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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/18/2026 has been entered.
Status of the Claims
Claims 1-3 and 5-20 are pending and under current examination.
Withdrawn Claim Rejections
All rejections not reiterated have been withdrawn.
Claim Objections
Claims 9 and 18 are objected to because of the following informalities:
Claim 9 lines 2, 5 and 7 all contain a typographical error in the phrase “solid plan material”. This could be remedied by changing the phrase to read “solid plant material”.
Claim 18, line 3, recites “a force of repulsion that leads to stable dispersion”. This phrase is missing the indefinite article “a”, as in “a force of repulsion that leads to a stable dispersion”.
Appropriate correction is required.
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 2-3, 5-9, 13-15, 17, and 18 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.
Claims 2 and 8 recite the limitations “first temperature” or “first selected temperature” and “first period of time”, which implies a second temperature and a second period of time within the claims. However, no mention is made of the second temperature or period of times, thereby rendering claims 2 and 8 indefinite.
Claim 8 recites the limitation "first selected temperature" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 contains the trademark/trade name shellac. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe shellac as a general category of polymer and does not designate natural or synthetic shellac and, accordingly, the identification/description is indefinite.
Claims 13 and 14 also recite a “first polymer”, which implies a second polymer within the claims. However, no mention is made of the second polymer, thereby rendering claims 13 and 14 indefinite.
Claim 14 recites the limitation "the first polymer" in line 1. There is insufficient antecedent basis for this limitation in the instant claim 1, which does not recite a polymer.
Claim 15 does not contain the word “and” before the last element of the Markush group. This renders the claim indefinite because it fails to define a closed group. Please refer to MPEP 2173.05(h):
“When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper.”
Claim 17 recites the limitation “a net charge that is 15mV or higher”. This renders the claim indefinite because it is not clear what the upper limit of the net charge of the particle may be.
Claim 18 is indefinite because it requires stability without reciting conditions that make the dispersion stable. The diluted starting material, for example the number of particles in the dispersion, is not defined, so one cannot understand the conditions under which stability is required. The claim is indefinite because it is unclear what is being diluted and to what extent it is diluted.
Claim 18 recites the term “diluted at least up to 10 fold”. This renders the claim indefinite because it does not impose a clear boundary on the dilution of the aqueous suspension.
Regarding claims 3, 5-7, and 9, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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.
Claims 1-3 and 5-20 are rejected under 35 U.S.C. 103 as being unpatentable over Durkacz (U.S. Patent Application No. 2020/0079751, publication year: 2020) in view of Keller (U.S. Patent Application No. 2021/0177754, publication date: 6/17/2021).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1-3, Durkacz teaches a method of extracting and concentrating cannabinoids and other target compounds from cannabis using ultrasound-enhanced solvent extraction [0003]. Shredded, particulate cannabis plant is mixed with a solvent, chilled or heated, subjected to ultrasound, and filtered to recover the oil-based extracts of cannabis [0069-0073].
Regarding claim 5, Durkacz teaches that an on-going solvent recovery application may be integrated into the extraction process, especially post-ultrasound treatment of the slurry. The solvent recovery can include EVAP/vacuum recovery and boiling recovered solvent through a distillation system that not only removes the solvent but also removes any water emanating from the harvested cannabis plant [0071]. Figure 1 illustrates that after the slurry undergoes ultrasonic treatment (26) the mixture is filtered (28) and solvent is directed to solvent recovery (Figure 1).
Regarding claim 6, Durkacz teaches that the EVAP/vacuum recovery removes the solvent from the ultrasound treated slurry [0071]. The Examiner considers the phrase “removes the solvent” to read on the “at least 95% of the extraction solvent” limitation of the instant claim.
Regarding claim 7, Durkacz teaches that the extraction solvent may be ethanol [0069] and that during solvent recovery the ethanol is fed to a condenser [0116].
Regarding claim 8, Durkacz teaches that the solvent can be utilized in a range from preferably between -80 to 95oC [0070]. The slurry mixture is mixed for a duration ranging between thirty seconds to ten minutes [0091] and ultrasound is applied for a duration of thirty seconds to a maximum of five minutes [0092].
Regarding claim 9, Durkacz teaches that solid/liquid separation techniques such as centrifugation can be performed to the slurry following treatment with ultrasound [0096]. A centrifugal filter can separate fine particles from the liquid component [0109].
Regarding claim 10, Durkacz teaches that the methods may be utilized to derive extracts from lavender [0145].
Regarding claims 11-19 Durkacz teaches the relevant limitations of claim 1 above.
Regarding claim 20, Durkacz teaches a method of extracting and concentrating cannabinoids and other target compounds from cannabis using ultrasound-enhanced solvent extraction [0003]. Shredded, particulate cannabis plant is mixed with a solvent, chilled or heated, subjected to ultrasound, and filtered to recover the oil-based extracts of cannabis [0069-0073]. The methods may be utilized to derive extracts from lavender [0145]. The solvent can be utilized in a range from preferably between -80 to 95oC [0070]. The slurry mixture is mixed for a duration ranging between thirty seconds to ten minutes [0091] and ultrasound is applied for a duration of thirty seconds to a maximum of five minutes [0092]. The EVAP/vacuum recovery removes the solvent from the ultrasound treated slurry [0071]. The Examiner considers the phrase “removes the solvent” to read on the “at least 90 wt.% of the extraction solvent” limitation of the instant claim.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1 and 11-20, Durkacz does not teach that the cannabis extracts may be encapsulated in a nanoparticle. However, this deficiency is cured by Keller.
Keller teaches a method for stabilizing flavorants, active ingredients, or both, comprising providing a nanoemulsion comprising an oil, water, an emulsifying agent and an active ingredient, wherein stabilizing comprises reducing air oxidation, evaporation or both [0037]. The nanoemulsion comprises nanoparticles having a size of from 20 to about 200nm [0012]. The active ingredient comprises a botanical ingredient derived from natural plant materials, such as extracts or isolates from plant materials or treated plant materials [0065], such as cannabis in the form of an isolate from plant material [0091] and lavender [0063] and may be lipophilic [0101]. The nanoemulsions are prepared by adding the hydrophobic active ingredients and/or flavors to the oil phase. The aqueous and oil phases are combined and homogenized [0138]. The Examiner considers the phrase “combined and homogenized” to read on the “encapsulated” and “dispersing” limitations of the instant claim.
Regarding claim 5, Durkacz does not teach that the extractant solution filtrate A is added to the carrier solvent prior to removal of the extraction solvent or the order of performing process steps as recited in the instant claim. However, this deficiency is cured by Keller.
Keller teaches that the nanoemulsions are prepared by adding the hydrophobic active ingredients and/or flavors to the oil phase. The aqueous and oil phases are combined and homogenized [0138].
Regarding claim 7, Durkacz does not teach a carrier solvent. However, this deficiency is cured by Keller.
Keller teaches that the carrier oil may include coconut oil [0047]. The instant specification teaches that natural sources of medium-chain triglycerides includes coconut oil [00395 of instant specification]. The Examiner therefore considers coconut oil to read on the “medium-chain triglycerides” limitation of the instant claim.
Regarding claim 11, Durkacz does not teach the inclusion of the recited additional components. However, this deficiency is cured by Keller.
Keller teaches that the active ingredient may include cannabidiol [0063].
Regarding claim 12, Durkacz does not teach the inclusion of an emulsifying agent. However, this deficiency is cured by Keller.
Keller teaches that the emulsifying agent may be Tween 20, Tween 80, Span 40, Span 60, or Span 80 [0058].
Regarding claims 13 and 14, Durkacz does not teach a polymer present in the composition. However, this deficiency is cured by Keller.
Keller teaches that the nanoemulsion may include additional components such as binders [0106], including methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and carboxymethyl cellulose [0119]. With regards to the “retards the release” limitations of instant claim 14, the prior art teaches the same cellulose polymers as claimed in the instant claim 13 and therefore, the release modifying properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claims 15 and 16, Durkacz does not teach the inclusion of the claimed additional ingredients. However, this deficiency is cured by Keller.
Keller teaches that the composition may include resveratrols, isoquercitrin, quercitrin, epigallocatechol gallate, epigallocatechol [0088], catechin [0092], curcumin [0092] and terpenes [0094].
Regarding claim 17, Durkacz does not teach a net charge of nanoparticles. However, this deficiency is cured by Keller.
Keller teaches that the nanoparticles have a zeta potential from about -40mV to about 40mV [0141].
Regarding claim 19, Durkacz does not teach a weight percentage of nanoparticles present in the composition. However, this deficiency is cured by Keller.
Keller teaches that the amount of oil present within the disclosed nanoemulsion can be from about 5% to about 80% by weight, based on the total weight of the nanoemulsion [0051].
Regarding claim 20, Durkacz does not teach a heating and ultrasound duration within the range of the instant claims.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1, 5, 7, and 11-20, it would have been prima facie obvious to one of ordinary skill in the art of filing to stabilize the cannabis extract obtained by the method of Durkacz in the nanoparticles of Keller. One would have understood in view of Keller that lipophilic extracts of cannabis may be stabilized in a nanoemulsion and in view of Durkacz that cannabis extracts may be obtained by exposing the plant material to an extraction solvent. One of ordinary skill in the art at the time of filing would have been motivated to encapsulated the cannabis extract obtained by the method of Durkacz in the nanoparticles of Keller in order to stabilize the extract and prevent or reduce air oxidation, evaporation or both [0037]. The artisan of ordinary skill would have had reasonable expectation of success because Keller teaches that cannabis extracts may be stabilized in the nanoemulsions.
Regarding the stability and force of repulsion properties of the nanoparticles as recited in the instant claims 1, 18, and 19, although Durkacz, in view of Keller, does not disclose all the characteristics and properties of the composition disclosed in the present claims, based on the substantially identical process using identical components, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition disclosed by Durkacz, in view of Keller. Because the PTO has no means to conduct analytical experiments, the burden of proof is shifted to the Applicant to prove that the properties are not inherent. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).” MPEP § 2112
Regarding claim 5, it would have been prima facie obvious to one of ordinary skill in the art of filing to add the cannabis extract obtained by Durkacz to the carrier oil taught by Keller. One would have understood in view of Keller that the active ingredients to be stabilized by the nanoemulsion may be added to the oil phase during preparation. It would have been obvious to add the cannabis extract of Durkacz to the oil phase, or carrier oil, during preparation of the nanoemulsion taught by Keller. One of ordinary skill in the art at the time of filing would have been motivated to add the cannabis extract of Durkacz to the oil phase of Keller in order to disperse the lipophilic extracts cannabis in the nanoemulsion. The artisan of ordinary skill in the art would have had reasonable expectation of success because Keller teaches that the active ingredient may be dissolved in the oil phase.
Regarding the order of method steps as recited in claim 5, please refer to MPEP 2144.04(IV)(C), which states: “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”. Therefore, it would have been prima facie obvious to remove the extraction solvent after dispersing the extract in the carrier oil because the order of process steps as claimed yields an identical result (plant extract dispersed in a carrier oil) as the process steps taught by the prior art.
Regarding the duration of heating and ultrasound application as specified in claim 20, MPEP 2144.05 states:
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).
Furthermore, Durkacz teaches that the ultrasound releases intracellular contents into the solvent (Abstract) and may be applied to the biomass for a time, duration, frequency, and power sufficient to reduce the mass of the biomass (Claim 40) and that the solvent is the means by which the cannabinoids is derived from the plant material [0063]. The Applicants' specification provides no evidence that the selected duration of mixing and ultrasound application in claim 20 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the effects of the duration of ultrasound application on the mass of the biomass and the effect mixing with solvent on deriving hydrophobic cannabinoids from the plant material, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the duration of mixing and ultrasound application. One of ordinary skill in the art would have been motivated to change the duration of ultrasound application and mixing as this could be expected to be advantageous for increasing the amount of cannabinoids extracted from the plant material and reducing the mass of the biomass to the desired size.
Conclusion
No claims are allowed.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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