DETAILED ACTION
Supplemental Non-Final Action
This action is being mailed to applicant to restart the time period for response and to provide non-patent literature cited in the instant action.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group III in the reply filed on July 9th, 2025 is acknowledged. Applicant’s arguments have been fully considered. The restriction between Group I (Claims 1-23, 27), Group II (Claim 24), Group III (Claim 25) and Group IV (Claim 26) is deemed proper, for reasons of record, and therefore made final.
Claims 1-48 are pending of which claims 1-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Pending claims 28-48 have been examined on the merits.
The Examiner assigned to this case has changed. Please note the Examiner' s contact information at the close of this Office action.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on August 13th, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Please note a typographical error has been found on the IDS, however has been presently corrected in the PTO-892 (US Patent Application No. 2020/0010786).
Electronic copies of the following two non-patent literature documents were included and listed in the PTO-892 because the attached copies in the instant application file were partially illegible:
Alañón, M. E. et al. Extraction of natural flavorings with antioxidant capacity from cooperage by-products by green extraction procedure with subcritical fluids. Industrial Crops & Products 2017, 103, 222-232. doi: 10.1016/j.indcrop.2017.03.050
Ko, M. J.; Nam, H. H.; Chung, M. S. Subcritical water extraction of bioactive compounds from Orostachys japonicus A. Berger (Crassulaceae). Scientific Reports 2020, 10, 10890. doi: 10.1038/s41598-020-67508-2
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 28-30, 33-35, and 44-48 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ragot et al. (US 20150037389 A1).
Ragot et al. anticipates claims 28-30, 33-35, and 44-48 through the teachings of record below. Ragot et al. teaches a plant product as follows: “The invention relates to an edible product comprising plant materials as raw materials. In particular, the edible product may comprise a fibrous plant product and a plant extract” (paragraph [0006]). When describing the use of solvents, Ragot et al., teaches: “In one embodiment of the invention, one or more plant components (plant material or plant funish (sic)) such as, for example, stems, scraps, leaves, fines, dust and/or shorts, are initially mixed with a solvent (e.g., water and/or other compounds) at elevated temperatures” (paragraph [0088]; see instant claims 28+, 33, 34, 45, and 46+). This quote describes contacting plant material with a solvent such as water. Ragot et al. further teaches: “Once separated from the insoluble residue fraction of the plant solution, the soluble extracts fraction can optionally be concentrated using any known type of concentrator, such as a vacuum evaporator” (paragraph [0091]; see instant claim 44). This quote renders obvious the concentration of soluble extracts.
Ragot et al. describes pressure and temperature parameters for the extraction in paragraph [0103] (emphasis made by the examiner):
“Extraction may also be performed by means other than using hot water, namely by extraction with supercritical gases, such as carbon dioxide, or by using, for example, ethanol, hexane, acetone, R134a (1,1,1,2-tetrafluoroethane), carbon dioxide and hydrofluorocarbons. In one embodiment, the extraction can be carried out by using at least one solvent at room temperature and under atmospheric pressure. Extraction may also be performed by using a mixture of different solvents. In another embodiment, extraction may be performed using at least one solvent, such as for example R134a or carbon dioxide, at different temperatures and at different pressures and different states (liquid or gaseous). For example, extraction may be performed using solvents in a liquid state (such as solvent that are volatile or non-volatile at room temperature), in a subcritical state (such as water at a temperature above 100.degree. C. and a pressure above 1 bar), or in a supercritical state (such as carbon dioxide at a temperature above 31.degree. C. and a pressure above 73 bar)”.
In the quoted paragraph Ragot et al. teaches certain non-ethanolic and aqueous extractions (including extractions using water as a solvent; see instant claims 28+, 33, 34, 45, and 46+); and extractions under different temperature and pressure regimes, including examples of extractions under greater-than-ambient temperature (100 °C) and/or pressure regimes (73 bar) (see instant claims 28+, 45, and 46+). Extractions under greater-than-ambient temperature regimes are broadly understood to require applying heat to the reaction mixture by applying at least one heat source to the container holding the reaction mixture (see instant claims 28+, 45, and 46+). Extractions under pressure regimes are broadly understood as requiring a reaction mixture in an airtight, sealed container to provide isolation from the ambient atmosphere (see instant claims 28+, 35, 45, and 46+). Greater-than ambient pressure regimes are broadly understood to require applying at least one pressure source to the reaction mixture or a sealed container holding the reaction mixture (see instant claims 28+, 45, and 46+).
Furthermore, regarding extraction conditions, Ragot et al. recites: “Certain plants may require specific extraction conditions (time, temperature, solid/liquid ratio) due to the ingredients contained therein, which may be temperature sensitive or must not be subjected to certain extraction conditions” (paragraph [0104]). This quote lists time as a condition in an extraction procedure (see instant claims 28+, 45, and 46+). Ragot et al. further provides a list of “plants that are useful in accordance with the present invention” (paragraph 0114), including the Cannabaceae family members Cannabis sativa and Humulus lupulus (paragraph 0115; see instant claims 28+, 29, 30, 45, 46+, 47, and 48).
Claim Rejections - 35 USC § 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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 28-31, 33-35, and 44-48 are rejected under 35 U.S.C. 103 as being unpatentable over Ragot et al. (US 20150037389 A1) as applied to claim 28-30, 33-35, and 44-48 above, and further in view of Cunningham (J. Nat. Prod. 2019, 82, 636−646).
The claims and teachings of the cited references are as record above.
Claim 28 is drawn to a method of making an extract of cannabis.
The claims are further distinguished in that Claim 31 recites: “, wherein said at least one sample comprising cannabis comprises Cannabis indica”.
Although Ragot et al. does not explicitly teach a Cannabis indica extract, it would have been obvious at the time of the instant invention effective filing date to have provided such an extract with known medicinal plants. One would have been motivated to have made an extract in a process as claimed comprising C. indica extract, because Ragot teaches that “medicinal plants” and “any plant having one or more substances desired for use” were known and are useful therewith (see Ragot at [0114]-[0115]), and as recited by Cunningham C. sativa and C. indica were known in the art as alternatives of medicinal plants (“Whereas the psychoactive effects may be sought after by recreational and spiritual users, secondary metabolites produced by Cannabis sativa L. and Cannabis indica Lam. (Cannabaceae) possess diverse therapeutic and medicinal potential” (see Cunningham at Introduction, paragraph 2)). Considering the therapeutic and medicinal potential of Cannabis indica metabolites, one of ordinary skill in the art would have been motivated to prepare an extract of Cannabis indica and provided in the method of Ragot before the effective filing date of the claimed invention.
Ragot and Cunningham are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by these references with respect to the extracting plant and Cannabis sp. in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable plant material and extraction conditions (time, temperatures, pressures, solvents, amounts, sequence of steps, and selection of the general reactors sufficient therefor) and ranges in which to perform such an extracting), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effective filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 28-30, 32-35, and 44-48 are rejected under 35 U.S.C. 103 as being unpatentable over Ragot et al. (US 20150037389 A1) as applied to claim 28-30, 33-35, and 44-48 above, and further in view of Beutler and Der Marderosian (Economic Botany 1978, 32 (4), 387-394) and Wirth et al. (J. Pharm. Sci. 1980, 69 (11), 1359-1360).
The claims and teachings of the cited references are as record above.
Claim 28 is drawn to a method of making an extract of cannabis.
The claims are further distinguished in that Claim 32 recites: “wherein said at least one sample comprising cannabis comprises Cannabis ruderalis”.
Although Ragot et al. does not explicitly teach a Cannabis ruderalis extract, the reference teaches that “medicinal plants” and “any plant having one or more substances desired for use” were known and are useful therewith (see Ragot at [0114]-[0115]), and it would have been obvious to provide C. ruderalis considering the following, recited by Beutler and Der Marderosian: “The percentage of CBC was found to be relatively constant within the experiment, from 3 to 9 % of total cannabinoids in the progeny. Parent strains also had CBC as a non-variable cannabinoid at about the same concentration” (Results and Discussion, paragraph 1, p. 389-390), where parent strains are Cannabis sativa and Cannabis ruderalis (p. 390, Fig. 2), and CBC is cannabichromene (Materials and Methods, paragraph 10, p. 389). Therefore, one of ordinary skill in the art would have expected to find cannabichromene in Cannabis ruderalis. Cannabichromene is known to be anti-inflammatory (Wirth et al., paragraphs 1 and 5). Therefore, one of ordinary skill in the art would have been motivated, or at least it would have been obvious to try, to prepare an extract of Cannabis ruderalis and would have been prima facie obvious to have provided (added to) or substituted among the medicinal plants, and especially among the finite number of Cannabis alternatives including C. sativa and C. ruderalis, before the effective filing date of the claimed invention.
Ragot and Beutler and Der Marderosian are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by these references with respect to the extracting plant and Cannabis sp. in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable plant material and extraction conditions and ranges in which to perform such an extracting), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effective filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 28-30, 33-41, and 44-48 are rejected under 35 U.S.C. 103 as being unpatentable over Ragot et al. (US 20150037389 A1) as applied to claim 28-30, 33-35, and 44-48 above, and further in view of Ju (KR 20170064729 A).
The claims and teachings of the cited references are as record above.
Claim 28 is drawn to a method of making an extract of cannabis.
The claims are further distinguished in that Claim 36 recites: “wherein said at least one sealed container comprises a pressure cooker”.
Claim 37 recites: “The method of claim 28, wherein said at least one heat source is a light source, a hot water source, a steam source, an electric source, a gas source, or any combination thereof”. Claim 38 recites: “The method of claim 28, wherein said at least one pressure source is a pressure cooker, an autoclave, a sealed container, said at least one sealed container, air pressure, water pressure, steam pressure, heat generated pressure, or any combination thereof”. Claim 39 recites: “The method of claim 28, wherein said temperature is between about 185 F and about 300 F”. Claim 40 recites: “The method of wherein said temperature within said sealed container is between about 229 F and about 244 F”. Claim 41 recites: “The method of claim 28, wherein said pressure is between about 0.5 atmospheres and about 10 atmospheres”.
Although Ragot et al. does not explicitly teach the equipment, temperatures, and pressures of claims 36-41, there is support for their obviousness from Ju: “That is, the present invention extracts pine needles at a temperature of 100 to 200 DEG C and a pressure of 2 to 16 kgf /cm2 [sic “2 to 16 kgf / cm < 2 >”]; As the extractor, a pressure cooker can be used most simply. Here, the extraction time is not limited, and may be varied depending on the amount of the pine needle used for the extraction. For example, the extracting time can be 10 to 60 minutes” (KR 20170064729 A, Description-of-Embodiments, machine translation page 3 of 15). Considering the aforementioned use of a pressure cooker for a plant (pine needles) extraction, using a pressure cooker for a cannabis extraction, as recited in claims 36 and 38, would have been obvious to try, or to have provided or substituted from among the known alternative and equivalent pressure-providing devices, to one of ordinary skill in the art. A pressure cooker is broadly understood as an electrical device applying heat and pressure to substances in a sealed container. Therefore, claim 37 is also rendered obvious by Ju. The temperature range given by Ju for the extraction is 100-200 °C, i.e. 212-392 °F, overlapping with the temperature range of Claim 39 and encompassing the temperature range of claim 40. Therefore, the temperature ranges of claims 39 and 40 would be obvious to try over the course of routine optimization. The pressure range of 2 to 16 kgf / cm2 given by Ju is equivalent to 1.9-15.5 atmospheres, encompassing that given in claim 41, rendering it obvious to try over the course of routine optimization. Therefore, the equipment, pressures, and temperatures recited by claims 36-41 would have been at least obvious to try to one of ordinary skill in the art before the effective filing date of the claimed invention.
Ragot and Ju are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by these references with respect to the extracting plants and conditions and devices and in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable plant material and extraction vessel and operating conditions thereof) and ranges in which to perform such an extracting), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effective filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 28-30, 33-35, 42, and 44-48 are rejected under 35 U.S.C. 103 as being unpatentable over Ragot et al. (US 20150037389 A1) as applied to claim 28-30, 33-35, and 44-48 above, and further in view of Wang et al. (Molecules 2015, 20 (1), 430–445).
The claims and teachings of the cited references are as record above.
Claim 28 is drawn to a method of making an extract of cannabis.
The claims are further distinguished in that Claim 42 recites: “wherein said pressure within said sealed container is between about 5.8 psi and about 11.6 psi”.
Although Ragot et al. does not explicitly teach the pressures of claim 42, there is support for the obviousness from Wang et al. Wang et al. recites: “Vacuum assisted extraction (VAE) technology is developed based on pressurized liquid extraction (PLE) except in the vacuum controlled region. …. Like PLE, VAE can accelerate the release of solutes from the plant matrix by the vacuum assisted breakdown of cell components, and facilitate the solid-liquid mass transfer between the extraction solvent and matrix. The working pressure is stable and adjustable from 0 to 1000 mbar” (Introduction, paragraph 3). The pressure range recited by Wang et al. for a plant extraction, equivalent to 0-14.5 psi, encompasses that of claim 42 (about 5.8-11.6 psi). Therefore, performing a cannabis extraction at about 5.8-11.6 psi was obvious to try to one of ordinary skill in the art before the effective filing date of the claimed invention.
Ragot and Wang are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by these references with respect to the extracting plant and Cannabis sp. And providing of pressure in extractions, in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable plant material and extraction and extractor conditions (time, temperatures, pressures, solvents, amounts sufficient therefor) and ranges in which to perform such an extracting), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effective filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 28-30, 33-35, and 43-48 are rejected under 35 U.S.C. 103 as being unpatentable over Ragot et al. (US 20150037389 A1) as applied to claim 28-30, 33-35, and 44-48 above, and further in view of Kim et al. (KR 860001349 B1).
The claims and teachings of the cited references are as record above.
Claim 28 is drawn to a method of making an extract of cannabis.
The claims are further distinguished in that Claim 43 recites: “wherein said reaction is run at a time between about 1 hour and about 6 days”.
Although Ragot et al. does not explicitly teach the reacting times of claim 43, these times are rendered obvious to try by Kim et al. Kim et al. describes an extraction of seaweed in a pressure cooker: “In step 1 of Examples 1, 2 and 3, the seaweed was extracted by heating using a pressure cooker (Auto Clave) instead of a steam cooker (Auto Clave) for 1.5 hours at 1.2Kg / cm 2 of steam pressure and filtered to obtain an extract solution 2” (Example 4, machine translation). In this description, the extraction time is 1.5 hours, within the time range of claim 43. Therefore, reaction times within the range of claim 43 were obvious to try over the course of routine optimization to one of ordinary skill in the art before the effective filing date of the claimed invention.
Ragot et al., Ju, Wang et al., and Kim et al. are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the reaction times, temperature conditions, and pressure conditions of the cannabis extraction, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the cannabis extract), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Ragot et al. in view of Ju, Wang et al., and Kim et al., the invention as a whole, drawn to a method of preparing a cannabis extraction as described in Claim 28, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing
Applicants’ methods with the methods (including compositions thereof) of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed methods and the methods of the prior art (and compositions thereof). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655