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 1-3, 5-8, 11, 13, 16 in the reply filed on 19 August 2025 is acknowledged. The traversal is on the ground(s) that “a special technical feature is common to all of the Groups, as will be established during prosecution. Once the elected claims are found allowable, the unity of invention requirement will have to be reevaluated and withdrawn”. This is not found persuasive because as stated in the Restriction Requirement filed 19 May 2025, the different inventions lack unity of invention because even though the inventions of
these groups require the technical feature of a protein-bound cannabinoid formulation, method of obtaining a protein-bound cannabinoid formulation and method of treatment whereby the cannabinoid formulation is comprised of a homogeneously dispersed protein-bound cannabinoid and a holding medium, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Chancey (US 2020/0254104 A1), who discloses a cannabinoid composition comprising a cannabinoid bound to a peptide to form a cannabinoid-peptide complex, the peptide comprising at least one amino acid, wherein the w/w (mg:g) ratio of cannabinoid to peptide is about 1:1; 1:<10; 10:>1. The peptide comprises various proteins (whey-, egg- and oat-protein isolates, hemp protein and Brown rice protein isolate). The cannabinoid-containing formulation provides for increased solubility and bioavailability. See, page 1 [0005] – page 2 [0008]; Claims 1-2 (page 9). Therefore, the different inventions lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 21-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 19 May 2025.
Claims 1-3, 5-8, 11, 13, 16, 21-30 are pending in this action. Claims 4, 9, 10, 12, 14-15 and 17-20 are cancelled. Claims 21-30 are withdrawn based on non-elected invention. Claims 1-3, 5-8, 11, 13 and 16 have been examined on the merits. Claims 1-3, 5-8, 11, 13 and 16 are rejected.
Claim Rejections - 35 USC § 102
5. 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.
6. 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.
7. Claim(s) 1-3, 5-8, 11, 13 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0254104 A1 (Chancey).
8. Regarding claims 1-3, 5-8, 11, 13 and 16, Chancey discloses a cannabinoid composition comprising a cannabinoid bound to a peptide to form a cannabinoid-peptide complex, the peptide comprising at least one amino acid, wherein the w/w (mg:g) ratio of cannabinoid to peptide is about 1:1; 1:<10; 10:>1; 25:1; 1:25, 50:1 or 1:50; 10:1, 20:1; >50:1; <50:1; 100:1; <100:1, 200:1; <200:1. This reads on the weight ratios of instant claims 1-2. Also disclosed are methods of preparing a cannabinoid complex comprising obtaining a cannabinoid, obtaining a peptide and mixing the cannabinoid and peptide in a solvent. The complexing agents are conjugated to a therapeutically effective amount of one or more cannabinoids wherein the complexing agents are selected from proteins, peptides, amino acids, polysaccharides, disaccharides, monosaccharides, glycol-proteins, etc. disposed in a pharmaceutically acceptable excipient, diluent or carrier (excipient/diluent/carrier reads on the generic “holding medium” as claimed). The cannabinoid-containing formulation provides for increased solubility and bioavailability. See, Abstract, page 1 [0005] – page 2 [0010]; Claims 1-3 (page 9).
9. In some instances, it is possible to combine two cannabinoids with a conjugate material, e.g., Cannabidiol (CBD) and cannabidiolic acid (CBDA) can be mixed and conjugated with a protein, page 2, [0014-15], page 4 [0027]. This reads on claim 13. Examples of oligo- and polypeptides and full-length proteins used in the complexes include any one of the caseins: human serum albumin (HSA), bovine serum albumin (BSA), beta-lactoglobulin; alpha-lactalbumin, human serum immunoglobulin (Ig); page 4 [0029]. This disclosure reads on the proteins recited in instant claims 6-8 and 11. Further peptides comprise whey protein isolate, egg protein isolate, oat protein isolate, hemp protein and Brown rice protein isolate, page 4, [0030-0032]; claim 8. This reads on the generic “protein” recited in instant claim 1-3 and 5.
10. The dose range of the cannabinoid complexed with a protein administered to a patient is from about 0.05 to 100 mg/kg of the patient’s body weight, page 6, [0042].
11. As noted above, Chancey discloses a cannabinoid composition comprising a cannabinoid bound to a peptide, wherein the ratio of cannabinoid to peptide is about 1:1; 1:<10; 10:>1; 25:1; 1:25, 50:1 or 1:50; 10:1, 20:1; >50:1; <50:1; 100:1; <100:1, 200:1; <200:1 (see claims 1-3, page 9). This teaching reads on the weight ratios of instant claims 1-2 as these values anticipate with sufficient specificity those instantly claimed (of at least 10mg cannabinoid to 50mg protein, 10:50).
Instant claim 3 recites “particles having a mean particle size of up to 10µm” and instant claim 5 recites “at least 90% of the particles have a particle size of less than 20µm” which is met by Chancey. The “up to 10µm” and “less than 20µm” includes particle size values of zero. The particles disclosed by Chancey will inherently have particle sizes greater than zero, including mean particle sizes of greater than zero. Therefore, Chancey anticipates these values with sufficient specificity. As delineated above, the complexing agents are conjugated to a therapeutically effective amount of one or more cannabinoids; page 1, [0006-0007]. This reads on claim 16 of the formulation being free of unbound cannabinoid. The examples on pages 7-9 further demonstrate how the cannabinoid/cannabidiol-protein complex formulations are prepared and used. In sum, the instant invention is clearly anticipated based on the teachings of Chancey, as discussed above.
12 Claim(s) 1-3, 5-8, 11, 13 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/167795 A1 (Cohen et al. hereinafter “Cohen”).
13. Regarding claims 1-3, 5-8, 11, 13 and 16, Cohen discloses at least one protein-bound cannabinoid bound to a plasma protein for use as a medicament for treatment of a condition, wherein a total cannabinoid dose of the at least one protein-bound cannabinoid, administered over a time period comprising multiple administrations, is lower relative to a total cannabinoid dose of the at least one protein-bound cannabinoid when administered in unbound form for achieving a same degree of therapeutic effect for treating the condition (see Abstract).
14. Compositions comprising cannabinoids bound to a plasma protein prolongs the therapeutic effect of cannabinoids when compared to administration of the cannabinoids alone, in an unbound state, page 2, [0006-0008], page 8, [0037]. The composition is substantially free from cannabinoid not bound to the plasma protein, page 13, paragraph [0067]. These teachings read on claim 1 of a protein-bound cannabinoid and claim 16 of the formulation being free of unbound cannabinoid. In one embodiment, the plasma protein is non-covalently bound to the at least one cannabinoid, resulting in the formation of a protein-cannabinoid complex, page 3, [0010].
15. The composition comprises one of or a combination of more than one of albumin, lipoprotein, glycoprotein, alpha, beta, and gamma globulin and diluted blood plasma and mixtures of one or more thereof, page 3, [0011]; page 16, [0078]. In one embodiment, the plasma protein is albumin, which may comprise human serum albumin (HSA), bovine serum albumin or egg albumin (OVA). This disclosure reads on the proteins recited in instant claims 6-8 and 11. Suitable cannabinoids for use in the invention are disclosed on page 3, paragraph [0012] and include cannabidiol (CBD) and cannabidiolic acid (CBDA), including mixtures of cannabinoids. This reads on instant claim 13.
16. The examples and Tables 1 and 2 starting on page 5 [0020] further demonstrate how the protein-bound cannabinoid complex formulations are prepared. In one embodiment (example 1a-b), the cannabinoid-protein solutions were formed using ethanol and water in a 1:5 ratio, page 5 [0023]. The relative amount of cannabinoid to HSA can be between 20 micrograms and 100 micrograms of cannabinoid to 1 mg of HSA, page 5 [0024]. The pharmaceutical compositions are presented in unit dosage form including in the form of a tablet, capsule, lozenge, wafer, patch, ampoule, vial, metered-dose inhaler (oral or nasal route) or pre-filled syringe, page 13, paragraph [0065], page 14 [0068]. The protein-bound cannabinoid composition is administered with a pharmaceutically acceptable carrier or diluent and is administered through oral administration, parenteral administration or inhalation, page 13, paragraph [0066]; page 14, [0070]. In one embodiment, the daily dosage of the protein-bound cannabinoid is between 0.1 micrograms and 1500 milligrams, page 14, paragraph [0072]. These values read on the weight ratios of instant claims 1-2 as these values anticipate with sufficient specificity those instantly claimed (of at least 10mg cannabinoid to 50mg protein, 10:50). See also page 16, [0079-0088] onwards for cannabinoid dosages.
17. Regarding instant claim 3, which recites “particles having a mean particle size of up to 10µm” and instant claim 5, which recites “at least 90% of the particles have a particle size of less than 20µm”, this is met by Cohen. The “up to 10µm” and “less than 20µm” includes particle size values of zero. The particles disclosed by Cohen will inherently have particle sizes greater than zero, including mean particle sizes of greater than zero. Therefore, Cohen anticipates these values with sufficient specificity. In sum, the instant invention is clearly anticipated based on the teachings of Cohen, as discussed above.
Claim Rejections - 35 USC § 103
18. 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.
19. 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.
20. 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.
21. Claim(s) 1-3, 5-8, 11, 13 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 110302179 (Fu et al. hereinafter “Fu”) in view of US 2020/0254104 A1 (Chancey).
22. Fu teaches pharmaceutical preparations comprising a cannabidiol nano albumin preparation method and application. The method includes the following steps: step 1) dissolving CBD (cannabidiol) into an organic solvent to obtain a CBD-containing organic phase; step 2) dissolving albumin into water, adjusting PH to 6.0 and adding an organic solvent to form an aqueous phase; step 3) slowly dropwise adding the organic phase into the aqueous phase and stirring at a high speed to obtain an oil-in-water emulsion; step 4) subjecting the oil-in-water emulsion to high pressure homogenization, subjecting a system obtained after homogenization to rotary evaporation to remove the organic solvent and performing low-temperature freeze drying to obtain cannabidiol nano albumin. A preparation process of the nano CBD albumin is simple, the organic solvent is low in consumption and avoids residues, and high safety, low cost and easiness in industrial application are realized. See Abstract. Thus, Fu teaches a holding medium (oil-in-water emulsion) having dispersed therein a protein(albumin)-bound cannabinoid (cannabidiol) as in instant claim 1. Fu teaches a protein – albumin which reads on the proteins of instant claims 6-8. The cannabidiol disclosed by Fu reads on the cannabidiol (CBD) of instant claim 13. As the cannabinoid (cannabidiol) is dispersed in an oil-in-water emulsion (holding medium), the formulation of Fu is considered to be free of unbound cannabinoid and meets the limitation of claim 16.
23. Regarding instant claim 3, which recites “particles having a mean particle size of up to 10µm” and instant claim 5, which recites “at least 90% of the particles have a particle size of less than 20µm”, this is met by Fu. The “up to 10µm” and “less than 20µm” includes particle size values of zero. The particles disclosed by Fu will inherently have particle sizes greater than zero, including mean particle sizes of greater than zero. Therefore, Fu sufficiently meets these claimed particle sizes, absent a showing of evidence to the contrary.
24. The teachings of Fu are discussed above. Fu does not explicitly teach the weight ratio of cannabinoid to protein of at least 10 mg cannabinoid to 50 mg protein of instant claim 1, nor a weight ratio within a range of 30:50 and 500:50 of instant claim 2.
25. In the same field of endeavor, Chancey teaches a cannabinoid composition comprising a cannabinoid bound to a peptide to form a cannabinoid-peptide complex, the peptide comprising at least one amino acid, wherein the w/w (mg:g) ratio of cannabinoid to peptide is about 1:1; 1:<10; 10:>1; 25:1; 1:25, 50:1 or 1:50; 10:1, 20:1; >50:1; <50:1; 100:1; <100:1, 200:1; <200:1. These ratios read on and overlap with the weight ratios of instant claims 1-2. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The complexing agents are conjugated to a therapeutically effective amount of one or more cannabinoids wherein the complexing agents include proteins and peptides, etc. disposed in a pharmaceutically acceptable excipient, diluent or carrier. The cannabinoid-containing formulation provides for increased solubility and bioavailability. See, Abstract, page 1 [0005] – page 2 [0010]; Claims 1-3 (page 9).
26. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide for a protein-bound cannabinoid such as that taught by Fu and having the weight ratios of cannabinoid: protein disclosed in Chancey which overlap with those ratios claimed by applicant, in order to obtain a therapeutically effective protein/cannabinoid formulation having improved solubility and enhanced bioavailability.
Correspondence
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/HUMERA N. SHEIKH/Supervisory Patent Examiner, Art Unit 1784