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 .
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 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.
DETAILED ACTION
Claims 157-186 are pending, claims 1-156 are canceled in this application. This application claims foreign priority to PA202300252, filed on 03/21/2023 in Denmark and to PA202300253, filed on 03/21/2023 in Denmark.
Priority
The examiner noted that the instant application claims PA202300253 and PA202300252 as foreign priority; however, the examiner couldn’t find the certified copies of the claimed PA202300253 and PA202300252 of record. The examiner would appreciate the assistance form the applicants in procuring the documents for addition to the file; otherwise the claim to foreign priority will not be met and the right of priority may be lost. See MPEP 215.03:
The claim for priority and the certified copy of the foreign application specified in 35 U.S.C. 119(b) or PCT Rule 17 must, in any event, be filed before the patent is granted. If the claim for priority or the certified copy of the foreign application is filed after the date the issue fee is paid, it must be accompanied by the processing fee set forth in § 1.17(i), but the patent will not include the priority claim unless corrected by a certificate of correction under 35 U.S.C. 255 and § 1.323
In the application data sheet: applicant bears the ultimate responsibility for ensuring that a copy of the foreign priority application is received by the office from the participating foreign intellectual property office or a certified copy of the foreign priority application is filed, within the time period specified in 37 CFR 1.55(g)(1).
Claim Rejections - 35 USC 112(b)
The following is a quotation of the second paragraph 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.
Claims 157-186 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The recitation of "the one or more self-emulsifying systems including" and the recitation of “and” between items i) and ii) in claims 157, 185, and 186 render claims 157, 185, and 186 indefinite. With “and” between item i) and ii), both items i) and ii) are required and thus there must be two systems which is not consistent with "the one or more self-emulsifying systems”. It is confusing to one of ordinary skill whether "the one or more self-emulsifying systems including" both items i) and ii) or selected from the group consisting items i) and ii) and mixture thereof. Claims 158-184 are rejected as dependent claims of a rejected claim.
To expedite the prosecution "the one or more self-emulsifying systems including" and “and” between items i) and ii)" is given their broadest reasonable interpretations by the examiner in light of the specification as "the one or more self-emulsifying systems selected from the group consisting” items i) and ii) and mixture thereof in the 103 rejections.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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 157-171 and 173-186 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bruun et al. (US 2020/0330425 A1).
Bruun et al. teach an oral cavity disintegrating lozenge tablet (the claimed orally dissolvable in the instant claims 157 and 184) (paragraph 186) composition for improved delivery of cannabinoids to mucosal surfaces both in the oral cavity and the gastrointestinal tract (thus the claimed properties in the instant claim 158) (claim 138 and paragraph 197) comprising
solid or liquid self-emulsifying drug delivery systems (SEDDS) (the claimed carrier system loaded with cannabinoids in the instant claim 157) (paragraph 10, 13, and 14) comprising granules (the claimed tableted powder in the instant claim 157) (paragraph 183) comprising self-emulsifiers, cannabinoids, an oil phase, a surfactant, solvent and co-solvents (the claimed item i) in the instant claim 157) (paragraph 201-203);
>50% by weight of sugar alcohols (the claimed water-soluble agents in the instant claims 157) (abstract and claim 139);
0.01-5% by weight of flavors (the instant claim 157) (paragraph 145);
wax (commonly known as being solid at room temperature, the instant claim 167);
magnesium-alumino-metasilicates (the claimed mesoporous silica carrier in the instant claims 178 and 179) (claim 157);
wherein the oil includes caprylic triglycerides (C8, also glyceryl caprylate) (the claimed oil as a lipid in the instant claims 163-165) (paragraph 52);
wherein the one or more self-emulsifying agents including phospholipids (lecithin) (the claimed surfactant without polyethylene glycol and soy phosphatidylcholine in the instant claims 159 and 173) (paragraph 200), propylene glycol mono laurate (the claimed propylene glycol esters of fatty acids in the instant claims 169 and 170), sorbitan monolaurate (the instant claim 171), polyoxyethylene (20) sorbitan monolaurate (the claimed PEGylated emulsifier in the instant claim 177) (paragraph 204);
wherein SEDDS forms oil-in-water emulsion spontaneously in the oral cavity or at body temperature (the claimed gastrointestinal, or alternatively, as an inherent property in the instant claim 162);
wherein cannabinoids include isolated or synthetical (the claimed item i) in the instant claim 157) (paragraph 233) with ≥99% purity (paragraph 237);
wherein the solvent includes polyethylene glycol 300 (the instant claims 174 and 175) (paragraph 56);
wherein the composition comprising 10-25% by weight of mucosal delivery enhancing component (the instant claim 180) (paragraph 92) and the plurality of solid particles are present in an amount of ≤30% by weight of the composition (paragraph 99) (the weight ratio between solid particles (the claimed solid carrier) and mucosal delivery enhancing component (the claimed SEDDS) is calculated to be 1.25-3:1 (30%/10% = 3 and 30/25% = 1.25) (within the claimed 2:8 to 8:2 → 0.25-4:1 in the instant claim 183));
wherein the weight of lozenge is about 200-2000 mg (paragraph 146) and the weight of cannabinoids in the lozenge is 1-20 mg (paragraph 147-149) (the weight percentage of cannabinoids in the lozenge is calculated to be 0.5-10% (1/200=0.5% and 20/200=10%) (the instant claims 157)) and cannabinoids (the instant claim 161); and
wherein the composition comprising 10-25% by weight of mucosal delivery enhancing component (the instant claim 180); and exemplified
in example 1 a cannabinoid component containing 50% CBD (cannabinoids) and <50% wax → >1:1 cannabinoids to wax ratio (the instant claim 182);
in example 9 a cannabinoid component containing solution of 60% Labrafac Lipophile WL1349 (caprylic/capric triglyceride, oil, 40.2%: 60% x (100-33%) = 40.2%) and 25% Labrasol (PEG containing surfactant, <16.75% relative to SEDDS: 25% x (100% - 33%) = 16.75%, the instant claims 176 and 177), and 15% propylene glycol (10.05%: 15% x (100%-33%) = 10.05%, the claimed solvent in the instant claims 174 and 175) was mixed followed by adding CBD to obtain a 33% solution of CBD, followed by applying the solution with CBD with one or more sugar alcohols → <33% CBD relative to SEDDS (the instant claim 161) and 1 : 1.22 cannabinoids to caprylic/capric triglyceride oil ratio before being applied to sugar alcohol (33% : 40.2% = 1 : 1.22) (within the claimed 1: 0.1-10 ratio in the instant claim 181);
in example 22 a lozenge 139 comprising 1.2% by weight of Labrafac Lipophile WL 1349 (caprylic/capric triglyceride, oil, the instant claim 166); a lozenge 141 comprising 2% by weight of CBD-extract (loaded 50%) → < 1% wax (the instant claim 168).
Bruun et al. teach SEDDS being capsules filled with a liquid or a gel that consists of self-emulsifiers, one or more cannabinoids, oil, and a surfactant (the instant claim 186) (paragraph 201).
Bruun et al. do not specify the same weight percentage of water-soluble agents relative to the composition (sugar alcohols, ≥50% vs the claimed 20-80% in the instant claims 157, 185, and 186).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition overlaps with the range disclosed in the prior art, such as in the instant rejection.
The claimed range of water-soluble agents is 20-80% by weight and the range of sugar alcohols taught in the prior art is ≥50% by weight and therefor, overlaps with the claimed range.
Bruun et al. do not specify the same weight percentage of cannabinoids relative to the composition (0.5-10% vs the claimed ≥10% relative to the composition in the instant claims 157, 185, and 186 and <33% vs ≥20% relative to SEDDS in the instant claim 161).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition overlaps with the range disclosed in the prior art, such as in the instant rejection.
The claimed range of cannabinoids relative to the composition is ≥10% by weight and the range of cannabinoids relative to the composition taught in the prior art is 0.5-10% by weight and therefor, overlaps with the claimed range.
The claimed range of cannabinoids relative to SEDDS is ≥20% by weight and the range of cannabinoids relative to SEDDS taught in the prior art is <33% by weight and therefor, overlaps with the claimed range.
Bruun et al. do not specify the weight percentage of non-PEG surfactant relative to SEDDS (the claimed ≥5% in the instant claim 160).
This deficiency is cured by Bruun et al.’s teachings of both lecithin and polysorbate being suitable self-emulsifiers (paragraph 200) and <16.75% of PEG surfactant relative to SEDDS (example 9 as discussed above) and the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition overlaps with the range disclosed in the prior art, such as in the instant rejection.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Bruun et al. to specify the weight percentage of lecithin as a self-emulsifier relative to SEDDS being <16.75%. Both lecithin and polysorbate being suitable self-emulsifiers and <16.75% of PEG surfactant relative to SEDDS being incorporated were well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from both lecithin and polysorbate being suitable self-emulsifiers and <16.75% of PEG surfactant relative to SEDDS having been used in the prior art, and from both lecithin and polysorbate being suitable self-emulsifiers and <16.75% of PEG surfactant relative to SEDDS being recognized in the prior art as useful for the same purpose. The claimed range of non-PEG surfactant is ≥5% by weight and the range of non-PEG surfactant taught in the prior art is <16.75% by weight and therefor, overlaps with the claimed range.
Bruun et al. do not specify the same weight percentage of wax relative to the composition (<1% vs the claimed 1-30% in the instant claim 168).
This deficiency is cured by the rationale that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties.
The claimed range of wax is 1-30% by weight and the range of wax taught in the prior art is <1% by weight and therefor while both amounts of wax are suitable in SEDDS.
Bruun et al. do not specify the same weight percentage of PEG surfactant (<16.75% vs the claimed <15% in the instant claim 176).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection.
The claimed range of PEG surfactant is <15% by weight and the range of PEG surfactant taught in the prior art is <16.75% by weight and therefor, overlaps with the claimed range.
All-in all, with regard to the prima facia obvious in ranges of weight percentage and ratios, it is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. Please refer to MPEP 2144.05.II.A.
Claims 157-186 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bruun et al. (US 2020/0330425 A1) in view of Gierke et al. (US 2018/0110254 A1).
The teachings of Bruun et al. are discussed above and applied in the same manner.
Bruun et al. do not teach the self-emulsifiers including ascorbic palmitate (the instant claim 17).
This deficiency is cured by Gierke et al. who teaches addition of ascorbyl palmitate to a lecithin-comprising formulation distinctly improved the self-emulsifying properties in the stomach model (paragraph 46).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Bruun et al. and Gierke et al. to add ascorbyl palmitate to lecithin-containing self-emulsifying drug delivery system taught by Bruun et al. Addition of ascorbyl palmitate to lecithin-containing self-emulsifying drug delivery system improving the self-emulsifying properties in the stomach model was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose with improved self-emulsifying properties in the stomach model.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 157-186 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,925,853 B2, claims 1-25 of U.S. Patent No. 10,933,017 B2, claims 1-26 of U.S. Patent No. 11,013,685 B2, claims 1-27 of U.S. Patent No. 11,154,496 B2, claims 1-27 of U.S. Patent No. 11,166,910 B2, claims 1-27 of U.S. Patent No. 11,191,720 B2, claims 1-29 of U.S. Patent No. 11,471,405 B2, claims 1-21 of U.S. Patent No. 11,633,351 B2, claims 1-26 of U.S. Patent No. 11,833,117 B2, claims 1-23 of U.S. Patent No. 11,903,919 B2, claims 1-22 of U.S. Patent No. 12,533,367 B2.
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matte
Although the patent and instant claims are not identical, they are not patentably distinct from each other because claims in both applications are drawn to the same composition.
Claims 157-186 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 and 21-24 (dated 07/17/2025) of copending Application No. 18/175,110, claims 1-9, 11-14, 17, 19, 20, 22 (dated 11/21/2025, allowance dated 01/21/2026) of copending Application No. 18/490,896, claims 1-22 (dated 10/24/2023) of copending Application No. 18/493,276, claims 164, 166-178, and 181-188 (dated 08/18/2025, allowance dated 10/02/2025) of copending Application No. 18/512,067, claims 138, 139, and 141-145 (dated 10/02/2025) of copending Application No.18/612,007, claims 138, 140-144, 146-156, 158, 160, 161, 163, and 165 (dated 06/25/2025) of copending Application No. 16/852,168. Although the patent and instant claims are not identical, they are not patentably distinct from each other.
Although the patent and instant claims are not identical, they are not patentably distinct from each other because claims in both applications are drawn to the same composition.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614