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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/28/2025 has been entered.
Status of claims
Claims 1-18 as amended on 12/28/2025 are pending.
Claims 17-18 were have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1-16 as amended on 12/28/2025 are under examination in the instant office action.
Claim Rejections - 35 USC § 112
Indefinite
Claims 1-16 as amended are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 as amended recites the limitation "oil-related flavors” in a composition comprising at least two oils as two separate components including 1) “a cannabis oil” and 2) “a carrier oil”. Thus, if it unclear what “oil-related flavor” is intended to be improved. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 as result of current amendment appears to recite the same limitiaotn that is recited in claim 1. Thus, there is an uncertainly about scope of claim 10.
Claim 14 recites the limitation "a carrier oil” in the composition of claim 1 which already contains “a carrier oil”. Thus, there is uncertainty in the claim and/or there is insufficient antecedent basis for this limitation in the claims.
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.
Claims 1-12 and 16 as amended are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/033241 (Langan et al) and Peshkovsky (“Water-Soluble Cannabis Oils: Microemulsion, Liposomes or Nanoemulsion?”. Sonomechanics Blog, posted for public on Nov. 24, 2016; webpage https://blog.sonomechanics.com/blog/water-soluble-cannabis-oil-microemulsion-liposomes-or-nanoemulsion; pages 1-3 of 36; retrieved on 2/26/2026)
The cited document WO 2016/033241 (Langan et al) discloses a composition product or oral administration, wherein the composition comprises a combination of: 1) an extracellular portion from a mycelial aqueous culture comprising a filamentous fungus (see abstract) including Cordyceps sinensis (see abstract); and 2) a food product ingredient (abstract) such as cannabinoid or Cannabis (par. 0029 on page 6, last line); wherein the composition has a reduced undesirable taste compared with the same composition lacking the extracellular portion (abstract; par. 0028). The product is intended for oral administration and is provided as a food, or a dietary supplement (abstract; 0015). The cited document WO 2016/033241 (Langan et al) explicitly acknowledges that a supernatant (extracellular portion) of mycelial aqueous culture of Cordyceps sinensis improves and enhances taste of food (abstract) that are based on bitter plant extracts (0028) including Cannabis (0029).
The disclosure of WO 2016/033241 (Langan et al) is silent about a form of cannabinoid or Cannabis in which it is incorporated into the final food products. In particular and as applied to claim 1 as amended, the disclosure of WO 2016/033241 (Langan et al) is silent about incorporation of a surfactant and a carrier oil in the composition together with an extracellular portion of mycelial extract and a plant derived cannabinoid/cannabis oil.
However, the prior art document by Peshkovsky teaches that Cannabis or cannabinoid in food or beverage provided as cannabis oil extract and that cannabinoid-containing formulations are provided as oil-in-water emulsions, microemulsions, liposomes or nano-emulsion (pages 1-3). The cannabinoid-containing formulations comprise a carrier oil and a surfactant (page 3). In particular, the nano-emulsions are made using lower surfactant amounts than microemulsions or liposomes, thereby avoiding soapy taste (pages 2-3). Peshkovsky teaches that in a typical cannabinoid-containing product for every 20-30 mg of cannabis oil there is 7-11 mg of surfactant (page 3). Peshkovsky teaches that nano-emulsions are water-compatible and can be easily mixed into food or beverages.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide a cannabinoid ingredient in the composition of WO 2016/033241 (Langan et al) as oil-in-water emulsions or nano-emulsions of Peshkovsky {which comprise cannabis oil, surfactant and a carrier oil, and wherein for every 20-30 mg of cannabis oil there is 7-11 mg of surfactant} with a reasonable expectation of success in providing a final composition suitable for oral administration and having better taste because cited document WO 2016/033241 (Langan et al) explicitly acknowledges that a supernatant of mycelial aqueous culture of Cordyceps sinensis improves and enhances taste of food including food with Cannabis and because Peshkovsky teaches that Cannabis oil extract used in food or beverage is provided in a form of nano-emulsion with low amounts of surfactant on order to avoid unpleasant taste.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Further as applied to claims 2-3: the cited document WO 2016/033241 (Langan et al) teaches that the filamentous fungus is selected from the group consisting of Ganoderma lucidum, Ganoderma applanatum, Cordyceps sinensis, Cordyceps militaris, Hericium erinaceus, Lentinula edodes, Agaricus blazei, Grifola frondosa, Auricularia auricula, Flammulina velutipes, Trametes versicolor, Morchella spp., Inonotus obliquus, Lanicifomes officinalis, Fomes fomentarius, Fomes officinalis, Fomes fomitopsis, Tricholoma matsutake, Boletus edulis, Clitocybe nuda, Clitocybe saeva, Plearotus spp., Tremella fuciformis, Piptoporus betulinus, Polyporus umbellatus, Pholiota nameko, Volvariella volvacea, Hypsizygus marmoreus, Stropharia rugosoannulata, and Laetiporus sulohureus. The profred filamentous fungus is Cordyceps sinensis.
As applied to claims 4-8: the cited document WO 2016/033241 (Langan et al) teaches that the extracellular portion of the mycelial aqueous culture is prepared by a method comprising culturing the mycelial aqueous culture in a media, separating the extracellular portion from the mycelial cells; and collecting the extracellular portion of the mycelial aqueous culture (0027). The extracellular portion of the mycelial aqueous culture is obtained by filtration and pasteurized (par. 0022, last 3 lines; par. 0016) or centrifugation of the mycelial aqueous culture.
As applied to claims 9 and 16: both cited documents teach the product for oral administration such as food, or a dietary supplement, or a medical formulation, or a beverage. For example: see WO 2016/033241 (Langan et al) at abstract and 0015. For example: see Peshkovsky at page 3. Peshkovsky also teaches that Cannabis oil extract used in beverage or medical formulation is provided in a form of nano-emulsion with low amounts of surfactant on order to avoid unpleasant taste as explained above.
As applied to claim 10: Peshkovsky teaches that Cannabis or cannabinoid in food or beverage is provided as cannabis oil extract in oil-in-water emulsion or nano-emulsions as explained above. (pages 1-3).
As applied to claim 11: a combination of a water-soluble extracellular portion from a mycelial aqueous culture Cordyceps sinensis of WO 2016/033241 (Langan et al) with cannabis oil extract in oil-in water nano-emulsion of Peshkovsky is a water-in-oil emulsion within the bordeast meaning of the claims.
As applied to claim 12: Peshkovsky teaches that surfactant can be lecithin (page 3).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/033241 (Langan et al) and Peshkovsky (“Water-Soluble Cannabis Oils: Microemulsion, Liposomes or Nanoemulsion?”. Sonomechanics Blog, posted for public on Nov. 24, 2016; webpage https://blog.sonomechanics.com/blog/water-soluble-cannabis-oil-microemulsion-liposomes-or-nanoemulsion; pages 1-3 of 36; retrieved on 2/26/2026) as applied to claims 1-12 and 16 above, and further in view of WO 2018/061007 (Garti et al).
The cited WO 2016/033241 (Langan et al) and Peshkovsky as above.
Peshkovsky teaches that in the cannabinoid-containing product a surfactant, which is used in oil-in-water emulsions with cannabis oil extract, can be lecithin (page 3). Further, the cited WO 2018/061007 (Garti et al) also teaches that cannabinoid-containing formulations comprise a carrier oil and a surfactant (page 3, lines 12-14), wherein the surfactant is lecithin such as soy lecithin, sunflower lecithin and/or egg lecithin (page 9, par. 3); and wherein the oil comprises triglycerides (page 7, lines 4-5).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 12/18/2025 have been fully considered but they are moot in view of new grounds of rejection necessitated by amendment.
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Vera Afremova
February 6, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653