Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on July 22, 2026 has been entered.
Claims 1, 5-9, 12, 13 and 27-43 are pending.
Claims 2-4, 10, 11, 14-26, 44 and 45 are cancelled.
Claims 1 and 27 are currently amended.
Claims 31-42 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 5-9, 12, 13, 27-30 and 43 as filed on July 22, 2026 are pending and under consideration to the extent of the elected species, e.g., the species of oil is cannabis oil and the species of carrier particulate is silica.
Withdrawn Objections / Rejections
In view of the amendment of the claims, all previous claim rejections under 35 USC 112(a) are withdrawn.
Applicant’s arguments have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Specification
The use of terms such as VersaPro™ Gel (e.g., paragraphs [0040], [0078], [0079], [0097]), which are trade names or marks used in commerce, have been noted in this application. These terms should be accompanied by the generic terminology; furthermore these terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
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.
Response to Arguments: Specification
Applicant's statement that the specification already includes appropriate symbols is acknowledged but not found persuasive because Applicant has been repeatedly advised that the specification lacks appropriate corresponding generic terminology for all of the disclosed trademarked products. Therefore, the objection is properly maintained and made again.
Claim Objections
Claims 1 and 27 are objected to because of the following informalities:
Claim 1, first line of “placing” clause: “body , wherein” should presumably recite “body, wherein”.
Claim 27, new wherein clause: “an internal temperature” should presumably recite “the internal temperature” because there is presumably only one internal temperature.
Appropriate correction is required.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of 35 U.S.C. 112 (pre-AIA ). See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/465,690, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph for one or more claims of this application. While the prior-filed application discloses aggregates (e.g., paragraph [013]), the prior-filed application does not disclose a powder having less than 1 wt% of aggregates as newly recited in independent claim 1. The prior-filed application also does not disclose maintaining an internal temperature below a critical temperature at which ingredients evaporate, sublimate or phase separate as newly recited in independent claim 27.
The disclosure of the prior-filed application, Application No. 63/425,177, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph for one or more claims of this application. While the prior-filed application discloses aggregates (e.g., paragraph [12]), the prior-filed application does not disclose a powder having less than 1 wt% of aggregates as newly recited in independent claim 1. While the prior-filed application discloses a degradation temperature threshold of an oil or wax (e.g., paragraph [61]), the prior-filed application also does not disclose maintaining an internal temperature below a critical temperature at which ingredients evaporate, sublimate or phase separate as newly recited in independent claim 27.
The earliest date available to the pending claims is November 14, 2023.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 5-9, 12, 13, 27-30 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Nowak et al. (US 2020/0061022, published February 27, 2020, of record) in view of Danopoulos et al. (US 2019/0008723, published January 10, 2019, of record); and Karolchyk (US 2021/0196775, published July 1, 2021) or/and Vialpando et al. (US 2020/0345684, published November 5, 2020).
Nowak teaches particles comprising cannabinoids and a porous bead core; the particles are prepared by mixing (title; abstract; claims 12-16, 19, 51-53). The core is a carrier for the absorption and release of liquids (capable of oil sorption) (paragraph [0051]). The core comprises silica such as mesoporous silica (claim 15; paragraphs [0051], [0053]), as required by instant claims 5, 6. The mesoporous silica may have a particle size distribution of 120 to 170 microns and an oil absorption capacity of 3 grams oil per gram silica (selecting amounts, about 3 mL oil per gram silica assuming an oil density of about 1 g/mL, however, because oil densities are just less than 1 g/mL (e.g., oil floats on water), the absorption capacity is just greater than 3 mL oil per gram silica) and an angle of repose of 36º (Tables 1, 5), as required by instant claims 5-9, 13, 43.
The particles may further comprise a granulating liquid comprising an oil inclusive of cannabis oil (paragraph [0062]; Example 3), as required by instant claim 12. Exemplary particles prepared by loading THC and CBD (cannabinoids) onto porous silica bead cores are non-aggregated as viewed by SEM (Example 3; Figure 8). Furthermore, Nowak teaches beads to be an alternative form to agglomerates (aggregates) (paragraph [0016]).
The mixing may be by methods known in the art; examples of mixing devices may include, but are not limited to, a magnetic stirrer, shaker (bladeless), paddle mixer or/and homogenizer (placing ingredients into a container is implicit) (paragraphs [0064], [0076]). The mixing may occur until a free-flowing powder mixture is produced (selecting time) (paragraph [0076]), as required by instant claims 8, 9.
The particles may be blended with excipients and processed into a dosage form (paragraph [0077]). The dosage form may be administered to a subject for treating a health issue (claim 51; paragraphs [0078]-[0079]), as required by instant claim 29. Administration may be oral (claim 52; paragraph [0083]), as required by instant claim 28. The dosage may be sprinkled on food (claim 53; paragraph [0084]), as required by instant claim 29.
The particles are characterized by uniform loading (paragraphs [0016]-[0017]). The particles may have a particular size distribution (uniform mean size) (paragraph [0056]).
Nowak does not specifically teach the provision of a container having a body and a lid, placing ingredients in the body, closing the lid, placing the closed container in a bladeless planetary mixer, and mixing the ingredients with the bladeless planetary mixer imparting rotation and revolution as required by claims 1, 27.
Nowak does not specifically teach a powder having less than 1 wt% aggregate as required by claim 1 as currently amended.
Nowak does not specifically teach the mixing includes “selecting” parameters such that the internal temperature is maintained below a critical temperature at which an ingredient undergoes evaporation, sublimation or phase separation as required by claim 27 as currently amended.
Nowak does not teach a cosmetic product as required by claim 30.
These deficiencies are made up for in the teachings of Danopoulos, Karolchyk and Vialpando.
Danopoulos teaches a container assembly for use in a planetary mixer for use in the field of compounding (mixing) pharmaceutical compositions having improved quality (title; abstract; claims; Figures, in particular 6; paragraph [0002]). The compounding method comprises providing a container including therein a carrier and a pharmaceutical active (API) and subjecting the container to superimposed revolution and rotation movements performed using a planetary mixer; such dual action eliminates the need for mixing rods or blades (bladeless) and can dramatically reduce processing times relative to other mixing devices that use blades to mix ingredients (paragraphs [0017], [0114]-[0125], [0209], [0212]). A deficiency associated with mixing devices involving mixing blades is high shearing forces, which can generate so much heat during mixing so as to degrade the API (paragraph [0007]). Additionally or/and alternatively, many mixing devices often require mixing in device-specific mixing containers, increasing the risk of material loss (paragraph [0010]). Figure 6 shows the planetary mixing system for compounding (paragraphs [0040], [0166]-[0170]):
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comprising jar 102, lid 106 and jar holder 104. Danopoulos further teaches the container assembly is suitable for APIs which are thermally labile, meaning the API is altered or degraded when exposed to high temperatures (paragraphs [0101]-[0103]; Figures 44, 45). The superimposed revolution and rotation processing is sufficiently gentle to prevent the internal temperature from reaching or getting close to a degradation temperature threshold of the API (paragraph [0117]).
Karolchyk teaches a water-soluble, powdered cannabinoid and/or terpene extract; the cannabis may be loaded onto mesoporous silica (title; abstract; claims, in particular 1, 6; paragraphs [0027]-[0030]). Karolchyk further teaches a flowable powder free of aggregates (paragraph [0041]).
Vialpando teaches free flowing powder compositions comprising a cannabinoid adsorbed onto mesoporous silica (title; abstract; claims; Example 1). The compositions are prepared by heating the cannabinoid and mixing (claim 23; paragraphs [0107], [0109]-[0111]). Vialpando further teaches adsorption of cannabis onto mesoporous silica reduces the volatility of terpenes, thereby reducing evaporative losses (paragraph [0065]). Vialpando further teaches a food, beverage or cosmetic product comprising the free flowing powder (claims 20, 21), as required by instant claim 30.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing method of the cannabinoids / cannabis oil and the porous bead cores / mesoporous silica of Nowak to comprise the planetary mixing system as taught by Danopoulos comprising a lidded jar for placement within the jar holder within the planetary mixer because the superimposed revolution and rotation movements performed by the planetary mixer eliminates the need for mixing rods or blades which may produce undesirably high shear or/and undesirable heat and because the planetary mixer dramatically reduces processing times relative to other mixing devices that use blades to mix ingredients. In order to do so, it would have been obvious to place the cannabinoids and porous bead cores within the jar of Danopoulos, to affix the lid to the jar, to place the lidded jar into the jar holder within the planetary mixer, and to turn the mixer on. There would be a reasonable expectation of success because Nowak embraces mixing by any method known in the art.
Although Nowak exemplifies cannabinoid loaded mesoporous silica bead core to be non-aggregated when viewed by SEM and Nowak expressly teaches beads as an alternative form to agglomerates rendering obvious non-agglomerated (non-aggregated) beads, in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannabinoid loaded mesoporous silica beads produced by the process of Nowak in view of Danopoulos to be free of aggregates (0 wt%) as taught by Karolchyk. One would be motivated to do so in order to improve the uniformity of the beads for dosing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing method of Nowak in view of Danopoulos to adjust (select) the superimposed revolution and rotation motion to be sufficiently gentle as taught by Danopoulos in order to prevent the internal temperature from reaching or getting close to a degradation temperature threshold of the API / cannabinoid. One would have been motivated to do so because Vialpando teaches cannabinoids comprise volatile terpenes which are desirably adsorbed onto mesoporous silica. It would take nothing more than routine experimentation to determine appropriate planetary mixing parameters sufficient to mix / compound ingredients without volatilization (evaporation, phase separation) of the terpene component of the cannabinoid / API.
Regarding claim 30, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannabinoid loaded mesoporous silica beads produced by the process of Nowak in view of Danopoulos to take the form of a cosmetic as taught by Vialpando because cannabinoid loaded mesoporous silica is suitable for cosmetic applications.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant's arguments have been fully considered but are not persuasive.
Applicant’s statement that the Office has failed to establish prima facie obviousness is unpersuasive.
Applicant states that neither Nowak nor Danopoulos discloses a powder having less than 1 wt% aggregates as newly claimed. This is unpersuasive because Nowak is clearly in possession of such a powder as illustrated by the SEM data.
Applicant states that neither Nowak nor Danopoulos discloses an internal temperature below a critical temperature as newly claimed. This is unpersuasive because Danopoulos expressly discloses the superimposed revolution and rotation processing of the container assembly thereof is sufficiently gentle to prevent the internal temperature from reaching or getting close to a degradation temperature threshold of the API (paragraph [0117]). While cannabis oil / cannabinoids as elected is / are not known to sublimate as newly claimed, at least Vialpando (newly applied) evidences certain components of cannabis are more volatile than others.
Therefore, the rejections of record have been updated as necessitated by Applicant’s amendments.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lee et al. (US 2016/0030345) teaches a process for adsorbing an active pharmaceutical onto a substrate inclusive of mesoporous silica (title; abstract; claims).
Martani et al. (WO 96/05864 A1, as evidenced by the Google translation) teaches pharmaceutical particulates that form a non-aggregate free-flowing powder comprising a resin comprising adsorbed liposoluble liquid active substances (title; abstract; claims).
Biopharma Asia online Technical Paper, “ SYLOID® XDP silica: optimized for liquisolid and lipid-based formulations,” posted 2014 illustrates the structure of Syloid® silica beads (e.g., page 3).
Perez-Roman et al. “Development of a solid formulation containing a microemulsion of a novel Artemisia extract with nematocidal activity for oral administration,” Pharmaceutics 12:873, 2020 teaches loading of a microemulsion formulation within Syloid® XDP 3150 silica showed a free-flowing appearance without any aggregates (title; abstract; page 3, section 2.2.2, first paragraph; page 5, section 3.1, first paragraph; Figure 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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