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 .
Receipt is acknowledged for preliminary amendment filed 07/17/2024 and IDS filed 09/16/2024.
Claims 4-7, 9-10, 13-14, 16-17, 19, 21-24, 31, 34-36 and 40-42 are canceled.
Claims 3, 8, 11-12, 15, 18, 20, 25-26, 28-30, 32, 37 and 39 are amended.
Claims 1-3, 8, 11-12, 15, 18, 20, 25-30, 32-33 and 37-39 are pending.
Priority
This application claims benefit of 63/568,872 filed 03/22/2024 and 63/462,888 filed 04/28/2023.
Information Disclosure Statement
The IDS filed 09/16/2024 has been considered by the examiner.
Claim Rejections - 35 USC § 103
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 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 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.
Claim(s) 1-3, 8, 11-12, 15, 18, 20, 25-29 and 37-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over BRUUN et al. (WO 2020177819 A, cited by applicant in an IDS).
The process of claim 1 prepares a coated surface by applying to the surface a composition comprising about 0.001% to about 2% w/w of a cannabinoid, at least one aqueous stabilizing agent, at least one cellulose derivative, and at least one masking agent.
About 2% includes 2.2% and 1.8%.
BRUUN teaches coating tableted chewing gum with a composition comprising cannabinoid, water, mannitol, gum Arabica, polysorbate and the suspension is applied in 3 subsequent steps (page 78, lines 1-5, Table bridging pages 77 and 78, page 78, lines 6-13); coating composition comprises film coating composition for coating the tableted chewing gum (page 52, lines 11-15; page 53, lines 9-19); the film coating composition comprises methylcellulose (MC), hydroxypropyl cellulose (HPC) or hydroxypropyl methylcellulose (HPMC) (page 53, lines 21-29); the coating composition also contains sugar, flavor compounds (page 52, lines 17-27). BRUUN specifically teaches that one or more cannabinoids is present in the coating of the chewing gum (page 31, lines 23-31; page 32, line 2). The coating composition in CG146 in the Table bridging pages 77 and 78, the cannabinoid is at 2.2%. Methylcellulose (MC), hydroxypropyl cellulose (HPC) or hydroxypropyl methylcellulose (HPMC) meet the limitation of stabilizing agent and cellulose derivative of claim 1. Mannitol is a sweetener meeting the taste masking agent of claim 1. Sucrose, maltose, fructose, lactose and dextrose are also named sweeteners (page 47, lines 11-13; page 52, lines 17-24).
Therefore, for claims 1, 3 and 8, BRUUN teaches applying coating composition to the surface of chewing gum tablet, the composition comprises methylcellulose (MC), hydroxypropyl cellulose (HPC) or hydroxypropyl methylcellulose (HPMC) meeting the limitation of stabilizing agent and cellulose derivative, mannitol sweetener meeting taste masking agent, and 2.2% cannabinoid. BRUUN differs form claims 1, 3 and 8 by teaching 2.2% cannabinoid and not the claimed cannabinoid in the range of from about 0.0001 to about 2% (claims 1) or from about 1.5% to about 2% (claim 3) or from about 1.9% to about 2.0% (claim 8). However, about 2% includes 2.2% and 1.8%. Therefore, before the effective date of the invention, the artisan looking at the teachings of BRUUN would expect to use 2.2% cannabinoid in the coating composition of BRUUN with the expectation of having predictable cannabinoid release.
For claim 2, before the effective date of the invention, BRUUN does not teach the cannabinoid to be present at about 0.001% to about 1%. However, in general, 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. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
For claim 11, BRUUN teaches that the cannabinoid comprises delta-9-tetrahydrocannabinol (page 28, lines 15-16).
For claims 12 and 15, methylcellulose (MC), hydroxypropyl cellulose (HPC) or hydroxypropyl methylcellulose (HPMC) meeting the limitation of stabilizing agent and cellulose derivative for claims 12 and 15.
For claim 18, the sweetener mannitol or sucrose, maltose, fructose, lactose and dextrose meet claim 18.
From claim 20, sucrose and maltose are disaccharides.
For claim 25, mannitol is present at 11% in CG146 in the Table bridging pages 77 and 78.
For claim 26, the suspension composition applied to the chewing gum meets the claim.
For claim 27, the presence of glycerol (page 30, line 29) meets the claim.
For claims 28 and 29, BRUUN employs spray drying (page 46, line 9) to achieve desired release characteristics.
For claim 37, BRUUN teaches coating suspension that comprises cannabinoid, water, mannitol, gum Arabica, polysorbate and the suspension is applied in 3 subsequent steps (page 78, lines 1-5, Table bridging pages 77 and 78, page 78, lines 6-13); coating composition comprises film coating composition for coating the tableted chewing gum (page 52, lines 11-15; page 53, lines 9-19) and composition is homogeneous (see the whole document with emphasis on examples 6 and 7 on page 64) homogenization leads to homogeneous composition.
For claim 38, methylcellulose (MC), hydroxypropyl cellulose (HPC) or hydroxypropyl methylcellulose (HPMC) (page 53, lines 21-29) and sucrose, maltose, fructose, lactose and dextrose are also named sweeteners (page 47, lines 11-13; page 52, lines 17-24) meet the claim.
For claim 39, when the composition further contains mixtures of cellulose derivatives (page 53, lines 21-31) with the cellulose derivatives meeting the aqueous stabilizing agent in claim 39.
Thus, BRUUN renders claims 1-3, 8, 11-12, 15, 18, 20, 25-29 and 37-39 prima facie obvious.
Claim(s) 1-3, 8, 11, 12, 15, 18, 20, 25-28, 30 and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Upsdell et al., (US 20220186063 A1) in view of Lee et al., (US 20180296495 A1).
Upsdell teaches coating interior surface of a drinking straw with a composition comprising active ingredient, film forming polymer, non-ionic surfactant, plasticizer, and diluent and the active ingredient is cannabinoid (see the whole document with emphasis on the abstract, paragraphs [0011], [0042], claim 8). The diluent is maltodextrin (paragraphs [0014], [0026], [0039], [0045]) meeting the limitation of taste masking agent of claim 1. Film forming polymer is pullulan (paragraphs [0013], [0015], [0017], [0038], [0042]). Film forming polymer meets the limitation of stabilizing agent of claim 1.
The cannabinoid active agent is present at up to 30% (paragraph [0015] and claim 8) with up to 30% including amounts of at least about 1% to 30%. Upsdell differs from claims 1-3 and 8 by not teaching the amount of cannabinoid in the ranges claimed. However, up to 30% overlaps about 0.001% to about 2%. In general, 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. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
For claims 1, 12 and 15, Upsdell does not teach the film forming agent as Hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC). However, Lee teaches that hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC) and pullulan are film forming polymer (paragraphs [0007], [0067] and claim 5) and thus pullulan and HPC and HPMC are functionally equivalent. Therefore, one functionally equivalent film forming agent can be used in place of the other with the expectation of predictably achieving film forming characteristics.
For claim 11, Lee teaches delta-9-tetrahydrocannabinoid (Delta-9-THC) (paragraph [0005]).
For claims 18 and 20, the maltodextrin sweetener is a polysaccharide.
For claim 25, the maltodextrin is present at 5-25% (paragraph [0015]) and this range overlaps and encloses the claimed range of about 10% to about 20% with the disclosed range allowing for about 10% to about 20%.
For claim 26, the aqueous solution in Upsdell is applied to the internal surface of the drinking straw.
For claim 27, the coating composition comprises glycerol (see at least paragraphs [0015], [0017], [0027], [0039], [0042], [0045]).
For claim 28, the aqueous dispersion on the surface of the drinking straw is dried (see the whole document with emphasis on paragraphs [0017]-[0019], [0032]).
For claims 30 and 32, the interior surface of the drinking straw meets the claims as the drinking straw us a drinking vessel.
For claim 33, the coating composition comprises water (paragraph [0032]).
Thus, Upsdell in view of Lee renders claims 1-3, 8, 11, 12, 15, 18, 20, 25-28, 30 and 32-33 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613