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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1124/2025 has been 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.
Any rejection not reiterated below are hereby withdrawn.
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
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?
Furthermore, the “ultrasonic process” is indefinite because the different phases do not have any parameters for speed, frequency, pulse or temperature. How does the phase differ from one another?
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 Coles (US 8445034 B1). This is 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, ultrasonic processing.
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 pulverizing 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).
Cole teaches a method for extracting cannabinoids from cannabis plant material with ultrasonic waves, wherein the processor controls the extractor to extract in a predetermined materials to solvent amount required to produce a specified cannabinoid (Claim 1).
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 Psi, 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.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use ultrasonic wave for extracting cannabis plants because Cole teaches a method for extracting cannabinoids from cannabis plant material with ultrasonic waves, wherein the processor controls the extractor to extract in a predetermined materials to solvent amount required to produce a specified cannabinoid (Claim 1). One would have been motivated to use ultrasonic wave 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 liquid phase contains both THC and CBD.
In response to Applicant’s argument, please amend the claims to indicate what liquid phase contains.
Applicant argues that the limitations of producing THC and CBD are not taught by the references.
In response to Applicant’s argument, the references all teach a way to obtain CBD from CBN by temperature decarboxylation. One of ordinary skill in the art would know the temperature and conditions for optimizing conversion of CBN to CBD. THC and CBD amounts are not claimed by the Applicant. Any amount of THC would be inherently present in the extract.
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
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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