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 .
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 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 of this title, 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.
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 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 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Camera et al. US 2023/0087756 in view of Steindler et al. US 2021/0169795.
Regarding Claim 11, Camera et al. discloses a container (beverage pod 130) for preparation of a single serving of a beverage (infused beverage 126) (‘756, Paragraph [0052]) wherein the container (beverage pod 130) comprises a body (outer container 136) defining a cavity, a packed bed (‘756, Paragraph [0041]) of a dry beverage precursor ingredient (plant matter 120 including ground coffee beans mixed with a powdered concentrate) disposed within the cavity (‘756, FIG. 1B) (756, Paragraphs [0042]-[0043]) and a colloid (homogenous solution of an emulsion) comprising nanoparticles (‘756, Paragraph [0028]) comprising cannabidiol particles (‘756,. Paragraph [0072]) and at least one surfactant (‘756, Paragraph [0133]).
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Camera et al. discloses the packed bed including ground and/or roasted coffee beans or tea leaves (‘756, Paragraph [0042]) wherein the packed bed of plant matter is mixed with one or more additional water soluble materials in the form of a powdered concentrate and/or a liquid concentrate (‘756, Paragraph [0043]). However, Camera et al. is silent regarding the colloid being mixed into the packed bed.
Steindler et al. discloses a method of making a colloidal mixture comprising a cannabinoid or an oleoresin, an emulsifying or stabilizing agent in sufficient amounts to suspend the cannabinoid or oleoresin within the colloidal mixture to prevent phase separation wherein the cannabinoid or oleoresin remains suspended throughout the colloidal mixture (‘795, Paragraph [0003]) wherein the colloidal suspension of cannabis plant extract is incorporated or combined into any and all forms of substances including food, beverages, concentrates, gels, powders, or any other product classified as a botanical drug substance (BDS) for medical and pharmaceutical uses (‘795, Paragraph [0017]) wherein the concentrated colloidal mixture is prepared to the desired dosage, dehydrated and crushed to a fine powder, and mixed into any instant form off coffee including pod type coffees (‘795, Paragraphs [0093]-[0095]).
Both Camera et al. and Steindler et al. are directed towards the same field of endeavor of beverage containers used in a beverage making machine. Both beverage containers of Camera et al. and Steindler et al. contain cannabinoid formulations. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the beverage container of Camera et al. and mix the colloid into the packed bed of coffee since Steindler et al. teaches that mixing a colloid containing cannabidiol particles into coffee was a known and conventional way to incorporate cannabinoids into a coffee composition used in a beverage container.
Further regarding Claim 11, the limitations “for preparation of a single serving of a beverage” are seen to be recitations regarding the intended use of the “container.” In this regard, applicant’s attention is invited to MPEP § 2114.I. and MPEP § 2114.II. which states features of an apparatus may be recited either structurally or functionally in view of In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima facie case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possess the functionally defined limitations of the claimed apparatus in view of In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40,100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on in view of In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971). Additionally, apparatus claims cover what a device is, not what a device does in view of Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claimed in view of Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Furthermore, if the prior art structure is capable of performing the intended use, then it meets the claim. Nevertheless, Camera et al. discloses the container (beverage pod 130) being capable of preparing a single serving of a beverage (infused beverage 126) (‘756, Paragraphs [0052] and [0056]). It is noted that the claim does not specify any particular volume of single serving beverage that is prepared. Therefore, any amount of prepared beverage reads on the claimed single serving of a beverage.
Regarding Claim 12, Camera et al. discloses the dry beverage precursor ingredient being ground coffee beans or tea leaves (‘756, Paragraph [0040]).
Regarding Claim 13, Camera et al. discloses the at least one surfactant being sucrose esters (sucrose fatty acid esters) (‘756, Paragraph [0136]).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Camera et al. US 2023/0087756 in view of Steindler et al. US 2021/0169795 as applied to claim 11 above in view of Steup US 2018/0020699 as further evidenced by “Emulsifiers vs Solubilisers: How Are They Different?” <https://www.maha.asia/blog/living-sciences-4/emulsifiers-vs-solubilisers-how-are-they-different-9> (published February 5, 2021) in further view of Benson et al. US 2015/0352044 and Eades et al. US 2020/0197358.
Regarding Claims 14-16, Camera et al. modified with Steindler et al. is silent regarding the CBD nanoparticles and the at least one surfactant present in the colloid being approximately equal amounts by weight or the CBD nanoparticles and the at least one surfactant each being present in the colloid in an amount of between about 5 wt% and about 50 wt% or between about 10 wt% and about 33 wt%.
Steup discloses a beverage comprising a CBD containing formulation and at least one emulsifier (‘699, Paragraph [0001]) wherein the emulsifier is tween 20 or tween 80 (‘699, Paragraph [0010]) wherein a dosage of 1 mg/kg to 5 mg/kg CBD is administered/applied to a human or an animal (‘699, Paragraph [0027]) wherein CBD dosage concentrations includes properties including increased concentration, increased cognitive ability, and increased memory function (‘699, Paragraphs [0028]-[0030]). Emulsifiers vs Solubilisers: How Are They Different provides evidence that it was known in the art that emulsifiers are part of the surfactant family (Page 1). Benson et al. discloses a container (single serve container 300) for preparation of a single serving of a beverage wherein the container (single serve container 300) comprises a body (body portion 306) defining a cavity (‘044, FIG. 6) (‘044, Paragraph [0056]), a bed of a dry beverage precursor ingredient (freeze dried cannabis) disposed within the cavity (‘044, Paragraph [0080]) and a colloid comprising cannabidiol (CBD) particles (‘044, Paragraphs [0091] and [0117]) wherein the colloid is distributed throughout at least a portion of the bed (‘044, Paragraph [0094]) wherein the amount of cannabis product added to the container depends on the desired dosage level of the container (‘044, Paragraph [0090]). Eades et al. discloses a cannabinoid delivery system comprising a mixture of a cannabinoid or cannabinoid analogue, at least one lipid, and at least one surfactant (‘358, Paragraph [0029]) wherein the amount of lipid and surfactant in the lipid based formulation are chosen so as to enable relatively high compound loadings of cannabinoid with acceptable formulation dispersibility (‘358, Paragraph [0041]) wherein the cannabinoid analogue is cannabidiol (CBD) (‘358, Paragraphs [0005] and [0030]) wherein the surfactant is tween 20 or tween 80 (‘358, Paragraph [0040]) wherein the cannabinoid composition is used to make food (‘358, Paragraph [0007]).
Modified Camera et al., Steup, Benson et al., and Eades are all directed towards the same field of endeavor of edible CBD compositions. All of the edible CBD compositions of modified Camera et al., Steup, and Eades et al. all contain emulsifiers/surfactants. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the CBD composition disposed in the container of modified Camera et al. and adjust the concentration of CBD nanoparticles and the concentration at least one surfactant since differences in the concentration of CBD nanoparticles and the concentration of the at least one surfactant in the colloid will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration of CBD nanoparticles and concentration of the at least one surfactant encompassed by the prior art unless there is evidence indicating such concentration of CBD nanoparticles and concentration of the at least one surfactant is critical. Where 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.). One of ordinary skill in the art would adjust the concentration of CBD nanoparticles of the colloid of modified Camera et al. based upon the desired dosage concentrations of CBD that imparts properties including increased concentration, increased cognitive ability, and increased memory function as taught by Steup et al. (‘699, Paragraphs [0028]-[0030]) and based upon the desired dosage of cannabis product as taught by Benson et al. (‘044, Paragraph [0090]). Additionally, one of ordinary skill in the art would adjust the concentration of emulsifier/surfactant of the colloid of modified Camera et al. based upon the desired formulation dispersability as taught by Eades et al. (‘358, Paragraph [0041]).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Camera et al. US 2023/0087756 in view of Steindler et al. US 2021/0169795 as applied to claim 11 above in view of Vangara et al. US 2020/0360286.
Regarding Claims 14-15, Camera et al. modified with Steindler et al. is silent regarding the CBD nanoparticles and the at least one surfactant present in the colloid being approximately equal amounts by weight or the CBD nanoparticles and the at least one surfactant each being present in the colloid in an amount of between about 5 wt% and about 50 wt% or between about 10 wt% and about 33 wt%.
Vangara et al. discloses an oral dosage (‘286, Paragraphs [0004] and [0074]) of a self-emulsifying cannabidiol composition comprising from about 1 to about 40% w/w cannabidiol and from about 40% to about 99% w/w w/w or one or more surfactants of a propylene glycol (‘286, Paragraph [0020]). Vangara et al. teaches an embodiment of the cannabidiol composition comprising about 40% w/w cannabidiol and about 40% w/w of one or more surfactants of a propylene glycol, which falls within the claimed
Both modified Camera et al. and Vangara et al. are directed towards the same field of endeavor of orally ingestible cannabidiol (CBD) compositions. Both CBD compositions of Camera et al. and Vangara et al. comprises a propylene glycol surfactant. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the CBD composition disposed in the container of modified Camera et al. and CBD nanoparticles and the at least one surfactant present in the colloid being approximately equal amounts by weight or the CBD nanoparticles and the at least one surfactant each being present in the colloid in an amount of between about 5 wt% and about 50 wt%. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the concentration of CBD particles and the concentration of the at least one surfactant disposed in the container of modified Camera et al. to have the claimed concentration of CBD particles and the claimed concentration of the at least one surfactant as taught by Vangara et al. since where the claimed concentration of CBD particles and the claimed concentration of the at least one surfactant encompassed the concentration of CBD particles and the concentration of the at least one surfactant disclosed by the prior art, a prima facie case of obviousness exists in view of 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) (MPEP § 2144.05.I.).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Camera et al. US 2023/0087756 in view of Steindler et al. US 2021/0169795 as applied to claim 11 as further evidenced by Cardoso US 2014/0106036.
Regarding Claim 17, the limitations “wherein the body comprises a first puncturable portion associated with an upper portion of the cavity and a second puncturable portion associated with a lower portion of the cavity wherein the container is configured such that when the first and second puncturable portions of the body are punctured an aqueous liquid may flow into the upper portion of the cavity through the packed bed of the dry beverage precursor ingredient and out of the lower portion of the cavity” are intended use limitations and as such are rejected for the same reasons regarding intended use enumerated in the rejections of Claim 11 provided above. Nevertheless, Camera et al. explicitly discloses the body comprising a first puncturable portion (lid 132 includes a pierceable material that can be pierced by a needle) (‘756, FIG. 1B) (‘756, Paragraph [0053]) wherein an aqueous liquid (water) is capable of flowing into the upper portion of the cavity (via pierced lid 132) (‘756, Paragraph [0053]) through the packed bed of the dry beverage precursor ingredient and out of the lower portion of the cavity (outer container 136 includes a pierceable material wherein a hole is generated by piercing the outer container 136 with a needle) (‘756, Paragraph [0054]).
Cardoso provides further evidence that it was known in the beverage container art that beverage containers (container 110) comprising a body defining a cavity (interior space 114) are capable of having a first puncturable portion (lid 113) associated with an upper portion of the cavity (interior space 114) and a second puncturable portion (bottom surface 112) associated with a lower portion of the cavity (interior space 114) (‘036, Paragraph [0030]) wherein the container (container 110) is configured such that when the first (lid 113) and second (bottom surface 112) puncturable portions of the body are punctured an aqueous liquid is capable of flowing into the upper portion of the cavity (interior space 114) through the beverage ingredient and out of the lower portion of the cavity (interior space 114) (‘036, FIG. 1) (‘036, Paragraphs [0032]-[0033]).
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Regarding Claim 18, Camera et al. discloses a filter (infused porous substrate 122 made of filter paper) (‘756, FIG. 1B) (‘756, Paragraph [0044]).
Further regarding Claim 18, the limitations “configured to substantially prevent the dry beverage precursor ingredient from being carried out of the container due to flow of the aqueous liquid” are limitations with respect to the properties of a generic filer. Any filter, e.g. the filter paper of the infused porous substrate 122, by definition is considered to substantially prevent any ingredients disposed within the filter from being carried out. Camera et al. also discloses a flow of the aqueous liquid (‘756, Paragraph [0039]).
Claims 11-13 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Bhairam US 2018/0098552 as further evidenced by Levy US 2021/0353589 in view of Millikin US 2020/0377290 and Heller US 2020/0054702.
Regarding Claim 11, Bhairam discloses a container for preparation of a single serving of a beverage (‘552, Paragraph [0013]), the container comprising a body defining a cavity, a packed bed (‘552, Paragraph [0020]) of a dry beverage precursor ingredient disposed within the cavity (‘552, Paragraph [0036]) and a colloid comprising cannabidiol (CBD) particles and at least one surfactant (propylene glycol) (‘552, Table 1) (‘552, Paragraphs [0009] and [0030]). Levy provides evidence that it was known in the art that propylene glycol is a type of surfactant (‘589, Paragraph [0187]) for a water soluble cannabinoid formulation (‘589, Paragraph [0002]) in the form of a dispersible powder used for the preparation of a beverage (‘589, Paragraph [0009]). Therefore the propylene glycol that is mixed with cannabinoids and ground coffee disclosed by Bhairam (‘552, Paragraph [0022]) is a type of surfactant as evidenced by Levy (‘589, Paragraph [0187]). Bhairam also discloses the colloid being distributed throughout at least a portion of the packed bed (homogenous mixture) (‘552, Paragraph [0011]).
Bhairam is silent regarding the cannabidiol particles to be cannabidiol nanoparticles.
Millikin discloses a container (single use coffee containment system 100) for preparation of a single serving of a beverage wherein the container (single use coffee containment system 100) comprises a body (housing 102) defining a cavity, a packed bed of a dry beverage precursor ingredient (ground cannabis plant matter 206) disposed within the cavity (‘290, Paragraph [0024]) and a colloid comprising cannabidiol (CBD) nanoparticles (‘290, FIG. 1) (‘290, Paragraphs [0029] and [0037]) wherein the nanoparticles reduces the chances of having undesirable sediment in the beverage (‘290, Paragraph [0035]).
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Heller discloses a beverage powder comprising cannabinoid emulsions (‘702, Paragraph [0379]) embedded in a colloidal solution and dehydrated into the powder (‘702, Paragraph [0010]) comprising cannabinoid nanoparticles having particle sizes between about 50 nm and about 20 microns for efficient absorption in the body (‘702, Paragraph [0004]) and at least one surfactant (‘702, Paragraph [0072]).
Bhairam, Millikin, and Heller are all directed towards the same field of endeavor of cannabinoid beverage powders. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the CBD particles disposed in the container of Bhairam and use CBD particles that are sized as nanoparticles since Millikin teaches that nanoparticles reduces the chances of having undesirable sediment in the beverage (‘290, Paragraph [0035]) and since Heller teaches that CBD nanoparticles allow for efficient absorption in the body (‘702, Paragraph [0004]).
Further regarding Claim 11, the limitations “for preparation of a single serving of a beverage” are seen to be recitations regarding the intended use of the “container.” In this regard, applicant’s attention is invited to MPEP § 2114.I. and MPEP § 2114.II. which states features of an apparatus may be recited either structurally or functionally in view of In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima facie case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possess the functionally defined limitations of the claimed apparatus in view of In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40,100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on in view of In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971). Additionally, apparatus claims cover what a device is, not what a device does in view of Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claimed in view of Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Furthermore, if the prior art structure is capable of performing the intended use, then it meets the claim. Nevertheless, Bhairam discloses the container being capable of preparing a single serving of a beverage (‘552, Paragraphs [0013] and [0020]). It is noted that the claim does not specify any particular volume of single serving beverage that is prepared. Therefore, any amount of prepared beverage reads on the claimed single serving of a beverage.
Regarding Claim 12, Bhairam discloses the beverage precursor ingredient being ground coffee beans, tea leaves, and hot chocolate (‘552, Paragraphs [0020] and [0022]).
Regarding Claim 13, Heller discloses the at least one surfactant being tween 20, tween 80, span 20, span 80, or a polypropylene glycol (‘702, Paragraph [0142]).
Both Bhairam and Heller disclose CBD compositions used for making beverages. Both CBD compositions of Bhairam and Heller use at least one surfactant containing a propylene glycol. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the CBD composition disposed in the container of Bhairam and also incorporate tween 20, tween 80, and/or span 80 as the at least one surfactant as taught by Heller since the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination in view of Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (MPEP § 2144.07). Heller teaches that there was known utility in the food and beverage art to make an edible CBD composition with at least one surfactant containing tween 20, tween 80, and /or span 80.
Regarding Claim 17, Bhairam discloses the body comprising a first puncturable portion (foil lid) associated with an upper portion of the cavity and a second puncturable portion (bottom of the K-Cup) associated with a lower portion of the cavity (‘552, Paragraph [0020]).
Further regarding Claim 17, the limitations “wherein the container is configured such that when the first and second puncturable portions of the body are punctured an aqueous liquid may flow into the upper portion of the cavity through the packed bed of the dry beverage precursor ingredient and out of the lower portion of the cavity” are intended use limitations and as such are rejected for the same reasons regarding intended use enumerated in the rejections of Claim 11. Nevertheless, Bhairam explicitly discloses these intended use limitations (‘552, Paragraph [0020]).
Regarding Claim 18, Bhairam discloses a filter (‘552, Paragraph [0020]).
Further regarding Claim 18, the limitations “configured to substantially prevent the dry beverage precursor ingredient from being carried out of the container due to flow of the aqueous liquid” are limitations with respect to the properties of a generic filer. Any filter, e.g. the filter paper of the infused porous substrate 122, by definition is considered to substantially prevent any ingredients disposed within the filter from being carried out. Bhairam also discloses a flow of the aqueous liquid (hot water) (‘552, Paragraph [0020]).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bhairam US 2018/0098552 as further evidenced by Levy US 2021/0353589 in view of Millikin US 2020/0377290 and Heller US 2020/0054702 as applied to claim 11 above in further view of Steup US 2018/0020699 as further evidenced by “Emulsifiers vs Solubilisers: How Are They Different?” <https://www.maha.asia/blog/living-sciences-4/emulsifiers-vs-solubilisers-how-are-they-different-9> (published February 5, 2021) in further view of Benson et al. US 2015/0352044 and Eades et al. US 2020/0197358.
Regarding Claims 14-16, Bhairam as further evidenced by Levy in view of Millikin and Heller is silent regarding the CBD nanoparticles and the at least one surfactant present in the colloid being approximately equal amounts by weight or the CBD nanoparticles and the at least one surfactant each being present in the colloid in an amount of between about 5 wt% and about 50 wt% or between about 10 wt% and about 33 wt%.
Steup discloses a beverage comprising a CBD containing formulation and at least one emulsifier (‘699, Paragraph [0001]) wherein the emulsifier is tween 20 or tween 80 (‘699, Paragraph [0010]) wherein a dosage of 1 mg/kg to 5 mg/kg CBD is administered/applied to a human or an animal (‘699, Paragraph [0027]) wherein CBD dosage concentrations includes properties including increased concentration, increased cognitive ability, and increased memory function (‘699, Paragraphs [0028]-[0030]). Emulsifiers vs Solubilisers: How Are They Different provides evidence that it was known in the art that emulsifiers are part of the surfactant family (Page 1). Benson et al. discloses a container (single serve container 300) for preparation of a single serving of a beverage wherein the container (single serve container 300) comprises a body (body portion 306) defining a cavity (‘044, FIG. 6) (‘044, Paragraph [0056]), a bed of a dry beverage precursor ingredient (freeze dried cannabis) disposed within the cavity (‘044, Paragraph [0080]) and a colloid comprising cannabidiol (CBD) particles (‘044, Paragraphs [0091] and [0117]) wherein the colloid is distributed throughout at least a portion of the bed (‘044, Paragraph [0094]) wherein the amount of cannabis product added to the container depends on the desired dosage level of the container (‘044, Paragraph [0090]). Eades et al. discloses a cannabinoid delivery system comprising a mixture of a cannabinoid or cannabinoid analogue, at least one lipid, and at least one surfactant (‘358, Paragraph [0029]) wherein the amount of lipid and surfactant in the lipid based formulation are chosen so as to enable relatively high compound loadings of cannabinoid with acceptable formulation dispersibility (‘358, Paragraph [0041]) wherein the cannabinoid analogue is cannabidiol (CBD) (‘358, Paragraphs [0005] and [0030]) wherein the surfactant is tween 20 or tween 80 (‘358, Paragraph [0040]) wherein the cannabinoid composition is used to make food (‘358, Paragraph [0007]).
Modified Bhairam Steup, Benson et al., and Eades are all directed towards the same field of endeavor of edible CBD compositions. All of the edible CBD compositions of modified Bhairam, Steup, and Eades et al. all contain emulsifiers/surfactants. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the CBD composition disposed in the container of modified Bhairam and adjust the concentration of CBD nanoparticles and the concentration at least one surfactant since differences in the concentration of CBD nanoparticles and the concentration of the at least one surfactant in the colloid will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration of CBD nanoparticles and concentration of the at least one surfactant encompassed by the prior art unless there is evidence indicating such concentration of CBD nanoparticles and concentration of the at least one surfactant is critical. Where 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.). One of ordinary skill in the art would adjust the concentration of CBD nanoparticles of the colloid of modified Bhairam based upon the desired dosage concentrations of CBD that imparts properties including increased concentration, increased cognitive ability, and increased memory function as taught by Steup et al. (‘699, Paragraphs [0028]-[0030]) and based upon the desired dosage of cannabis product as taught by Benson et al. (‘044, Paragraph [0090]). Additionally, one of ordinary skill in the art would adjust the concentration of emulsifier/surfactant of the colloid of modified Bhairam based upon the desired formulation dispersability as taught by Eades et al. (‘358, Paragraph [0041]).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bhairam US 2018/0098552 as further evidenced by Levy US 2021/0353589 in view of Millikin US 2020/0377290 and Heller US 2020/0054702 as applied to claim 11 above in further view of Vangara et al. US 2020/0360286.
Regarding Claims 14-15, Bhairam as further evidenced by Levy in view of Millikin and Heller is silent regarding the CBD nanoparticles and the at least one surfactant present in the colloid being approximately equal amounts by weight or the CBD nanoparticles and the at least one surfactant each being present in the colloid in an amount of between about 5 wt% and about 50 wt% or between about 10 wt% and about 33 wt%.
Vangara et al. discloses an oral dosage (‘286, Paragraphs [0004] and [0074]) of a self-emulsifying cannabidiol composition comprising from about 1 to about 40% w/w cannabidiol and from about 40% to about 99% w/w w/w or one or more surfactants of a propylene glycol (‘286, Paragraph [0020]). Vangara et al. teaches an embodiment of the cannabidiol composition comprising about 40% w/w cannabidiol and about 40% w/w of one or more surfactants of a propylene glycol, which falls within the claimed
Both modified Bhairam and Vangara et al. are directed towards the same field of endeavor of orally ingestible cannabidiol (CBD) compositions. Both CBD compositions of modified Bhairam and Vangara et al. comprises a propylene glycol surfactant. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the CBD composition disposed in the container of modified Bhairam to have the claimed concentration of CBD particles and the claimed concentration of the at least one surfactant as taught by Vangara et al. since where the claimed concentration of CBD particles and the claimed concentration of the at least one surfactant encompassed the concentration of CBD particles and the concentration of the at least one surfactant disclosed by the prior art, a prima facie case of obviousness exists in view of 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) (MPEP § 2144.05.I.).
Response to Arguments
Examiner notes that the previous Claim Objections have been withdrawn in view of the amendments.
Examiner notes that the previous anticipation rejections under 35 USC 102 to Camera et al. have been withdrawn in view of the amendments. Applicant’s arguments with respect to the previous anticipation rejections under 35 USC 102 to Camera et al. are moot since this particular rejection has been withdrawn.
Examiner notes that a new obviousness rejection under 35 USC 103(a) to Camera et al. in view of Steindler et al. has been made in view of the amendments.
Applicant's arguments filed September 15, 2026 with respect to the obviousness rejections under 35 USC 103(a) to Bhariam as further evidenced by Levy in view of Millikin and Heller have been fully considered but they are not persuasive.
Applicant argues on Page 8 of the Remarks that Bhairam does not teach mixing a CBD colloid into a packed bed and that Bhairam discloses a cannabinoid extract is dissolved in propylene glycol wherein propylene glycol can be included in a coffee beverage to the extent necessary to dissolve the extracted cannabinoids and describes propylene glycol as a solvent for THC/cannabis plant extract and that in a solution there is no dispersed phase or a solute present as discrete particles. Applicant contends that Bhairam does not meet the definition of a colloids as used in the application as a mixture in which particles of one substance (dispersed phase) are dispersed throughout a volume of a different substance (dispersion medium).
Examiner argues Bhairam discloses an embodiment wherein the cannabinoids are first premixed with propylene glycol at elevated temperature to produce a homogeneous mixture and then the homogenous mixture is admixed or infused into a coffee product of ground coffee (‘552, Paragraph [0011]). Levy provides evidence that it was known in the art that propylene glycol is a type of surfactant (‘589, Paragraph [0187]) for a water soluble cannabinoid formulation (‘589, Paragraph [0002]) in the form of a nontoxic consumable liquid form or a dispersible powder form used for the preparation of a beverage (‘589, Paragraph [0009]). Therefore the propylene glycol that is mixed with cannabinoids and ground coffee disclosed by Bhairam (‘552, Paragraph [0022]) is a type of surfactant as evidenced by Levy (‘589, Paragraph [0187]). Bhairam discloses a homogeneous mixture of cannabinoids first premixed with propylene glycol surfactant at elevated temperature to produce a homogeneous mixture (‘552, Paragraph [0011]), which necessarily meets applicant’s claimed definition of a colloid wherein particles of one substance (dispersed phase) are dispersed throughout a volume of a different substance (dispersion medium). Therefore, these arguments are not found persuasive.
Applicant argues on Pages 8-9 of the Remarks that the proposed combinations of Bhairam with Millikin and Heller are inapposite in that the cannabinoid containing particles of Millikin are particles of ground cannabis plant matter that have been size reduced to a particle size of no more than 120 µm or no more than 1000 µm and that Millikin is directed to a dry particulate and not a colloid since Millikin offers no teaching relating to a dispersion medium. Applicant contends it is unclear how the teachings relating to the dry particulate can be combined with the teachings of Bhariam relating to dissolution of cannabinoids in propylene glycol. Applicant continues it is unclear how the encapsulated cannabis derived particles of Heller could be incorporated into the teachings of Bhairam since Heller also teaches propylene glycol as a solvent and not a surfactant. Applicant continues that Heller does not teach the use of propylene glycol as an emulsifier/surfactant for cannabinoids and that propylene glycol and polypropylene are different material with different properties and uses.
Examiner argues the primary reference of Bhairam already teaches a colloid mixture containing cannabinoid particles mixed with a surfactant (propylene glycol) (‘552, Paragraph [0011]). The disclosure of Paragraph [0011] of Bhariam that the cannabinoids are first premixed with propylene glycol at elevated temperatures to produce a homogenous mixture which homogenous mixture is then admixed or infused into a coffee product of ground coffee necessarily entails a colloid. The secondary references of Millkin and Heller are being relied upon to teach the limitations regarding the size of cannabinoid particles being nano particle sized to reduce the chances of having undesirable sediment in the beverage as taught by Millikin. Millikin is not being relied upon for the limitations with respect to a colloid (which is already taught by the primary reference of Bhariam) but rather is being relied upon for its teachings of using nano sized cannabinoids to reduced undesirable sediment in the beverage. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). With respect to applicant’s comments on Heller, it is noted that Claim 11 recites a generic at least one surfactant and does not specify the particular surfactant used in the colloid. The primary reference of Bhairam teaches using at least one surfactant of propylene glycol. Even though Heller discloses propylene glycol in another context, Heller teaches using a generic surfactant in which the type of surfactant has an impact on particle size on the emulsion system (‘702, Paragraph [0091]) for cannabinoid emulsions (‘702, Paragraph [0142]) wherein the cannabionoids are homogeneously distributed or dispersed throughout the solution (‘702, Paragraph [0241]) wherein the cannabinoid is in a colloidal solution (‘702, Paragraph [0010]) in which colloidal milling reduces the particle size of the components suspended in a liquid (‘702, Paragraph [0237]) in which nanoparticle size cannabinoids reduces the time for onset of action in the body o a consumer who ingests the emulsion (‘702, Paragraph [0004]). The secondary reference of Heller teaches a colloid comprising cannabinoid nanoparticles which nanoparticle sizes reduces ingestion time. Therefore, these arguments are not found persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Reillo et al. US 2018/0069078 discloses a lipophilic active agent infused beverage product obtained by providing lipophilic active agent infused tea leaves, coffee beans, or cocoa powder (’078, Paragraph [0012]).
Wong et al. US 2012/0258221 discloses a capsule comprising an extractable or soluble product such as ground coffee, instant coffee, chocolate, cacao, tea, soup mixture, etc. wherein the capsule accommodates a powder to form a colloid upon interaction with a fluid supplied by a dispensing device (‘221, Paragraph [0057]).
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.
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/ERICSON M LACHICA/Examiner, Art Unit 1792
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