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 .
Response to Amendment
Applicant's amendment and argument filed 06/04/2026 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1, 3-5, 7, 8, 10-12, 14-15, 17-21, and 23-25 are pending and being examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-5, 7, 8, 10-12, 14-15, 17-21, and 23-25 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1, in part (d) is new matter. The claim recites “supplying at least a portion of the cannabis extract produced in step (b) from the evaporator used in step (b) to a distillation unit operation separate from the evaporator and located downstream of the evaporator, wherein the distillation unit operation distills the cannabis extract after removal of ethanol in step (b) to produce said distillate”. This is new matter because the application as originally filed does not teach distilling after the process of steps (a)-(c) or any separate downstream distillation unit after removal of ethanol or supplying at least a portion of the cannabis extract produced from step (b) to a downstream distillation unit. The drawings do not depict this and the specifications given no guidance to these steps. The original filed application describes that the apparatus or evaporator (J11) used is a thin-film evaporator (J11A) which can also have a distillation column (see Fig 17D or page 72). This does not efficiently describe the process as claimed.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
These rejections are all new rejections based on the amendments and arguments filed on 6/4/2026.
Claims 1, 3-5, 7, 8 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Michael Popp et. al. (US7291250B1), Joseph Finley et. al. (WO2016123475A1), Erich Krell (Handbook of Laboratory Distillation, Vol 2, Elsevier Scientific Publishing Co., 1982) and Risto Saari et. al. (US3875017A).
Regarding claims 1, 3-5, 21, and 23-25 Popp teaches “a process for concentrating a plant extract in the form of an aqueous alcoholic solution comprising the steps of:
a) placing the solution under vacuum in an evaporator to form an overhead product and a bottoms product being a concentrated plant extract;
b) pressurizing and transporting said overhead product to a multi-stage condenser having rectification means between the condenser stages;
c) condensing at least a portion of said overhead product by rectification in said multi-stage condenser into a liquid condensate; and
d) recycling at least part of said liquid condensate to said bottoms product of said evaporator to maintain a substantially constant ratio of more volatile to less volatile constituents in the solution in the evaporator (see claim 36). Recycling the condensate would also be mixing it with an ingredient when so broadly claimed.
Popp teaches “in the process of the invention the spissum extract to be concentrated is fed into the evaporator, relaxed and the evolving gases removed by the concentration means. The distillation residue or the bottoms product, respectively, drops into the bottom space and is directed past the heat exchangers as the cooling liquid. Since new extract is continuously supplied through the line and concentrated extract may be removed via the bottom line, the process may be conducted continuously. Optionally, a batch process may be employed. In both cases, the alcohol content of the bottoms product may be adjusted continuously by the amount of the recycled alcohol” (see lines 34-45, column 6). Popp discusses wherein after evaporation of volatile components there is a process of condensing and recognizes that distillation must occur as this is what is described as the bottom residue product which is directed past heat exchangers as the cooling liquid and then teaches recycling of the ethanol content.
Popp does not specifically teach that the plant is cannabis, teach the specific evaporators being claimed or that the distillation is downstream of the evaporator.
Finley teaches “a method for preparing a cannabis oil extract, the method comprising: eluting cannabinoids from cannabis plant material with a solvent to produce an eluate; filtering the eluate with a filter to produce a filtrate; evaporating the solvent from the filtrate with a distiller to produce a distillate; and purging the distillate under conditions sufficient to remove residual solvent, thereby preparing the extract” (see claim 1). Finley teaches that the solvent is ethanol (see claim 10).
Finley teaches “in one or more embodiments, the eluate or menstruum collected from this pouring step can be poured over the same cannabis plant material 103 again to elute more of the cannabinoids 107 from the cannabis plant material 103. This pouring step can be repeated until the cannabis plant material 103 has been poured over a total of three to six times, or until the coloration of the eluate or menstruum exhibits hues of green due to accumulation of chlorophyll or other undesired plant material in the eluate (see 0064). Here Finley teaches concentration of the eluate to presumably be further processed as just described and this would ultimately teach the repeated process steps of instant claims 1.
Finley teaches “the method of claim 1, further comprising mixing a quantity of one or more ingredients selected from the group consisting of vitamin E, an essential oil, an herbal extract, a probiotic, a homeopathic remedy, a flower essence, and a carrier oil with the extract to produce a cannabis oil composition” and this teaches the instant step (f) of claim1.the multifunctional composition.
Finley teaches cooling the eluate (see 0039, 0053 and 0080) and teaches dehydration of solvents to be done with evaporators or vacuum pumps (see 0093 and 0096) and teaches checking and controlling the pressure daily by bringing it back down to 21-27 mbar (see 0184), which indicates reduced pressure.
Finley teaches using cannabis flowers, buds, trichomes, leaves, stems, portions therein or combinations thereof (see 0052).
Krell’s general disclosure is a handbook on distillation.
Krell teaches of many different evaporators used in the distillation process and teaches many of the evaporators being claimed. Krell teaches specifically of evaporators wherein heat is supplied in a first evaporating stage and then the re-evaporation of the distillate takes place at reduced pressure by a water jet pump placed before the condenser (see page 227 at bottom). Krell teaches of continuous distillation which recycles the solvent (see 5.2.2 page 246) and teaches of employing vacuums during evaporation (see at least 255, 270-271, 274-275, 277 more specifically reduced pressure 278 bottom and top 279, 249) and teaches if reduced pressure is used to prevent decomposition there is danger that the volatile constituent will escape uncondensed but that this can be avoided through the use of a thin-film distillation (see page 283 bottom-284 top).
Thin-film distillation is used for both the evaporation of solid solutions and the
partial separation of liquid mixtures. As shown by Waelm and Mil3 [132a] the two methods can be combined in special cases. The possible combinations are compared concerning the separating efficiency and heat requirement on the basis of an ideal phase equilibrium of the volatile components. The author’s thin-film apparatus, as developed further by VEB Glaswerk Stiitzerbach and illustrated in Fig. 196, was adapted from the early types of molecular stills operating with a falling film. It contains two concentric tubes. The inner tube, which IS interchangeable by the provision of a ground joint, can be heated by an element a and functions as a surface for evaporation. The outer tube acts as condensing surface.
Krell teaches different thin-film evaporators which are falling-film with vertical heated tubes, straight or spiral-shaped down the outer walls of which the liquid flows (see 284) and these are great for separating waxes (see page 286, 2nd to last para.). Krell teaches of falling-film evaporators can be utilized for using a countercurrent of vapor and liquid for material transfer so that considerably higher separating efficiency can be obtained (see 289, first para.). These are evaporators that are highly effective for reuse of solvents and can be used for fractioning oils and for distilling waxes and oil fatty acids (see 288 at bottom).
Saari’s general disclosure is to a multi-stage thin film evaporator (see abstract).
Saari teaches an “evaporator, comprising an evaporator chamber, means for introducing the liquid to be evaporated into the evaporator chamber and for conducting the vapor there produced out of the evaporator chamber, a vertical heat exchanger within the evaporator chamber wherein the liquid to be evaporated flows downwardly, means for heating said heat exchanger with a fluid warmer than the liquid to be evaporated, whereby at least part of the liquid evaporates and a mixture of liquid and vapor is discharged onto the bottom of the evaporator chamber, means for removing the liquid from the bottom of the evaporator, a stationary helically shaped flow duct within the evaporator chamber into which flow duct the vapour ascends from the bottom of the evaporator chamber and is set into a powerful rotary motion, apertures on the outer periphery of said flow duct, a space surrounding the flow duct and closed at its top so that through said apertures the liquid droplets present in the vapor are flung into said space, whence the liquid flows back to the bottom of the evaporator chamber, an aperture above the flow duct so that the pure vapor escapes through said aperture to the means for conducting the vapor out of the evaporator chamber” (see claim 1).
Saari then teaches of a “distilling apparatus, comprising an evaporator according to claim 1 and, furthermore, a condenser wherein the vapor produced in the evaporator is condensed to become a distillate” (see claim 2).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to produce a cannabis extract by mixing cannabis plant material with ethanol, and then evaporating to produce vapor and the cannabis extract because Popp teaches of extraction methods which utilize evaporators and vacuum distillation as a means for extracting volatile components in the same manner as what is being claimed. Selecting cannabis as a starting material for extraction is made obvious because cannabis is known to contain volatile components. Using a falling-film evaporators can be utilized for using a countercurrent of vapor and liquid for material transfer so that considerably higher separating efficiency as discussed by Krell. Krell teaches of many different evaporators/distillers that recycle the solvents and teaches both evaporation and distillation. Multiple evaporations through the use of one of these disclosed devices (i.e. falling-film evaporators) would indeed reuse the solvent through a process of evaporation and condensing and if run through multiple times would indeed distill after the evaporation step as these are both doing the same thing, evaporating and distilling. Also Popp teaches recycling at least part of the condensate. It would have been obvious to use a thin-film evaporator with downstream distillation separate from the evaporator because Saari teaches of such downstream methods for thin-film evaporators and distillation devices which are made obvious to use from Krell’s teaching.
Claims 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Michael Popp et. al. (US7291250B1), Joseph Finley et. al. (WO2016123475A1), Erich Krell (Handbook of Laboratory Distillation, Vol 2, Elsevier Scientific Publishing Co., 1982) and Risto Saari et. al. (US3875017A) as applied to claims 1, 3-5, 7-8 and 23-25 above, and further in view of Guolin Zhang and Jing Wang (CN201632081U) hereinafter Zhang.
Popp, Finley, Krell and Saari teach the instantly claimed method however are silent on the use of a multiple effect evaporator.
Zhang’s general disclosure is to a multiple-effect vapor recompression vaporization energy-saving system (see abstract).
Zhang teaches “The utility model discloses a multi-effect vapor recompression vaporization energy saving system, which at least comprises a first effective evaporator device. The evaporator device includes vaporization chambers and vapor-liquid separation chambers mutually connected, a conveying pump and a roots vapor compressor, wherein the conveying pump drives fluid in the vaporization chambers and the vapor liquid separation chambers to flow, the vapor-liquid separation chambers are connected to an input end of the roots vapor compressor to input secondary vapor into the roots vapor compressor, an output end of the roots vapor compressor is connected to the vaporization chambers to input recompressed high-temperature vapor into the vaporization chambers. The multi-effect vapor recompression vaporization energy saving system can avoid use of high latent heat vapor as heat source, while the high latent heat vapor is produced from recompressed secondary vapor during long distance conveying of high-temperature vapor, thereby greatly reducing corresponding human resource cost and energy consumption, and effectively increasing production benefits” (see abstract).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date to select and a use multiple-effect vapor recompression vaporization energy-saving system because as Zhang teaches this system can save costs and energy consumption while increasing production. Additionally, it is prima facie obvious to use an equivalent known for the same purpose and/or to combine prior art elements according to known methods to yield predictable results. In this case, ethanol evaporation for solvent removal is taught and known in the prior art and substituting one evaporator for another one would have been obvious to those skilled in the art.
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Michael Popp et. al. (US7291250B1), Joseph Finley et. al. (WO2016123475A1), Erich Krell (Handbook of Laboratory Distillation, Vol 2, Elsevier Scientific Publishing Co., 1982) and Risto Saari et. al. (US3875017A) as applied to claims 1, 3-5, 7-8 and 23-25 above, and further in view of Russell Thomas (WO2016161420A1).
Popp, Finley, Krell and Saari teach the instantly claimed method however are silent on the use of a rising film evaporator.
Thomas’s general disclosure is to improved methods for extracting botanical oils (see abstract).
Thomas teaches methods of extracting cannabis oils and terpenes from cannabis and using ethanol as extraction solvents and teaches vaporizing and condensing (see first para of summary of the invention).
Thomas teaches “the evaporation device 31 is preferably, but not limited to, an evaporation device such as a thin film evaporator, wiped film evaporator, short path evaporator, rising film evaporator, falling film evaporator, spray dryer evaporator, centrifugal thin-film evaporator, or a conventional still design such as, but not limited to, stills that are commonly used to distill ethanol-based spirits. However, any suitable evaporation device may be used and one or more evaporation devices may be used alone or in combination for enhanced evaporation or multiple effect evaporation”
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date to select and a use a rising film evaporator as claimed because these are known to be used in the art as can be appreciated from Thomas’s teachings.
Claims 12, 14-15, 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Michael Popp et. al. (US7291250B1), Joseph Finley et. al. (WO2016123475A1), Erich Krell (Handbook of Laboratory Distillation, Vol 2, Elsevier Scientific Publishing Co., 1982) and Risto Saari et. al. (USA) as applied to claims 1, 3-5, 7-8 and 23-25 above, and further in view Alessandro Guido and Cavalieri Manasse (WO2013050960A1).
Popp, Finley, Krell and Saari teach the instantly claimed method however are silent on mixing a portion of the cannabis extract with an ingredient other than starch powder or maltodextrin in creating foodstuffs.
Finley teaches “The method of claim 1, further comprising mixing a quantity of one or more ingredients selected from the group consisting of vitamin E, an essential oil, an herbal extract, a probiotic, a homeopathic remedy, a flower essence, and a carrier oil with the extract to produce a cannabis oil composition” and this teaches the instant step (f) of claim 21 of making the multifunctional composition.
Guido’s general disclosure is to gluten-free food products made with cannabis derivatives (see abstract).
Guido teaches “It has in fact been surprisingly observed that food products that are perfectly suitable for the diet of gluten-intolerant patients can be prepared with the combined properties of the derivatives of Cannabis sativa, which are rich in essential fatty acids, amino acids, vitamin E and of the derivatives of 5- methyltetrahydrofolic acid, thus not only allowing the absorption of substances not tolerated by the bodies of such patients to be prevented, but also allowing their diet to be supplemented with elements that assist the re-establishment of the correct functioning of the body. Thus, in another aspect, the present invention concerns food products comprising said composition, in the form of sweet and savoury baked products, preparations for sweet and savoury products, cornflakes, bread, pasta, pizza, croissants, cake, pie, chocolate cream, biscuits, crackers, muesli, diet bars, candy, chocolate or vegetal milk” (see 2nd and 3rd para of summary of the invention).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date to create foodstuffs such as baked goods, confectionery, candies, cookies and beverages such as specialty milks, because Guido teaches creating these multifunctional compositions without the use of maltodextrin or starch powders.
Response to Arguments
Applicant's arguments filed 06/04/2026 have been fully considered but they are not persuasive. The applicant argues that the claims are directed to a specific architecture which require 1) extraction of cannabis oil from plant material using ethanol, 2) evaporation of ethanol from the resulting liquid mixture to produce ethanol vapor and a cannabis extract, 3) condensation of the ethanol vapor to produce liquid ethanol, 4) recycling of the condensed liquid ethanol from the condensation step back to the extraction step and reuse of the condensed liquid ethanol as extraction solvent to extract cannabis oil from cannabis plant material, 5) supplying the cannabis extract produced by the evaporator to a distillation unit separate from and located downstream of the evaporator and 6) distillation of the cannabis extract. This process essentially describes what happens through the use of many evaporators/distillation devices. Evaporation and distillation go hand-in-hand. Popp already teaches these steps but does not teach that cannabis is used for extraction which is why Finely is relied upon. The downstream distillation separate from the evaporation is discussed by Saari and a reason to select a thin-film evaporator is discussed by Krell because the separating efficiency and heat requirement on the basis of an ideal phase equilibrium of the volatile components are improved. Saari teaches of thin-film evaporators with downstream distillation devices. The applicant argues that the Office does not articulate or identify where the cited references teach or suggest the claimed process architecture, however this is not true as this was just explained here and again in the above rejection.
The applicant argues that the rejection relies upon identifying individual process features in separate references and assembling those features using applicant’s disclosure. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The applicant argues that the Office has not established a motivation to combine the cited references, however the motivation to combine the art was discussed in the above rejection and again in the above response.
The applicant argues that the Office does not establish a reasonable expectation of success. The process as claimed essentially only describes a process of using a thin-film (rising or falling) evaporator to extract cannabis oil. Contacting cannabis with ethanol and then using thin-film (rising or falling) evaporator to extract cannabis oil is prima facie obvious. Evaporation and condensation take place with evaporators as does distillation. Recycling solvents is part of the continued flow through process with these evaporators as they are built for industrial use and batching. These are the steps that the applicant is claiming and the applicant does not argue against the art or the above rejection or point out specifically where they believe the art to not teach the instant claims. Rather, the applicant is only repeating the same argument that the art does not teach the architecture of the claimed process and that there is no reason to combine the art.
The applicant argues that Popp does not disclose the relationship of the downstream distillation and rather discusses the distillation and evaporation in a single unit. The Office brings in art from Saari that teaches this separation of a downstream distillation. Additionally, it does not appear that applicant is in possession of such a process or apparatus as claimed. The applicant appears to claim the same evaporators as what is previously known in the art. Evaporators are used in tandem with distillation. Evaporators are used as a preliminary step in distillation in multistage distillation or during evaporative concentration before separation. Many devices do this simultaneously however the process can be separated as currently claimed and as discussed by Saari. Popp is still being relied upon as the primary source because it is believed that the applicant does not have support for the downstream separate distillation as currently claimed.
Conclusion
Currently no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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