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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/17/2026 has been entered.
DETAILED ACTION
Claims 1-9 are canceled. Claims 10-12 are pending and under consideration.
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, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications, Application Nos. 15/076,931, 15/204,280, 16/148,462, and 16/270,033 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claim 1 recites “wherein prior to preparation as said unit dosage form the bacterial fermentation of said native hemp increases the cannabidiol and/or cannabidiol acid amount by between 12-300% without increasing the amount of tetrahydrocannabinol and further wherein said bacterially fermented native hemp contains terpene compounds therein, and further wherein an additional cannabinoid selected from the group consisting of cannabigerol, cannabidivarin, cannabichromene, and cannabinol is also present”. There is no support for these limitations in provisional applications: 62/912,930, 62/190,039, and 62/138,099; and no support in applications: 15/076,931, 15/204,280, 16/148,462, and 16/270,033.
Accordingly, claims 10-12 are entitled to an effective filing date of 04/03/2020.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites “prior to preparation as said unit dosage form the bacterial fermentation of said native hemp increases the cannabidiol and/or cannabidiol acid amount by between 12-300% without increasing the amount of tetrahydrocannabinol” in lines 5-7, which renders the claim indefinite because it is unclear how the limitation structurally affects the claimed product. In one interpretation the unit dosage form requires cannabidiol and/or cannabidiol acid to be present in an amount that is increased between 12-300%. Under an alternative interpretation the unit dosage form does not require any particular amount of cannabidiol and/or cannabidiol acid because the claim explicitly states “prior to the preparation as said unit dosage form” and the instant claims are drawn to the structure of the unit dosage form, not the preparation method. Claim 10 further recites “a maximum cannabinoid dose per unit form of 20 mg in stabilized form…and further wherein an additional cannabinoid selected from the group consisting of cannabigerol, cannabidivarin, cannabichromene and cannabinol is also present”, which renders the claim indefinite because it is unclear whether the limitation requiring the maximum cannabinoid dose per unit form to be 20 mg in stabilized form applies to the additional cannabinoid or not. Consequently, it is unclear whether the cannabinoid total is required to be at or below 20 mg. Moreover, claim 10 recites “said bacterially fermented native hemp contains terpene compounds therein, and further wherein an additional cannabinoid” in lines 7-8, which renders the claim indefinite because it is unclear whether “said bacterially fermented native hemp” is referring to the whole unextracted native hemp in the cannabinoid oral dosage, or the native hemp prior to the preparation as said unit dosage form.
Claims 11-12 depend from claim 10 and are rejected for the reasons set forth above.
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.
Claims 10-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product, which is a judicial exception, without significantly more. Each step described below is in reference to the subject matter eligibility test for products and processes (MPEP 2106).
Claim 10 recites a “cannabinoid oral dosage form” in line 1. Therefore, claims 10-12 are directed to a composition of matter, which is one of the statutory categories (Step 1:Yes).
Claim 10 further recites “bacterially fermented whole unextracted native hemp” in line 2. Evidentiary reference Ribeiro (Appl Microbiol Biotechnol 99, 4471–4484, 2015) teaches the dew retting of hemp. See p. 4472 right column first paragraph second sentence. Ribeiro discloses that retting is a fermentation process involving bacteria. In dew retting, plant straw is spread on the ground and exposed to the action of bacteria. See p. 4472 left column. According to the instant specification, native hemp has a soluble dietary fiber to insoluble dietary fiber ratio of 1:30. See [008]. Furthermore, the instant specification discloses that native hemp contains naturally occurring co-factors including cannabinoids, and terpenes. See [007]. The instant specification states that “[w]hen native or activated hemp are bacterially fermented, the action of the bacteria increase at least the cannabidiol (CBD) and cannabidiol acid (CBDA) constituency, enhancing the presence of the most desirable cannabinoids but NOT the THC [i.e. tetrahydrocannabinol]. This combined increase in CBD plus CBDA, or the total of the two, is between about 12% to 300%”. See [007]. Compared to the closest naturally occurring counterpart, there is no structural difference between the natural product (i.e. hemp during dew retting) and the instantly claimed product (i.e. bacterially fermented whole unextracted native hemp). Because there is no indication in the record that the instantly claimed bacterially fermented whole unextracted native hemp has a markedly different characteristic in structure, function, or other properties as compared to its natural counterpart claims 10-12 are directed to a natural-product, which is a judicial exception (Step 2A Prong 1: Yes).
The additional claimed elements separately and accumulatively fail to integrate the product of nature into practical application. Besides the natural product, claim 10, in the preamble, recites: a cannabinoid oral dosage form in unit dosage form for ingestion. This recitation does not integrate the judicial exception into a practical application, because it is merely an attempt to link the natural product to its field of use for oral ingestion. Claim 10 requires the bacterially fermented whole unextracted native hemp (i.e. the natural product) to be compounded as a tablet or a powder or within a capsule. This limitation at best indicates that the natural product is held within any generic capsule, which fails to meaningfully limit the claim because it is the equivalent of adding the words “apply it” to the judicial exception. Furthermore, claim 10 recites “having a maximum cannabinoid dose per unit dosage form of 20 mg in stabilized form” in line 4. This limitation does not integrate the judicial exception into a practical application because the limitation merely describes the characteristics of the natural product that are generally linked to its field of use for oral ingestion. Claim 10 recites “having viable bacteria therein as a probiotic dietary supplement” in lines 4-5. This limitation is recited with a high level of generality, because the bacteria is not limited in anyway. As such, this limitation encompasses bacteria present in the natural product, and consequently the limitation does not constitute as an additional element that can integrate the natural product into a practical application. Claim 11 requires the cannabinoid oral dosage form to contain less than 10% water as moisture. This provides insufficient specificity to add anything of significance to the judicial exception because at best the claim merely implies that the composition can contain a water element in addition to or as part of the judicial exception. Claim 12 requires the native hemp to have 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. As such claim 12, merely describes the way in which the natural product is formed without adding an additional structural element that can integrate the natural product judicial exception into a practical application. Therefore, the claim as a whole, does not integrate the judicial exception into a practical application (Step 2A Prong 2: No).
The additional elements fail to amount to an inventive concept. Ninonelli teaches fermenting hemp flour with water containing lactic acid bacteria to prepare and ferment dough. See p. 16 section 2.5. Ninonelli teaches Lactobacillus plantarum. See p. 16 section 2.9. Mullerova (MendelNet, 2016, 23, 610-615) suggests that enriching recipes with raw materials can give a product a higher nutritional value. See p. 60 first paragraph of the introduction. Mullerova teaches preparing dough from raw materials including hemp grits. See p. 611 table 1. Mullerova further discloses that hemp includes terpenes. See p. 610 second to last full paragraph. Lalge (MendelNet 2016: Proceedings of International PhD Students Conference, 2016, pp. 600-604) discloses that hemp flour includes cannabidiol. See table 3. As such, compositions comprising hemp powder, water and L. plantarum were well-understood and conventional at the time of filing. Thus, the additional limitations in claims 10-12 fail to amount to an inventive concept (Step 2B: No).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Nionelli (International journal of food microbiology, 279, 14-25, 2018) in view of Mullerova, (MendelNet, 2016, 23, 610-615) with evidence from Lalge, (MendelNet 2016: Proceedings of International PhD Students Conference, 2016, pp. 600-604).
Claim interpretation: instant claim 10 recites whole unextracted native hemp. The instant specification discloses that native hemp is raw. See [007].
Regarding claim 10, Ninonelli teaches fermenting hemp flour (i.e. powder) with Lactobacillus plantarum (i.e. viable bacterium probiotic). See p. 16 section 2.9. Ninonelli teaches preparing dough from hemp flour, 62.5g, and water containing a cellular suspension of lactic acid bacterium. See p.16 section 2.5 first paragraph. Ninonelli teaches hemp sourdough breads that have an acidic taste (i.e. oral dosage). See p. 24 first full paragraph. As evidenced by Lalge (p. 603 table 3), hemp flour has 0.7620 mg/g cannabidiol. Therefore, the 62.5g hemp flour taught by Ninonelli has 47.625 mg cannabidiol (i.e. a cannabinoid).
Ninonelli does not teach bacterially fermented whole unextracted native hemp, compounded as tablet or a powder or within a capsule, having soluble dietary fiber to insoluble dietary fiber ratio of 1:30, further wherein prior to preparation as said unit dosage form the bacterial fermentation of said native hemp increases the cannabidiol and/or cannabidiol acid amount by between 12-300% without increasing the amount of tetrahydrocannabinol and further wherein said bacterially fermented native hemp contains terpene compounds therein.
Mullerova suggests that enriching recipes with raw materials gives a product a higher nutritional value. See p. 60 first paragraph of the introduction. Mullerova discloses that common hemp includes monoterpene phenolic compounds (i.e. terpene). See p. 610 second to last full paragraph. Mullerova teaches preparing dough from raw materials. Mullerova teaches recipes that include hemp flour, hemp oil, hemp grits or hemp protein. See p. 611 table 1 and the first paragraph under table 1.
The instant specification discloses that native hemp has a soluble dietary fiber to insoluble dietary fiber ratio of 1:30. See [008]. The instant specification states that “[w]hen native or activated hemp are bacterially fermented, the action of the bacteria increase at least the cannabidiol (CBD) and cannabidiol acid (CBDA) constituency, enhancing the presence of the most desirable cannabinoids but NOT the THC [i.e. tetrahydrocannabinol]. This combined increase in CBD plus CBDA, or the total of the two, is between about 12% to 300%”. See [007].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine Mullerova’s raw hemp (i.e. native hemp) with Ninonelli’s Lactobacillus plantarum (i.e. viable bacterium probiotic), which necessarily arrives at a soluble to insoluble dietary fiber ratio of 1:30 and an increased cannabidiol and cannabidiol acid percentage. One of ordinary skill in the art would have been motivated to do so because Mullerova suggests that raw materials give a product a higher nutritional value. There would have been a reasonable expectation of success Ninonelli demonstrates using Lactobacillus plantarum for hemp flour dough fermentation (section 2.5), and Mullerova demonstrates preparing dough with additional hemp compounds including hemp grits.
Regarding claim 11, Ninonelli teaches hemp flour 62.5 g and tap water 37.5 ml, containing the cellular suspension of lactic acid bacteria to prepare 100 g of dough. See p. 16 section 2.5 first paragraph. Therefore, Ninonelli suggests 37.5% water.
Mullerova teaches that the addition of hemp flour influenced the loss of water through baking. Furthermore, Mullerova teaches a variant with a water loss that is low and amounted to 10.62%. See p. 612 first full paragraph.
Ninonelli and Mullerova do not teach an oral dosage form that contains less than 10% water as moisture.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to optimize the water percentage in the composition of Ninonelli and Mullerova. One of ordinary skill in the art would have been motivated to do so because Mullerova suggests that baking causes water loss. There would have been a reasonable expectation of success because Ninonelli teaches a composition with 37.5% water as moisture from which one of ordinary skill in the art could reasonably optimize. MPEP 2144.05(II)(A) indicates that differences in concentration or temperature generally amount to “routine optimization” and will not support patentability unless there is evidence indicating the claimed feature is critical. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 12, Ninonelli teaches fermenting hemp flour with Lactobacillus plantarum. See p. 16 section 2.9.
Response to Arguments
Applicant's arguments filed 04/17/2026, with respect to the rejection of claims 10-12 under 35 U.S.C. 103, have been fully considered but they do not apply to the new grounds of rejection set forth above.
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 1-6 of U.S. Patent No. 11,547,669 B2 (as cited previously) in view of Mullerova, (MendelNet, 2016, 23, 610-615).
Patent claim 1 recites a cannabinoid oral dosage form in unit dosage form, consisting essentially of bacterially fermented hemp pomace, compounded as a tablet or within a capsule, powder or other unit dosage form as the predominant or exclusive ingredient, having a soluble dietary fiber to insoluble dietary fiber ratio of 1:30, having a maximum cannabinoid dose per unit dosage form of 25 mg, and having viable bacteria therein as a probiotic dietary supplement.
Patent claim 2 recites the oral dosage form of claim 1, wherein each oral dosage form contains less than 10% water and wherein said cannabinoid is selected from the group consisting of cannabidiol, cannabigerol, cannabidivarin, cannabichromene, cannabinol and a combination thereof.
Patent claim 3 recites the oral dosage form of claim 1, wherein said 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.
Patent claim 4 recites the oral dosage form of claim 1, wherein said dosage form contains no more than 10 mg cannabinoid per unit dosage form.
Patent claim 5 recites the oral dosage form of claim 1 wherein said cannabinoid is present at a level of between 12 and 300% greater than a starting level of said cannabinoid due to the action of bacterial fermentation on same pomace.
Patent claim 6 recites the oral dosage form of claim 5 wherein said cannabinoid is present in the amount of 1.1-7.5% in said hemp pomace.
The patent claims lack: a maximum cannabinoid dose per unit dosage form of 20 mg in stabilized form and further wherein said bacterially fermented native hemp contains terpene compounds therein (relevant to instant claim 10).
However, Mullerova discloses that common hemp includes monoterpene phenolic compounds (i.e. terpene). See p. 610 second to last full paragraph.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to optimize the maximum cannabinoid dose per unit dosage form of 25 mg recited in patent claim 1, and to further recognize that the hemp pomace (i.e. native hemp) recited in patent claim 1 necessarily includes terpene in order to arrive at a cannabinoid oral dosage form in unit dosage form for ingestion.
Claims 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,590,186 B2 in view of Nionelli (International journal of food microbiology, 279, 14-25, 2018) and Mullerova, (MendelNet, 2016, 23, 610-615).
Patent claim 1 recites a cannabinoid oral dosage form in unit dosage form, consisting essentially of hemp pomace, compounded as a tablet or within a capsule, powder or other unit dosage form as the predominant or exclusive ingredient, wherein said hemp pomace is the resulting material remaining after extraction and removal of cannabinoids therefrom, and having a soluble dietary fiber to insoluble dietary fiber ratio of 1:30 and a maximum cannabinoid dose per unit dosage form of 25 mg.
Patent claim 2 recites a cannabinoid oral dosage form in unit dosage form, consisting essentially of hemp pomace, compounded as a tablet or within a capsule, powder or other unit dosage form as the predominant or exclusive ingredient, wherein said hemp pomace is the resulting material remaining after extraction and removal of cannabinoids therefrom, and having a ratio of non hallucinogenic/addictive cannabinoid (CBD or CBG) to THC of 30:1-120:1.
Patent claim 3 recites the oral dosage form of claim 1, wherein each oral dosage form contains less than 10% water as moisture and wherein said cannabinoid is one or more of cannabidiol, cannabigerol, cannabidivarin, cannabichromene, or cannabinol.
Patent claim 4 recites the oral dosage form of claim 1, wherein said hemp pomace is fermented with a bacteria or fungus prior to compounding.
Patent claim 5 recites the oral dosage form of claim 1, wherein said dosage form contains no more than 10 mg cannabinoid per unit dosage form.
The patent claims lack: whole unextracted native hemp, a maximum cannabinoid dosage per unit dosage form of 20 mg in stabilized form, and having viable bacteria therein as a probiotic dietary supplement, further wherein prior to preparation as said unit dosage form the bacterial fermentation of said native hemp increases the cannabidiol and/or cannabidiol acid amount by between 12-300% without increasing the amount of tetrahydrocannabinol and further wherein said bacterially fermented native hemp contains terpene compounds therein (relevant to instant claim 10); and wherein said native hemp has been fermented with 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 (relevant to instant claim 12).
However, Ninonelli teaches fermenting hemp flour with Lactobacillus plantarum. See p. 16 section 2.9. Mullerova teaches preparing dough from raw materials including hemp grits. See p. 611 table 1 and the first paragraph under table 1. Mullerova discloses that common hemp includes monoterpene phenolic compounds (i.e. terpene). See p. 610 second to last full paragraph (relevant to instant claims 10 and 12).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to substitute Mullerova’s native hemp for the hemp pomace recited in patent claim 1, and to further substitute Ninonelli’s Lactobacillus plantarum for the bacteria recited in patent claim 4.
Response to Arguments
Applicant's arguments filed 04/17/2026, with respect to the double patenting rejection of claims 10-12, have been fully considered but they do not apply to the new grounds of rejection set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/EST).
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657
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