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 .
DETAILED ACTION
Claims 1-20 are canceled. Claims 21-23 are new.
Claims 21-23 are pending and under examination.
Response to Amendment dated 8/6/2025
The previous rejection of claims 15-17 under 35 U.S.C. §101 is withdrawn in light of the cancellation of the claims.
The previous rejection of claims 15-17 under 35 U.S.C. §103 is withdrawn in light of the cancellation of the claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Modified rejection necessitated by amendment: Claims 21-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claim 21 recites “a co-fermentation product containing cannabinoids”. Claim 22 recites the “co-fermentation product has a soluble dietary fiber/ insoluble dietary fiber ratio of 1:25-1:29”. Claim 23 recites the “co-fermentation product contains compounds formed by mushroom culture metabolism of insoluble dietary fiber and other nutrients in said cannabis”. Thus, the claims are directed to a product (Step 1: Yes).
The claims set forth a judicial exception which is a product of nature. In claim 21, the product comprises “a co-fermentation product containing cannabinoids”, which encompasses any product containing cannabinoids and inoculated with mycelium culture. The claim requires solid mycelium culture “comprising a culinary or nutritional mushroom suitable for human consumption or oral administration”, and the specification states that any complex fungi suitable for consumption can be utilized. Thus, this limitation is being interpreted to require that any species can be selected as long as there is no reason to believe the selected species is toxic. The specification identifies that the product consists of hemp and mushroom cultures co-fermented together (specification p.4, [007]). The specification identifies that the ratio of soluble dietary fiber (SDF) to insoluble dietary fiber (IDF) will remain similar but not exactly the same as in the starting hemp, with an SDF/IDF ratio of slightly higher than 1:30, and the fungal fermentation process itself is responsible for increasing the digestibility of the dietary fiber fraction of the cannabis (specification p.6, [012]).
This judicial exception is not integrated into a practical application. There are no additional elements recited in claim 21. Dependent claims 22-23 do not recite any additional components to the product, and do not integrate the natural product into a practical application because the limitations do not impose any meaningful limits on the natural product. The claim recites a co-fermentation product containing cannabinoids, which is produced by inoculating shredded cannabis leaves with solid mycelium culture. Shredded cannabis leaves are a nature-based product, so it is compared to its closest naturally occurring counterpart, which are unshredded cannabis leaves on a cannabis plant, to determine if it has markedly different characteristics. Similarly, the solid mycelium culture is a nature-based product, so it is compared to its closest naturally occurring counterpart, which is mycelium. Because there is no indication in the record that the isolation of cannabis leaves or solid mycelium culture has resulted in a marked difference in structure, function or other properties as compared to its counterpart, a co-fermentation product containing cannabinoids is a product of nature exception. The claims are directed towards a judicial exception (product of nature, Step 2A: Yes).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B: No). While the claims do not recite any additional elements, the claim is a product by process. However, the steps of dividing the cannabis material to obtain stems leaves, or flowers into particles; mixing the cannabis with water to form a slurry; sterilizing the slurry; inoculating the slurry with solid mycelium culture; incubating the inoculated slurry; drying the mycelial biomass and powdering said co-fermentation product do not result in a marked difference from the naturally occurring product. The steps of dividing cannabis material, adding water, sterilizing the slurry, inoculating the slurry, incubating the slurry, drying the biomass and powdering the co-fermentation product are well-understood, routine and conventional activities that do not structurally or functionally modify the natural product.
Citterio et al. (“The arbuscular mycorrhizal fungus Glomus mosseae induces growth and metal accumulation changes in Cannabis sativa L.”, Chemosphere, 2005, Vol. 59, Issue 1, pp.21-29; previously cited) teaches growing hemp inoculated with the arbuscular mycorrhizal fungus Glomus mosseae (abstract). As evidenced by Seemakram et al. (“Enhancement of growth and Cannabinoids content of hemp (Cannabis sativa) using arbuscular mycorrhizal fungi”, Frontiers in Plant Science, 2022, Vol. 13, article 845794; previously cited), arbuscular mycorrhizal fungi enhance growth and cannabinoid content of hemp (Cannabis sativa) (title). Seemakram also states that arbuscular mycorrhizal fungi (AMF) develop extraradical mycelia and can also help plants to grow under unfavorable environmental conditions (relevant to inoculating with solid mycelium culture) (p.02, 1st column, last paragraph). Citterio teaches that the prepared pots were placed in field conditions to grow hemp in a natural environment, with minimal and maximal temperatures ranging from 5 to 15 and 25 to 34°C, respectively, which equates to 41 to 59°F as the minimal and 77 to 93.2°F as the maximal temperatures (relevant to incubating at 66-70 degrees) (p.23, 1st column 2nd paragraph). Citterio further teaches plant growth (dry biomass), the mycorrhizal colonization indices, and heavy metal content in roots, stems, leaves and seeds were determined for each treatment (relevant to cannabis material consisting of stems, leaves) (p.23, 1st column 3rd paragraph).
Yamada et al. (“Cultivation of mushrooms of edible ectomycorrhizal fungi associated with Pinus densiflora by in vitro mycorrhizal synthesis”, Mycorrhiza, 2001, Vol. 11, pp.67-81) teaches edible ectomycorrhizal fungi that were cultivated in the same manner as Citterio et al., where mycorrhizas of 24 species in association with various Pinaceae hosts using in vitro syntheses and open-pot cultures were studied.
Therefore, a co-fermentation product containing cannabinoids is a naturally occurring product, as taught by Citterio and evidenced by Seemakram, and as taught by Yamada.
Sakai et al. (EP 1407679 A1, published on April 14, 2004; previously cited) teaches preparing an extraction from plants containing an active ingredient by collecting and fermenting leaves (relevant to step a); consisting of leaves; relevant to containing cannabinoids; relevant to having a cannabinoid content therein) (description p.3, paragraph 0002). Sakai further teaches crushing and shearing a plant to produce particles 0.1um to 1mm in size (relevant to step a) 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 step b) (description p. 8, paragraph 0034).
Hong et al. (CN102599004A, published on July 25, 2012; previously cited) Hong teaches the preparation of a fermentation medium containing 30-50% hemp seed meal, wherein the ratio of material to water is 1.2:1 (relevant to step b – at least one up to 2 parts water) (English translation p.2, paragraph 0009). Hong further teaches sterilizing the slurry at 121°C (equivalent to 250°F) for 60 minutes (relevant to 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 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 step f) (English translation p.2, paragraph 0011). Hong teaches crushing the dried fermented substance into a powder (relevant to step g) (English translation p.2, paragraph 0011).
The steps of dividing cannabis material consisting of leaves into particles to create a quantity of shredded cannabis; mixing shredded cannabis with water to form a slurry; sterilizing the slurry and allowing it to cool; inoculating the slurry with solid mycelium culture; incubating the inoculated slurry; drying the biomass; and powdering the co-fermented biomass are well-understood, routine and conventional in the field of plant bioactives, as taught by Sakai and Hong.
Thus, claims 21-23 are rejected under 35 U.S.C. 101.
Response to Arguments
Applicant argues that for good measure to the now-resolved 101 issue, Dr. Rubin’s accompanying Declaration explains how Arbuscular Mycorrhizal Fungi are not edible mycelia according to the present invention and are not grown for human consumption (See Remarks dated 3/26/2025; p.1, 1st paragraph).
Applicant's arguments filed March 26, 2025 have been fully considered but they are not persuasive. As discussed in the rejection above, there is no indication that the isolation of cannabis leaves or solid mycelium culture has resulted in a marked difference in structure, function or other properties as compared to its counterpart. As taught by Citterio, fungi can naturally grow on Cannabis plants, and as taught by Yamada, there are edible mycorrhizal fungi species.
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 Declarations under 37 CFR 1.132 filed on March 26, 2025; July 18, 2025 and 8/8/2025 are insufficient to overcome the previous rejection of claims 15-17 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 dated 3/26/2025, item 4). Applicant further argues that Arbuscular Mycorrhizal Fungi (AMF) are not edible mycelia according to the present invention (declaration dated 3/26/2025, item 4). This argument is not persuasive, as Yamada teaches there are edible mycorrhizal fungi species known in the art. Applicant further argues that the excessive amount of water in the present claims is a key feature as to the new and unexpectedly improved results attainable with the claimed invention (declaration dated 3/26/2025, item 5). This argument is not persuasive because it is directed towards a process step in obtaining a product; however the claims are directed towards a product and does not depend upon the method by which the product is produced.
The declaration submitted on July 18, 2025 was not signed by the inventor, and therefore does not comply with formal matters. The items listed in the declaration are directed towards the method steps in producing the desired product. However, the instant claims are directed towards a product, and do not depend upon the method by which the product is produced.
The declaration submitted on August 8, 2025 is further directed towards data obtained in testing different ratios of water to cannabis in a method of producing the desire product. However, the instant claims are directed towards a product, and do not depend upon the method by which the product is produced.
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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (CN102599004A, published on July 25, 2012; previously cited) in view of Sakai et al. (EP 1407679 A1, published on April 14, 2004; previously cited). As the original Hong reference is in Chinese, an English translation is relied upon for support.
Regarding claim 21, the limitation “a co-fermentation product containing cannabinoids resulting from the following method” is considered a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant claim 15, while the claim is directed towards the co-fermentation product, one of ordinary skill who practices the method of making the co-fermented would necessarily obtain the product. Therefore, if the method of making the product is obvious, the product obtained by practicing the method is rendered obvious.
The broadest reasonable interpretation is a dried aggregate of particulates comprising cannabis co-fermented with solid mycelium culture.
Regarding steps (b) – (g) of the method of co-fermentation; Hong teaches the preparation of a fermentation medium containing 30-50% hemp seed meal, wherein the ratio of material to water is 1.2:1 (relevant to step b – at least one up to 2 parts water) (English translation p.2, paragraph 0009). Hong further teaches sterilizing the slurry at 121°C (equivalent to 250°F) for 60 minutes (relevant to 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 steps d and e; relevant to “comprising a culinary or nutritional mushroom suitable for human consumption) (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 step f) (English translation p.2, paragraph 0011). Hong teaches crushing the dried fermented substance into a powder (relevant to step g) (English translation p.2, paragraph 0011).
Hong does not teach dividing leaves of the cannabis into particles and mixing 1 part of shredded cannabis with 2 parts water to form a slurry, steps (a) and (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 step a); consisting of leaves; relevant to containing cannabinoids; relevant to having a cannabinoid content therein) (description p.3, paragraph 0002). Sakai further teaches crushing and shearing a plant to produce particles 0.1um to 1mm in size (relevant to step a) 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 step b) (description p. 8, paragraph 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the hemp seed meal taught by Hong with shredded Cannabis leaf particles taught by Sakai, because it would have amounted to a simple substitution of one known cannabis part (fruits/seeds) for another cannabis part (leaves). Hong teaches using hemp and cordyceps together to obtain the combined medicinal properties of both of these plants. The teachings of Hong and Sakai suggest that starting with an aerial part of the plant, either hemp seed meal or 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 Sakai in the method of fermentation taught by Hong would predictably result in obtaining a co-fermented product containing cannabinoids and mycelial biomass 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 have increased the sterilization time taught by Hong to identify optimum conditions and obtain a sterilized product with 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 have optimized 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 have optimized 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.
Based on the above discussion, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have obtained a dried aggregate of particulates comprising a co-fermentation product of cannabis and mycelium culture as a product-by-process obtained by practicing the method of co-fermentation as taught by Hong in view of Sakai. One of ordinary skill in the art would reasonably expect that practicing the method would predictably result in necessarily producing and obtaining the co-fermentation product as claimed.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (CN102599004A, published on July 25, 2012; previously cited) in view of Sakai et al. (EP 1407679 A1, published on April 14, 2004; previously cited), as applied to claim 15 above, and further in view of Reguła et al., (“Dried Shitake Lentinulla edodes) and Oyster (Pleurotus ostreatus) Mushrooms as a Good Source of Nutrient”, Acta Scientiarum Polonorum Technologia Alimentaria, 2007, vol. 6, issue 4, pp. 135-142; previously cited).
Regarding claim 22, neither Hong nor Sakai teach a soluble dietary fiber/insoluble dietary fiber ratio of 1:25-29.
However, Reguła teaches dried shitake (Lentinula edodes) and oyster (Pleurotus ostreatus) mushrooms as a good source of nutrient (title). Reguła further teaches that both dried mushrooms had high content of dietary fiber, Fe, Cu, Mg, K but low in fat, Na and Ca (abstract). Reguła teaches that the soluble dietary fiber content of dried Pleurotus ostreatus was 2.01 + 0.33, and the insoluble dietary fiber content was 39.8 + 0.55, which is a soluble dietary fiber/insoluble dietary fiber ratio of 0.05 (p. 138, Table 1). Reguła further teaches that the soluble dietary fiber content of dried Lentinula edodes was 1.95 + 0.18, and the insoluble dietary fiber content was 44.2 + 0.39, which is a soluble dietary fiber/insoluble dietary fiber ratio of 0.044 (p.138, Table 1). The claimed soluble dietary fiber/insoluble dietary fiber range of 1:25 – 1:29 is equivalent to 0.03 to 0.04.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the ratio of soluble dietary fiber to insoluble dietary fiber (SDF/IDF ratio) of the co-fermentation product obtained from the method of fermentation of Hong in view of Sakai using the teachings of the SDF and IDF content of dried mushrooms taught by Reguła to identify optimum conditions to obtain a desired SDF/IDF ratio with a reasonable expectation of success, by adjusting the amounts of cannabis product and the selected species of mushroom. The results would have been predictable to one of ordinary skill in the art because the determination of soluble fiber and insoluble fiber content was known at the time of invention.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hong et al., (CN102599004A, published on July 25, 2012; previously cited) in view of Sakai et al. (EP 1407679 A1, published on April 14, 2004; previously cited) as applied to claim 15 above, and further in view of Handa et al. (“Parameters of the fermentation of soybean flour by Monascus purpureus or Aspergillus oryzae on the production of bioactive compounds and antioxidant activity”, Food Chemistry, 2019, pp. 274-283, and first available online July 26, 2018; previously cited).
Regarding claim 23, neither Hong nor Sakai expressly teach wherein said co-fermentation product contains compounds formed by mushroom culture metabolism of insoluble dietary fiber and other nutrients in said cannabis.
However, Handa teaches the effects of solid-state fermentation of defatted soybean flour (DSF) by Monascus purpureus or Aspergillus oryzae on the bioactive compounds (abstract). Handa teaches that in the fermentation process by microorganisms, antioxidant phenolic compounds are either produced via secondary metabolic pathways or released from the substrate by enzymes produced by the microorganisms, thus improving the phenolic content and antioxidant activity (relevant to said co-fermentation product contains compounds formed by mushroom culture metabolism of insoluble dietary fiber and other nutrients) (p.274, 2nd column last sentence to p.275, 1st column first sentence). Handa further teaches that achieving suitable fermentation parameters is essential to increase bioactive compounds in the DSF that makes it promising for food industrial applications (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the co-fermentation product obtained by replacing the hemp seed meal taught by Hong with shredded Cannabis leaf particles taught by Sakai in the method of fermentation taught by Hong would contain compounds formed by mushroom culture metabolism of insoluble dietary fiber and other nutrients in said cannabis, because Handa teaches the formation of beneficial antioxidants by Monascus purpureus or Aspergillus oryzae. One of ordinary skill would have reasonably expected that the co-fermentation product of cannabis with mycelial culture resulting from practicing the method of Hong in view of Sakai would predictably result in the product containing compounds formed by mushroom culture, because Handa teaches that Monascus purpureus and Aspergillus oryzae produce compounds when co-fermented with defatted soybean flour (dietary fiber). One of ordinary skill would expect that mycelium would metabolize cannabis fiber in the same manner as defatted soybean flour to produce compounds which would be contained in the co-fermentation product.
Response to Arguments
Applicant argues that while Hong teaches the use of only hemp seed, which the present claims do not embrace, and Sakai always extracts the Cannabis as a first step, which the claimed invention does not do, of record now is the evidence of new and improved results based on the critical water content of the mycelial culture of between one part by weight up to two parts by weight (See Remarks dated 3/26/2025, p.1, 2nd paragraph). Applicant argues Sakai teaches extracting Cannabis with 1 and 100 times the weight of the Cannabis in water, which addresses extraction and not fermentation (See Remarks dated 3/26/2025, p.1, 2nd paragraph). Applicant argues that the accompanying Declaration of Dr. Jordan Rubin explains that the ratio of one up to two parts water represents a surprisingly large amount of water, which gives the invention new and unexpectedly improved results (See Remarks dated 3/26/2025, p.1 last paragraph – p.2 top paragraph). Applicant argues that Rivas uses water only in distillation processes; Hong discloses two parts material to one part water; Sakai addresses only extraction and does not disclose water ratios with mushroom growth media at all; and in light of Dr. Rubin’s Declaration, the new and unexpectedly improved results are not taught or suggested by any of the prior art of record or all of it taken together (See Remarks dated 3/26/2025, p.2, top paragraph).
Applicant's arguments filed March 26, 2025 have been fully considered but they are not persuasive. Hemp seeds or hemp seed meal and cannabis stems, leaves and flowers all originate from a cannabis plant, and are considered “aerial parts” of a plant. Both Hong and Sakai teach combining a cannabis plant product with water to obtain a slurry. It was known in the art at the time of invention that Cannabis plants contain active ingredients (Sakai, description p.3, paragraph 0002). It was also known in the art prior to the effective filing date of invention to co-culture a hemp product (hemp seeds) with fungus Cordyceps sinensis to obtain a co-fermented product that was then dried and powdered (Hong, description p.2, paragraphs 0009-0011). Thus, one of ordinary skill in the art would have found it obvious to replace the hemp seed meal taught by Hong with shredded cannabis leaves taught by Sakai in the co-culturing method taught by Hong, because one of ordinary skill would reasonably expect that the substitution of one hemp-derived material for another in the method taught by Hong would predictably result in a dried co-fermented particulate product of hemp and mushroom, as required by the claimed invention. One of ordinary skill in the art would have recognized that substituting the leaves of Cannabis plants taught by Sakai for the hemp seed of Hong would necessarily result in a final product containing cannabinoids as required by the claimed invention.
The Declarations of Dr. Rubin refer to unexpected results obtained by practicing a specific method that can be used to obtain a product containing cannabinoids of the instant claims. However, the instant claims are directed to a product. Even though product-by-process claims are described by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/ patents/apply/applying-online/eterminal-disclaimer.
Maintained rejection: Claims 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,510,951 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the patented claim.
Patented claim 1 of ‘951 is directed to an oral tablet or capsule dosage form consisting essentially of hemp pomace co-fermented with a fungus, within a powder dosage form. The broadest reasonable interpretation of instant claim 1 is a dried aggregate of particulates comprising cannabis co-fermented with solid mycelium culture (i.e. product by process). The product of patented claim 1 contains hemp pomace (cannabis) co-fermented with a fungus (mycelium biomass) compounded as a tablet or within a capsule or powder dosage form (aggregate of particulates). Thus, the examined claims are directed towards a product that encompasses the product in patented claim 1 of ‘951, and therefore would be obvious over the reference claim.
Maintained rejection: Claims 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,376,291. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the patent claims.
Practicing the method of patented claims 1-3 results in a dried co-fermented product comprising cannabis and mycelium, which anticipates the claimed product of a dried aggregate of particles comprising fermented cannabis co-fermented with mycelium culture of one species of mushroom resulting from the method recited in instant claim 15. The products resulting from the two methods are similar in that they are both dried products created through methods of co-culturing cannabis plant material that is inoculated with mycelium culture and allowed to mature or co-ferment for several days, yielding a co-fermented product comprising cannabis and mycelium.
Response to Arguments
Applicant argues that no terminal disclaimer is necessary with respect to US 11,510,951 or 11,396,291 because the claimed subject matter of the present claims and issued patents are different, those claims are directed to the use of extracted cannabis (not the present native cannabis) in the form of hemp pomace (See Remarks dated 3/26/2025; p.2, paragraph 2). Applicant argues that the prior patents, directed to cannabis from which cannabinoids have been extracted, are fundamentally different technologies, and the two intellectual properties are owned by different entities and therefore cannot be terminally disclaimed (See Remarks dated 3/26/2025, p.2, paragraph 2).
Applicant's arguments filed March 26, 2025 have been fully considered but they are not persuasive. As cited in the double-patenting rejections above, the two patents are of the same inventor (Jordan Seth Rubin). The product resulting from the patented claims would contain cannabinoids in some amount, meeting the requirement of the claimed invention of “having a cannabinoid content therein”.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEEPA MISHRA whose telephone number is (571) 272-6464. The examiner can normally be reached Monday - Friday 9:30am - 3:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached on (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEEPA MISHRA/Examiner, Art Unit 1657
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1657