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
Action Is Final
Applicants' response to the Non-Final Office Action mailed 20 March 2025, has been entered and the Remarks therein, filed 22 September 2025, are fully considered here.
It is noted that a reference has been added for evidentiary purposes in the Response to Arguments section. Therefore, this action is a Final Office action, not necessitated by Applicants' amendment, received 22 September 2025 (see MPEP 2144.03(D)).
Status of Claims
Claims 10-12 are pending.
Claims 10-12 are rejected.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. §119(e) or under 35 U.S.C. §120, §121, or §365(c) is acknowledged. This application claims benefit of 62/912,930, 10/09/2019, and is a CIP of 16/148,462, 10/01/2018, which is a CON of 15/076,931, 03/22/2016, which claims benefit of 62/138,099, 03/25/2015.
Applicant also claims that the instant application is a CIP of 16/270,033, 02/07/2019, which is a CON of 15/204,280, 07/07/2016, which claims benefit of 62/190,039, 07/08/2015.
However, although Applicant describes cannabinoid dosage forms in provisional application 62/912,930, with regard to Applicant’s claim of a CIP relationship between instant application 16/839,343 and 16/148,462, the instant application does not repeat a substantial portion of prior application 16/148,462. In fact, the specifications are totally different. In addition, with regard to Applicant’s claim of a CIP relationship between instant application 16/839,343 and 16/270,033, the instant application does not repeat a substantial portion of prior application 16/270,033. In fact, the specifications are totally different.
In addition, with regard to applications 15/076,931 and 15/204,280, for which Applicant is claiming a continuation (CON) relationship, the specifications of these two applications are different from each other and neither is the same as the specification filed in instant application 16/839,343. Therefore, it is not clear that Applicant has established either CIP or CON relationships with regard to the domestic priority claims made by Applicant.
Therefore, claims 10-12 have the effective filing date of 09 October 2019.
Claim Objections
The objections to Claim 10, in the Non-Final Office Action mailed 20 March 2025, are withdrawn in view of Applicants' amendment received 22 September 2025 in which the cited claim was amended.
Claim Rejections - 35 U.S.C. § 112
35 U.S.C. § 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.
35 U.S.C. §112(a) and pre-AIA 35 U.S.C. §112, first paragraph require that the specification include the following (MPEP 2161 (I)):
(A) A written description of the invention;
(B) The manner and process of making and using the invention (the enablement requirement); and
(C) The best mode contemplated by the inventor of carrying out his invention.
Claims 10-12 are rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contain(s) subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
[Claims 11 and 12 are dependent on claim 10, contain the limitations of claim 10, and, therefore, are rejected for the same reason.]
(1) Claims 10-12 fail to comply with the written description requirement, because the claim text(s) recite(s) limitations which are not described in the specification and/or which encompass a claim breadth which is not supported by the specification.
[This rejection cited in the Non-Final Office Action mailed 20 March 2025.]
Claim 10 recites: “A cannabinoid oral dosage form in unit dosage form for ingestion, consisting essentially of bacterially fermented whole unextracted native hemp,…the bacterial fermentation of said native hemp increases the cannabidiol and/or cannabidiol acid by between 12-300% without increasing the amount of tetrahydrocannabinol;…”
Applicant’s working examples show the use of the bacterium Acetobacter (species not identified) in order to demonstrate that, after fermenting a native hemp starting material (and a noncannabinoid spice mix) substrate with said bacterium, the percentage of CBD (cannabidiol) and/or CBDA (cannabidiol acid) in the native hemp material is increased (paginated specification filed 21 November 2022, pp. 9-10, para. [017], Example 2, Tables II and III).
However, the level of tetrahydrocannabinol (THC) was not measured.
Therefore, it is not clear that Applicant has support for claiming a fermented native hemp oral dosage form in which, after bacterial fermentation, the amount of tetrahydrocannabinol has not been increased.
MPEP 2163.03 (V) states, in part: “The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification”.
MPEP 2163 (I)(A) states, in part: “The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art.”
The art of fermentation of hemp or Cannabis is an unpredictable art which is not widely described in the prior art. For example, Chatterly (previously cited and on the record) teaches that contacting marijuana plants with lactic acid bacteria (LAB), so as to allow the LAB to ferment the plant material, results in a higher presence of cannabinoids including both THC and CBD (pg. 4). Chatterly does not describe any particular species of LAB. Therefore, because it is clear that not all species of bacteria will ferment native hemp so as to result in an increase in cannabinoids (CBD), but not THC, one of ordinary skill in the art would not know or could not envisage which particular species of bacterium would give the desired results; i.e., increased CBD, but not THC.
However, because Applicant is claiming that the particular strain of bacterium cited in the working examples does not increase THC, the burden is on Applicant to demonstrate this lack of increase (i.e., by providing the measured amount of THC), because Chatterly shows that some bacteria do cause an increase in THC when the bacteria come into contact with marijuana plants.
To overcome this rejection, Applicant may attempt to demonstrate (by means of argument or evidence) that the original disclosure establishes that he or she was in possession of the claim, or the claim limitation may be deleted from the claim.
(2) Claim 12 fails to comply with the written description requirement, because the claim text recites limitations which are not described in the specification and/or which encompass a claim breadth which is not supported by the specification.
[This rejection cited in the Non-Final Office Action mailed 20 March 2025.]
Claim 12 recites: “…, wherein said native hemp has been fermented with one or more bacteria selected from the group consisting of Bacillus subtilis, Bacillus
subtilis ssp Natto, Bacillus coagulans, Lactobacillus plantarum, Acetobacter pasteurianus, Acetobacter ghanensis, Komagataeibacter oboediens, and Komagataeibacter saccharivorans prior to compounding.”
However, Applicant’s working examples only show the use of Acetobacter (no species given) in order to demonstrate that, after fermenting a native hemp starting material (and a noncannabinoid spice mix) substrate with said bacterium, the percentage of CBD (cannabidiol) and/or CBDA (cannabidiol acid) in the native hemp material is increased (paginated specification filed 21 November 2022, pp. 9-10, para. [017], Example 2, Tables II and III). Applicant also asserts that there was not a concomitant increase in tetrahydrocannabinol (THC).
However, it is not clear that, apart from the Acetobacter species, any of the other bacteria listed in the Markush group of claim 12 would, after fermenting the native hemp substrate, result in an increase in CBD and CBDA recovery in said native hemp material (but not an increase in THC). For example, Chatterly (previously cited and on the record) teaches that contacting marijuana plants with lactic acid bacteria (LAB), so as to allow the LAB to ferment the plant material, results in a higher presence of cannabinoids including both THC and CBD (pg. 4). Chatterly does not describe any particular species of LAB. Therefore, one or ordinary skill in the art would not be able to predict or identify which bacterial species that ferment native hemp would not cause an increase in THC.
MPEP 2163 (II)(A)(3)(a)(ii) states, in part: “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above),…, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021)”;
“The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’. LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005)”; and
“Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.”
To overcome this rejection, Applicant may attempt to demonstrate (by means of argument or evidence) that the original disclosure establishes that he or she was in possession of the claim, or the claim limitation may be amended to list the bacterial species that Applicant has experimental support for.
Claim Interpretations
(1) Claim 10 recites: "A cannabinoid oral dosage form in unit dosage form for ingestion consisting essentially of bacterially fermented whole unextracted native hemp, ... , the bacterial fermentation of said native hemp increases the cannabidiol and/or cannabidiol acid..."
It is noted that an American English dictionary definition of the word 'hemp' is: the cannabis plant. Therefore, the terms 'cannabis' and 'hemp' will be considered to be synonymous with each other, and so can be applied interchangeably when referring to the instant application and the prior art.
In addition, cannabis is notably associated with the cannabinoid products cannabidiol and cannabidiol acid. Therefore, one of ordinary skill in the art would interpret the fermentation substrate 'whole unextracted native hemp' in instant claim 10 to be the same as or synonymous with 'cannabis', because instant claim 10 describes cannabidiol and/or cannabidiol acid as being measurable in (native) hemp.
(2) Claim 10 recites the transitional phrase "consisting essentially of".
Applicant has not defined, described or explained what is meant by the term 'consisting essentially of'.
Therefore, for the purpose of examination, the phrase will be considered to have the same meaning as the transitional term 'comprising'. Therefore, the cannabinoid oral dosage form will be considered to contain at least bacterially fermented native hemp. It is noted that hemp (inherently) contains soluble dietary fiber, insoluble dietary fiber, several cannabinoids and terpene compounds (see references cited below in the 103 rejection).
(3) Claim 10 recites: "A cannabinoid oral dosage form in unit dosage form for ingestion, consisting essentially of bacterially fermented whole unextracted native hemp,..."
The specification recites: "..., the dosage form material is predominantly or completely 'whole' hemp" (paginated specification filed 21 November 2022, pg. 5, para. [011]); and "The ability of whole, unextracted (native or activated) hemp that is bacterially fermented is thus able to serve as a uniquely effective delivery system for any and all cannabinoids (spec., pg. 7, para. [014]).
That is, it appears as though the adjectives 'whole' and 'unextracted' appear to be synonyms for 'native' or 'activated' hemp. Therefore, prior art which shows native or activated hemp will be considered to (inherently) show whole, unextracted hemp.
Claim Rejections - 35 U.S.C. § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. §102 and §103 (or as subject to pre-AIA 35 U.S.C. §102 and §103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. §103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 10-12 are rejected under 35 U.S.C. §103 as being unpatentable over Yoon et al. ((2018) J. Life Sci. 28(6): 688-696); see NPL as human translation (in HT) for page# (i.e., 1-27) and para. citations) as evidenced by Andre et al. ((2016) Front. Plant Sci. 7(19): 1-17) in view of Hugh (U.S. Patent Application Publication No. 2017/0202895 A1), Callaway ((2004) Euphytica 140: 65-72), and Chatterly ((2019 May) Datasheet [online], CannabisWiki; pp. 1-3).
[This rejection cited in the Non-Final Office Action mailed 20 March 2025.]
Yoon et al. as evidenced by Andre et al. addresses some of the limitations of claims 10 and 12.
Yoon et al. provides information from which one of ordinary skill in the art would have expected that a cannabinoid dosage form containing increased amounts of cannabidiol and cannabidiol acid would not contain increased tetrahydrocannabinol (THC) amounts, by way of addressing the limitations of claim 10.
Regarding claim 10, pertaining to bacterially fermented whole unextracted native hemp for ingestion; said (bacterially fermented) native hemp contains terpene compounds therein; an additional cannabinoid selected from the group consisting of cannabigerol, cannabidivarin, cannabichromene and cannabinol is also present in the (bacterially fermented) native hemp,
[See Claim Interpretations section- (1) thru (3) above.]
Yoon et al. shows a study in which hemp seeds were inoculated with lactic acid bacteria and fermented. The changes in the various physiological activities and functional changes of the fermented hemp were identified (pg. 5, last para. thru pg. 6, lines 1-2). Hemp seeds used in the described study were purchased from a red ginseng company (pg. 6, para. 1 [i.e., whole unextracted native hemp]).
Yoon et al. does not explicitly show that native hemp (inherently) contains terpenes and several different species of cannabinoid, including cannabigerol, with regard to claim 10.
Andre et al. shows that the native hemp shown by Yoon et al. contains terpenes and other cannabinoid species, by way of addressing the limitations of claim 10.
Andre et al. teaches that Cannabis sativa L. is an important herbaceous species originating in Central Asia, which has been used in folk medicine and as a source of textile fiber since the dawn of times. It is indeed a treasure trove of phytochemicals. The rich spectrum of hemp phytochemicals, which includes cannabinoids, terpenes and phenolic compounds, are discussed in the described review (pg. 1, Abstract).
Andre et al. also teaches that phytocannabinoids have been detected in, minimally, Cannabis/hemp plant flowers and seeds (pg. 3, column 1, lines 9-16). In addition, Table 1 shows a summary of the concentrations of the different cannabinoids found in different parts of hemp plants and includes: cannabidiol (CBD), cannabinol (CBN), cannabigerol (CBG), and cannabichromene (CBC) (pg. 4, Table 1).
Further regarding claim 10, pertaining to a probiotic dietary supplement, for ingestion,
Yoon et al. teaches that hemp seed fermented with lactic acid bacteria can be used as a functional material and developed into a food product. That is, hemp seed fermented with lactic acid bacteria promotes antioxidant, α-glucosidase inhibitory activity and tyrosinase inhibitory activity (pg. 26, last line thru pg. 27, lines 1-5).
Further regarding claim 10, pertaining to a cannabinoid form, containing cannabidiol and/or cannabidiol acid,
Yoon et al. teaches that the substances contained in hemp seeds are representative of tetrahydrocannabinol (THC) and cannabidiol (CBD) (pg. 4, lines 1-3).
Further regarding claim 10, pertaining to bacterial fermentation of hemp without increasing the amount of tetrahydrocannabinol,
Yoon et al. teaches that the large amount of CBD in hemp seeds inhibits THC (pg. 4, lines 6-7).
Regarding claim 12, pertaining to Lactobacillus plantarum,
Yoon et al. shows that one of the lactic acid bacterial strains used in the hemp seed fermentation was Lactobacillus plantarum (pg. 6, para. 2).
Yoon et al. as evidenced by Andre et al. does not show: 1) a cannabinoid oral form in unit dosage form [Claim 10]; 2) compounded as a tablet or a powder or within a capsule [Claim 10]; 3) having a soluble dietary fiber to insoluble dietary fiber ratio of 1:30 [Claim 10]; 4) having a maximum cannabinoid dose per unit dosage form of 20 mg in stabilized form [Claim 10]; 5) increases the cannabidiol and cannabidiol acid by between 12-300% [Claim 10]; 6) the oral dosage form contains less than 10% water as moisture [Claim 11]; and 7) bacterially fermentation is conducted prior to preparation as said unit dosage, and prior to compounding [Claims 10 and 12].
Hugh addresses some of the limitations of claim 10, and the limitations of claim 11.
Regarding claim 10, pertaining to a cannabinoid oral dosage form in unit dosage form, compounded as a tablet or a powder or within a capsule,
Hugh shows a cannabis composition. The cannabis composition may include a cannabinoid resin. The cannabinoid resin may include one or more of a tetrahydrocannabinol extract and a cannabidiol extract (pg. 1, para. [0016] [nexus to Yoon et al.- a hemp composition containing cannabidiol]). The cannabis composition as a compressed pellet form is shown, as well as, a method of preparing a cannabis composition in a compressed pellet form (pg. 1, para. [0015]). The compressed pellet may be one of a plurality of compressed pellets characterized by a standardized dose per pellet of the cannabinoid resin (pg. 2, para. [0022]). In some embodiments, the compressed pellet form may include, minimally, a capsule or a tablet (pg. 3, para. [0027]). An ingestible compressed pellet may be swallowed or contacted with a mucous membrane for absorption over time (pg. 3, para. [0028] [nexus to Yoon et al.- an ingestible form of cannabinoid]).
Further regarding claim 10, pertaining to having a cannabinoid dose per unit dosage form in mg in stabilized form,
Hugh shows that in several embodiments, the compressed pellet may include the cannabinoid resin in an amount in milligram (mg) of one or more of, minimally, about 25, 50, 100, 125 up to 2000mg or any range between any of the preceding values. The compressed pellet may be one of a plurality of compressed pellets characterized by a standardized dose per pellet of the cannabinoid resin (pg. 4, para. [0043]).
Regarding claim 11, pertaining to the oral dosage form contains less than 10% water as moisture,
Hugh shows that the method of making the cannabis composition may include dehydrating the Cannabis crop. The dehydrating may include heating (pg. 3, para. [0034]). After dehydrating, the Cannabis crop may include a moisture content percentage (w/w) with respect to the Cannabis crop of less than about one or more of, minimally: 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8% and 7% (pg. 3, para. [0034]). The moisture percentage may refer to a water concentration (pg. 5, para. [0049]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the cannabinoid form for ingestion consisting essentially of bacterially fermented native hemp, as shown by Yoon et al. as evidenced by Andre et al., by: 1) providing the cannabinoid form in a unit dosage form [Claim 10]; and 2) compounding the form as a tablet or a powder or within a capsule [Claim 10], as shown by Hugh, with a reasonable expectation of success, because Hugh shows a cannabis composition which includes cannabidiol and which is in ingestible form, which is the cannabinoid form, shown by Yoon et al. (MPEP 2143 (I)(G)).
It would have been further obvious to have formulated the cannabinoid form to contain a maximum cannabinoid dose per unit dosage form of 20 mg in stabilized form [Claim 10], with a reasonable expectation of success.
Hugh shows that the cannabis composition as a compressed pellet may include the cannabinoid resin in an amount in milligram (mg) of one or more of 25mg, 50mg or more. Therefore, barring a showing of criticality for the specific limitation, it would have been obvious to one of ordinary skill in the art to have used routine optimization to have formulated the cannabinoid oral dosage form to have a maximum cannabinoid dose per unit dosage form of 20mg or any other amount, depending on the intended use of the cannabis oral dosage form; for example, as a test dose to determine whether or not the subject ingesting the dosage form can tolerate the cannabis composition or depending on the body weight of the subject ingesting the dosage form (MPEP 2144.05 (II)(A) and (III)(A)).
One of ordinary skill in the art would have been motivated to have made those modifications, because one of ordinary skill in the art of cannabinoid oral dosage form production would be motivated to optimize the health-related beneficial characteristics of said oral dosage form, such as the form having a high amount of cannabidiol, which has therapeutic properties.
It would have been further obvious (and one of ordinary skill in the art would have been motivated) to have performed the bacterial fermentation of native hemp, shown by Yoon et al., prior to forming or compounding the resulting composition into a unit dosage form, as shown by Hugh, with regard to claims 10 and 12, because the instantly-claimed dosage form has specific properties (e.g., increased amount of cannabidiol and/or cannabidiol acid) which are only achieved after the bacterial fermentation has been performed (MPEP 2144 (I)).
It would have been further obvious to have formulated the oral dosage form to contain less than 10% water as moisture [Claim 11], as shown by Hugh et al., with a reasonable expectation of success, because Hugh et al. shows a cannabis composition which includes cannabidiol and which is in ingestible form, which is the cannabinoid form, shown by Yoon et al. (MPEP 2143 (I)(G)).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Callaway provides information that would have enabled one of ordinary skill in the art to have determined a specific soluble dietary fiber to insoluble dietary fiber ratio (e.g., 1:30) as a property of the bacterially fermented native hemp shown by Yoon et al., with regard to claim 10.
Callaway teaches that non-drug varieties of Cannabis, commonly referred to as hemp, have not been studied extensively for their nutritional potential in recent years, nor has hempseed been utilized to any great extent by the industrial processes and food markets that have developed during the 20th century (pg. 65, Summary [nexus to Yoon et al.- hemp seed composition as food product for ingestion]).
Regarding claim 10, pertaining to having a soluble dietary fiber to insoluble dietary fiber ratio,
Callaway teaches that the ripened seed of hemp and seed meal are excellent sources of dietary oil, fiber and protein (Table 1) (pg. 65, column 1, para. 1 ). Table 1 shows that whole seed has a digestible [= soluble] dietary fiber amount of 5.4% and a non-digestible [= insoluble] dietary fiber amount of 22.2%. Seed meal has a soluble dietary fiber amount of 16.4% and an insoluble dietary fiber amount of 26.2% (pg. 66, column 1, Table 1 ).
Accordingly it would have been further obvious to have prepared a bacterially fermented cannabinoid oral dosage form, as shown by Yoon et al. as evidenced by Andre et al., having a soluble dietary fiber to insoluble dietary fiber ratio of 1:30 [Claim 10], with a reasonable expectation of success, because Callaway teaches that different forms of a hemp product (i.e., whole seed vs seed meal) can have different soluble to insoluble dietary fiber ratios.
Therefore, it would have been obvious to one of ordinary skill in the art to have selected that part of the native hemp plant that would have provided a desired soluble to insoluble dietary fiber ratio (e.g., 1:30) or to have selected the strain of native hemp that would have given a desired soluble to insoluble dietary fiber ratio (e.g., 1:30) (MPEP 2143 (l)(G) and MPEP 2144 (I)).
That is, it appears as though the ratio of soluble to insoluble dietary fiber is an inherent property of the hemp plant.
One of ordinary skill in the art would have been motivated to have made that modification, because one of ordinary skill in the art of cannabinoid oral dosage form production would have been motivated to have optimized the health-related beneficial characteristics of said oral dosage form, such as the form having a high amount of insoluble dietary fiber, which has therapeutic properties.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Compare to Applicant's recitation that " ... , hemp (prior to bacterial fermentation) contains total dietary fiber (TDF) having a ratio of 1 part SDF (soluble dietary fiber) to 30 parts IDF (insoluble dietary fiber)" (originally-filed specification, para. [013]).
That is, it appears as though the specific SDF to IDF ratio does not result from the bacterial fermentation process, but from the hemp source used, as noted above.
Chatterly addresses some of the limitations of claim 10.
Regarding claim 10, pertaining to bacterial fermentation increases the cannabidiol and cannabidiol acid,
Chatterly shows that combining lactic acid bacteria with marijuana plants is one of the safest and most natural ways to boost the cannabinoids, terpenes and yield from a marijuana plant (pg. 2, para. 1). The microbes can be applied directly to plants (pg. 3, para. 2). The benefits of using lactic acid bacteria on marijuana plants includes a higher presence of cannabinoids, including CBD (pg. 4, para. 1 [nexus to Yoon et al.- bacterially fermented native hemp]).
Accordingly, it would have been further obvious to have prepared a bacterially fermented cannabinoid oral dosage form, as shown by Yoon et al. as evidenced by Andre et al., having an increased amount of cannabidiol and/or cannabidiol acid of between 12-300% [Claim 10], with a reasonable expectation of success, because Chatterly shows that fermenting marijuana/cannabis with a lactic acid bacterium (LAB) increases the amount of cannabinoids in the plant, including, cannabidiol (CBD) (and, therefore, would also be contained in a product made from said plant) (MPEP 2143 (I)(G)).
Therefore, one of ordinary skill in the art would have used routine optimization to have adjusted the amount of LAB inoculum used or to have adjusted the length of time or fermentation conditions, so as to have achieved an increase in CBD amount of 12-300% (MPEP 2144.05 (II) and MPEP 2144 (I)).
One of ordinary skill in the art would have been motivated to have made that modification, because Yoon et al. shows that hemp seed fermented with lactic acid bacteria promotes antioxidant, α-glucosidase inhibitory activity and tyrosinase inhibitory activity; i.e., the resulting hemp composition, which contains cannabinoids such as CBD, has health-promoting properties. Therefore, one of ordinary skill in the art would have been motivated to have produced a cannabinoid oral dosage form containing the highest amount of cannabinoid content.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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.
Claims 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5 of Patent No. 11,547,669 B2.
The claimed subject matter of instant Application No. 13/737,787 is:
Claim 10. A cannabinoid oral dosage form in unit dosage form. The dosage form consists essentially of bacterially fermented whole unextracted native hemp, compounded as a tablet or a powder or within a capsule. The dosage form has a soluble dietary fiber to insoluble dietary fiber ratio of 1:30. The dosage form has a maximum cannabinoid dose per unit dosage form of 20 mg. The dosage form comprises viable bacteria as a probiotic dietary supplement. Bacterial fermentation of said native hemp increases the cannabidiol and/or cannabidiol acid amount by between 12-300% without increasing the amount of tetrahydrocannabinol. Bacterially fermented native hemp contains terpene compounds therein. An additional cannabinoid selected from the group consisting of cannabigerol, cannabidivarin, cannabichromene and cannabinol are also present.
Claim 11. The oral dosage form contains less than 10% water as moisture.
Claim 12. Said native hemp has been fermented with one or more bacteria selected from the group consisting of Bacillus subtilis, Bacillus subtilis ssp Natto, Bacillus coagulans, Lactobacillus plantarum, Acetobacter pasteurianus, Acetobacter ghanensis, Komagataeibacter oboediens, and Komagataeibacter saccharivorans prior to compounding.
The claimed subject matter of Patent No. 11,547,699 is:
Claim 1. A cannabinoid oral dosage form in unit dosage form. The dosage form consists essentially of bacterially fermented hemp pomace, compounded as a tablet or within a capsule, powder or other dosage form. The dosage form has a soluble dietary fiber to insoluble dietary fiber ratio of 1:30. The dosage form has a maximum cannabinoid dose per unit dosage form of 25 mg. The dosage form comprises viable bacteria as a probiotic dietary supplement.
Claim 2. Each oral dosage form contains less than 10% water. Said cannabinoid is selected from the group consisting of cannabidiol, cannabigerol, cannabidivarin, cannabichromene, cannabinol and a combination thereof.
Claim 3. Hemp pomace is fermented with one or more bacteria selected from the group consisting of Bacillus subtilis, Bacillus subtilis ssp Natto, Bacillus coagulans, Lactobacillus plantarum, Acetobacter pasteurianus, Acetobacter ghanensis, Komagataeibacter oboediens, and Komagataeibacter saccharivorans prior to compounding.
Claim 5. The cannabinoid is present at a level of between 12-300% greater than a starting level due to the action of bacterial fermentation.
Although the claims are not identical, they are not patentably distinct from each other because, as demonstrated above in the claim sets from each application, the cannabinoid oral dosage form, described in Patent No. 11,547,669 exhibits minor species modifications that anticipate the cannabinoid oral dosage form, described in instant Application No. 16/839,343.
The minor species modification is the recitation of hemp pomace which is a species of native hemp. That is, hemp pomace could be made from native hemp. Patent No. 11,547,669 is silent on whether or not tetrahydrocannabinol is increased.
Response to Arguments
Applicant’s arguments, pp. 1-2, filed 22 September 2025, with respect to the prior art references cited in the 35 U.S.C. §103 rejections, have been fully considered, but they are not persuasive.
1. Applicant remarks (pg. 1, para. 2), it appears with regard to the 112(a) rejections, but this is not clear, that the Chatterly reference is nonanalogous to the present disclosure and cannot call the inventor's inherently sworn statements (in the specification) into question as a result. There is thus no basis for any skepticism on the Examiner's part as to the assertions in the specification (to which Jordan Rubin swore an oath in his inventor's declaration). The present invention does not GROW cannabis with bacteria, it ferments harvested cannabis together with bacteria (so the cannabis obviously does not grow further as a plant). Chatterly is directed to growing Cannabis plants in the presence of bacteria to increase yield and production, including all sorts of cannabinoids. The present specification are thus directed to two completely different cannabis technologies. There is therefore no basis to doubt the assertions in the present specification either as to the suitability of the claimed types of bacteria or as to the inventor's assertion that the bacterial co-fermentation increases cannabinoids but not THC.
However, in response to Applicant, first, there is no inventor's declaration (under 37 CFR 1.132, for example) filed in the instant application. A signed oath or declaration under 37 CFR 1.63 merely attests to the identity of the inventor as the original inventor or an original joint inventor, and acknowledges the penalty for willfully making false statements. The signed oath or declaration does not overcome or supersede other issues with Applicant's application, e.g., with regard to the fulfilment of the written description requirement(s) under 35 USC §112(a). It is not relevant to the argument against the written description rejection that Chatterly shows that bacteria are applied to growing cannabis plants vs the instantly-claimed dosage form in which bacteria are incorporated into or onto a whole, unextracted native hemp substrate.
In both scenarios, there is contact between the hemp or cannabis and bacteria which ferment said hemp or cannabis, and it is this fermentation process which results in the increase in the levels of cannabidiol (CBD) and/or cannabidiol acid (and, in the case of Chatterly, of tetrahydrocannabinol (THC)). The fact that Chatterly shows that bacterial fermentation of cannabis (no specific genus or species of bacterium cited) results in an increase in THC- and Applicant purports that the instant bacterially fermented hemp does not result in a rise in THC levels- shows the unpredictability in the art and requires Applicant to show in the specification numerical support for the lack of an increase in THC levels.
2. Applicant remarks (pg. 1, para. 3), with regard to the references cited in the 103 rejection, that Yoon cannot teach or suggest bacterial fermentation of hemp to increase non-THC cannabinoids without increasing THC. Bacterial fermentation of hemp seed is nothing like bacterial fermentation of native hemp. Yoon explains that fermented hemp seed attained antibacterial activity whereas unfermented hemp seed did not, and therefore both the investigation and results of Yoon versus the present invention "do not track."
However, in response to Applicant, Applicant's remark that ' Bacterial fermentation of hemp seed is nothing like bacterial fermentation of native hemp' is opinion evidence, as no supporting documents or data are offered (MPEP 716.01 (c)(llI)). It is noted that the primary reference of Yoon et al. shows the use of lactic acid bacteria, e.g., Lactobacillus and Pediococcus, to ferment hemp seed and that this fermentation process has been shown to result in the production of antibacterial substances detrimental to harmful gut bacteria (Yoon et al., pg. 5, lines 1-6). It would be admittedly counterproductive for Yoon et al. to ferment hemp seed using bacteria which would result in being eradicated by their own fermentation efforts.
For example, it is well known that probiotic bacteria (aka 'probiotics') has been shown to treat or prevent many gastrointestinal infections by pathogenic bacteria. For example, Scott et al. ((2015) Microb. Ecol. Health. Dis. 26: 1-10 (provided here)) teaches that probiotics have beneficial health effects for different diseases and digestive symptoms. These effects can be due to the direct effect of the probiotic bacterium or its products itself, as well as effects of the probiotic on the resident microbiota. Probiotics can influence the microbiota composition as well as the activity of the resident microbiota (pg. 1, Abstract, Results). The ability of a probiotic to efficiently use a niche in the digestive tract to grow and to use available sources of energy may prevent growth of exogenous microbes and lower substrate availability for pathogens. This mechanism of microbial exclusion is likely involved in the effects of certain probiotics to prevent the occurrence of diarrhea and Clostridium difficile infection during or after the use of antibiotic(s) (pg. 5, column 1, para. 3).
3. Applicant remarks (pg. 1, para. 3) that every time Yoon mentions anything "increasing" it is something other than cannabinoids-polyphenols, flavonoids, and so on, but not cannabinoids. The present claims are directed to increasing non-THC cannabinoid generation when bacterial fermentation takes place.
However, in response to Applicant, Yoon et al. does teach that hemp seed contains a large amount of CBD which in and of itself inhibits THC (see 103 rejection above). Although Yoon et al. does not specifically show that the fermentation process increases the production of the already large amounts of CBD, the Chatterly reference does show this (see 103 rejection above).
In addition, with regard to Yoon et al. not specifically showing that the bacterial fermentation of hemp seed increases the cannabidiol and cannabidiol acid, Yoon et al. does show that the total polyphenol content of the fermented hemp seeds (FHS) was measured and was increased compared to unfermented hemp seeds (Yoon et al., pg. 14, para. 1). Bow et al. ((2016) Persp. Med. Chem. 2016(8): 17-39 (cited in the Non-Final Office Action mailed 20 March 2025)) teaches that cannabinoids (CBDs) are a simple class of terpenophenolic compounds with a phenolic hydroxyl (pg. 17, Abstract). Yoon et al. teaches that polyphenols are contained in almost all plants and have been reported to be involved in various physiological activities such as anti-inflammatory, anti-cancer and antioxidant (pg. 14, para. 1 ). That is, although Yoon et al. does not specifically measure CBDs, one of ordinary skill in the art of determining the potential probiotic effects of bacterially fermented native hemp would have been motivated to have measured the level of CBDs in FHS, with the understanding that the polyphenolic compounds measured in Yoon et al. potentially include CBDs (and, therefore, would also be increased post-fermentation)- or that, like non-cannabinoid polyphenolic compounds, CBDs would also be increased as phenolic compounds.
4. Applicant remarks (pg. 2, para. 1) that Andre's mentioning of terpenes does not change the fact that Andre does not address bacterial fermentation of actual cannabis as claimed (not hemp seed) at all. Andre mentions "cultures" but the culture media do not contain bacteria but are instead some other sort of cell growth efforts. Andre thus does not correct the flaw in Yoon, namely, that Yoon's fermented hemp seed is disclosed as creating an antibacterial effect, or increases in various constituents but never cannabinoids, not the results of the present claims.
However, in response to Applicant, Andre et al. was cited as an evidentiary reference in combination with Yoon et al. to show that native hemp contains terpenes and other cannabinoid species, for example, phytocannabinoids. Andre et al. is not cited to correct any purported flaw in Yoon et al.
5. Applicant remarks (pg. 2, para. 2), with regard to the double patenting rejection, that issued patent 11,547,669 is directed to fermented hemp POMACE, which is cannabis from which cannabinoids have previously been extracted prior to fermentation. The present invention contain no such "pomace" terminology nor any step of extracting cannabinoids-nor would extraction of cannabinoids be consistent with the "consisting essential of' claim which prohibits any inconsistent methods steps' inclusion.
However, in response to Applicant, the oral dosage form described in Patent No. 11,547,699 is a cannabinoid oral dosage form, which has a maximum cannabinoid dose per unit dosage form of 25mg. That is, contrary to what Applicant is stating about hemp pomace not containing cannabinoids (because they have been previously extracted), the cited claims of Patent No. 11,547,699 do disclose the bacterially fermented hemp pomace as comprising cannabinoids. Therefore, the instantly-claimed oral dosage form is obvious over the oral dosage form described in the cited patent.
6. Applicant remarks (pg. 2, para. 3) that the addition of "whole unextracted" both distinguishes U.S. patent No. 11, 547,669 and, most importantly, takes the present claims "away" from the hemp seed disclosure of Yoon. "Whole" hemp certainly means the whole plant, and even if a "whole plant" includes some seeds a "whole plant" is still nonanalogous to the particular disclosure of SOLELY hemp seeds, of Yoon.
However, in response to Applicant, it is not clear that the phrase 'whole unextracted' native hemp refers to the entire hemp plant (which Applicant seems to be implying) vs some part of the hemp plant (such as the seed(s)). The specification recites: "The ability of whole, unextracted (native or activated) hemp that is bacterially fermented is thus able to serve as a uniquely effective delivery system for any and all cannabinoids" (spec., pg. 7, para. [014]). It appears that the phrase 'whole, unextracted' or the individual terms 'whole' and 'unextracted' are merely synonymous with the terms 'native' or 'activated' hemp (see Claim Interpretations section- (3) above). It is not clear if the terms 'whole' and 'unextracted' merely refer to any part of a whole plant (i.e., leaves, flowers or seeds) from which compounds have not been extracted. Therefore, the phrase 'whole, unextracted' has been interpreted as in the Claim Interpretations section above.
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 extension fee 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 date of this final action.
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/SMP/ Examiner, Art Unit 1651
/Adam Weidner/ SPE, Art Unit 1651