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 .
Priority
The instant application was filed on 16 February 2022 and claims domestic benefit to provisional application no. 62/896,820 filed on 06 September 2019. Therefore, the effective filing date of the instant application is 06 September 2019.
Examiner’s Note
Applicant's amendments and/or arguments filed 31 December 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 31 December 2025, it is noted that no claims have been amended or added. No new matter has been added.
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.
Claim(s) 1, 4-7, 9-13, 16, 18, 26, 27, 29, 30, 32-43, 45-55, 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Volker et al. (WO 2020014200 A1).
Volker et al. teach a cannabinoid (CBD and THC) composition (abs) that may be in the form of a microemulsion (entire teaching, para. 14, 91, 144). Volker defines a classic oil-in-water microemulsion as one that consists of water, a co-solvent, oil, surfactants (para. 15), and with dispersed oil droplets that are less than 100 nm in diameter (para. 14), addressing claims 7, 9-13. Volker discusses several favorable properties of microemulsions, such as excellent shelf stability (para. 15) and clear solutions (para. 14). Volker teaches that phosphatidylcholine may be used as an emulsifier for the composition (para. 75), where an emulsifier with a HLB of less than 10 is a hydrophobic emulsifier (para. 45), addressing claim 22. The formulation may include medium chain triglycerides (para. 111), partially addressing claim 1. Sugars and sugar alcohols, such as glycerol (para. 114), may be an additive or carrier (para. 114), and may be incorporated into the composition (para. 110), thus far addressing claims 33-35 and partially claim 1.
The microemulsion composition may be administered orally (para. 15) and Volker reports various blood samples and concentrations for the composition (para. 199), which is interpreted as edible and an uptake of the oil-soluble species (CBD or THC) into the bloodstream, which addresses claims 4 and 5. Solubilizing agent is synonymous with an emulsifier or surfactant (para. 47), such as phosphatidylcholine, addressing claim 6.
Additional components may include sterol or antibiotics (para. 110), an antioxidant such as quercetin (para. 93), and TPGS-1000 as a solubilizing agent (para. 30) addressing claims 16, 18, 26, 27, and partially claim 1. Phospholipids are also an additive (para. 111) and phosphatidylcholine is an option for an emulsifier, where it is interpreted that the amount of phospholipid may be completely or 100% phosphatidylcholine, addressing the weight limitation in claim 23. The lipid portion may also include caprylic, caproic, or capric acid (para. 170), addressing claims 29, 30, and partially claim 1. Ethanol may be used as a co-solvent (para. 21), where it is obvious that when alcohol is incorporated it may be 100% ethanol, which addresses claim 32.
The oil-soluble species, such as CBD or THC, may be in an amount of about 10-99% (para. 19) or 0.01-10% (para. 25), addressing claims 36 and 37. Volker teaches various amounts of the components, such as at least 5% or all the way up to at least 50% water (para. 51), as well as a broad range of 0.1-99% of any additive or carrier (para. 173). For example, the amount of phospholipid (considered an additive, para. 110) may be 0.1-99% (para. 173), phosphatidylcholine may be 1% or 0.1-99% when considered a solubilizing agent (additive, para. 110), oil may be 2% or 0.1-99% when considered a vehicle/solvent (para. 114), polyethylene glycol (para. 21) may be 0.5%, TPGS may be 0.1-99% when considered a solubilizing agent/additive (para. 60, 110), ethanol may be 4% or 0.1-99% when considered a carrier (para. 115), glycerol may be 7% or 0.01-50% (para. 176), and water may be 5%.
In regards to claims 38 and 39, the amount of phospholipid may be 0.1-99%, the amount of oil may be 2% or 0.1-99%, PEG or PEG derivative may be 0.5% or 0.1-99%, ethanol/alcohol may be 4% or 0.1-99%, glycerol or may 7% or 0.01-50%, and water may be 5% or at least 50%. Therefore, the ratio of the components may be 1:2:0.6:4:7:5, addressing claims 38 and 39.
In regards to claims 40 and 41, the amount of oil may be 0.1-99% and the amount of an oil-soluble species (THC) may be 0.01-10%. Therefore, the ratio of oil to THC may be 1:0.05, addressing claims 40 and 41.
In regards to claim 42, the amount of phospholipid may be 0.1-99% (when considered an additive, para. 110).
In regards to claim 43, the amount of PEG or TPGS may be 0.1-99% (when considered a solubilizing agent/additive, para. 60, 110).
In regards to claims 1 and 45, the ratio of phospholipid to PEG derivative may therefore be 1:1.6 or 1:0.4.
In regards to claim 46, the amount of oil may be 0.1-99% when considered a vehicle/solvent (para. 114).
In regards to claims 1 and 47, the amount of alcohol or ethanol may be 0.1-99% when considered a carrier (para. 115).
In regards to claim 48, the ratio of oil to alcohol/ethanol may be 1:1.5.
In regards to claims 49 and 50, the amount of sugar or sugar alcohol may be 0.01-50%.
In regards to claims 51 and 52, the amount of water may be 5% or up to at least 50%.
In regards to claim 69, the ratio of sugar or sugar alcohol (glycerol) to water may be 2:1.
Volker teaches blood concentration samples for THC and CBD (para. 206, 208) that includes a Cmax of 1.4 ng/mL and a Tmax of 10 mins (para. 208), addressing claims 53-55.
Volker does not teach an exact combination of the claimed components in claim 1.
In regards to selecting a combination of CBD and THC, phosphatidylcholine, TPGS-1000, quercetin, caprylic and capric acids (MCT), glycerol, water, and ethanol “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients (combinations of CBD and THC, phosphatidylcholine, TPGS-1000, quercetin, caprylic and capric acids, glycerol, water, and ethanol) from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Volker teaches stable CBD and THC compositions that may be in the form of an oil-in-water microemulsion. The claimed invention is directed towards an oil-in-water microemulsion comprising sugar or sugar alcohol, water, and phosphatidylcholine. Since Volker teaches the individual components of the claimed invention (CBD and THC, phosphatidylcholine, TPGS-1000, quercetin, caprylic and capric acids, glycerol, water, and ethanol), is it therefore obvious for one of ordinary skill in the art to pick and choose the ingredients to arrive at the claimed invention with a reasonable expectation of success.
In regards to the various amounts and ratios of the components in at least claims 1, 38-43, 45-52, and 69, Volker teaches a wide range, such as 0.1-99% of additives (see above). That being said and in lieu of objective evidence of unexpected results, the amounts and ratios can be viewed as a variable that achieves the recognized result of successfully making the emulsion composition. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts and ratios of ingredients as nonobvious.
Claim(s) 1, 4-7, 9-13, 16, 18, 26, 27, 29, 30, 32-43, 45-59, 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Volker et al. (WO 2020014200 A1) and Sloat et al. (WO 2020123407 A1).
In regards to claim(s) 1, 4-7, 9-13, 16, 18, 26, 27, 29, 30, 32-43, 45-55, 69, Volker, as applied supra, is herein applied in its entirety for its teachings of a nanoemulsion composition comprising CBD, phosphatidylcholine, quercetin, TPGS-1000, caprylic and capric acids, glycerol, water, and ethanol.
Volker does not teach the blood concentration of CBD or THC for emulsion or oil blend compositions in claims 56-59.
Sloat et al. teach compositions that may comprise CBD (abs), phosphatidylcholine (para. 5), caprylic/capric acids (para. 7), glycerol (para. 80), and water (para. 9), and may be in the form of a microemulsion (para. 144). The amount of CBD may be from 1-100 mg/mL (para. 69) or up to 10% by weight of CBD (para. 17). Within 20 mins after administration, the CBD nanoparticle is about 1 ng/mL (Fig. 9D). The plasma concentration results are interpreted as the CBD entering the bloodstream through the oral route, addressing claim 5. Sloat mentions that the nanoparticle-based composition term may refer to oil-in-water emulsions (para. 2).
Figures 9A-D compare the CBD plasma concentrations of different CBD oils with a CBD lipid nanoparticle composition (Fig. 9A-D). Fig. 9D indicates roughly 10 ng/mL plasma concentration for the lipid nanoparticle, whereas the CBD oils have roughly less than 1 ng/mL plasma concentration within 1 hour following administration. At about 1 hr, the nanoparticle plasma concentration is about 8 ng/mL, and the CBD oil plasma concentration is about 1 ng/mL. Additionally, within 180 mins, the nanoparticle plasma concentration is about 12 ng/mL, and one of the CBD oil plasma concentrations is about 3 ng/mL.
Since Volker does not teach that their composition provides a certain blood concentration for emulsion or oil blend composition in claims 56-59, one skilled in the art would have been motivated to use the general blood concentration findings from Sloat et al. to address these deficiencies. A person of ordinary skill in the art would have been motivated to combine these teachings because both Volker and Sloat et al. demonstrate a microemulsion composition comprising CBD, phosphatidylcholine, caprylic/capric acids, glycerol, and water, where both prior art references teach blood concentration studies for their compositions.
Response to Arguments
Applicant’s arguments filed 31 December 2025 have been fully considered but they are not persuasive.
Most of the repeated remarks on pgs. 10-21 have been address in the previous Office Action dated 03 July 2025 and will not be further addressed herein.
The Applicant argues that Volker teaches phosphatidylcholine amongst approximately 60 other emulsifiers without any direction of its use (Remarks, pgs. 12-13).
Applicant’s argument is not found persuasive. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
The Applicant argues that Applicant’s claims incorporate unexpected results regarding the phospholipids providing stability (Remarks, pg. 13).
Applicant’s argument is not found persuasive. The Applicant points to [0049] of the instant specification, which mentions that the claimed phospholipids unexpectedly demonstrate shelf-stable and visually clear microemulsions. The Applicant is encouraged to point to and expand upon data and results that may further provide evidence of unexpected results, especially comparative data. Furthermore, it is known in the art that phosphatidylcholine and other phospholipids provide visual clarity (Table 1), stability to emulsions and other drug delivery vehicles, and also increase bioavailability and solubility of poorly soluble drugs (Placzek, 2019, pgs. 92, 93). Therefore, it is not unexpected that the Applicant’s formulations resulted in shelf-stable and visually clear microemulsions.
The Applicant argues unexpected results regarding the ratio of PEG derivative and phospholipid, which allegedly resulted in shelf-stable and visually clear microemulsions (Remarks, pgs. 13-14).
Applicant’s argument is not found persuasive. The Applicant points to [0054]-[0055] of the instant specification, which mentions that the claimed PEG derivatives and phospholipids in a specific ratio resulted in visually clear and shelf-stable microemulsions. The Applicant is encouraged to point to and expand upon data and results that may further provide evidence of unexpected results, especially comparative data. Without substantial data, including comparative data, it is difficult to determine that the results are unexpected and surprising.
The Applicant argues lack of enablement in the references because “microemulsion” is only used once (Remarks, pgs. 22-24).
Applicant’s argument is not found persuasive. The Applicant is reminded that the teachings of KSR are actually an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385, 1395-96 (U.S.2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious”; “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions” exemplified by the holdings of cases such as Merck v. Biocraft.
Furthermore, the Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123).
Therefore, Volker does render obvious a microemulsion comprising CBD and THC, phosphatidylcholine, TPGS-1000, quercetin, caprylic and capric acids, glycerol, water, and ethanol.
In regards to Applicant’s argument that Sloat does not teach a microemulsion (Remarks, pg. 24), one skilled in the art would have been motivated to use the general blood concentration findings from Sloat et al. to address the deficiencies in Volker’s teaching. A person of ordinary skill in the art would have been motivated to combine these teachings because both Volker and Sloat et al. demonstrate a microemulsion composition comprising CBD, phosphatidylcholine, caprylic/capric acids, glycerol, and water, where both prior art references teach blood concentration studies for their compositions.
The Applicant argues that without being informed by the Applicant’s specification, it would be improbable for a skilled artisan to assimilate the ingredients to arrive at the claimed invention (Remarks, pgs. 24-25).
Applicant’s argument is not found persuasive. Since Volker teaches the claimed components as optional ingredients and also teaches a function for these components, such as solvent, emulsifier, surfactant, etc., it is interpreted that one of ordinary skill in the art would have been motivated with a reasonable expectation of success to combine the claimed components for the desired effects and functionalities of the solvent, emulsifier, surfactant, etc.
Additionally, 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 claims are not obvious over Volker (Remarks, pgs. 29). The Applicant argues that Volker provides many ingredients, such as phosphatidylcholine, amongst over 60 other emulsifiers (Remarks, pgs. 29-30).
Applicant’s argument is not found persuasive. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
The Applicant argues that Volker’s composition is not actually visually clear (Remarks, pgs. 30-31).
Applicant’s argument is not found persuasive. Volker explains that microemulsions can be less than 10 nm in diameter, which makes them transparent to visible light and can appear as clear solutions. If approximately 10% of the particles are outside this range, it is interpreted that 90% of the droplets fall within the range, making the microemulsion mostly visually clear.
The Applicant argues that the Applicant’s differentiation between phospholipid extracts of lecithin would be unexpected to a skilled artisan and would not be expected to make a shelf-stable and visually clear microemulsion (Remarks, pg. 30).
Applicant’s argument is not found persuasive. Phospholipids in general are known in the art for stabilizing microemulsions. Lecithin is also known in the art for being a good surfactant choice (Cilek, pg. 19) and providing a stable microemulsion (Cilek, pg. 24).
The Applicant argues improper use of hindsight (Remarks, pg. 31).
Applicant’s argument is not found persuasive. 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 Volker is not compatible with Sloat and are not combinable with one another (Remarks, pgs. 32-35).
Applicant’s argument is not found persuasive. Since Volker and Sloat both teach compositions that may be in the form of microemulsions, one of ordinary skill in the art would have been motivated with a reasonable expectation of success to combine the teachings, as both Volker and Sloat teach microemulsion compositions comprising CBD. Furthermore, even though microemulsions are mentioned briefly in Sloat and Volker, microemulsions are still a disclosed embodiment of both Sloat and Volker.
The Applicant argues the claimed invention offers superior bloodstream delivery over the prior art (Remarks, pgs. 35-43).
Applicant’s argument is not found persuasive. The Applicant’s microemulsion delivers a peak bloodstream concentration within 3 hours of administration that is nearly 4-times greater than the nanoemulsion of Sloat (Remarks, pgs. 39-40). The Applicant alleges that the list of ingredients and suggested ingredient ratios described in Volker and Sloat could never be used to provide the limitations of Applicant’s claims without guidance from the instant claims (Remarks, pg. 41). The Applicant compares AUC values between the Applicant’s composition and Sloat’s composition (Remarks, pg. 41).
Any evidence of improved pharmacokinetic values and better bloodstream delivery does not have a causal relationship with the merits and scope of the claimed invention, which is, very broadly, a microemulsion composition comprising several different phospholipids, PEG derivatives, and oils. The Applicant has not presented unexpected results or relevant data that demonstrate the full scope of the claimed composition. As such, the data are not commensurate in scope with the claims.
“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) (“If commercial success is due to an element in the prior art, no nexus exists.”); Ormco Corp., 463 F.3d at 1312 (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613