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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/12/2026 has been entered.
DETAILED ACTION
Claims 1-17 are cancelled. Claims 18-20 are pending and under examination.
Claim Objections
Claims 18 and 19 are objected to because of the recitation, “Cannabis”, which is improper notation of genus. Conventional recitation requires the italicized recitation of the genus with a capital letter, as in “Cannabis”. Appropriate correction is required.
Declaration under 37 C.F.R. 1.132
A Declaration is due full consideration and weight for all that it discloses. Declarations are reviewed for the following considerations: 1) whether the Declaration presents a nexus such as a side-by-side or single-variable comparison (In re Huang, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996)); 2) whether the Declaration presents a comparison to the closest art; 3) whether the Declaration is commensurate in scope with the scope of the claims (In re Kulling, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)); 4) whether the Declaration shows the difference in results are in fact unexpected and unobvious and of both statistical and practical significance (Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)); and 5) whether the prima facie case is sufficiently strong that allegedly superior results are insufficient to overcome the case for obviousness (Pfizer Inc. v. Apotex, Inc., 82 USPQ2d 1321, 1339 (Fed. Cir. 2007)).
The Declaration by Dr. Jordan Seth Rubin under 37 CFR 1.132 filed on January 12, 2026 is insufficient to overcome the previous rejection of claims 18-20 under 35 U.S.C. 103 because: while applicant presents information supporting the lack of cannabinoids in hemp seed, the lack of cannabinoids in hemp seed meal is not an unexpected result (declaration item 4). Applicant further argues that Arbuscular Mycorrhizal Fungi (AMF) are not edible mycelia according to the present invention, and that AMF are obligate plant symbionts that improve nutrition and health of their host plant but are not grown for human consumption (declaration item 4). It is noted that the primary reference Hong teaches adding Cordyceps sinensis mycelium strain to the fermentation medium, which is a mushroom suitable for human consumption.
Applicant further argues that edible mushrooms are exceedingly difficult to grow, particularly on a non-traditional growth medium, and the excessive amount of water in the present claims, 2 parts water compared to the weight of Cannabis growth medium amounting to four times higher than traditional mycelia culture processes, is what makes the present technology work and is a key feature of the unexpectedly improved results attainable with the claimed invention (declaration item 5). It is noted that applicant’s data shows growth occurred at both 1:1 and 2:1 ratios of water. Hong teaches a ratio of material to water of 1.2:1, and Sakai teaches water in a ratio of 1 to 100 parts water to 1 part by weight of plant, which falls within the scope of the water ratio required by claim 18. Applicant does not provide experimental data using water ratios of 1.2:1 or water ratios of 3 or higher as a comparison to the closest prior art water ratios of 1 to 100 to 1 part by weight plant material.
Applicant identifies experimental conditions (declaration item 6) and provides data for 4 different water ratios of 0.8:1; 1:1; 2:1; and 2.2:1; presented in text and graphical form (declaration items 10 and p.8 graph). Applicant identifies that mycelium growth was observed at water ratios of 1:1 and 2:1 but not at 0.8:1 and 2.2:1; thereby demonstrating the criticality of the water ratio (declaration items 11 and 13). The data appears to be a sample size of 1 without additional replicates. No data is provided for water ratios greater than 2.2:1 or less than 0.8:1.
While a graph is presented showing no growth (value zero) for water ratios of 0.8:1 and 2.2:1 and a growth of 100% (value 100) at water ratios of 1:1 and 2:1; the declaration does not provide a nexus such as a side-by-side comparison of a range of different water ratios and the resulting mycelial growth following fermentation. The declaration does not demonstrate a difference in results, nor present evidence that the results are in fact unexpected, unobvious, and of both statistical and practical significance.
Claim Interpretation
Claim 18 and the claims that depend from claim 18 contain the transitional language “consisting essentially of”. Applicant has not pointed to where in the specification the basic and novel characteristics are identified, and what particular steps are excluded by the claimed method that would materially affect the novel characteristics. Furthermore, the Examiner cannot identify any additional steps taught in the prior art that differentiate from the instantly claimed method. For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant's invention. PPG Industries Inc. V Guardian Industries Corp. 48 USPQ2d 1351 (Fed. Cir. 1998) and In re De Lajarte 337 F.2d 870, 143 USPQ 256 (CCPA 1964) See MPEP §2111.03.
The instant specification does not define the term “consisting essentially of” in a manner that would allow one skilled in the art to determine what basic and novel characteristics are being materially affected. The specification of the instant application teaches the steps of dividing cannabis into particles; mixing particulate cannabis with water in a 1:2 ratio to form a slurry; sterilizing the slurry; inoculating the slurry with mycelium; incubating the inoculated slurry; drying the mycelial biomass; and powdering the dried co-fermentation product. These are the same steps described by Hong, Sakai and Rivas for their methods.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The rejection of Claim 19 is evidenced by Pollio (“The Name of Cannabis: A Short Guide for Nonbotanists”, Cannabis and Cannabinoid Research, 2016, Vol. 1, Issue 1, pp.234-238).
Claim 19 recites that the Cannabis is selected from the group consisting of Cannabis indicus, Cannabis sativa, and Cannabis ruderalis. As evidenced by Pollio, the genus Cannabis only includes three species – Cannabis sativa, Cannabis indica and Cannabis ruderalis (abstract; p.236, 2nd column last paragraph). As there are no other recognized species of Cannabis, claim 19 does not further narrow claim 18 from which it depends, and therefore is an improper dependent claim.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
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 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (CN102599004A, published on July 25, 2012; of record) in view of Sakai et al. (EP 1407679 A1; published on April 14, 2004; of record) and Rivas (US20180296616A1, published on October 18, 2018; of record). As the original CN102599004A document is in Chinese, an English translation is relied upon for support.
Regarding claim 18 steps (b)-(g), Hong teaches a method for cultivating Cordyceps mycelium and fructus cannabis (English translation p.1, claim 1). Hong identifies that fructus cannabis is the Moraceae plant Cannabis sativa (English translation p.2, paragraph 0005). Hong teaches [for transforming] active ingredients into Chinese medicinal herb by microbial fermentation, the culture can be combined with the functional content of the microorganism and the medicine, which improves the treating and healthcare effect (English translation p.2, paragraph 0004). Hong teaches the preparation of a fermentation medium containing 30-50% hemp seed meal from Cannabis sativa, wherein the ratio of material to water is 1.2:1 (relevant to claim 18, step b) (English Translation p.2, paragraph 0009). Hong further teaches sterilizing the slurry at 121°C (equivalent to 250°F) for 60 minutes (relevant to claim 18, step c) (English Translation p.2, paragraph 0009). Hong teaches adding the Cordyceps sinensis mycelium strain to the sterilized fermentation medium and culturing at 10°C - 30°C for 30 days (equivalent to 50°F-86°F) (relevant to claim 18, steps d and e) (English Translation p.2, paragraph 0010). Hong further teaches drying the fermented product at 50°C (equivalent to 122°F) to constant weight (relevant to claim 18, step f) (English Translation p.2, paragraph 0011). Hong teaches crushing the dried fermented substance into a powder (relevant to claim 18, step g) (English Translation p.2, paragraph 0011).
Hong does not teach dividing leaves of the cannabis into particles [step (a)] and mixing 1 part of shredded cannabis with 2 parts water [step (b)].
However, Sakai teaches a method of producing a liquid plant extract containing plant powder (abstract). Sakai teaches that plants containing active ingredients include Cannabis sativa (description p.4, paragraph 0017). Sakai teaches preparing an extraction from plants containing an active ingredient by collecting and fermenting leaves (relevant to claim 18, step a) dividing any unextracted aerial parts leaves of one or more Cannabis species) (description p.3, paragraph 0002). Sakai further teaches crushing and shearing a plant to produce particles 0.1µm to 1mm in size (relevant to having a major dimension of 1cm or smaller) (description p. 9, paragraph 0045). Sakai teaches mixing the plant particles with a solvent such as water in a ratio of 1 to 100 parts water to 1 part by weight of plant (relevant to claim 18, step b) admixing one part by weight of shredded Cannabis from step a) with two parts by weight of water to form a slurry) (description p. 8, paragraph 0034).
Rivas teaches preparing a purified extract from fresh cannabis (relevant to any unextracted aerial parts leaves) (description p.1, paragraph [0001]). Rivas teaches fresh plants may be initially processed by being shredded and/or finely chopped (relevant to dividing to create a coquantity of shredded Cannabis) (description p.2, paragraph [0033]). Rivas teaches the fresh plant material maybe be placed in a distillation vessel (description p.2, paragraph [0035]). Rivas teaches an amount of water may then be added to the distillation vessel containing the raw plant material to prepare the mixture (relevant to admixing shredded Cannabis with water to form a slurry) (description p.2, paragraph [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace hemp seed meal taught by Hong with shredded fresh cannabis material taught by Rivas in the form of shredded Cannabis leaf particles taught by Sakai, because it would have amounted to a simple substitution of one known cannabis aerial part (fruits/seeds) for another aerial part (leaves). Hong teaches using hemp and cordyceps together to obtain the combined medicinal properties of both of these plants. The teachings of Hong, Sakai and Rivas all suggest that starting with an aerial part of the plant, either hemp seed meal and shredded cannabis leaves, represent functionally equivalent starting materials to obtain the predictable result of a cannabis-water mixture. Therefore, one of ordinary skill in the art would have a reasonable expectation of success that using fresh shredded leaves taught by Rivas and Sakai in the method of fermentation taught by Hong would predictably result in obtaining the method of co-fermenting cannabis with mycelial culture of one species of mushroom of the claimed invention.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to increase the sterilization time taught by Hong to identify optimum conditions and obtain a sterilized product with a reasonable expectation of success, by allowing more time for sterilization. The results would have been predictable to one of ordinary skill in the art as the process of sterilization was known at the time of invention.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the incubation time taught by Hong to identify optimum conditions and obtain the degree of incubation desired with reasonable expectation of success, by adjusting the incubation time based on the species of cannabis and mushroom selected. The results would have been predictable to one of ordinary skill in the art because the function of time and effects on growth was known at the time of invention.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the drying time taught by Hong to obtain the degree of dryness desired with a reasonable expectation of success by allowing the product to dry further by extending the drying time. The results would have been predictable to one of ordinary skill in the art as the function of time and effects on dryness were known at the time of invention.
Regarding claim 19, Hong teaches hemp seed comes from Cannabis sativa (English translation p.2, paragraph [0005]). Sakai teaches the cannabis species Cannabis sativa (description p.4, paragraph 0017).
Regarding claim 20, Hong teaches the mushroom species Cordyceps sinensis (English Translation p.2, paragraph 0010).
Response to Arguments
Applicant argues that the supplemental declaration illustrates that the water amounts claimed in this application are indeed critical and realize new and unexpectedly improved results over the prior art of record (See Remarks dated 1/12/2026, 1st paragraph). Applicant argues that the bar graph shows the “works/doesn’t work” nature of the water amount criticality in this application, and none of the references of record teach the critical water amounts relative to the Cannabis inclusion to get mycelium to grow in culture (See Remarks dated 1/12/2026, 1st paragraph). Applicant argues that claim 18 has been amended to identify the mushroom as edible, and AMF in the prior art is not an edible mushroom (See Remarks dated 1/12/2026, 2nd paragraph).
Applicant's arguments filed January 12, 2026 have been fully considered but they are not persuasive. Hong teaches the sequential method steps of preparing a fermentation medium containing a cannabis product (hemp seed meal) and water in a 1 to 1.2 ratio; sterilizing the slurry; adding Cordyceps sinensis mycelium strain to the sterilized fermentation medium; culturing for 30 days; drying the fermented product to constant weight; and crushing the dried fermented substance into a powder; which are the same method steps required by claim 18 steps c-f. Hong does not teach dividing unextracted leaves of cannabis, or mixing the shredded cannabis leaves with water in a 1:2 ratio.
Sakai teaches sequentially crushing and shearing a plant to produce particles 0.1µ to 1mm in size, and mixing the plant particles with a solvent such as water (i.e. cannabis leaves water slurry), and including water at a ratio of 1 to 100 parts water to 1 part plant material. Rivas further teaches shredding fresh cannabis leaves and mixing with water in a sequential manner (i.e. unextracted cannabis leaves water slurry). Thus, the sequential steps as claimed and the use of unextracted shredded cannabis leaves to make a slurry were known in the art at the time of invention, as taught by Hong in view of Sakai and Rivas, and are obvious for the reasons set forth in the rejection above.
Each of Hong, Sakai and Rivas teach mixing an aerial hemp-derived material with water to achieve a slurry. Thus, one of ordinary skill in the art would have reasonably expected that replacing the hemp seed meal from Cannabis sativa of Hong with shredded unextracted cannabis leaves from Cannabis sativa taught by Sakai and Rivas would predictably result in a cannabis-water slurry as required by the instant claims. Regarding Sakai’s teaching of extraction – Sakai teaches preparing a slurry by mixing cannabis leaves with water as required by the instant claim. The slurry required by the instant claims does not structurally distinguish from the slurry taught by Sakai.
Azmir et al. suggests that extraction of bioactive compounds from plant materials requires specific processing methods to extract the active components from plant materials (“Techniques for extraction of bioactive compounds from plant materials: a review:, Journal of Food Engineering, 2013, Vol.117, pp.426-436; previously cited) (title, abstract). Azmir discusses that bioactive compounds can be extracted by various classical extraction techniques based on the extracting power of different solvents in use and the application of heat and/or mixing (See p.427, 2nd column – 5. Conventional extraction techniques). Azmir further states that new non-conventional extraction techniques include ultrasound assisted extraction, enzyme-assisted extraction, microwave-assisted extraction, pulsed electric field assisted extraction, supercritical fluid extraction and pressurized liquid extraction (See p.429, 1st column – 6. Non-conventional extraction techniques). Thus, one would expect the leaves taught by Sakai and Rivas would be unextracted.
Applicant’s claim of unexpected results is not found persuasive because applicant claims unexpected results from the ratio of water to cannabis leaves which results in the growth of edible mushrooms. However, the growth of mycelial culture is not unexpected, and the claims do not require any specific metric to determine whether growth is improved based on the water content of the growth medium. The teaching of mixing plant particles with water in a ratio of 1 to 100 parts water to 1 part by weight of plant encompasses the claimed ratio of 2 parts water to 1 part Cannabis leaves. Hong teaches mixing water and hemp seed in a 1.2:1 ratio. One of ordinary skill in the art would reasonably expect that adjusting the water content of the medium would predictably result in obtaining the desired watery medium. Therefore, Applicant’s claims are in line with prior art teachings, and therefore are not unexpected. As discussed above, the declaration by Dr. Rubin does not contain a nexus such as a side-by-side comparison of different water ratios and the resulting mycelial growth following fermentation. The declaration does not provide statistical analysis of the results, does not provide experimental results with a sample size greater than 1. The declaration does not demonstrate a difference in results, nor present evidence that the results are in fact unexpected, unobvious, and of both statistical and practical significance.
Thus, as evidenced by Azmir, none of Hong, Sakai and Rivas teach the extraction of active compounds from Cannabis leaves, and therefore the prior art teachings address the use of unextracted leaves as required by step a) of claim 1.
Conclusion
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/DEEPA MISHRA/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657