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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 13, 2026 has been entered.
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.
Claim(s) 1 and 3-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alsayar et al (CA 3024645 A1) in view of Chordia et al (US 2021/0079315 A1) and Lopez (US 20160201009 A1).
In regard to claim 1, Alsayar et al discloses extraction and purification of cannabis oil (Abstract).
Alsayar et al discloses that initial extraction of cannabis oil could be performed by several methods including extraction using a polar solvent such as ethanol, butane, etc (page 7 [035]). This extract retains some waxes and/or terpenes endogenously present in the plant materials (page 7 [035]).
Alsayar et al further discloses that additional purification steps are performed to obtain oil having high purity (page 8 [38]):
[38] In a third option, one may include one or more purification steps after one of the above extraction steps, such as a winterization step, evaporation step or a distillation step. For example, US 7,700,368, US 2004/0049059 and US 2008/0167483, which are herein incorporated by reference in their entirety, each describes a process for extracting cannabinoids from cannabis plant material using CO, extraction followed by ethanol winterization to remove waxes. In another example US20160346339, which is incorporated by reference in its entirety, describes a process for extracting cannabinoids from cannabis plant material using solvent extraction followed by filtration, and evaporation of the solvent in a distiller to obtain a distillate.Implementing these processes is said to result in a cannabinoid having a chromatographic purity of greater than 99% (page 8 [38]).
US 7,700,368 discloses:
The crude BDS extract contains waxes and long chain molecules. Removal is by "winterisation", whereby the crude BDS extract is warmed to e.g. 40.degree. C..+-.4.degree. C. to liquefy the material. Ethanol is added in the ratio of 2:1 ethanol volume to weight of crude BDS extract. The ethanolic solution is then cooled to -20.degree. C..+-.5.degree. C. and held at this temperature for approximately 48 hours (Col. 18 lines 48-55).
On completion of the winterisation the precipitate is removed by cold filtration through a 20 .mu.m filter, to give an ethanolic solution of the BDS (Col. 18 lines 55-58).
US 7,700,368 discloses removal of solvent from filtrate by rotary evaporation (Col. 18 lines 65-67).
In regard to claims 12-14, US 7,700,368 discloses thin film evaporation under pressure (i.e. distillation) (Col. 18 lines 65-67). US 7,700,368 discloses film evaporation under reduced pressure (60.degree. C..+-.2.degree. C., with vapour at 40.degree. C..+-.2.degree. C./172 mbar and 72 mbar.+-.4 mbar) (Col. 18 lines 65-67).
Alsayar et al discloses that one or more purification steps after one of the above extraction steps, such as a winterization step, evaporation step or a distillation step may be employed. Hence, Alsayar et al discloses winterization step, evaporation step and/or a distillation of cannabis oil solvent extract. Alsayar et al discloses winterization step is performed after the crude extract solution has been obtained to remove waxes. The purified, winterized extract if further subjected to distillation to further purify the extract and remove the solvent.
Therefore, in regard to claim 1, Alsayar et al discloses:
A method of producing a plant raw material extract, the method comprising:
contacting the plant raw material with a non-aqueous solvent to form a solution (page 7 [035]);
subjecting the solution to a first processing step to form a plant extract; and
subjecting the plant extract to a second processing step to yield a purified hop oil product,
wherein the first processing step comprises winterization;
wherein the second processing step comprises distillation (page 8 [38]).
Alsayar et al discloses plant material from cannabis. Alsayar et al does not disclose hops as plant material. Another prior art reference to Chordia et al is made as a teaching of the same method steps applied to both cannabis and hops to obtain refined oils free from waxes, resins, and lipids:
An improved process for producing refined oils free of contaminating waxes, resins, and lipids from botanical plant matter using an improved in-line winterization process is disclosed (Abstract).
[0002] Refined oils are used in many applications, such as pharmaceutical, cosmetic, and agricultural applications, resulting in a great demand to scale their production process effectively. There are three main ways to extract oils: cold pressing, expeller pressing, and solvent extraction.
[0007] One CO.sub.2 extraction application is the production of cannabinoid rich oils from the Cannabis plant. Running the extraction at high pressures and temperatures results in higher yield of the cannabinoids, but it could also result in higher extraction of undesirable waxes/oleoresins and other compounds, such as fats and chlorophyll. Thus, refining Cannabis extracts typically involves a winterization step. A polar solvent, usually ethanol, is added to the crude extract, heated to dissolve the crude oil, and then chilled to low temperatures, sometimes even below the freezing point. The waxes and lipids in the extract will precipitate over time, allowing them to be separated.
[0008] Another CO.sub.2 extraction application is the production of refined oils from the hops plant. As with the production of cannabinoid rich oils from the Cannabis plant, running the extraction at high pressures and temperatures results in higher yield of the refined oil, and typically also results in higher extraction of undesirable waxes/oleoresins and other compounds. Thus, similar to refining oils from the Cannabis plant, refining hops extracts to produced refined oils also involves a winterization step wherein a polar solvent such as ethanol is added to the crude extract, heated to dissolve the crude oil, and then chilled to low temperatures to precipitate the waxes and lipids in the extract.
[0033] As used herein, the term “botanical starting material” may be taken to include the leaves, flowers, stems, bark, seeds, fruits, and roots of a wide range of plant materials. Exemplary plant materials include at least herbs, aromatics, and other medicinally relevant botanicals, such as Cannabis, hops, lavender, melaluca, green tea, etc. ...Cannabis has long been used for fiber (hemp), for seed and seed oils, for medicinal purposes, and as a recreational drug. Cannabidiol oils, derived from Cannabis , have been connected to reducing the risk of certain cancers, as well as reducing pain, improving the conditions of the heart, and helping people get a good night's sleep. Hops have been grown in Europe since the 14th Century as a bitter substance for brewing beer, and were later discovered to contain lupulin, bitter resinous substances (lupulone, humulone) and essential oils in the strobiles from female plants. These lupulins are reputed to have drug like activities for relieving anxiety and inducing sleep.
Another prior art reference to Lopez is made as a teaching of the same method steps applied to both cannabis and hops to obtain refined oils free from waxes, resins, and lipids. Lopez discloses a method for extracting oil from a starting plant material (Abstract).
Lopez discloses “[t]he solvent used for extraction includes but is not limited to petroleum ether, methanol, ethanol, isopropyl alcohol, butane, hexane and carbon dioxide” ([0002]). Lopez discloses extraction of plant oils with butane:
Butane is the solvent of choice for extraction. Butane is a non-polar solvent and thus does not carry an electrical charge in its molecules. Other advantages are low cost, easy availability and easy removal from the finished product ([0003]).
Extraction of active substances from plant material using butane as a solvent can be achieved either in an open loop system or in a closed loop system. ([0004]).
Lopez discloses that method for extracting oil from a starting plant material such as hops and cannabis (claim 3).
One of ordinary skill in the art would have been motivated to modify Alsayar et al in view of Chordia et al and Lopez and to employ the same extraction and purification techniques as described by Alsayar et al to hop plant material as suggested by Chordia et al and Lopez. Chordia et al discloses that the same extraction and purification techniques are used for both Cannabis and hops. Lopez discloses that the same extraction with solvents such as butane and purification techniques are used for both Cannabis and hops. Therefore, to employ hops as well as cannabis in the process disclosed by Alsayar et al would have been obvious. In this case prior art elements are combined according to known methods (extraction and purification of plant oils) to yield predictable results (purified plant oil). It would have been obvious to simply substitute one known element (cannabis plant) for another (ho plant) to obtain predictable results (purified plant oil).
In regard to claims 2-5, Alsayar et al discloses ethanol, butane, etc as a solvent ([35]). It is further noted that claim 2-5 list non-aqueous solvent comprising various substances without actually requiring any particular substance. Hence, Alsayar et al meets the limitations of claims 2-5.
In regard to the winterization and freezing in claims 7-11, Alsayar et al discloses:
[38] In a third option, one may include one or more purification steps after one of the above extraction steps, such as a winterization step, evaporation step or a distillation step. For example, US 7,700,368, US 2004/0049059 and US 2008/0167483, which are herein incorporated by reference in their entirety, each describes a process for extracting cannabinoids from cannabis plant material using CO, extraction followed by ethanol winterization to remove waxes.
US 7,700,368 discloses:
The crude BDS extract contains waxes and long chain molecules. Removal is by "winterisation", whereby the crude BDS extract is warmed to e.g. 40.degree. C..+-.4.degree. C. to liquefy the material. Ethanol is added in the ratio of 2:1 ethanol volume to weight of crude BDS extract. The ethanolic solution is then cooled to -20.degree. C..+-.5.degree. C. and held at this temperature for approximately 48 hours (Col. 18 lines 48-55).
On completion of the winterisation the precipitate is removed by cold filtration through a 20 .mu.m filter, to give an ethanolic solution of the BDS (Col. 18 lines 55-58).
US 7,700,368 discloses removal of solvent from filtrate by rotary evaporation (Col. 18 lines 65-67).
In regard to claims 12-14, US 7,700,368 discloses thin film evaporation under pressure (i.e. distillation) (Col. 18 lines 65-67). US 7,700,368 discloses film evaporation under reduced pressure (60.degree. C..+-.2.degree. C., with vapour at 40.degree. C..+-.2.degree. C./172 mbar and 72 mbar.+-.4 mbar) (Col. 18 lines 65-67).
In regard to claims 15-17, Alsayar et al discloses “[i]n this third option, the endogenous waxes and/or terpenes are removed by the purification step(s) and one obtains a cannabinoid source which is depleted from the endogenous solubilizing aiding agent” ([39]).
In regard to claims 18, Alsayar et al discloses addition of terpene to the purified oil ([39]).
Response to Arguments
Applicant's arguments filed March 13, 2026 have been fully considered but they are not persuasive.
In the Reply to the Final Office action mailed December 17, 2025, filed March 13, 2026, Applicant presents the following arguments (pages 6-7):
Applicant submits that the cited references fail to disclose a method as claimed, particularly with regard to producing a hop raw material extract where a first processing step includes winterization and a second processing step includes distillation.
Alsayar is directed to "a cannabis oil for use in a vaping device configured for feeding the cannabis oil to a vaporization system having a heating element supplied with cannabis oil to vaporize the cannabis oil through a wick system, the cannabis oil comprising at least 300 mg/ml of a cannabinoid." See ¶9; emphasis added. The process includes extraction of cannabis plant materials with CO₂ or polar solvents to obtain cannabis oil suitable for use in a vaping device. Id., ¶34-35.
However, Alsayar fails to teach or suggest hops extraction, as presently claimed. To address this failing, Chordia is relied upon.
Chordia, however, is related to a process for producing refined oils from botanical plant matter using a high-pressure fluid extraction step employing supercritical carbon dioxide, to extract crude oil from a biomass, followed by separation of waxes or lipids in one or more separating columns. See ¶ [0014], and the Office Action, p. 4.
Despite Alsayar not disclosing anything about hops, and despite Chordia conducting an entirely different extraction from the one claims, the Office concludes that a person of ordinary skill in the art (POSITA) would be motivated to modify Alsayar in light of Chordia, utilizing the extraction and purification methods detailed by Alsayar for hop plant material, as indicated by Chordia. Office Action p.6.
Conspicuously missing from this conclusion, however, is any scientific rationale justifying the basis for it. There is no basis in Alsayar to use butane extraction for hops, and because Chordia uses an entirely different type of extraction-utilizing a supercritical carbon dioxide with no parallels to Alsayar. The Office Action, at page 10, asserts that Alsayar is not cited as a reference for hops, nor is Chordia referenced regarding supercritical carbon dioxide extraction of plant material. Rather, Alsayar is referenced for its disclosure of methods involving the extraction and purification of cannabis oil through solvent extraction using butane as a solvent, followed by one or more purification steps such as winterization, evaporation, or distillation.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Alsayar et al is not relied upon as a teaching of hops. Alsayar et al is relied upon as a teaching of extraction and purification of cannabis oil. Alsayar et al is relied upon as a teaching of solvent extraction of cannabis oil employing butane as a solvent followed by one or more purification steps a such as a winterization step, evaporation step or a distillation step ([35], [38]).
Further in response to applicant's arguments against the references individually, it is noted that Chordia is not relied upon as a teaching of a supercritical carbon dioxide extraction of plant material. Alsayar et al teaches two alternative methods of cannabis oil extraction (i.e. “first option” and “second option’). More specifically, Alsayar et al teaches:
[34] In a first option, one may extract cannabis plant materials using CO2 extraction (under sub-critical or super-critical conditions) in order to obtain the cannabis concentrate.
[35] In a second option, one may extract cannabis plant materials using polar solvent extraction (e.g., ethanol, butane, etc.).
Hence, Alsayar et al teaches extraction of cannabis oil either by polar solvent extraction (e.g., ethanol, butane, etc.) or by CO2 extraction. Chordia et al teaches extraction followed by winterization applied to both cannabis and hops to obtain refined oils free from waxes, resins, and lipids. Hence, both references teaches obtaining refining oils from cannabis by extraction followed by winterization step. Chordia et al teaches that such method is applied to cannabis and hops. Chordia et al is not relied upon as a teaching of a supercritical CO2 extraction of hops. Chordia et al is relied upon as a teaching of obtaining refining oils from hops. Alsayar et al is relied upon as a teaching solvent extraction.
Chordia is not relied upon as a teaching of non-polar solvents recited in claim 1. Alsayar et al is relied upon as a teaching of non-polar solvents recited in claim 1.
Further in response to Applicant’s arguments regarding the butane extraction of hops, it is noted that another prior art reference to Lopez (US 20160201009 A1) is made as a teaching of the same method steps applied to both cannabis and hops to obtain refined oils free from waxes, resins, and lipids. Lopez discloses a method for extracting oil from a starting plant material (Abstract).
Lopez discloses “[t]he solvent used for extraction includes but is not limited to petroleum ether, methanol, ethanol, isopropyl alcohol, butane, hexane and carbon dioxide” ([0002]). Lopez discloses extraction of plant oils with butane:
Butane is the solvent of choice for extraction. Butane is a non-polar solvent and thus does not carry an electrical charge in its molecules. Other advantages are low cost, easy availability and easy removal from the finished product ([0003]).
Extraction of active substances from plant material using butane as a solvent can be achieved either in an open loop system or in a closed loop system. ([0004]).
Lopez discloses that method for extracting oil from a starting plant material such as hops and cannabis (claim 3).
Further in response to applicant's arguments regarding the “extraction” step and first and second processing steps, it is noted that Alsayar et al discloses that one or more purification steps after one of the above extraction steps, such as a winterization step, evaporation step or a distillation step may be employed. Hence, Alsayar et al discloses winterization step, evaporation step and/or a distillation of cannabis oil solvent extract (i.e. solution). Alsayar et al discloses winterization step is performed after the crude extract solution has been obtained (i.e. claimed solution) to remove waxes. The purified, winterized extract (extract after the “first processing step”) if further subjected to distillation (i.e. “second processing step”) to further purify the extract and remove the solvent.
Claim 23 has been canceled. Therefore, the rejection of claim(s) 23 under 35 U.S.C. 103 as being unpatentable over Alsayar et al (CA 3024645 A1) in view of Chordia et al (US 2021/0079315 A1) as applied to claim 1 and further in view of Rivas (CA 3060081 A1) has been withdrawn.
The Terminal Disclaimer was filed 10/29/2025 and it was approved. Hence the Double Patenting rejection has been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA STULII whose telephone number is (571)272-3221. The examiner can normally be reached Monday-Friday 5:30AM-3:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/VERA STULII/Primary Examiner, Art Unit 1791