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 .
Election/Restrictions
Applicant's election with traverse of Group I, claim(s) 1-16 in the reply filed on January 26, 2026 is acknowledged. The traversal is on the ground(s) that claim(s) 17 and 18 depend on claim 1 and that the examination of all claims (claim(s) 1-18) would not pose a serious burden. This is not found persuasive because group I and II are classified as two distinct types of inventions – group I is a method of making whereas group II is a composition. There can only be one patent for one invention which is why the groupings were made for the restriction.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 1-16 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 1 is indefinite because it is unclear what the term “sequential” means. In addition, is unclear what the term “biomass” means. The specification does not list the exact meaning of the phrases. Thus, the metes and bounds of the claim are unclear.
Claim 2 is indefinite because it is unclear what the term “coagulated compounds” means; it is unclear if the term is referring to specific compounds that are coagulated within the biomass or if the term is referring to a general sense of compounds that would be present within the biomass. The specification does not directly specify what entails “coagulated compounds”. Thus, the metes and bounds of the claim are unclear.
In claim 8, when is the seed crystal mixed with what extract and the terpenes? Clarification is requested about the process step being claimed.
Claim 11 is indefinite because it is unclear what the term “heated under a vacuum” means; it is unclear if the term refers to a vacuum oven (e.g. a heater that contains a vacuum) or if the term refers to a heater placed directly below the vacuum component. In addition, the specification does not list the exact meaning of the phrase. Thus, the metes and bounds of the claim are unclear.
Claim(s) 1, 4, 6-7, 10, 12-15 are indefinite because it is unclear what the term “about” means; it is unclear if the term refers to an amount slightly less than or slightly more than the disclosed numbers within the following claims. In addition, the specification does not list the exact meaning of the term. Thus, the metes and bounds of the claim are unclear.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
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.
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.
Claim(s) 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hopkins (U.S. Pub. No. 2017/0209809 A1) in view of Stoops (U.S. Pub. No. 2018/0236017 A1), Havens (U.S. Patent No. 10,857,482), Cole-Parmer Website (NPL - Last Updated November 01, 2019 and accessed March 30, 2026), Castillo (U.S. Pub. No. 2021/0154596 A1), Skell et al (Acta Crystal, (Year: 2021), vol. 77 (Part 2), pp. 84-89) and Krill et al (Metabolites, (Year: 2020), vol. 10, issue. 7, pp. 1-14).
Hopkins teaches an organic oil extraction device comprising: one or more connection ports; a first chamber; a second chamber; a heat source; one or more vacuum pumps; and a recovery assembly (abstract). Hopkins teaches closed loop oil extraction devices with burn off mechanisms and methods for extracting butane hash oil from organic matter such as cannabis plant matter (paragraph 0002). Hopkins teaches [that] the organic oil extraction device of claim 1, further comprising: a heat controller; wherein said heat controller is configured to regulate said heating of said heat source (claim 8). Hopkins teaches [that] butane may also refer to any other gas or solvent such as ethanol (paragraph 0031). Hopkins teaches that other embodiments may be used in addition or instead ([in terms of devices used, etc]) (paragraph 0021).
Hopkins does not teach said extraction process from cannabis biomass comprising sequential subcritical carbon dioxide that can be combined with butane (as stated within claim 1 of the present invention). Hopkins does not teach the composition obtained being combined with one or more terpenes to form a mixture (as stated within claim 1 of the present invention). Hopkins does not teach heating the obtained mixture within a temperature range between about 40 to 80oC (as stated within claim 1 of the present invention). Hopkins does not teach the use of a winterizing step and the use of a WPE in a mixture of 7 to 10% w/w terpenes (as stated within claims 2 and 7 of the present invention). Hopkins does not teach that the concentrate obtained comprises terpenes (as stated within claim 5 of the present invention). Hopkins does not teach that the terpenes are mixed within the extract in an amount of up to about 20% w/w (as stated within claim 6 of the present invention). Hopkins does not teach the presence of seed crystals and that the seed crystals are mixed with the concentrate and terpenes (as stated within claim 8 of the present invention. Hopkins does not teach the process of purging the concentrate, terpenes and WPE for a specific time period (as stated within claims 9 and 10 of the present invention). Hopkins does not teach the use of a vacuum for a closed loop system at specific pressures (as stated within claims 11 and 12 of the present invention). Hopkins does not teach the temperature and the pressures required for packaging said concentrate along with the addition of a THCA seed crystal within the cannabis concentrate after packaging (as stated within claims 13, 14 and 16 of the present invention). Lastly, Hopkins does not teach the resulting average of a post-purge mass (as stated within claim 15 of the present invention).
Stoops teaches a method for preparing a botanical extract ([e.g. cannabis]) comprising the steps of: using a raw botanical material (e.g. cannabis); [mixing] the [cannabis] with glycerin; blending the [cannabis] and glycerin to achieve a homogenous mixture; heating the mixture, repeatedly agitating the mixture, allowing the mixture to rest; repeatedly heating the mixture [and then] cool down the mixture; then separating a liquid component from a solid component of the mixture [in order to obtain] an extract of the [cannabis] and lastly, filtering out any remaining particulates (paragraph 0008). Stoops teaches preparing a cannabis extract using subcritical carbon dioxide and butane (paragraph 0005).
Havens teaches an extraction, reaction, and purification apparatus that comprises an entire unit designed to react, extract, purify, and isolate compounds and individual analyte from one or more source material(s) (abstract). Havens teaches [that] the separated off terpenes are recombined with the heat/oxygen-treated and dewaxed ([e.g. dewaxed is synonymous with winterized]) cannabinoid rich oil in one embodiment of this example, in another they are kept separate from the crystallized cannabinoids (paragraph 0090). Havens teaches [that] the purified medicinal compound is collected (claim 11). Havens teaches [that] the industrial hemp can be extracted [and] the remaining cannabinoids isolated, and the terpenes preserved (paragraph 0085). Havens teaches the use of a biomass processor, which extracts, isolates and purifies (paragraph 0011). Havens teaches a method of extracting the essential oils and other components from botanical products and recycling the post extracted biomass into fuel, and separating out the different oil based molecules using short path distillation in the post extraction vessel, before using the agro solvent, and combination of heat, cold, flocculent additives, and filtering to create a isolate, crystalline compound, or concentrate (paragraph 0035) and [that] this method can use solvents and co-solvents like ethanol (paragraph 0036).
Cole-Parmer Website teaches [that] after the extraction is completed, [a purge must be completed]; this purging removes any of the excess solvent and ensures the material is not ignited in anyway (under ‘Purging’ paragraph).
Castillo teaches a method of producing a cannabis extract and a “remainder” fraction (believed to comprise plant waxes, lipids and other active components) comprising the steps of: immersing a quantity of pulverized cannabis [within a] solvent of liquefied hydrocarbon gas at a temperature [in between] -15oC [to] -35oC [in order to yield] a cannabis extract [and] passing the cannabis extract through one or [multiple filters] to obtain an initial cannabis extract [that is] passed through one or [multiple filters] [wherein a] remainder fraction is retained by the filters; and subjecting the initial cannabis extract to purging in a vacuum chamber [in between] temperatures [of] 0oC-35oC to have a cannabis extract substantially free of solvent (paragraph 0011). Castillo teaches [that] in the butane extraction process, a commonly used method is to place the extract in a vacuum oven and heat it to between about 26° C. to about 140° C. (paragraph 0008).
Skell et al teaches [that] THCA-A is the nonpsychoactive precursor to psychoactive tetrahydrocannabinol (THC); upon heating THCA-A, decarboxylation to THC occurs (page 84, under 'Introduction').
Krill et al teaches that terpenes are found in cannabis biomass (abstract).
Regarding claim(s) 1-16, the cannabis plant matter that is used within the closed loop extraction method that uses a heat controller to regulate heat as taught by Hopkins can be modified to include that the extraction can be performed using subcritical carbon dioxide (CO2) and butane as taught by Stoops, in which that extract would contain a [number of] terpenes and that the terpenes can be recombined with the cannabis plant matter extract as taught by Havens where the cannabis plant matter extract (or concentrate) can be heated within a vacuum oven in between 26oC to about 140oC (more specifically, 40 to 80oC as claimed within the present invention) as taught by Castillo which would eventually produce a concentrate (or a purified medical compound) that would be collected through the use of a biomass processor also taught by Havens.
In addition, the closed loop extraction method as taught by Hopkins can include the information that naturally, the extraction method would naturally yield terpenes as taught by Havens and THCA crystals (e.g. seed crystals) as taught by Skell et al as a result of extraction directly from cannabis plant matter (e.g. cannabis plant matter can include any part of the cannabis plant which includes but is not limited to the branches, stalks, etc and cannabis plant matter can be synonymous with cannabis biomass) also taught by Hopkins.
Moreover, Hopkins can be modified to comprise a winterizing step (e.g. a “dewaxing” step) that focuses on using an extraction solvent, like ethanol to extract components from the biomass as taught by Havens with additional knowledge that extraction of biomass naturally yields terpenes that would already be present within the yielded extracted product as taught by Krill et al.
Furthermore, it would be obvious to collect what is left over from the concentrate that was produced at optimized parameters (e.g. temperatures and pressures) in order to achieve the optimal texture needed for storage, consumption, etc. As a whole, although the Havens, Castillo, Stoops, Cole-Parmer, Skell et al and Krill et al references have been used to remedy the deficiencies in Hopkins, one skilled in analytical and organic chemistry would reasonably expect that extraction methods for botanical compounds can vary significantly. In addition, within claim 1 of the present invention, applicant distinctly discloses that “[the] manufacturing [of] a cannabis concentrate comprising the following steps:” meaning that the steps disclosed within the present invention are not limiting, therefore leaving room for additional steps to occur in order to achieve the desired cannabis biomass concentrate.
All the aforementioned references do not specifically teach the ethanol concentration of about 0.50 w/w% that the cannabis biomass was contained in, the 20% w/w of terpenes that were mixed within the extract, 7 to 10% w/w of terpenes that were mixed with WPE, the time necessary for purging the extract, terpenes and the WPE, the vacuum pressure amounts (e.g. a psi of about -1 to -14 psi) during heating of the cannabis concentrate, instructions on the temperature and pressure necessary to package the concentrate, the specific amounts of THCA crystal within the concentrate and the resulting post-purge mass. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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).” The references teach the presence of specific ingredients or compounds in a composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
One of ordinary skill within the field of analytical and organic chemistry would reasonably expect that depending on the method of extraction and the degree of purity desired from the cannabis concentrate, that would influence what temperatures, pressures, the percentages of content of specific compounds, and purging time that are desired in order to obtain the ideal cannabis concentrate that would be packaged.
Lastly, one of ordinary skill in the art would reasonably expect that the extraction of cannabis would yield such compounds (e.g. terpenes, TCHA crystals or seed crystals) naturally while the cannabis biomass would also yield such compounds naturally (e.g. terpenes, TCHA crystals or seed crystals); one skilled in the art would reasonably expect to optimize certain parameters (e.g. temperature, pressure/psi, and content %) to achieve a sugar wax (as mentioned within the specification of the present invention).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached at (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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NASHARA L MOREAUExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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