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 .
Claims 1-20 represent all claims currently under consideration.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/12/2025 has been entered.
Priority
The applicant has made the claim for domestic priority to the filing dates of United States Provisional Patent Application Numbers 63/244,105 filed on 14 September 2021, 63/321 ,596 filed on 18 March 2022, and 63/356,369 filed on 28 June 2022. The applicant fails to disclose ultrasound extraction of plant material in application 63/244,105 filed on 14 September 2021, that is a limitation of independent claims of this instant invention. Therefore, a domestic priority date of 18 March 2022 is granted.
Acknowledgment is made of applicant’s statement (page 1 of Remark filed 03/25/2024) that “Applicant notes that the claims may evolve during prosecution…Applicant reserves the right to contest this designation of the priority date if doing so becomes relevant”.
Information Disclosure Statement
Three Information Disclosure Statement (IDS) filed 9/12/2025 is acknowledged and has been considered.
Rejections Withdrawn
The rejection under USC 103 over Durkacz and Garabagni as evidenced by Pall is withdrawn per applicant’s amendments and arguments.
The rejection under USC 103 over Durkacz, Garabagni and Faraci is withdrawn per applicant’s amendments and arguments.
As these rejections are withdrawn, applicant’s arguments toward these rejections are now moot.
Response to Applicant Arguments/Amendments
Applicant’s arguments and amendments are addressed by the new rejections below with additional prior art references that teach the added claim limitations.
New Rejections – As Necessitated by Applicant’s Amendments
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.
Claims 1-5, 7-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Durkacz et al. (US 10,851,077B2, patented 1 December 2020) in view of Garabagni et al. (WO 2020/044116A1, published 5 March 2020), in further view of Ovadia et al (Journal of Pharmaceutical Sciences, 1965, volume 54, pages 1013-1016), in further view of Opperman US 20210023155 A1 (published 01-28-2021, filing date of 7-22-2020 and with provisional application to 7-22-2019) and in further view of Braam US 20100193349A1, as evidenced by Pall (TFF NPL, published 2003).
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Durkacz et al. is directed to a method for extracting plant materials [Col. 22., lines 34-37] using ultrasound-assisted extraction [Abstract]. Durkacz et al. further discloses the shredded plant material is added to a mixing tank and pure ethanol (i.e. an extraction solvent) is added [Col. 9, line 12; limitation of instant claim 7] forming a slurry (i.e. eluant) that is mixed for 30 seconds to 10 minutes at 26°C (i.e. incubated for at a first temperature for a first duration) [Table1-1] prior to ultrasound [Col. 9, lines 65- 66]. Durkacz et al. then teaches the slurry is subjected to ultrasound [Col. 9, line 66] under temperature control [i.e. the extraction is carried out in a “temperature controlled reactor”; Col. 19, lines 30-35] followed by filtration through a disc filter [Col. 17, line 54;limitation of claim 9], membrane filtration techniques [Col. 14, lines 17-18], known to one familiar in the art as direct flow or tangential flow filtration (Pall NPL, Pg. 2;limitation of claim 10), or a centrifugal filter [Col. 14, line 8; limitation of claim 11]. This would produce a “first extractant solution filtrate’ and the plant material that remains after filtration corresponds to the instant “solid plant material product’. Following filtration, Durkacz et al. teaches the ethanol is vacuum distilled [Col. 15, line 7] and fed to a condenser for reuse [i.e. recovered by a recycling conduit; Col. 15, lines 22-24; limitations of claims 4, 5, and 7].
Ascertainment of the Difference Between the Scope of the Prior Art and Claims (MPEP §2141.012)
Durkacz et al. does not teach that the active ingredients are encapsulated to form nanoparticles and then dispersed in a non-aqueous carrier, as required by instant claims 1 and 20 . However, this deficiency is cured by Garabagni et al.. Durkacz does not teach the application of ultrasound waves in an on and off manner and the sonicator horn with diameter and directing of acoustic waves parallel to the bottom as amended into the claim.
Garabagni et al. is directed to therapeutic combinations of cannabinoid and curcumin for oral administration ([0005]; limitation of claims 12-13, and 20) that can be a tincture ([0006];limitation of claim 16). Garabagni et al. discloses formulations that include cannabinoids in addition to other natural health products, including curcumin, Echinacea, Lavender or St. John’s Wort [0073]. In addition, Garabagni et al. discloses the ingredients can be formulated as “liposomes (fully encapsulated or aggregated) and nanoparticles” [0075]. Garabagni et al. further discloses the cannabinoid is physically separated from the curcumin in the oral formulation [Claim 18] and “may also comprise terpenes” ([0032]; limitation of claim 3, 7 and 20). Moreover, Garabagni et al. discloses additional excipients including methylcellulose, hydroxypropyl methylcellulose, microcrystalline cellulose ([0077]; limitation of claim 18 and 20) and hydrogenated vegetable oil ((0077];limitation of claim 2).
Ovadia teaches using ultrasonic waves with a step horn that would send the waves parallel to the bottom of the container with the mixture (abstract and figure 1). Ovadia provides for better extraction of alkaloids in its teachings via the process (abstract and conclusions on page 1014). Ovadia teaches that 15 seconds of ultrasonic treatment resulted in greater yields than 5 hours of another extraction (Soxhlet) (page 1015). Ovadia provides tables II and III where there is already larger amounts of extracted alkaloids based on 0.25 min to 1 min of ultrasonic extraction than with the Soxhlet extraction. Importantly, Ovadia notes that ultrasonic energy has an accelerating effect on extraction (abstract). Ovadia teaches that the ultrasonic step horn was immersed into the extraction mixture (experimental on page 1013).
Opperman teaches the cannabis plant material/solvent mixture (equivalent to eluant of applicant where eluant is plant material in extraction solvent) may undergo ultrasonic cavitation from 1 to 60 seconds (paragraph 53, also see abstract). Opperman teaches ultrasonic cavitation that may be applied in pulses with on/off cycles where they can be 5 seconds on/5 seconds off, 30 seconds on/30 seconds off or 45 seconds on/45 seconds off (paragraph 55). Opperman teaches cannabinoids including “tetrahydrocannabinolic acid, Δ.sup.8 tetrahydrocannabinolic acid, Δ.sup.9 tetrahydrocannabinolic acid, tetrahydrocannabinol, Δ.sup.8 tetrahydrocannabinol, Δ.sup.9 tetrahydrocannabinol (THC), cannabidiolic acid, cannabidiol (CBD), cannabinol, cannabigerolic acid, cannabigerol, cannabigerolic acid, cannabichromene, and tetrahydrocannabivarin” (paragraph 24).
Braam teaches an ultrasonic horn with geometric features to distribute stress more evenly along their longitudinal length (abstract). Braam teaches diameters of 15 mm and 40 mm for the horns (paragraph 36) or diameters of 45 mm and 70 mm (paragraph 37).
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143)
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine the ultrasonic assisted extraction of plants that Durkacz et al. discloses with the method of making the suspensions of Garabagni et al., the method of using an ultrasonic horn of Ovadia for plant extractions by directing waves parallel to the bottom of the container/vessel, the time for on and off sonication cycles of Opperman for cannabis extraction, and the improved horn diameters of Braam, Garabagni’s composition for administering plant-based actives is a logical extension of the method of extracting active ingredients taught by Durkacz. This is true for the additional teachings of Ovadia, Opperman and Braam as they all provide teachings of ultrasonic waves for plant extraction as well as a characteristic of an ultrasonic horn that would be used due to its improved characteristics. This would have merely been combining prior art elements according to known techniques to yield predictable results. See MPEP 2143(A). Note that although Ovadia extracts from different plant materials, it provides for the use of ultrasonic waves for efficient plant extraction of plant compounds where Durkacz already recognizes the use of ultrasound waves for extraction.
In regards to claims 3, 7 and 20, these claims recite the limitation of “terpenes” as the non-aqueous suspension and this claim language is open and does not limit the amount of said terpenes. The examiner notes that the phrase “the non-aqueous suspension is a plurality of terpenes” and the phrase “the non-aqueous suspension is a mixture of terpenes” does not particularly limit the role or the state of the terpenes. The claim reads on a non-aqueous suspension containing any amount terpenes. Therefore, the examiner interprets Garabagni’s disclosure of terpenes as an ingredient that may be present in the composition to fall within the scope of the phrase “the nonaqueous suspension is a plurality of terpenes” of “the non-aqueous suspension is a mixture of terpenes’.
In regards to claim 4, the limitation of adding another solvent to the extracted plant active prior to distilling is considered obvious. Durkacz et al. teaches the ethanol is vacuum distilled [Col. 15, line 7] and fed to a condenser for reuse [Col. 15, lines 22- 24; limitation of claim 5] the addition of more ethanol, one of the carriers from claim 2 or the vegetable oil of Garabagni et al. ({0077];limitation of claim 2) prior to removing itis obvious. As the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results and selection of any order of mixing ingredients is prima facie obvious. See MPEP 2144.04 (IV)(C)
In regards to claim 5, the limitation “wherein at least 95% of the extraction solvent is recovered” is a variable when preparing concentrates of plant extracts that one familiar with the art would be motivated to optimize and remove the maximum percentage of solvent and recycle it to prevent waste. 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) See MPEP 2144.05 (II)(A)
In regards to claim 8 and 20, the limitation “temperature is in the range of 35°C to 300°C” and “time is in the range of 5 minutes to 12 hours” and incubating at “50°C for 60 minutes”. As stated above Durkacz et al. discloses a time and temperature for incubation of 30 seconds to 10 minutes at 26°C. Incubation time would be one variable known in the art that would be routinely optimized to improve the extraction of plants. 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) See MPEP 2144.05 (II)(A)
In regards to claim 15, the limitation “where the non-aqueous suspension can be vaped”. The combination of Durkacz et al. and Garabagni et al. results in an identical or nearly identical non-aqueous suspension and therefore it would be expected that these suspensions could be vaped. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 4380, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 (I)
In regards to claims 17 and 19, the limitations of “the non-aqueous suspension is shelf stable for at least 12 months” and “the first polymer retards the release of the first plurality of active ingredients” are inherent properties of the non-aqueous suspension. The combination of Durkacz et al. and Garabagni et al. results in an identical or nearly identical non-aqueous suspension and therefore it would be expected that these suspensions to have a shelf life of a least 12 months and exhibit delayed release of the active ingredient. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 (I)
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Durkacz et al. (US 10,851,077B2, patented 1 December 2020) in view of Garabagni et al. (WO 2020/044116A1, published 5 March 2020) in further view of Ovadia et al (Journal of Pharmaceutical Sciences, 1965, volume 54, pages 1013-1016), in further view of Opperman US 20210023155 A1 (published 01-28-2021, filing date of 7-22-2020 and with provisional application to 7-22-2019) and in further view of Braam US 20100193349A1 as applied to claims 1-5, 7-13, and 15-20 above, in further view of Faraci et al. (WO 2018/152334A1, published 23 August 2018).
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Durkacz et al., Garabagni et al., Ovadia, Opperman and Braam disclose the method of claim 1 as stated above. Durkacz et al. teaches further the use of ethanol [Col. 9, line 12], or suitable hydrocarbons such as coconut oil [Col. 5, line 16] for extraction of plant extracts. Garabagni discloses further that the compositions may be formulated to convert to an emulsion upon exposure to an aqueous environment (0075).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims (MPEP §2141.012)
Durkacz et al., Garabagni et al., Ovadia, Opperman and Braam do not teach medium-chain triglycerides as a non-aqueous carrier, and the extraction solvent and the non-aqueous carrier are the same solvent as required by instant claims 6, and 14, respectively. However, this deficiency is cured by Faraci et al.
Faraci et al. is directed to making and using cannabinoid formulations, including self-emulsifying formulations and micellar dispersions [Abstract]. Faraci et al. discloses a non-aqueous formulation [Claim 14] that comprises a cannabinoid or cannabinoid extract [Claim 1] and can contain other nutraceuticals, including curcumin, ginkgo biloba, or St. John’s Wort [pg. 10, lines 11, 12 and 21]. Faraci et al. also discloses the composition may contain a mono-, di- or triglyceride, where the triglyceride is a medium chain triglyceride and that the medium chain triglyceride may be coconut oil [pg. 20, lines 26-29, claim 62; limitation of claim 6]. The medium chain triglycerides contribute to the tendency of the composition to self-emulsify upon exposure to aqueous medium (e.g. page 4).
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143)
In regards to claim 6, it would have been prima facie obvious to include triglycerides such as coconut oil in the composition rendered obvious by Durkacz et al., Garabagni et al., Ovadia, Opperman and Braam. In view of Faraci, one having ordinary skill would have recognized oils containing triglycerides, for example coconut oil, are suitable vehicles for compositions for delivery of plant extracts. Moreover, in view of the teachings of Faraci, one having ordinary skill in the art would have been motivated to include a medium chain triglyceride to generate a self-emulsifying drug delivery system. One would have had reasonable expectation of success because Faraci discloses these systems to be useful for many of the same plant extracts as taught by Durkacz/Garabagni. The examiner notes that the phrase “the non-aqueous suspension is medium chain triglycerides” does not particularly limit the role or the state of the medium chain triglycerides. The claim reads on a non-aqueous suspension containing any amount of medium chain triglyceride.
With regard to claim 14, as noted above, Durkacz discloses using any suitable hydrocarbon for extraction. As many of these would also be suitable oils for use in the final composition as e.g. triglyceride source in Faraci’s invention or as a carrier vehicle, the examiner does not consider the requirement of instant claim 14 requiring the first extraction solvent and the non-aqueous suspension to be the same solvent to patentably define over the cited prior art. Choosing to use the same solvent or any combination is a variable that one skilled in the art would optimize to control formulation properties such as taste, absorption and safety. Therefore, substituting one solvent or carrier solvent for the same purpose is obvious. See MPEP 2144.07 (Il)
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Conclusion
Claims 1-20 are rejected, none are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613