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 .
Status of the Claims
Claims 1-4, 6, 8,10,12,15-17,19, 21-23, 28, 30-33 and 35 are pending and are subject to this office action. This is the first Office Action on the merits of the claims.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-4, 6, 8,10,12,15-17,19, 21-23, 28, and 30 in the reply filed on 07/01/2026 is acknowledged. The traversal is on the grounds that there is no undue burden to examine all claims in the application. This is not found persuasive because the restriction was based on unity of invention analysis and no indenpent and distinct analysis, as the application is a national stage application submitted under 35 U.S.C. 371. A lack of examination between the groups is not a requirement for unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 31-33 and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 07/01/2026.
Claim Rejections - 35 USC § 112
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 2, 12, 15, 19, 21, 22-23, and 28 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.
Claims 2, 12, 22, 23, and 28 recites the limitation "the extruded composition.” There is insufficient antecedent basis for this limitation in the claim because it is the first mention of an extruded composition. Claim 1 recites, “a method for preparing a composition” but does not recite “an extruded composition”. It is unclear if “the extruded composition” in claims 2, 12, 22, 23, and 28 is the same as the composition in claim 1 or if “the extruded composition” only refers to the portion of the composition that is extruded. For the purposes of examination, “the extruded composition” in claims 2, 12, 22, 23, and 28 will be interpreted as the composition recited in claim 1.
Regarding claim 12, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, claim 12 will be interpreted as wherein the extruded composition further comprises a water soluble material, optionally wherein the water soluble material is selected from the group consisting of: sugar alcohols; disaccharides; polysaccharides, optionally wherein the water soluble material is selected from the group consisting of: mannitol, sorbitol, xylitol, isomalt, erythritol, arabitol, ribitol, maltitol, dulcitol, iditol and lactitol guar gum, acacia gum (also known as gum arabic), xanthan gum, locust bean gum, gellan gum, alginates and sodium alginates, hydroxypropyl methylcellulose (HPMC), hydroxypropyl methylcellulose acetate succinate (HPMCAS), polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyethylene oxide (PEO), Macrogol 15 Hydroxystearate (Solutol HS 15@), and Vitamin E Polyethylene Glycol Succinate (Vit E TPGS).
Claim 12 contains the trademark/trade name Solutol HS 15®. Claim 19 contains the trademarks/trade names Tween®, Solutol HS 15®, Cremophor®, Myrj®, Span®, Brij®, and Nanoxynol ®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the water soluble component in claim 12 and the surfactant in claim 19 and, accordingly, the identification/description is indefinite. For the purposes of examination of claim 12, Solutol HS 15® will be interpreted as polyoxyethylene 15 hydroxy stearate. For the purposes of examination of claim 19, Tween® will be interpreted as any polyoxyethylene sorbitan fatty acid esters, Solutol HS 15® will be interpreted as polyoxyethylene 15 hydroxy stearate, Cremophor® will be interpreted as polyoxyethylene castor oil derivatives, Myrj® will be interpreted as polyoxyethylene stearates, Span® will be interpreted as sorbitan fatty acid esters, Brij® will be interpreted as polyoxyethylene alkyl ethers, and Nanoxynol ® will be interpreted as polyoxyethylene nonylphenol ether.
Claim 15 is also rejected by virtue of its dependence on claim 12, and Claim 21 is also rejected by virtue of its dependence on claim 19.
Regarding claim 22, the phrase "and the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). For the purposes of examination, claim 22 will be interpreted as the composition further comprises a disintegrant selected from the group consisting of: croscarmellose, sodium starch glycolate, and crospovidone, or povidone (PVP).
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 1-4, 6, 8,10,12,15-17,19, 23, 28, and 30 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Loira-Pastoriza (US 20220273585 A1).
Regarding claim 1, Loira-Pastoriza discloses a method of manufacturing a composition ([0148-0152]), the method comprising:
Mixing a natural cannabinoid (i.e. a constituent or derivative of cannabis) and a carrier to form a mixture (“a precursor composition”, [0150]), where the natural cannabinoid comprises at least one amorphous phase (“non-crystalline form”, [0063, 0152]), and
Extruding the mixture (“a precursor composition”) to form an extrudate ([0148-0151]).
Regarding claim 2, Loira-Pastoriza discloses the natural cannabinoid is soluble and/or dispersible in an aqueous medium (Fig. 1, [0153, 0186]). The Examiner is interpreting the extruded composition being soluble and/or dispersible in water as the extruded composition being at least partially soluble and/or dispersible in water and is interpreting an aqueous medium as a medium containing water. Since the cannabinoid (i.e. a constituent or derivative of cannabis) is part of the extruded composition ([0148-0152]), the extruded composition is considered to be soluble or dispersible in water.
Regarding claim 3, Loira-Pastoriza discloses the natural cannabinoid is soluble and/or dispersible in an aqueous medium (Fig. 1, [0153, 0186]). The Examiner is interpreting an aqueous medium as a medium containing water and therefore the cannabinoid (i.e. a constituent or derivative of cannabis) is considered to be soluble or dispersible in water.
Regarding claim 4, Loira-Pastoriza discloses the composition comprises a natural cannabinoid (i.e. a constituent or derivative of cannabis, [0063, 0148-0152]), where the natural cannabinoid is cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), cannabidivarin (CBDV), cannabigerovarin (CBGV), or cannabidiolic acid (CBDA, [0107]).
Regarding claim 6, Loira-Pastoriza discloses the composition comprises a natural cannabinoid ([0063, 0148-0152]), where the natural cannabinoid is in acid form such as cannabidiolic acid (CBDA, [0107]).
Regarding claim 8, Loira-Pastoriza discloses the method comprises mixing a natural cannabinoid (i.e. a constituent or derivative of cannabis) and a carrier to disperse the cannabinoid in the carrier to form a homogenous mixture (“a precursor composition”, [0015, 0150]). The Examiner is interpreting a colloid as the constituent, derivative, or extract of cannabis dispersed in another substance, and therefore the natural cannabinoid dispersed within the carrier is considered to be a colloid.
Regarding claim 10, Loira-Pastoriza discloses the cannabinoid is in powder form (i.e. a solid, [0175]) and the natural cannabinoid can include a second crystalline phase ([0063, 0152]).
Regarding claim 12, Loira-Pastoriza discloses the composition comprises a carrier comprising polysaccharides such as hydroxypropyl cellulose (HPC, “a water soluble component”, [0075, 0149-0151]).
Regarding claim 15, Loira-Pastoriza discloses the carrier comprising polysaccharides such as hydroxypropyl cellulose (HPC, “a water soluble component”, [0075, 0149-0151]) is present in an amount of amount of 5% to 90% by weight based on the total weight of the composition ([0131]). The range disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious.
Regarding claim 16, Loira-Pastoriza discloses the cannabinoid is present is present in an amount of 1% to 80% by weight based on the total weight of the composition (0129-0130]). The range disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious.
Regarding claim 17, Loira-Pastoriza discloses the carrier (part of the precursor composition) comprises hydroxypropyl cellulose (HPC), ([0149-0150]).
Regarding claim 19, Loira-Pastoriza discloses the composition comprises a surfactant including sodium ducosate ([0136, 0138]).
Regarding claim 23, Loira-Pastoriza discloses the method optionally comprises packaging the extrudate into an effervescent tablet ([0014, 0164-0165]) which reasonably suggests the composition comprises an effervescent agent. The Examiner notes that claim 23 does not require the precursor composition comprise an effervescent.
Regarding claim 28, Loira-Pastoriza discloses the method optionally comprises packaging the extrudate into pellet (“solid dosage form”, [0014, 0164-0165]) and the method comprises cutting or griding the extrudate into a powder ([0162]).
Regarding claim 30, Loira-Pastoriza discloses the method comprises cutting or griding the extrudate into a powder ([0162]).
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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Loira-Pastoriza (US 20220273585 A1) in view of Onallah Saad (US 20220218877 A1).
Regarding claim 21, Loira-Pastoriza discloses the composition comprises a surfactant including sodium ducosate ([0136, 0138]).
Loira-Pastoriza is silent to the amount of surfactant.
However, Onallah Saad, directed to a cannabinoid composition ([0002]), discloses:
A composition comprising a cannabinoid and polymer matrix, the composition comprising a surfactant in an amount of 5-10 wt% ([0013, 0016, 0036-0038]). The range disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Loira-Pastoriza by providing the surfactant in an amount of 5-10 wt% as taught by Onallah Saad because both Loira-Pastoriza and Onallah Saad are directed to cannabinoid compositions, Loira-Pastoriza disclosing including a surfactant but is silent to the amount of surfactant, Onallah Saad discloses a similar composition comprising a surfactant in an amount of 5-10 wt%, and one having ordinary skill in the art would be motivated to look to similar compositions for workable ranges of surfactant, and this involves applying surfactant in a known amount to a similar cannabinoid composition to yield predictable results.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Loira-Pastoriza (US 20220273585 A1) in view of Leone-Bay (US 20200254041 A1).
Regarding claim 22, Loira-Pastoriza discloses the extruded composition is formulated to increase the solubility of the cannabinoid in aqueous phase ([0012, 0153]).
Loira-Pastoriza is silent to the inclusion of a disintegrant.
However, Leone-Bay, directed to a cannabinoid formulation for oral delivery ([0015]), discloses:
The oral formulation can comprise a disintegrant to facilitate dissolution, the disintegrant may include sodium starch glycolate, cross-linked PVP, or croscarmellose sodium ([0218, 0222]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Loira-Pastoriza by providing a disintegrant comprising sodium starch glycolate, cross-linked PVP, or croscarmellose sodium in the composition as taught by Leone-Bay because both Loira-Pastoriza and Leone-Bay are directed to cannabinoid compositions, Leone-Bay discloses including a disintegrant to facilitate dissolution, and this involves applying a known additive to a similar cannabinoid composition to yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MORGAN FAITH DEZENDORF whose telephone number is (571)272-0155. The examiner can normally be reached M-F 8am-430pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Louie can be reached at (571) 270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.F.D./Examiner, Art Unit 1755
/ERIC YAARY/Examiner, Art Unit 1755
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