Patent Application 15790970 - Process For Producing A Fluid Soluble Cannabis

Title: Process For Producing A Fluid Soluble Cannabis Base Product

Application Information

Invention Title: Process For Producing A Fluid Soluble Cannabis Base Product
Application Number: 15790970
Submission Date: 2025-05-22T00:00:00.000Z
Effective Filing Date: 2017-10-23T00:00:00.000Z
Filing Date: 2017-10-23T00:00:00.000Z
National Class: 424
National Sub-Class: 725000
Examiner Employee Number: 82623
Art Unit: 1655
Tech Center: 1600

Rejection Summary

102 Rejections: 0
103 Rejections: 1

Cited Patents

The following patents were cited in the rejection:

US 9066910🔗

Office Action Text

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
The Amendments filed on Jan. 14, 2025 has been received and entered.
Currently, Claims 1-21 are pending. Claims 1-21 are examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant's election with traverse of the species anti-inflammation in the reply filed on Aug. 20, 2019 is acknowledged. The traversal is on the ground(s) that there is no burden to search. This is not found persuasive because a search of one group is not coextensive with the search of the other groups. Thus, it would be burdensome to search the entire claims.
The requirement is still deemed proper and is therefore made FINAL.

Information Disclosure Statement
The information disclosure statement (IDS) submitted on Oct. 23, 2017 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
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 1-21 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “breaking up a molecular tension in a structure of the EPM and hydroxyl substance and displacing the EPM with the hydroxyl substance” in claim 1 is used by the claim to mean “decarboxylation of cannabinoids.” The term is indefinite because the specification does not clearly redefine the term. The phraseology is not understood as conventional scientific terminology describing chemical reaction.
In Claim 1, the steps d) i-iv are indefinite because one does not know what part of EPM is being filtered out. What is the remaining product supposed to be? Is the product in the liquid or solid phase? Which part is being subjected to further filtering and /or extracting?
Please clarify.

Claim Rejections - 35 USC §103
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Deangelo et al. (US 9066910 B2) further in view of Softsecretes (https:/7softsecrets.com/us/2013/06/03/reverse-osmosis-for-beqinners/), Leafly (https://www.leafly.com/news/cannabis-101/what-is-decarboxylation), BiteSizeBio (2013, https://bitesizebio.com/13536/bringing-down-the-walls-part-ii-8-methods-to-break-down-cell-walls/), GlenMills (https://www.glenmills.com/product/french-press-g-m-high-pressure-cell-disruption/#:~:text=The%20FRENCH%20PRESS%20G%2DM%C2%AE,%3B%2035ml)%20can%20be%20used.), Travares et al. (JP 2007517985 A), Repka et al. (2006, Drug Dev Ind Pharm., 32(1): 21–32), and Teng et al. (2016, PLOS One, 11(4): e0153457). This is not a new rejection.
Deangelo et al. teaches a method of producing a composition comprising an effective amount of high purity trichomes from cannabis flower trimmings (this a acquiring a quantity of cannabis plant material step), comprising adding cannabis flower trimmings to ice water, soaking and agitating the cannabis flower trimmings to separate trichomes, filtering the water mixture through a series of mesh screens of progressively smaller mesh and discarding plant material and removing trichomes, placing trichomes on flat surface, drying and curing trichomes, pulverizing and grinding up high-purity trichomes to produce a topical ointment (Claim 1). The whole plant extract is mixed with water-soluble organic compound to create a paste (column 2, lines 30-32), which is fluid soluble. The composition primarily affects or binds to the CB2 receptors sites and CB1 receptors of the mammal (Column 4, lines 7-10). CBD naturally in the flower would have health benefits of Claims 4-6 and 17-19 and 21.
However, Deangelo et al. does not teach liquid nitrogen to break cell walls, reverse osmosis, decarboxylation, and 20-2000 tons per square inch pressure, four phases of amplitude processing with each phase increasing in temperature.
Softsecrets teaches reverse osmosis is a process for removing impurities from water (entire document); therefore, concentrating the impurities to be collected. It is essentially a form of concentration by removing water. The process involves the use of semipermeable membranes that allows water solution through, but prevent any large molecules from passing, therefore purifying the solution of all dissolved minerals and producing pure water.
Leafly teaches a process of decarboxylation occur over heat and time. THCA in cannabis decarboxylate at approximately 220 degree F after around 30-45 minutes. Cannabinol is formed through degradation and oxidation of THC (At What Temperature Does Decarboxylation Occur?). Cannabis (CBN) can be decarboxylated in a slow cooker by introducing solvents such as cooking oils or lecithin (How to Decarboxylate Cannabis at Home). Decarboxylation would inherently use hydroxyl functional groups for decarboxylation to occur.
BiteSizeBio teaches a method to breakdown cell walls with plant samples frozen in liquid nitrogen and disrupted and extracted with mortar pestle then further extracted with solvent (Mortar and Pestle). There would be pressure from using mortar and pestle.
Travares et al. teaches a method of pulverizating cell walls of cellulose fibers such as cannabis by preparing micronized cellulose fibers with sufficient pressure in the range of 21.75 Tsi, tons per square inch, to 65.25 Psi to form a wet part [paragraphs 21 and 23].
Repka et al. teaches a thermal processing method for enhancing THC heat and oxidation stability by using three different processing temperature (120, 160, 200 degree C) (Abstract). Table 1 illustrates that at 120, 160, and 200°C, the percent CBN increase in the polymeric systems was 0.5, 0.4, and 1.6%, respectively. An interesting parameter as reported in this table is the relative % CBN formation from % THC degraded. Our findings indicate that at 120 and 160°C, only 9.0% and 7.8%, respectively, of the total THC degraded appeared as CBN. However at 200°C, the THC converted to CBN was 29.1%. This could be attributed to the fact that decomposition of THC occurs at temperatures in the range of 200– 250°C as depicted in Fig. 5. Thus, although the degradation of THC is relatively low at 200°C, the extent of conversion of THC to CBN is high (page 6, paragraph 1).
Teng et al. teaches a method of extracting plant oil with ultrasonic-assisted extraction, which is a rapid and effective extraction technique that used ultrasound to generate rapid movement of solvents, resulting in a higher mass transfer speed and acceleration of extraction, which is economic, eco-friendly, and convenient (page 2, paragraph 1, lines 5-7).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use reverse osmosis and decarboxylation because reverse osmosis can remove water to concentrate the desired ingredients and decarboxylation by heating at 220 degree F can convert THC to CBN, which is the desired product as taught by Softsecrets and Leafly teaches a process of decarboxylation occur over heat and time. THCA in cannabis decarboxylate at approximately 220 degree F after around 30-45 minutes. Cannabinol is formed through degradation and oxidation of THC (At What Temperature Does Decarboxylation Occur?). Reverse osmosis increases purity and concentration by removing water from a product. One would have been motivated to make a process for obtaining the function product of cannabis for the expected benefit of converting THC to CBN. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
The references also do not specifically teach performing the process in the time span and temperature range and pressure claimed by applicant in four phases of amplitude processing with each phase increasing in temperature. Repka et al. teaches a thermal processing method for enhancing THC heat and oxidation stability by using three different processing temperature (120, 160, 200 degree C) (Abstract). Table 1 illustrates that at 120, 160, and 200°C, the percent CBN increase in the polymeric systems was 0.5, 0.4, and 1.6%, respectively. The addition of one more temperature phase increases the temperature at a smaller increment so as not to create THC degradation. The process in the time span and temperature range and pressure is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here 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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal process in the time span and temperature range to use in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use liquid nitrogen for breaking cell walls at 20-2000 tons per square inch pressure because BiteSizeBio teaches liquid nitrogen can be used for breaking plant cell walls and Travares et al. teaches a method of pulverizating cell walls of cellulose fibers such as cannabis by preparing micronized cellulose fibers with sufficient pressure in the range of 21.75 Tsi, tons per square inch, to 65.25 Tsi to form a wet part [paragraphs 21 and 23]. One would have been motivated to use liquid nitrogen and pressure as a method of break plant cell walls for the expected benefit of extracting a plant cell as taught by BIteSizeBio and Travares et al. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.

Response to Arguments
Applicant argues that the combination of references do not teach the processing in semipermeable membrane.
In response to Applicant’s argument, Softsecrets teaches reverse osmosis is a process for removing impurities from water (entire document); therefore, concentrating the impurities to be collected. It is essentially a form of concentration by removing water. The process involves the use of semipermeable membranes that allows water solution through, but prevent any large molecules from passing, therefore purifying the solution of all dissolved minerals and producing pure water. Thus, the limitation is taught.
Applicant argues that Repka teaches degradation of THC to CBN.
In response to Applicant’s argument, Applicant’s claims are drawn toward different increments of temperature for isolating THC. Repka et al. teaches a thermal processing method for enhancing THC heat and oxidation stability by using three different processing temperature (120, 160, 200 degree C) (Abstract). Table 1 illustrates that at 120, 160, and 200°C, the percent CBN increase in the polymeric systems was 0.5, 0.4, and 1.6%, respectively. An interesting parameter as reported in this table is the relative % CBN formation from % THC degraded. Our findings indicate that at 120 and 160°C, only 9.0% and 7.8%, respectively, of the total THC degraded appeared as CBN. However at 200°C, the THC converted to CBN was 29.1%. This could be attributed to the fact that decomposition of THC occurs at temperatures in the range of 200– 250°C as depicted in Fig. 5. Thus, although the degradation of THC is relatively low at 200°C, the extent of conversion of THC to CBN is high (page 6, paragraph 1). Therefore, an ordinary person in the art would know what temperatures to use to prepare a THC solution by preventing CBN conversion.
Applicant argues that the displacement of EPM with hydroxyl substance is not taught.
In response to Applicant’s argument, Leafly teaches a process of decarboxylation occur over heat and time. THCA in cannabis decarboxylate at approximately 220 degree F after around 30-45 minutes. Cannabinol is formed through degradation and oxidation of THC (At What Temperature Does Decarboxylation Occur?). Cannabis (CBN) can be decarboxylated in a slow cooker by introducing solvents such as cooking oils or lecithin (How to Decarboxylate Cannabis at Home). Decarboxylation would inherently use hydroxyl functional groups for decarboxylation to occur. For THC to be isolated, the decarboxylation must happen, which would require the displacement of EPM with hydroxyl substance.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.

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Catheryne Chen Examiner Art Unit 1655

/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655