DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 7/14/2025 wherein claims 1, 5, 16, 21 and 24 have been amended and claims 4, 6, 7, 9, 11-15, 1-20, 22, 23, 25, 26 and 30 have been cancelled.
Claims 1-3, 5, 8, 10, 16, 21, 24, 27-29 and 31-34 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments filed 7/14/2025 overcome the rejection of claims 8, 10, 18, 24, 26, 28 and 30 made by the Examiner under 35 USC 112(b). This rejection has been withdrawn.
Applicant’s amendments filed 7/14/2025 overcome the rejection of claims 5 and 21 made by the Examiner under 35 USC 112(d). This rejection has been withdrawn.
Applicant’s arguments filed 7/14/2025 regarding the rejection of claim 16 made by the Examiner under 35 USC 112(d) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 1/13/2025.
In regards to the 112(d) rejection, Applicant asserts the following:
A) the claim has been amended to overcome the rejection
In response to A, the Examiner finds that claim 16 recites the non-ionic surfactant solubilizer is present in a range of from about 0.03%-10% by weight whereas claim 1 comprises non-ionic surfactant solubilizer in a range of about 1%-40%. Claim 16 has a range that extends outside that recited by claim 1 and thus is not further limiting.
Applicant’s arguments filed 7/14/2025 regarding the rejection of claims 1-3, 5, 8, 10, 16, 21, 24, 27-29 and 31-34 made by the Examiner under 35 USC 103 over Smith et al. (US 2016/0303039) in view of Gizurarson et al. (US 2008/0275030) and Gumudavelli et al. (US 2018/0169061) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 1/13/2025.
In regards to the 103 rejection, Applicant asserts the following:
B) The property of self-emulsification is not even suggested by the prior art.
In response to B, the claimed property of being self-emulsifying would be an expected outcome of a composition comprising the claimed ingredients. It is noted that Smith is directed to an organogel composition but this feature does not mitigate the composition fromp having the property of being self-emulsifying as self-emulsification is an outcome of producing an emulsion simply by providing the claimed composition with a dispersing liquid. There is nothing to suggest that the combination of references would not have such a feature and given the fact that the prior art contains the very same ingredients as that claimed the properties would be expected to follow. It is also noted that Smith teaches that their composition includes emulsifiers so as to provide an anchor at the oil-water interface which provide emulsion stability (see [0023]) and Gumudavelli teaches that their cannabidiol composition have the property of self-emulsification/being an emulsion (see [0004, 0059]). The Examiner respectfully disagrees that the property of being self-emulsifying is not described by the prior art. However, as noted before, even if an emulsion was not described, due to the overlapping nature of the claimed and prior art compositions, the properties would be expected to follow.
Rejections, New (claim 29) and Maintained (claims 1-3, 5, 8, 10, 16, 21, 24, 27-29 and 31-34)
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.
Claim 29 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor.
Claim 29, dependent from claim 1, recites the limitation "the first partitioning solubilizer comprises dimethyl sorbide." However, claim 1 does not recite a ‘first partitioning solubilizer’, but only a ’partitioning solubilizer’. It is unclear if these are the same or difference. Clarification is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5, dependent from claim 1, recites “wherein the non-ionic surfactant solubilizer is an amount of from about 0.03% to about 10% by weight”. However, claim 1 requires the non-ionic surfactant solubilizer to be present in an amount of 1-10% by weight. The range of claim 5 is broader than the claim from which it depends and therefore is not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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.
Claims 1-3, 5, 8, 10, 16, 21, 24, 27-29 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2016/0303039), evidenced by in view of Gizurarson et al. (US 2008/0275030) and Gumudavelli et al. (US 2018/0169061).
Smith describes a transdermal cannabinoid formulation capable of diffusing into the bloodstream of the user. The composition is to comprise a cannabinoid compound, such as CBD or THC (see [0084]), in an amount between 0.01-5% by weight of the composition (see [0089]) (see instant claims 1-3). The composition may further include surfactants such as lecithin (ionic surfactant) in an of between 2-24% (see [0020]) (see instant claims 1, 8 and 28). Although the source of the lecithin is considered immaterial as lecithin’s structure is chemically conserved across sources, Smith teaches that the lecithin may be sourced from soy (i.e. soy lecithin) (see [0016]) (see instant claim 28). Smith’s composition may also include nonionic surfactants such as polysorbate 80 in an amount of between 0.5-3% by weight (see [0025-0026]) (see instant claims 1, 5 and 27). Penetration enhancers, such as diethylene glycol monomethyl ether and isopropyl myristate in an amount of between 1-40% (see [0035. 0036]). Sensates such as terpenes are also envisaged in amounts between 0.01-20% (see [0056] (see instant claims 1, 21 and 33) and humectants such as glycerin (i.e. glycerol) (‘clarifying solubilizer’) are present in an amount of between 1-10% by weight (see [0035, 0037]) (see instant claims 1 and 32). Methods of administering the cannabinoid composition are contemplated by administering an effective amount of the composition (see abstract and [0092]).
Smith fails to include a partitioning solubilizer (e.g. dimethyl isosorbide) in an amount of between 0.001-80% by weight and a clarifying solubilizer (e.g. b-cyclodextrin) in an amount between 0.01-80%,
Gizurarson describes a composition for delivering a therapeutic agent (e.g. tetrahydrocannibol, a cannabinoid; see [0053]) that is poorly soluble. The formulation includes various excipients such as absorption promoters which includes beta-cyclodextrin (a clathrate solubilizer) (see [0061]) (see instant claims 1 and 31) and solubilizers that act to enhance the solubility of the poorly soluble therapeutic substances. Exemplified solubilizers include diethylene glycol monoethyl ether (i.e. transcutol) and dimethyl isosorbide (‘second partitioning solubilizer’) and are taught to be present in an amount of between 0.1-50% (see [0062, 0063]) (see instant claims 1, 13 and 29). See MPEP 214.05(I) regarding the obviousness of overlapping ranges. It would have been obvious to modify Smith to include the solubilizers taught by Gizurarson (e.g. dimethyl isosorbide, etc.) to improve the solubility profile and delivery of the poorly soluble therapeutic agent.
Gumadavelli is directed to tetrahydrocannabinol compositions that are formulated to exhibit improved stability, dissolution and bioavailability wherein the composition comprises absorption enhancers such as cyclodextrins which are present in an amount of between 0.01-5% by weight (see [0037]) (see instant claims 1 and 16). It would have been obvious to use this amount of cyclodextrin in the combination of Smith and Gizurarson with a reasonable expectation for success in improving the absorptive activity of the cannabinoid solubilized in the composition. See MPEP 2143(I)(A) which states that combining prior art elements according to known methods to yield predictable results is indicia of obviousness.
Regarding the claimed composition being ‘self-emulsifying’, this property would be expected to occur upon arriving at the obvious composition as suggested from the prior art.
Regarding instant claim 24, although this claim is unclear (see above), the combination of Smith and Gizurarson teach a total surfactant (ionic and nonionic) of between about 2.5-27% by weight and a total solubilizer of between 0.01-5%. Formulating a composition having 5% the solubilizer component and 2.5% the surfactant component would result in a ratio of 2:1 which is within that being claimed. Where 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. See MPEP 2144.05(II)(A).
Regarding instant claim 6, the ratio of the weight of the cannabinoid to the volume of the formulation would be expected to follow from the prior art given the overlap in the weight percentage the cannabinoid comprises the composition. The prior art describes a composition that contains between 0.01-5% whereas instant claim 1 requires 0.001-40%. Thus, as the weight percentages overlap it would be the case the ratio of weight to volume must also overlap.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611