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 Claims
Claim Rejections - 35 USC § 112
2. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
3. Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Abstract and specification [0005] support thermally treating the vaporizable material and the specification [0023] and claims 16, 17 support thermally treating vaporizable material that has been first treated with a mixture of water and binding agent, the original Abstract, specification and claims do not support thermally treating vaporizable material that has been first treated with a mixture comprising a first binding agent and a second binding agent, “the treated vaporizable material.” The original Abstract and specification only support thermally treating the vaporizable material of claim 1 before treating with binding agent mixture to form a “treated vaporizable material.”
Claim Rejections - 35 USC § 103
4. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
5. Claims 1, 3-5, 9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Trzecieski US2019/0192810.
6. Regarding claim 1, Trzecieski discloses a method of making phyto material tablet for a tablet vaporizer comprising:
grinding a phyto material such as cannabis bud [0337], [0356-0357] (cannabis bud is a synonym for cannabis flower);
mixing the phyto material with cannabis resin as a binding agent [0279] and mixing the phyto material with cannabis extract to facilitate binding the tablets [0380]; and
forming the mixture into a tablet [0368-0369].
Trzecieski does not specifically disclose mixing cannabis flower with both cannabis extract and cannabis resin as first and second binding agents. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have mixed both cannabis resin and cannabis extract with cannabis flower as Trzecieski suggests the use of cannabis resin as additional resin for binding instead of the resin found within the cannabis and teaches that the cannabis extract not only functions as binding agent but also is used to control potency of the tablets, thus obvious to also provide it for this additional function.
Regarding claims 3 and 9, Trzecieski discloses providing terpene in the tablets and the terpene can be at least one of those claimed [0017], [0283-0292], [0360].
Regarding claim 4, Trzecieski discloses mixing the phyto material with cannabis extracts which not only function as binding agent but also is used to control potency of the tablets [0385]. By use of plural cannabis extracts, the mixture further comprises an extract comprising cannabinoid.
Regarding claim 5, Trzecieski discloses compressing the mixture in a mold to form a shape with lines of weakness to break the shape into tablets [0354].
Regarding claim 21, Trzecieski discloses that the quantity of cannabis extracts mixed with the phyto material is used not only to improve table binding but also used to control the potency of the tablet by blending phyto material with lower percentage of active ingredient with extract having higher percentage [0385].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have controlled the amount of cannabis extract (first binding agent) mixed with the cannabis flower, such as in amount of 50 wt% or greater of the formed tablet, depending on the desired potency of the tablet based on the potency of the cannabis flower and the extract.
7. Claims 1, 3, 4, 6, 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 11510870 to White in view of Trzecieski US2019/0192810.
8. Regarding claim 1, White teaches a method of manufacturing a vaporizable tablet (substrates (30)) for use in an atomizer of a vaporizer device (col. 5, ll. 50-53), comprising:
grinding base material (vaporizable material) into a fine powder;
mixing the powder with glycerin aerosol-former, sodium carboxymethylcellulose and water to form a paste; and
extruding the paste into strands and spheronizing into pellet substrates (col. 9, lines 12-22).
Per the present specification, the first binding agent may comprise any suitable aerosol-forming agent [0011]. Per White, sodium carboxymethylcellulose is used as a binder (col. 7, lines 36-40). Thus, by mixing the powder with glycerin aerosol-former, sodium carboxymethylcellulose and water, the ground base material is treated with a mixture comprising first binding agent (glycerin aerosol-former) and second binding agent (sodium carboxymethylcellulose).
White discloses that the mixing the base material with active agents such as THC and CBD and teaches that the base material is an organic fiber such as food or plant fiber but does not disclose using cannabis flower (bud) as the base material for making vaporizable tablets.
Trzecieski teaches that tablets for a tablet vaporizer can be made from cannabis
bud (flower) by grinding the cannabis bud, mixing with other components and molding into tablets [0356-0369].
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have used cannabis flower as the base material for making tablets in the process of White as taught by Trzecieski as another type of organic material used to make tablets for a tablet vaporizer. The disclosure of White of mixing the base material with active agents such as THC and CBD would have suggested to one of ordinary skill in the art that cannabis flower would be suitable and obvious to try as a base material for forming mixture to be made into tablets per the process of White.
Regarding claims 3 and 9, Trzecieski discloses providing terpene in tablets made from cannabis bud (flower) and the terpene can be at least one of those claimed [0017], [0283-0292].
Regarding claim 4, Trzecieski discloses mixing the phyto material with cannabis extracts which not only function as binding agent but also is used to control potency of the tablets [0385]. By use of plural cannabis extracts, the mixture further comprises an extract comprising cannabinoid. White also teaches providing aerosol agents such as THC or CBD in the mixture (col. 5, lines 13-23)
Regarding claim 6, White teaches extruding strands of the substrate material and introducing into a spheronizer to cut the strands into relatively short rods that form the pellet substrates (col. 8, lines 20-29). Short length rods meets the claimed disk-shaped body.
Regarding claim 7, White teaches a method of manufacturing a vaporizable tablet, comprising using a mixture of a first binding agent (glycerin aerosol-former) and second binding agent (sodium carboxymethylcellulose).
However, White does not explicitly teach the mixture comprising vegetable glycerin, propylene glycol or combinations.
White teaches the aerosol forming agent can be glycerin, vegetable glycerin, propylene glycol and mixtures (col. 17, lines 1-9) and teaches glycerin, vegetable glycerin and mixtures thereof (claim 17).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have used a combination of glycerin with vegetable glycerin and/or propylene glycol as the aerosol former to make the pellet substrates as White teaches that mixtures of aerosol formers such as glycerin, vegetable glycerin, propylene glycol can be used.
9. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over White in view of Trzecieski US2019/0192810, as applied to claim 1 above, and further in view of U.S. Patent No. 2022/0295863 to Clark, et al. (hereinafter “Clark”).
10. Regarding claim 8, White teaches a method of manufacturing a vaporizable tablet, using a mixture of a first binding agent (glycerin aerosol-former) and second binding agent (sodium carboxymethylcellulose).
However, White does not teach the second binding agent comprises microcrystalline cellulose, starches, isomalt, or a combination thereof.
Clark, directed to a substrate for use in aerosol delivery devices ([0006]), teaches the binding agent is selected from the group consisting of alginates, seaweed hydrocolloids, cellulose ethers, starches, gums, dextrans, carrageenan, povidone, pullulan, zein, or combinations thereof. ([0136]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to have modified White by including starches to the binding agent as taught by Clark because both White and Clark are directed to substrates comprising an aerosol forming material. Clark teaches certain binders, such as starches, may be employed in certain embodiments, in amounts sufficient to provide the desired physical attributes and physical integrity to the substrate ([0134]), and this merely involves substituting one known binder (i.e a starch) for another such as a cellulose ether (sodium carboxymethylcellulose) to yield predictable results (see MPEP 2143 I(B)).
Response to Arguments
11. Applicant’s arguments are moot in view of the new positions set forth in the current rejection based on the amendments. Regarding claim 6, a rod with length 2 times the diameter can be considered disk-shaped.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELVIN C MAYES whose telephone number is (571)272-1234. The examiner can normally be reached Monday – Friday, Mon-Fri 8:00am - 4:30pm.
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/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759