 12). THC and CBD were combined in a mixture with Tween 80, the mixture was then loaded into pores of the Neusilin US2 silica beads (¶¶ 102-103). In other embodiments, tablet compositions comprising CBD, Tween 80, Neusilin US2 are disclosed, where the CBD and Tween 80 are provided as a mixture and loaded into the pores of the Neusilin US2 particles (example 7). The Neusilin US2 silica beads had a particle size distribution of 44-177 microns, and a d90 of 108 microns (table 1). As evidenced by the instant specification, Neusilin is magnesium aluminosilicate (see example 2 of the instant specification). As evidenced by Millapore Sigma, Tween 80 is polyoxyethylene sorbitan monooleate (see synonyms).
Regarding claim 1, where Nowak discloses a composition comprising Neusilin US2 (magnesium aluminosilicate) particles having particles within the size range instantly claimed, on which a mixture of cannabidiol, D9-THC, and Tween 80 (polyoxyethylene sorbitan monooleate) are applied, the limitations are met.
Regarding claim 2, the composition disclosed above comprises magnesium aluminosilicate, thereby meeting the claimed limitation.
Regarding claim 7, where embodiments comprising cannabidiol (CBD), Tween 80 (polyoxyethylene sorbitan monooleate), and Neusilin US2 (magnesium aluminosilicate) particles are formulated into a tablet, the limitation is met.
Regarding claim 11, where the composition disclosed above comprises a particle size distribution of 44-177 microns, and a d90 of 108 microns, the composition comprises particles within the claimed range, thereby meeting the claimed limitation.
Claim Rejections - 35 USC § 103
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 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Nowak et al (US 20200046787 A1, hereinafter “Nowak”).
Nowak is discussed above and further teaches the cannabinoids may be present in an amount of about 1 wt% to about 90 wt%, or about 5 wt% to about 50 wt% (¶¶ 18, 36). In embodiments, the Neusilin particles are 33 wt% of the composition (tables 8, 12). In embodiments, the amount of Tween 80 is 26.5 wt% and 53 wt% (tables 10, 12). In other embodiments, the surfactant can range from about 15 wt% to about 35 wt% (¶ 24). The composition may be in various dosage forms, for example, in capsules, tablets, etc., that may comprise a coating (¶¶ 17, 37, 55, 58, 63).
Nowak does not specifically teach a single embodiment comprising the amounts and ratios of each component of claims 3 and 4.
Regarding claim 3, table 12 of Nowak comprises 14 wt% THC in sesame oil, 1.4% CBD, 26.5 wt% Tween 80, and 33 wt% Neusilin US2, and it would have been obvious for the skilled artisan to adjust the amount of total cannabinoid within the suitable ranges taught by the reference, such as from about 1 wt% to about 90 wt%, or about 5 wt% to about 50 wt%, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Further, it would have been well within the relative skills of the skilled artisan to routinely optimize the amount of the components in order to achieve desired therapeutic activity, etc. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where 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. See MPEP 2144.05(II)(A).
Regarding claim 4, it would have been obvious for the skilled artisan to adjust the amounts of each of the magnesium aluminosilicate particles, Tween 80, and cannabinoid, within the ranges taught to be suitable by Nowak, thereby resulting in ratios overlapping the instantly claimed range. See MPEP 2144.05(I). Further, it would have been well within the relative skills of the skilled artisan to routinely optimize the ratios of each component in order to achieve desired properties, release profiles, therapeutic activity, etc. See MPEP 2144.05(II)(A).
Claims 5, 6, and 12-14, are rejected under 35 U.S.C. 103 as being unpatentable over Nowak et al (US 20200046787 A1, hereinafter “Nowak”), as applied to claims 1, 2, 7, and 11 above, and further in view of Vailpando et al (WO 2020234675 A1, hereinafter “Vailpando,” cited on IDS dated 03/19/2024), Baranauskaite et al (Colloids and Surfaces A, 2018, 539, pp. 280-290, hereinafter “Baranauskaite”), and Nadeem et al (Appl Sci, 2019, 9, 3139, pp. 1-23, hereinafter “Nadeem”).
Nowak is discussed above and further teaches the compositions can be used to treat a variety of health issues including pain, inflammation, depression, etc. (¶¶ 25, claim 29).
Nowak does not specifically teach rosmarinic acid.
Vailpando teaches cannabinoid compositions comprising a cannabinoid and surfactant mixture loaded onto porous silica particles, including Neusilin, where it was known to formulate the compositions further comprising additional pharmacologically active agents, such as poorly soluble active agents, including anti-inflammatory agents, etc. (¶¶ 13, 28, 72, 142, 144).
Vailpando does not specifically teach rosmarinic acid.
Baranauskaite teaches rosmarinic acid was known to be loaded into Neusilin US2 particles (magnesium aluminometasilicate), where it improves dissolution rate, solubility, and bioavailability of poorly soluble drugs (intro). Oregano essential oils, comprising rosmarinic acid, were known to possess antioxidative, antibacterial, antifungal, diaphoretic, carminative, antispasmodic, and analgesic activities (pg 281 1st col 2nd ¶). Disclosed are embodiments comprising 20.08 +/- 0.7% rosmarinic acid and 30.05 +/- 0.1 carvacrol (table 2). Other embodiments show oregano oil with about 15 and 20 mg/g extraction yield of rosmarinic acid (fig. 1A). Neusilin US2 could absorb triple of its own mass of these extracts (pg 285 1st col 3rd ¶).
Nadeem teaches rosmarinic acid was a known natural active ingredient that exerts powerful antimicrobial, anti-inflammatory, antioxidant, antidepressant, antiaging, antidiabetic, cardioprotective, hepatoprotective, nephroprotective, and antiallergic effects (abs, into).
Regarding claim 5, where Nowak teaches magnesium aluminosilicate particles loaded with CBD and THC, and Vailpando teaches cannabinoid loaded Neusilin particles were known to further comprise addition active ingredients, it would have been obvious to include other known actives suitable for loading into Neusilin US2 particles, such as rosmarinic acid, as taught by Baranauskaite, in order to achieve desired therapeutic activity. Further, where Nowak teaches the compositions can treat pain, inflammation, depression, etc., it would have been obvious to include other known active agents suitable for Neusilin US2 loading that were also known to have analgesic, anti-inflammatory, antioxidant, antidepressant, etc., activities, as taught by Baranauskaite and Nadeem, in order to achieve desired therapeutic properties for desired treatments.
Regarding claims 6, and 12-14, where the extracts were loaded up to three times the weight of the mass of the Neusilin particles and teaches compositions comprising oregano extract with rosmarinic acid at about 15 and 20 mg/g, as taught by Baranauskaite, the total amount by weight is calculated to be up to about 4.5 to about 6 wt% at 3x loading. Accordingly, depending on the loading and the content of rosmarinic acid, it would have been obvious to include rosmarinic acid within the ranges instantly claimed. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, it would have been well within the relative skills of the skilled artisan to determine the working range for rosmarinic acid in order to achieve desired therapeutic activity, antioxidative effects, etc. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where 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. See MPEP 2144.05(II)(A).
Claims 1-4, 7, and 11, are rejected under 35 U.S.C. 103 as being unpatentable over Nowak et al (US 20200046787 A1, hereinafter “Nowak”).
Nowak is discussed above, and purely arguendo, if somehow the particle sizes of the Neusilin particles do not anticipate the claimed range, the following also applies.
Regarding the particle sizes of claims 1 and 11, the limitations appears to be anticipated above by Nowak, however, purely arguendo, if the particle sizes somehow do not anticipate the claimed range, it would have been obvious to formulate the particles with a particle size within the claimed ranges, as taught by Nowak. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claims 2-4, and 7, the claims are rejected for the same reasons discussed above as applied to each and every claimed limitation.
Claims 5, 6, and 12-14, are rejected under 35 U.S.C. 103 as being unpatentable over Nowak et al (US 20200046787 A1, hereinafter “Nowak”), as applied to claims 1-4, 7, and 11 above, and further in view of Vailpando et al (WO 2020234675 A1, hereinafter “Vailpando,” cited on IDS dated 03/19/2024), Baranauskaite et al (Colloids and Surfaces A, 2018, 539, pp. 280-290, hereinafter “Baranauskaite”), and Nadeem et al (Appl Sci, 2019, 9, 3139, pp. 1-23, hereinafter “Nadeem”).
Nowak is discussed above but do not specifically teach rosmarinic acid.
Vailpando, Baranauskaite, and Nadeem are discussed above.
It would have been obvious to modify the composition made obvious above by further including rosmarinic acid, and in known amounts, for the same reasons discussed above by Vailpando, Baranauskaite, and Nadeem.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/
Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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