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 Status
Applicant’s remarks and amendments, filed 20 January 2026 in response to the non-final rejection mailed 23 July 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 20 January 2026 replaces all prior versions and listings of the claims.
Claims 1, 3, 8-10, 12, 13, and 18-23 are pending. Claims 2, 4-7, 11, and 14-17 are canceled by Applicant’s amendment. Claims 21-23 are newly added. Claims 1, 8, 9, 18, and 20 are amended. Claims 1, 3, 8-10, 12, 13, and 18-23 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendments to the specification have overcome the specification objection in regards to capitalization of Cannabis. The objection to the specification has thus been withdrawn.
Applicant’s amendments to Claims 1, 7-9, 17, and 18 have overcome the claims objection in regards to capitalization of genus names, italicizing scientific names, and duplicate listings in the Markush groups. The objection to Claims 1, 7-9, 17, and 18 has thus been withdrawn.
Claim Objections
Claim 1, 3, 8-10, 12, 13, and 18-23 are objected to because of the following informalities:
Throughout the claims, the spelling of “psilocybin” changes; in Claim 1, “psilocybin” is used, however in Claim 9, “psylocibin” is used. Please use consistent spelling to refer to this compound throughout.
In Claim 22, line 1, the phrase “popcorn kernels; ; and” should instead read --popcorn kernels; and--.
In Claim 22, line 14, the phrase “(/U)” should instead read --(U)--.
Appropriate correction is required. All other claims depend directly or indirectly from objected to claims and are, therefore, also objected to for the reasons set forth above.
Please also note that in claim 1 the step labels presently begin with step (K), resultant of the cancellation of subject matter (A) through (J). Although not presently objected to, the claim (and claims depending therefrom) would be objected to or amended prior to any potential allowability notice. Accordingly, it is presently suggested that during prosecution that the step labels be sequentially renumbered.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1, 3, 8-10, 12, 13, and 18-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for infusing coconut oil with whole spectrum mushroom compounds, does not reasonably provide enablement for infusing coconut oil with whole spectrum mushroom compounds comprising psilocybin and psilocin. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to perform the method commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of producing a coconut oil infused with whole spectrum mushroom compounds comprising psilocybin and psilocin. Thus, the claims imply that the method is for extraction of psilocybin and psilocin using an oil-based solvent.
The disclosure, however, is drawn to a method for infusing a food grade oil with whole spectrum Cannabis compounds and whole spectrum mushroom compounds, which is then used to infuse consumables with the whole spectrum Cannabis and mushroom oil.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
It is known in the art that psilocybin and psilocin are extractable with polar solvents such as methanol, ethanol, and hydroalcoholic solutions due to their high polarity (Galdino et al., Pharmaceuticals, 2025, 3.4., page 9). Psilocin is slightly more soluble in non-polar solvents (Galdino et al., 3.4., page 9), however polar solvents are most frequently used and known in the art for extraction of these compounds (Galdino et al., Table 2, pages 18-19) and use of the weakly polar solvent chloroform resulted in an unsuccessful extraction, highlighting the need for use of polar solvents to efficiently obtain psilocybin and psilocin (Galdino et al., 3.4., page 20).
Since the extraction of psilocybin and psilocin using a food grade oil as a solvent remains largely unsolved, means for successful extraction is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high, with respect to successful solvent extraction of psilocybin and psilocin in general. However, extraction of psilocybin and psilocin with food grade oil as the solvent remained unresolved as evidenced by Galdino et al. as described above, and beyond the purview of one of skill. Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided a method for infusing food grade oil with mushroom compounds (see e.g., [0050]-[0059]). However, the specification does not provide evidence of successful extraction of psilocybin or psilocin (or the highly polar compounds norpsilocin, baeocystin, norbaeocystin, and aeruginascin of Claim 23) using this method, nor does it imply that the method is specific for the extraction of these polar compounds. While the specification mentions that psilocybin and psilocin are found in mushrooms collectively known as psilocybin mushrooms which provide psychoactive and psychedelic effects when consumed ([0006]-[0007], there is no mention of their extraction or implication that they are extractable with the disclosed method.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Galdino et al. and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to determine whether the method as disclosed provides the function of extraction of psilocybin or psilocin from mushroom material.
It is the Examiner’s position that one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. §112(a) for the reasons set forth above.
Claim Rejections - 35 USC § 112(b)
The following is a quotation 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 8-10, 12, 13, and 18-23 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 recites the limitation "the coconut oil.” There is insufficient antecedent basis for this limitation in the claim.
Claim 1 states that the whole spectrum mushroom compounds comprise psilocybin and psilocin, and that the mushroom material is psilocybin-containing mushroom material, however dependent Claim 8 lists psilocybin mushrooms along with a Markush group of other mushrooms which do not comprise psilocybin and psilocin. It is unclear whether the claim is implying that all of the mushrooms of Claim 8 are intended to be known as psilocybin-containing mushrooms, whether there are mushrooms in addition to the psilocybin mushroom, or if another meaning is intended.
Claim 9 states that whole spectrum mushroom compounds comprise psilocybin and psilocin, and that the mushroom material comprises a psilocybin mushroom, however dependent Claim 18 indicates that the mushroom material is selected from a group consisting of numerous mushrooms, including those which do not comprise psilocybin and psilocin. Again, it is unclear whether the claim is implying that all of the mushrooms of Claim 18 are intended to be known as psilocybin-containing mushrooms, whether there are mushrooms in addition to the psilocybin mushroom, or if another meaning is intended.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. §112(b) for the reasons set forth above.
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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.
The factual inquiries 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 1, 8-10, 13, 18, 19, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Randel (US 2021/0092972 in view of Kubala (HealthLine, 2021, 14 pages).
The instant claims are as of record, drawn to a method comprising repeated heating and freezing steps for producing whole spectrum mushroom compound-infused food grade oil and consumables.
Randel teaches a method for making Cannabis infused coconut oil comprising providing Cannabis, freezing the Cannabis, providing an orally ingestible (food grade) oil at a temperature of 150-200°F, adding at least a portion of the Cannabis to the oil to form a mixture, heating to 150-200°F for 4-8 hours, freezing the mixture, heating the mixture to 150-200°F for 2-4 hours, straining the mixture to separate the oil and yield an infused (whole spectrum or full spectrum; see Randel, col. 2, ln. 63), orally ingestible oil (Randel, Claim 1, page 4; as required for instant Claim 1, steps K-P; and instant Claim 9, steps K-Q).
The method further comprises adding an orally ingestible consumable to the infused oil to form a mixture, heating the mixture to 190-200°F for 4-12 hours, freezing the mixture, heating to 190-200°F for 4-12 hours, freezing the mixture, heating to 100-150°F for 2-4 hours, and removing (straining) the consumable from the mixture to yield an orally ingestible consumable (Randel, Claim 6, page 4; as required for instant Claim 9, steps S-W and instant Claims 20-22). The heating and freezing steps after combining the consumable and oil can be repeated at least one time (Randel, Claim 6, steps K-N, page 4; as required for instant Claim 13) and freezing provides pressure to the coffee beans, roasted nuts, or roasted seeds that deepens the depth of infusion into the consumable (Randel, [0039], page 2; as required for instant Claims 1, 9, and 20-22). The orally ingestible consumable can be coffee beans, roasted nuts, or roasted seeds (Randel, Claim 10, page 4; as required for instant Claims 9, 19, and 20), which are subsequently frozen (Randel, Claim 13, page 4; as required for instant Claim 10).
Randel does not teach wherein the method is for infusion with mushroom compounds or providing mushroom material.
Kubala, however, teaches that adaptogenic mushrooms including cordyceps, Lion’s mane, and reishi (as required for instant Claims 1, 8, 9, 18, and 23) are popular in the health and wellness world (Kubala, entire document). Lion’s mane extract (e.g., whole spectrum mushroom compounds), for example, helps reverse stress-related changes in neurotransmitters, reduce stress-related inflammatory markers, and reverse down-regulation of brain-derived neurotrophic factor (Kubala, page 5).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Randel and Kubala to arrive at the instantly claimed invention. A skilled artisan exploring the field of bioactive-compound-infused foods would be motivated to do so due to the health benefits and popularity of adaptogenic mushroom extracts and products (Kubala, page 1). Additionally, a skilled artisan would have a reasonable expectation of success because the known method of Randel has been demonstrated as effective for obtaining whole spectrum infused coconut oil which can then be used to make oil-infused consumables.
Claims 1, 3, 8-10, 12, 13, 18, 19, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Randel (US 2021/0092972 in view of Kubala (HealthLine, 2021, 14 pages) as applied to Claims 1, 8-10, 13, 18, 19, and 23 above, and further in view of Xiao et al. (Sci Rep, 2015, 11 pages).
The instant claims and teachings of Randel and Kubala are as of record.
Randel and Kubala do not teach wherein the freezing and thawing cycles are repeated one or more times.
Xiao et al. teach that repeated freeze-thaw treatment (as required for instant Claim 3 and 12,) of a mushroom biomass (e.g., truffle), provides a product with improved aroma and flavor (Xiao et al., Abstract, page 1).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Randel, Kubala, and Xiao et al. to arrive at the instant invention. A skilled artisan would be motivated to use the repeated freeze-thaw cycles provide an improved aroma for the mushrooms (Xiao et al., Abstract, page 1). A skilled artisan could therefore incorporate the method of Xiao et al. into the method of Randel using mushrooms as taught by Kubala with a reasonable expectation of success.
Claims 1, 8-10, 13, and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Randel (US 2021/0092972 in view of Kubala (HealthLine, 2021, 14 pages) as applied to Claims 1, 8-10, 13, 18, 19, and 23 above, and further in view of Randel ‘819 (US 11,464,819 B2).
The instant claims and teachings of Randel and Kubala are as of record.
Randel and Kubala do not teach wherein the orally ingestible consumable comprises cacao beans or popcorn kernels, or the specific temperatures of Claims 20-22.
Randel ‘819, however, teaches infused consumables such as cocoa (cacao) beans, which can be used to make chocolate products, and popcorn (e.g., popcorn kernels of microwave popcorn; Randel ‘819, col. 4, ln. 5-26; as required for instant Claims 21 and 22). Additionally, Randel ‘819 teaches that the consumable and coconut oil mixture is heated to 175-185°F, preferably 170°F for popcorn kernels (Randel ‘819, col. 4, ln. 34-59; col. 7, ln. 25; as required for instant Claims 20-23).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Randel, Kubala, and Randel ‘819 to arrive at the instantly claimed invention. A skilled artisan exploring the field of bioactive-compound-infused foods would have a reasonable expectation of success because the known method of Randel has been demonstrated as effective for obtaining whole spectrum infused coconut oil which can then be used to make oil-infused consumables, and a skilled artisan would be further motivated to incorporate the method of Randel ‘819 in order to provide additional consumables such as chocolates and popcorns due to the popularity of adaptogenic mushroom extracts and products.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Relevant Art Made of Record but not Relied Upon
The following documents are considered relevant to the state of the art regarding methods of making infused food grade oil products.
Baar (eGForums, 2006, 5 pages) discusses recipes for porcini mushroom oil infusions and high-level methods of making a porcini-infused olive oil.
HMMessinger (Food52, 2015, 5 pages) discloses a recipe for shiitake-infused grapeseed oil.
Response to Arguments
Applicant's arguments and affidavit filed 20 January 2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the teachings of Sloat have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The affidavit (and Remarks, pages 4-7) is drawn specifically to extraction of psilocybin and psilocin from mushroom material using an oil-based carrier for extraction, stabilization, and infusion of whole spectrum mushroom compounds. The claims, however, are not drawn to a method for extracting psilocybin and psilocin, nor is there any indication in the claims or the disclosure that there are unexpected results of successful use of a non-polar, coconut oil solvent for extraction of these compounds from mushrooms and subsequent infusion into consumable products. While it is acknowledged that a skilled artisan would not expect to be able to extract highly polar compounds using a non-polar oil, the instant disclosure does not provide a method or supporting evidence for success of the claimed method at doing so; see the 35 USC § 112(a) rejection above. It is stated that the “claimed infusion process preserved and transferred a range of mushroom-derived compounds” into the oil system, including those with differing chemical properties and stability profiles such as psilocybin and psilocin (Affidavit, Item 8). Again, as discussed above, the disclosure does not indicate which compounds are infused into the coconut oil, nor is there specific disclosure or evidence of extraction of psilocybin and psilocin; the instant disclosure is drawn to a method for infusing a food grade oil with whole spectrum Cannabis compounds and whole spectrum mushroom compounds, which is then used to infuse consumables with the whole spectrum Cannabis and mushroom oil.
In response to applicant's argument that Randel and Xiao are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Randel, Kubala, Randel ‘819, and Xiao et al. are all within the field of bioactive consumable products. Randel and Randel ‘819 disclose methods for making oils and consumables infused with bioactive compounds; Kubala discloses that mushrooms contain bioactive compounds which are popular products; and Xiao et al. discloses freeze-thaw cycles to make consumable mushroom products taste better. The art is, therefore, analogous and falls within the same field of bioactive consumable products.
Applicant goes on to argue that Xiao et al. would not be examined by a person of ordinary skill in the art because the problem faced by the inventor is that there are many methods of consuming psilocybin mushrooms, but some have an unpleasant taste and can be messy (Remarks, page 9). First, it is noted that improved taste and reduced messiness are not recited in the instant claims, nor is a requirement for health or psychoactive effects. Second, it is noted that Xiao et al. teach that repeated freeze-thaw cycles resulted in an improved quality of aroma, which was due to volatile organic compounds which affect aroma (and by extension, taste, because it is well known that there is a connection between the sense of taste and the sense of smell), going from “liked slightly” to “liked moderately” (Xiao et al., Abstract, page 1). This is not only within the same field of endeavor (e.g., consumable products comprising bioactive components), but is also relevant to an artisan in providing a method which would help improve aroma, and by extension taste, of the claimed consumables.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., stabilization, increase in coffee mass, extraction of polar compounds with a non-polar oil, exclusion of a polar solvent, specific health or psychoactive effects) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
No claims are allowed.
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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655