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 .
Status of the Claims
Per Applicant’s amendment to the claims, submitted on 12/22/2025, claims 1-2, 10, 14-16, and 19 are amended, claims 5, 7-9, 11-13, and 18 are canceled, and claims 20 and 21 are newly added. Currently, claims 1-4, 6, 10, 14-17, and 19-21 are pending in the instant application.
Election/Restrictions
In accordance with the existing Election requirement, claims 17 and 21 are withdrawn as being directed to non-elected subject matter. Claims 1-4, 6, 10, 14-16, and 19-20 are currently pending examination.
Claim Rejections - 35 USC § 112 Second Paragraph – Withdrawn
Rejections of claims 9-10 and 13:
In light of Applicant’s amendment to the claims, the rejections are hereby withdrawn. Claim 10 now depends upon claim 1, and no longer provides improper antecedence with regards to the recited C8 and C10 triglycerides. Claims 9 and 13 are canceled.
Claim Rejections - 35 USC § 103 – Maintained
Claim(s) 1-4, 6, 10, 14-16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedman (previously referenced).
Rejections of claims 1-4, 6, 10, 14-16, and 19:
Applicant’s arguments are not persuasive, the rejections are hereby maintained. It is appreciated that Applicant has amended the claims to more narrowly align the claimed invention with the working examples (solutions 6 and 8) provided in the disclosure (Remarks page 9). However, it is still maintained that the currently amended claims would be obvious over the teachings of Friedman.
Firstly, Applicant indicates the motivation for the instant invention. Namely that the formulation of the instant claims is directed to providing increased stability to CBD in order to prevent conversion to THC impurity (Remarks page 9). Applicant further provides exemplary solutions 6-8 and contends that the displayed increased stability of CBD, and the inhibition of the conversion of CBD to THC are unexpected results of the instant invention. However, the teachings of Friedman appear to be geared towards the similar, if not the same end goal of increased stability of the active within composition. Friedman indicates that their formulations provide improved stability by the use of emulsification. Per Friedman, the small droplet size of emulsifications is associated with improved stability (specification [0051])1. With regards to emulsification, Friedman teaches the use of emulsifiers to achieve such emulsification. Given the teachings of Friedman, it would not be wholly unexpected to achieve superior stability for CBD as an active in such formulations. Furthermore, even in arguendo if the intent of Friedman in creating their formulations was directed to a purpose or endpoint different to that of the Applicant, it still remains that Friedman teaches each of the structural aspects of the claimed cannabidiol composition and provides predictable function for each of the components. Per MPEP2141(I):
“The Supreme Court in KSR reaffirmed the familiar framework for determining obviousness as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), but stated that the Federal Circuit had erred by applying the teaching-suggestion-motivation (TSM) test in an overly rigid and formalistic way. KSR, 550 U.S. at 404, 82 USPQ2d at 1391. Specifically, the Supreme Court stated that the Federal Circuit had erred in four ways: (1) "by holding that courts and patent examiners should look only to the problem the patentee was trying to solve " (Id. at 420, 82 USPQ2d at 1397); (2) by assuming "that a person of ordinary skill attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem" (Id.); (3) by concluding "that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘obvious to try’" (Id. at 421, USPQ2d at 1397); and (4) by overemphasizing "the risk of courts and patent examiners falling prey to hindsight bias" and as a result applying "[r]igid preventative rules that deny factfinders recourse to common sense" (Id.). See also Novartis Pharms. Corp. v. West-Ward Pharms. Int'l Ltd., 923 F.3d 1051, 1059, 2019 USPQ2d 171676 (Fed. Cir. 2019); Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1047-48, 120 USPQ2d 1400, 1410 (Fed. Cir. 2016); and Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324, 1332, 102 USPQ2d 1445, 1449 (Fed. Cir. 2012).”
Applicant’s newly amended independent claim 1 now recites the inclusion of a mixture of C8 and C10 triglycerides rather than the previously recited plethora of lipophilic solvents. While the previously cited formulation CBD22 of Friedman contained Cremophor (castor oil) as a lipophilic solvent, Friedman also teaches easily substituted emulsifiers including caprylic/capric triglycerides PEG-4 esters (Labrafac Hydro WL 1219), caprylic/capric glycerides PEG-6 esters (Softigen 767), and caprylic/capric glycerides PEG-8 esters (Labrasol) which are all considered as mixtures of C8 and C10 fatty acid esters (specification [0090])2. Accordingly, a case for obvious substitution exists, as a person of ordinary skill in the art would have found it obvious to substitute one emulsifier for another, as their functions would be predictable.
For the purpose for clarity and record, the previous outstanding rejections will be reiterated below.
Reiterated Rejections:
Claim 1 recites a composition comprising:
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Friedman teaches self-emulsifying, high concentration and high dose cannabinoid compositions and formulations. The teachings of Friedman are directed towards cannabinoid compositions that readily self-emulsify, thereby providing improved properties including the enabling of more efficient administration regimens, greater bioavailability, and higher stability over traditional cannabinoid compositions (paragraph [0051])3. Friedman provides the following exemplary cannabinoid formulations (Table 3, Page 19):
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Of particular relevance is composition CBD22 which comprises CBD of 99.9% purity, caryophyllene (i.e., BCP), TPGS (i.e., alpha tocopherol), and Cremophor EL (i.e., ethoxylated castor oil (an oil from a nut or seed)). Furthermore, the composition does not appear to include any of the excluded components recited in the instant claim. Friedman does not explicitly teach:
The specific w/w concentrations of each of elements a, b, and c
The ratio of BCP to additional lipophilic solvent
However, it would be obvious for a person of ordinary skill in the art to be able to alter the concentrations of each of the elements and the ratio of BCP to lipophilic solvent per the principle of routine optimization.
As indicated above, the composition taught by Friedman comprises: a) CBD of 99.9% purity, b) caryophyllene and Cremophor (castor oil), and c) vitamin E TPGS. CBD is included as an active cannabinoid, while caryophyllene, Cremophor, and TPGS are included as emulsifier components. Given that each of the components are provided by Friedman as having specific function, there is a degree of predictability in their use and inclusion in the composition. The differences between the composition of Friedman and a composition of the instant claim lie mainly in the concentrations or ratio of each component. Given the teachings of Friedman, it would have been obvious and well within the capabilities of one of ordinary skill in the art to find the optimal amount or ratio of each component through the process of routine optimization. See MPEP2144.05(II)(A):
“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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").”
Claim 2 further limits the composition of claim 1 wherein the volume ratio of BCP to the at least one additional lipophilic solvent is about 1:2.
As discussed above, the differences in regards to concentrations and ratio amounts between the teachings of Friedman and the instant claims are rendered obvious per the principle of routine optimization as described in MPEP2144.05(II)(A). the instant claim is rejected for the same obviousness reasons as claim 1.
Claim 3 further limits the composition of claim 1 wherein the CBD is present in an amount from about 2% w/w to about 25% w/w.
As discussed above, the differences in regards to concentrations and ratio amounts between the teachings of Friedman and the instant claims are rendered obvious per the principle of routine optimization as described in MPEP2144.05(II)(A). the instant claim is rejected for the same obviousness reasons as claim 1.
Claim 4 further limits the composition of claim 3 wherein the CBD is present in an amount from about 9% w/w to about 23% w/w.
As discussed above, the differences in regards to concentrations and ratio amounts between the teachings of Friedman and the instant claims are rendered obvious per the principle of routine optimization as described in MPEP2144.05(II)(A). the instant claim is rejected for the same obviousness reasons as claim 3.
Claim 6 further limits the composition of claim 1 wherein the CBD is at least 99.8% pure.
The composition of Friedman comprises CBD with 99.9% purity.
Claim 12 recites a composition consisting of:
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Friedman teaches self-emulsifying, high concentration and high dose cannabinoid compositions and formulations. The teachings of Friedman are directed towards cannabinoid compositions that readily self-emulsify, thereby providing improved properties including the enabling of more efficient administration regimens, greater bioavailability, and higher stability over traditional cannabinoid compositions (paragraph [0051])4. Friedman provides the following exemplary cannabinoid formulations (Table 3, Page 19):
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Of particular relevance is composition CBD22 which comprises CBD of 99.9% purity, caryophyllene (i.e., BCP), TPGS (i.e., alpha tocopherol), and Cremophor EL (i.e., ethoxylated castor oil (an oil from a nut or seed)). Furthermore, the composition does not appear to include any THC. Friedman does not explicitly teach:
A composition consisting of elements a, b, and c (i.e., a composition exclusionary of other components)
The constituents a, b, and c in the recited w/w concentrations
A BCP to lipophilic volume ratio between 1:1 and 1:3
However, it would have been obvious for a person of ordinary skill in the art to modify the teachings of Friedman to arrive at such a composition because:
Friedman teaches the use of individual emulsifiers or combinations thereof
A person of ordinary skill in the art would seek to improve upon the art per the principle of routine optimization
With regards to the constituency of the composition (item (i)), Friedman’s composition CBD22 would not explicitly meet the limitations because it includes Span 80 and Surphope 1811 which are not listed in the Markush groups of the instant claim. However, Friedman explicitly teaches that each of TPGS, Span 80, Cremophor EL, and Surphope 1811 are each included as emulsifiers. Such emulsifiers are selected from a plethora of possible species and mixtures thereof (paragraph [0020])5. Such emulsifiers are intended to form microparticles with the cannabinoid active in order to provide greater bioavailability and improved stability to the active cannabinoid (paragraph [0051])6. Given that Friedman teaches the inclusion of these components as emulsifiers, a person of ordinary skill in the art would understand that they have a level of predictability in their use. It would have been obvious for a person to modify the components to remove Span 80 and/or Surphope 1811 because there would have been a reasonable expectation of success in attaining a resulting composition still having self-emulsifying properties.
Regarding items (ii) and (iii), Friedman teaches the use of several components recited in the instant claim in order to form a CBD composition. Such components include 99.9% pure CBD, BCP, an additional lipophilic carrier, and TPGS. While Friedman does not explicitly teach the recited amounts of each component, it would be well within the ability of one of ordinary skill in the art to elucidate such amounts through experimentation and routine optimization. See MPEP2144.05(II)(A).
In summary, Friedman teaches self-emulsifying cannabinoid compositions comprising CBD of 99.9% purity, BCP, Cremophor EL (ethoxylated castor oil), TPGS, and various emulsifiers. While Friedman does not explicitly teach a composition consisting of the recited components, it would have been obvious at the time of invention for a person of ordinary skill in the art to remove the additional emulsifier components. The reason for such obviousness is that there would be a reasonable expectation that the combination of BCP, Cremophor, and TPGS would have success in creating a CBD composition with improved bioavailability and stability per their properties as emulsifiers. Likewise, it would have been further obvious for a person of ordinary skill in the art to alter the concentration of the components per the principle of routine optimization.
Claim 14 recites a method of stabilizing synthetic CBD in an oral composition, the method comprising: mixing synthetic CBD having a purity of at least 99.8% with a lipophilic carrier and alpha tocopherol, the carrier consisting of beta caryophyllene and C8 and C10 triglycerides, wherein:
The volume ratio of the BCP to the triglycerides is from about 1:1 to about 1:3; and
The alpha tocopherol is present in an amount from about 0.5% w/w to about 1.5% w/w
Friedman teaches self-emulsifying, high concentration and high dose cannabinoid compositions and formulations. The teachings of Friedman are directed towards cannabinoid compositions that readily self-emulsify, thereby providing improved properties including the enabling of more efficient administration regimens, greater bioavailability, and higher stability over traditional cannabinoid compositions (paragraph [0051])7. Friedman provides the following exemplary cannabinoid formulations (Table 3, Page 19):
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Of particular relevance is composition CBD22 which comprises CBD of 99.9% purity, caryophyllene (i.e., BCP), TPGS (i.e., alpha tocopherol), and Cremophor EL. By combining the aforementioned components, Friedman essentially teaches a method of stabilizing cannabinoid formulations. Friedman does not explicitly teach a method of making a singular formulation which contains the CBD, BCP, tocopherol, and the C8/C10 triglycerides together, in particular the inclusion of C8/C10 triglycerides. Friedman also does not explicitly teach a BCP to triglyceride ratio of about 1:1 to about 1:3 or tocopherol being present in an amount from about 0.5% w/w to about 1.5% w/w. However, it would be obvious to modify the teachings to include C8/C10 triglycerides because Friedman teaches use of such triglycerides in alternative stable CBD formulations. It would be further obvious to modify the amounts of the constituents per the principle of routine optimization.
Firstly, Friedman teaches alternate stable CBD compositions comprising triglycerides as shown below (paragraph [0211]. Table 7):
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As can be seen in the table, formulation CBD31 contains capric/caprylic triglycerides (i.e., a mixture of C8/C10 triglycerides), under the trade name Myritol 318PH. Given that the teachings of Friedman are directed towards stabilized formulations of CBD, it would be obvious to include a triglyceride such as Myritol to the composition of CBD22, as there would be a reasonable expectation of success in formulating a stabilized CBD composition.
With regards to the recited BCP:triglyceride volume ratio and tocopherol concentration, such amounts would be obvious per the principle of routine optimization. As indicated above, the teachings of Friedman are directed towards compositions of stabilized CBD and methods of making the same. Additionally, Friedman teaches each of the individual components of the compositions (i.e., CBD 99.9%, BCP, tocopherol, C8/C10 triglyceride). Given that all recited components are known, and that Friedman teaches said components and combinations thereof as having stabilizing effects on substantially pure CBD, the limitations of the instant claim regarding amounts would be considered as optimizations achievable by a person of ordinary skill in the art through routine experimentation. See (MPEP2144.05(II)(A)).
In summary, Friedman teaches methods of making stabilized CBD compositions. Among the compositions taught by Friedman are CBD22 which contains 99.9% pure CBD, TPGS, and BCP, and CBD31 which contains C8/C10 triglycerides. It would have been obvious at the time of invention for a person of ordinary skill in the art to combine the aspects of both compositions, and further optimize for component amounts through routine experimentation to arrive at the method of the instant claim, because there would have been reasonable expectation of success in creating a stabilized CBD formulation.
Claim 15 further limits the method of claim 14 wherein the volume ratio of BCP to the triglycerides is about 1:2.
As discussed above in the claim 14 rejection, the ratio of BCP to triglyceride would be obvious to a person or ordinary skill in the art per the principle of routine optimization, as each of the components are taught by Friedman as an aspect of stabilizing CBD formulations. Accordingly, the instant claim is rejected for the same obviousness reasons as claim 14.
Claim 16 further limits the method of claim 15 wherein the weight ratio of said C8 triglyceride to said C10 triglyceride is from about 55:45 to about 65:35.
While Friedman does not explicitly indicate a C8:C10 triglyceride ratio from about 55:45 to about 65:35, Friedman does indicate the use of Myritol 318. Commercially available Myritol 813 contains a C8:C10 triglyceride ratio or approximately 70:30 (BASF, page 3)8. While not explicitly within the recited range, such a ratio would still be considered obvious as an approaching value per MPEP2144.05(I):
“Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical);”
In the case of the instant claim, and without evidence of criticality of the range, one of ordinary skill in the art would have no reason to believe that a triglyceride ratio of 70:30 would have significantly different properties than a triglyceride ratio of 65:35.
Claim 19 further limits the composition of claim 12 wherein the composition consists of:
synthetic CBD having a purity of at least 99.8% w/w based on the weight of the CBD in a concentration of from about 2 % w/w to about 12 % w/w;
BCP in a concentration of from about 28 % w/w to about 30 % w/w;
a mixture of C8 and C10 triglycerides in an amount from about 56 % w/w to about 60 % w/w;
alpha tocopherol (Vitamin E) in a concentration of from about 0.5 % w/w to about 1.5% w/w;
wherein THC is absent or present as an impurity in an amount less than 10 ppm based on the total composition.
As discussed in the claim 12 rejection above, Friedman teaches a composition comprising CBD of 99.9% purity, BCP, cremophore EL, and alpha tocopherol. The teachings of Friedman obviate a composition of claim 12. The instant claim differs from claim 12 wherein the lipophilic carrier is a mixture of C8 and C10 triglycerides, and wherein the amounts of each of the components is narrower in range. Friedman does not explicitly teach a method of making a singular formulation which contains the CBD, BCP, tocopherol, and the C8/C10 triglycerides together, in particular the inclusion of C8/C10 triglycerides.
However, it would be obvious to modify the teachings to include C8/C10 triglycerides because Friedman teaches use of such triglycerides in alternative stable CBD formulations. It would be further obvious to modify the amounts of the constituents per the principle of routine optimization.
Firstly, Friedman teaches alternate stable CBD compositions comprising triglycerides as shown below (paragraph [0211]. Table 7):
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As can be seen in the table, formulation CBD31 contains capric/caprylic triglycerides (i.e., a mixture of C8/C10 triglycerides), under the trade name Myritol. Given that the teachings of Friedman are directed towards stabilized formulations of CBD, it would be obvious to include a triglyceride such as Myritol to the composition of CBD22, as there would be a reasonable expectation of success in formulating a stabilized CBD composition.
With regards to the amounts of components present, Friedman teaches the use of several components recited in the instant claim in order to form a stabilized CBD composition. Such components include 99.9% pure CBD, BCP, C8/C10 triglycerides, and TPGS. While Friedman does not explicitly teach the recited amounts of each component, it would be well within the ability of one of ordinary skill in the art to elucidate such amounts through experimentation and routine optimization. See MPEP2144.05(II)(A).
Claim Rejections - 35 USC § 103 – Necessitated by Amendment
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.
Claim 20 is newly added per the amendment filed on 12/22/2025. The newly added claim is dependent upon claim 19, which is currently subject to a 103 obviousness rejection over Friedman.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedman (previously referenced).
Claim 20 further limits the composition of claim 19 wherein the weight ratio of C8 triglyceride to the C10 triglyceride is from about 55:45 to about 65:35.
As indicated previously (see maintained 103 rejections), Friedman teaches various emulsifiers which can be used or obviously substituted in the disclosed compositions. Among the emulsifiers taught by Friedman are caprylic/capric triglycerides PEG-4 esters (Labrafac Hydro WL 1219), caprylic/capric glycerides PEG-6 esters (Softigen 767), and caprylic/capric glycerides PEG-8 esters (Labrasol), which are all considered as mixtures of C8 and C10 triglycerides. As indicated by the accompanying trade names, each of these emulsifiers are commercially available and standardized. For instance, a Softigen 767 technical data sheet is provided below for reference (IOI Oleochemical, Softigen 767 Data Sheet, page 1):
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As can be seen from the table above, Softigen 767 has a typical C8 to C10 weight ratio of about 58:41 which falls within the claimed range.
Conclusion
Claims 1-4, 6, 10, 14-16, and 19-20 are rejected.
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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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 “Besides their superior cannabinoid content, the pharmaceutical compositions and dosage forms provided by the present invention readily and quickly self-emulsify in biological fluids under physiological conditions to produce fine particles which are highly bioavailable. The small droplet size, formed upon emulsification, is associated with improved stability.”
2 “The emulsifier component of the formulation can be used to improve cannabinoid solubilization and the self-emulsifying properties of the formulation. Emulsifier components are selected from the group consisting of poly-glycolized glycerides and polyoxyethylene glycerides of medium to long chain mono-, di-, and triglycerides, such as: almond oil PEG-6 esters, almond oil PEG-60 esters, apricot kernel oil PEG-6 esters (Labrafil® M1944CS), caprylic/capric triglycerides PEG-4 esters (Labrafac® Hydro WL 1219), caprylic/capric triglycerides PEG-4 complex (Labrafac® Hydrophile), caprylic/capric glycerides PEG-6 esters (Softigen® 767), caprylic/capric glycerides PEG-8 esters (Labrasol®)…”
3 “Provided by the present invention are self-emulsifying compositions and dosage forms having high loads of cannabinoids and cannabinoid mixtures. Due to their high cannabinoid content, these dosage forms can replace others, having lower cannabinoid content, which minimizes the need for repetitive administration while treating cannabis-responsive diseases, syndromes and symptoms. Besides their superior cannabinoid content, the pharmaceutical compositions and dosage forms provided by the present invention readily and quickly self-emulsify in biological fluids under physiological conditions to produce fine particles which are highly bioavailable. The small droplet size, formed upon emulsification, is associated with improved stability. Moreover, the high droplet surface area associated with the small droplet size often leads to a high reactivity with biological cells and macromolecules”
4 “Provided by the present invention are self-emulsifying compositions and dosage forms having high loads of cannabinoids and cannabinoid mixtures. Due to their high cannabinoid content, these dosage forms can replace others, having lower cannabinoid content, which minimizes the need for repetitive administration while treating cannabis-responsive diseases, syndromes and symptoms. Besides their superior cannabinoid content, the pharmaceutical compositions and dosage forms provided by the present invention readily and quickly self-emulsify in biological fluids under physiological conditions to produce fine particles which are highly bioavailable. The small droplet size, formed upon emulsification, is associated with improved stability. Moreover, the high droplet surface area associated with the small droplet size often leads to a high reactivity with biological cells and macromolecules”
5 “ In certain embodiments, the pharmaceutical composition comprises about 25% to about 50% by weight of an emulsifier or a mixture of emulsifiers. In certain embodiments, the emulsifier is selected from the group consisting of polysorbate 80, oleoyl polyoxyl-6 glycerides, polyoxyl 35 hydrogenated castor oil, sucrose distearate, tocopherol polyethylene glycol 1000 succinate, lauroyl polyoxyl-32 glycerides, sorbitan monooleate, salts thereof, derivatives thereof, and mixtures of emulsifiers.”
6 “Besides their superior cannabinoid content, the pharmaceutical compositions and dosage forms provided by the present invention readily and quickly self-emulsify in biological fluids under physiological conditions to produce fine particles which are highly bioavailable. The small droplet size, formed upon emulsification, is associated with improved stability. Moreover, the high droplet surface area associated with the small droplet size often leads to a high reactivity with biological cells and macromolecules “
7 “Provided by the present invention are self-emulsifying compositions and dosage forms having high loads of cannabinoids and cannabinoid mixtures. Due to their high cannabinoid content, these dosage forms can replace others, having lower cannabinoid content, which minimizes the need for repetitive administration while treating cannabis-responsive diseases, syndromes and symptoms. Besides their superior cannabinoid content, the pharmaceutical compositions and dosage forms provided by the present invention readily and quickly self-emulsify in biological fluids under physiological conditions to produce fine particles which are highly bioavailable. The small droplet size, formed upon emulsification, is associated with improved stability. Moreover, the high droplet surface area associated with the small droplet size often leads to a high reactivity with biological cells and macromolecules”
8 “C-Chain ratio of the main components: C8 : C10 approx. 70 : 30”