DETAILED 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 26th, 2026 has been entered.
This office action is in response to the amendment filed June 26th, 2026. Claims 50-54, 59, 60, and 71-74 were cancelled. The applicant has added new claims 75-95. Any objections or rejections not reiterated below are hereby withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 28, 49, 55-58, 61-70, and 75-95 are pending and were examined on the merits.
Drawings
The drawings were received on August 13th, 2023. These drawings are acceptable.
Withdrawal of Objections and Rejections
The objection to claims 50-53 has been withdrawn, claims 50-53 having been cancelled by the applicant.
Applicant’s arguments filed June 26th, 2026, with respect to the objection to claim 55 for a misspelling have been fully considered and are persuasive. The objection to claim 55 for a misspelling has been withdrawn. The applicant has amended claims 55 to recite the correct spelling of “Cannabis sativa”.
Applicant’s arguments filed June 26th, 2026, with respect to the objection to claims 55-58 over a lack of italicization of scientific names of species of organisms have been fully considered and are persuasive. The objection to claims 55-58 over a lack of italicization of scientific names of species of organism has been withdrawn. The applicant has amended claims 55-58 to italicize the scientific names of species of organisms.
The objection to claims 73 and 74 is withdrawn, these claims having been cancelled by the applicant.
Applicant’s arguments filed June 26th, 2026, with respect to the rejection of claims 65-69 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 65-69 under 35 U.S.C. 112(b) has been withdrawn. The applicant has amended claims 65-69 to remove the term “about” that rendered claims 65-69 indefinite.
Applicant’s arguments filed June 26th 2026, with respect to the rejection of claims 28, 49, 55-58, 61-70 under 35 U.S.C. 103 over Ragot and further in view of Xavier, Vu, and Tucker have been fully considered and are persuasive. The rejection of claims 28 and 49-70 under 35 U.S.C. 103 over Ragot and further in view of Xavier, Vu, and Tucker has been withdrawn. The applicant has amended independent claim 28, from which claims 49-70 depend to recite at least one aqueous solvent is filtered water, purified water, tap water, or any combinations thereof, and cannabis is contacted with said at least one aqueous solvent to provide at least one reaction mixture. In contrast, Ragot in further view of Xavier teaches extraction (from plant material) and separation procedures for cannabinoids using organic solvents. Vu does not cure the deficiencies of Ragot and Xavier with respect to the solvent system used. Tucker teaches using steam distillation to extract terpenes from cannabis, but does not teach extraction within a pressurized reaction mixture, as taught in instant independent claim 28 step h); Tucker also does not clarify the extent to which boiling water in a steam distillation procedure dissolves the terpenes from cannabis.
The rejection of claims 71-74 under 35 U.S.C. 103 is withdrawn, these claims having been cancelled by the applicant.
Pending Objections and Rejections
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is still objected to because of the following informalities: the specification does not recite the units of the horizontal axes for the graphs in Figures 8A-X. The applicant may intend to recite the unit “nm” or “nanometers” but these units must be recited explicitly. In the amendment to the specification the applicant recites that for Fig. 8A through 8X, the X-axis (understood as the horizontal axis) is absorbance and the Y-axis (understood as the vertical axis) is wavelength. However, this statement appears to be a mistake. One of skill in the art would recognize that absorbance is a function of wavelength in optical spectra. For absorbance to be a function of wavelength in the graphs of Fig. 8A-8X, as they are currently presented, the X-axes would be appropriately labeled as the wavelength and the Y-axes as the absorbance. The Y-axes would require no units, because absorbance is unitless, but the x-axes would require a wavelength unit such as “nanometers” or “nm”.
The objection to the specification over the use of trademarks and/or tradenames is maintained.
The use of the terms Ball, Kingsford, Weber, Home Depot, Green Flash, Crock Pot, Jack Daniel's, Johnny Walker, Longship Brewery, Abomination, Instant Pot, GrowlerWerks, Jim Beam, Protector Brewery, and Bigelow, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service
marks, certification marks, and collective marks) are permissible in patent applications, the
proprietary nature of the marks should be respected and every effort made to prevent their use in
any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 56 and 79 are objected to because of the following informalities: the term "Cannabis sativia" should be spelled "Cannabis sativa" for consistency with the accepted spelling in the art. Appropriate correction is required.
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. The term “pressure cooker” (claims 62, 64, 85, and 87) is understood as an apparatus that applies both heat and pressure to a material, such that the material is under a greater pressure, and at a greater temperature, than ambient conditions (25 °C and 0.1 MPa), not limited by the capabilities of any particular apparatus marketed as a “pressure cooker”.
Claim Rejections - 35 USC § 112
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 28, 76, 77, and 95 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. The examiner currently interprets the at least one aqueous solvent recited in claims 28 and 77 to be water. Claims 28 and 77 refer to at least one aqueous solvent being water, and claims 76 and 95 refer to ppm, but it is unclear what ppm refers to in relation to the water being at least one aqueous solvent.
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, 49, 55-58, 61-70, 75, and 77-94 are rejected under 35 U.S.C. 103 as being unpatentable over Ragot (US 20150037389 A1) and further in view of Xavier (CA 3089490 A1); Donaduzzi et al. (US 20180264121 A1), abbreviated “Donaduzzi”; Bhatarah et al. (US 20100087518 A1), abbreviated “Bhatarah”; Wakai et al. (The Journal of Physical Chemistry B 2005, 109 (36), 17028–17030), abbreviated “Wakai”; Maryott and Smith (NBS Circular 1951, 514, III-IV and 1-44), abbreviated “Maryott”; Uematsu and Frank (Journal of Physical and Chemical Reference Data 1980, 9 (4), 1291-1306), abbreviated “Uematsu”.
Claim 28 recites:
“A method of making a psychoactive extract of cannabis, comprising:
a) providing at least one sample comprising cannabis;
b) providing at least one aqueous solvent is filtered water, purified water, tap water, or any combinations thereof;
c) providing at least one sealed container;
d) providing at least one heat source;
e) providing at least one pressure source;
f) contacting said at least one sample comprising cannabis with said at least one aqueous
solvent in said at least one sealed container to provide at least one reaction mixture comprising at least one bulk aqueous solvent;
g) exposing said at least one container with said at least one reaction mixture to at least one of:
1) heat from said at least one heat source;
2) pressure from said at least one pressure source;
h) reacting said at least one reaction mixture under a regime of conditions comprising:
1) temperature,
2) pressure, and
3) time;
to provide at least one psychoactive extract of cannabis”.
Claim 49 recites “The method of claim 28, wherein said at least one psychoactive extract of cannabis is intoxicating”. Claim 55 recites “The method of claim 28, wherein said at least one sample comprising cannabis comprises at least one of Cannabis sativa, Cannabis indica, Cannabis ruderalis, or any combinations thereof”. Claim 56 recites “The method of claim 28, wherein said at least one sample comprising cannabis comprises Cannabis sativia”. Claim 57 recites “The method of claim 28, wherein said at least one sample comprising cannabis comprises Cannabis indica”. Claim 58 recites “The method of claim 28, wherein said at least one sample comprising cannabis comprises Cannabis ruderalis”. Claim 61 recites “The method of claim 28, wherein said at least one sealed container is substantially airtight, airtight, or any combinations thereof, when in operation”. Claim 62 recites “The method of claim 28, wherein said at least one sealed container comprises a pressure cooker”. Claim 63 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 combinations thereof”. Claim 64 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 combinations thereof”. Claim 65 recites “The method of claim 28, wherein said temperature is between 185 F and 300 F”. Claim 66 recites “The method of claim 28, wherein said temperature within said sealed container is between 229 F and 244 F”. Claim 67 recites “The method of claim 28, wherein said pressure is between 0.5 atmospheres and 10 atmospheres”. Claim 68 recites “The method of claim 28, wherein said pressure within said sealed container is between 5.8 psi and 11.6 psi”. Claim 69 recites “The method of claim 28, wherein said reaction is run at a time between 1 hour and 6 days”. Claim 70 recites “The method of claim 28, wherein said at least one extract of cannabis is concentrated”. Claim 75 recites “The method of claim 28, wherein said at least one aqueous solvent has a pH between 1 and 12, between 2 and 11, between 3 and 10, between 4 and 9, between 5 and 8, between 6 and 7, or any combinations thereof” .
Claim 77 recites:
“A method of making a psychoactive extract of cannabis, comprising:
a) providing at least one sample comprising cannabis;
b) providing at least one aqueous solvent is water;
c) providing at least one sealed container;
d) providing at least one heat source;
e) providing at least one pressure source;
f) contacting said at least one sample comprising cannabis with said at least one aqueous
solvent in said at least one sealed container to provide at least one reaction mixture comprising at least one bulk aqueous solvent;
g) exposing said at least one container with said at least one reaction mixture to at least one of:
1) heat from said at least one heat source;
2) pressure from said at least one pressure source;
h) reacting said at least one reaction mixture under a regime of conditions comprising:
1) temperature,
2) pressure, and
3) time;
to provide at least one psychoactive extract of cannabis”.
Claim 78 recites “The method of claim 77, wherein said at least one psychoactive extract of cannabis is intoxicating”. Claim 79 recites “The method of claim 77, wherein said at least one sample comprising cannabis comprises at least one of Cannabis sativa, Cannabis indica, Cannabis ruderalis, or any combinations thereof”. Claim 80 recites “The method of claim 77, wherein said at least one sample comprising cannabis comprises Cannabis sativia”. Claim 81 recites “The method of claim 77, wherein said at least one sample comprising cannabis comprises Cannabis indica”. Claim 82 recites “The method of claim 77, wherein said at least one sample comprising cannabis comprises Cannabis ruderalis”. Claim 83 recites “The method of claim 77, wherein said at least one aqueous solvent is filtered water, purified water, tap water, or any combination thereof”. Claim 84 recites “The method of claim 77, wherein said at least one sealed container is substantially airtight, airtight, or any combinations thereof, when in operation”. Claim 85 recites “The method of claim 77, wherein said at least one sealed container comprises a pressure cooker”. Claim 86 recites “The method of claim 77, 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 combinations thereof”. Claim 87 recites “The method of claim 77, 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 combinations thereof”. Claim 88 recites “The method of claim 77, wherein said temperature is between 185 F and 300 F”. Claim 89 recites “The method of claim 77, wherein said temperature within said sealed container is between 229 F and 244 F”. Claim 90 recites “The method of claim 77, wherein said pressure is between 0.5 atmospheres and 10 atmospheres”. Claim 91 recites “The method of claim 28, wherein said pressure within said sealed container is between 5.8 psi and 11.6 psi”. Claim 92 recites “The method of claim 77, wherein said reaction is run at a time between 1 hour and 6 days”. Claim 93 recites “The method of claim 77, wherein said at least one extract of cannabis is concentrated”. Claim 94 recites “The method of claim 77, wherein said at least one aqueous solvent has a pH between 1 and 12, between 2 and 11, between 3 and 10, between 4 and 9, between 5 and 8, between 6 and 7, or any combinations thereof”.
Ragot recites 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, 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, 77, and 83). This quote describes contacting plant material with a solvent such as water. Ragot 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 claims 70 and 93). This quote renders obvious the concentration of soluble extracts.
Ragot describes pressure and temperature parameters for the extraction in paragraph[0103]: “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 teaches certain non-ethanolic and aqueous extractions including extractions using a mixture of solvents 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, 63, 77, and 86). 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 and 77). It is within the knowledge of one of skill in the art while performing extractions under pressure regimes, to enclose the reaction mixture in an airtight, sealed container, to provide isolation from the ambient atmosphere, to avoid depressurization (see instant claims 28, 61, 64, 66, 68, 77, 84, 87, 89, and 91). 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, 64, 77, and 87).
Furthermore, regarding extraction conditions, Ragot 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 and 77). Ragot further provides a list of “Examples of plants that are useful in accordance with the present invention” (paragraph [0114]), including the Cannabaceae family member Cannabis sativa (paragraph [0115]; see instant claims 28, 55, 56, 77, 79, and 80). Although Ragot does not explicitly recite using a pressure cooker for extraction, a pressure cooker is broadly known in the art as a heat and pressure source, and it is within the knowledge of one of skill in the art to use a pressure cooker with a seal to prevent its internal contents from depressurizing to the pressure of the surrounding atmosphere (instant claims 62, 64, 85, and 87). Even if Ragot is interpreted not to recite hot water as a heat source; hot water, a gas burner, or an electric heating element are all heat sources that are broadly known in the art, and outside the art as common knowledge (instant claims 63 and 86).
The instant claims are distinguished from Ragot in that Ragot does not teach making a psychoactive extract of cannabis. However, one of skill in the art would have had a motivation to make a psychoactive extract of cannabis to deliver the psychoactive compound tetrahydrocannabinol, known to have calming effects and antioxidant effects (Xavier, paragraph [6]; instant claims 28, 49, 77, and 78). The calming effect of THC is reasonably considered a form of intoxication by those of skill in the art along with other effects including decreased short-term memory and impaired visual perception and motor skills (Xavier, paragraph [6]; instant claims 28, 49, 77, and 78). One of skill in the art would have had a reasonable expectation of success at preparing a psychoactive extract of cannabis by using cannabis as a botanical source material (Xavier, paragraph [6]; instant claims 28 and 77), and extracting using an appropriate solvent, as detailed further below. The psychoactive compound THC is mostly non-polar as a hydrocarbon with hydrocarbons with 21 carbon atoms, two oxygen atoms, and no other heteroatoms. Therefore, one of skill in the art would have a reasonable expectation of success at extracting THC from cannabis using a non-polar solvent such as hexane, or certain amphiphilic solvents such as ethanol (Bhatarah et al., paragraph [0006]). However, one of skill in the art would have been motivated to use water as a solvent instead of organic solvents such as ethanol and hexane because water is more readily available, being dispensed from municipal sources. One of skill in the art would have had a reasonable expectation of success at extracting THC from cannabis using pressurized and heated liquid water, because of its decreased polarity, as detailed below (instant claims 28, 77, and 83).
The dielectric property is known in the art as a measure for the polarity of a solvent (Wakai, Introduction paragraph 2). At 25 °C, water, a polar substance, has a dielectric of 78.54 (Maryott, page A. Standard Liquids); ethanol, which is less polar than water, has a lower dielectric of 24.30 (Maryott, page 8). However, one of skill in the art could lower the dielectric water by increasing the temperature (Uematsu, Table 4). Although pressure has the opposite effect, increasing the dielectric of water, one of skill in the art could have still achieved a net decrease in the dielectric of water (compared to water under one atmosphere (0.1 MPa) at 25.0 °C) under combined increase in temperature and increase in pressure (Uematsu, Table 4). With this net decrease in the dielectric of water, there is reasonably a decrease in the polar property of water as a bulk solvent. Under a pressure of 10.0 MPa and temperature of 275.0 °C, the dielectric of water decreases to 23.90, less than that of ethanol at 25 °C, of record above (Maryott, page 8; Uematsu, Table 4). Therefore, one of skill in the art would have had a reasonable expectation of success at decreasing the polarity of water to an extent of dissolving the psychoactive compound THC by increasing the temperature and pressure. One of skill in the art would have been motivated to apply the pressure to decrease the vaporization of liquid water which would result from increasing temperature, keeping a larger quantity of the water as a liquid solvent interfacing with plant material undergoing extraction. One of skill in the art could reasonably apply this pressure by heating the water and cannabis in a rigid sealed container, having constant volume (Ideal Gas Law). Therefore, one of skill in the art would have had motivation and a reasonable expectation of success at making a psychoactive extract of cannabis by subjecting the water solvent to increased temperature and increased pressure (instant claims 28, 77, and 83). The cited regime of 10.0 MPa and temperature of 275.0 °C is not a limiting example of a temperature-pressure regime that could enable THC extraction into water. Temperature-pressure regimes accessible through the use of a pressure cooker would be obvious to one of skill in the art, because they are among a finite number of regimes accessible to one of ordinary skill in the art where the polarity of water is reasonably less than that at ambient temperature and pressure, 25 °C and 0.1 MPa (Uematsu, Table 4), increasing the solubility of the psychoactive compound THC in water (instant claims 28, 62, 64, 77, 83, 85, and 87).
The instant claims are distinguished from Ragot in that Ragot does not explicitly recite using Cannabis sativa, Cannabis indica, or Cannabis ruderalis as source materials for making a psychoactive extract of cannabis. However, it would be obvious to one of skill in the art to prepare a psychoactive extract using any of these three plants because they contain the compound THC, as recited by Donaduzzi: “The plants of the genus Cannabis (Cannabis sativa, Cannabis ruderalis and Cannabis indica) have various substances of interest in science and medicine, so-called cannabinoids, for example: Δ9-tetrahydrocannabinol (D9-THC), Δ8-tetrahydrocannabinol (D8-THC), tetrahydrocannabinol acid (THC-A), tetrahydrocannabivarin (THCV), tetrahydrocannabinoline (THC-A), tetrahydrocannabinoline (THCV-A), tetrahydrocannabinoline acid (THCV-A), cannabidiol (CBD), cannabidiol acid (CBD-A), cannabichromene (CBC), cannabidivarine (CBDV), cannabidivarine acid (CBDV-A), cannabigerol (CBG), cannabigerol-acid (CBG-A), cannabigerovarine (CBGV), cannabinol (CBN), cannabinovarin (CBNV), among others” (paragraph [0005]; instant claims 28, 55-58, 77, and 79-82); Donaduzzi later recites Δ9-tetrahydrocannabinol and cannabiniol as psychoactive compounds (paragraph [00043]; instant claims 28, 55-58, 77, and 79-82).
The instant claims are distinguished from Ragot in that Ragot does not explicitly recite an extraction temperature between about 185 F and about 300 F, or between about 229 F and about 244 F in a sealed container, for making a psychoactive extract of cannabis (instant claims 65 and 66, respectively, and 88 and 89, respectively). However, one of skill in the art could have achieved these extraction temperatures through routine optimization. One of skill in the art could adjust the temperature by adjusting the heat applied to the reaction mixture using an electric hot plate, or another electric device with an adjustable heat setting. The temperature of the heated materials could be measured using a thermometer. The concentration of the known psychoactive compound THC (tetrahydrocannabinol) from cannabis could be measured using HPLC. Therefore, one of skill in the art could have adjusted the extraction temperature to optimize the extraction yield, rendering the limitations of instant claims 65, 66, 88, and 89 obvious to one of skill in the art over routine optimization.
The instant claims are distinguished from Ragot in that Ragot does not explicitly recite an extraction pressure of between about 0.5 atmospheres and about 10 atmospheres, or between 5.8 psi and 11.6 psi in a sealed container (instant claims 67 and 68, respectively, and 90 and 91, respectively). However, one of skill in the art could have achieved these extraction pressures through routine optimization. One of skill in the art could increase the pressure above one atmosphere by adjusting the heat applied to the reaction mixture in a sealed container using an electric hot plate, or another electric device with an adjustable heat setting (Ideal Gas Law). One of skill in the art could decrease the pressure below one atmosphere using vacuum pump and the sealing the container to prevent ambient gases from entering. The pressure within the container could be measured using an air pressure gauge. The concentrations of the known psychoactive compound THC (tetrahydrocannabinol) from cannabis could be measured using HPLC. Therefore, one of skill in the art could have adjusted the extraction pressure to optimize the extraction yield, rendering the limitations of instant claims 67, 68, 90, and 91 obvious to one of skill in the art over routine optimization.
The instant claims are distinguished from Ragot in that Ragot does not explicitly recite a reaction time of between about between about 1 hour and about 6 days for making a psychoactive extract of cannabis using an aqueous non-ethanolic solvent (instant claim 69 and 92). However, one of skill in the art could have achieved these reaction times through routine optimization, using a timer to measure reaction times, and ending the reaction at specific times, by removing heat and pressure and separating the extraction solvent from the botanical source material. The concentrations of the known psychoactive compound THC (tetrahydrocannabinol) from cannabis could be measured using HPLC. Therefore, one of skill in the art could have adjusted the reaction time to optimize the extraction yield, rendering the limitations of instant claims 69 and 92 obvious to one of skill in the art over routine optimization.
It is within the knowledge of one of skill in the art that water has pH between 1 and 12 (Claims 75 and 94).
Ragot, Xavier, Donaduzzi, Batarah, Wakai, Maryott, and Uematsu 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 extraction conditions for cannabis, 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 extraction method), 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 in view of Xavier, Donaduzzi, Batarah, Wakai, Maryott, and Uematsu, the invention as a whole, drawn to an extraction method as described in Claims 28, 49, 55-58, 61-70, 75, and 77-94, 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).
Relevant and Prior Art Made of Record
The relevant and/or prior art made of record and not relied upon is considered pertinent to applicant's disclosure, including the following:
Sawamura et al. The Journal of Physical Chemistry B 2001, 105 (12), 2429-2436
Sawamura et al. discloses an increase in the water solubility of certain hydrophobic compounds, alkylbenzenes (toluene, ethylbenzene, and propylbenzene), in water as temperature increases from 298.2 K to 323.2 K (Table 1) and as pressure increases from 0.1 MPa to a pressure between 75 and 250 MPa (Table 1, Abstract).
Additional prior art has been sent by the applicant through electronic mail and were cited on the PTO-892 form.
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***.
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
