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 .
DETAILED ACTION
Claims 27-31 are pending in the application. Claims 27-31 are rejected.
Response to Amendments
Objections and rejections made in the Office Action mailed August 4, 2025 that do not appear below have been overcome by Applicant’s amendments to the claims and have been withdrawn.
Response to Arguments - 35 USC § 112(a)
The 35 U.S.C. § 112(a) rejection of claims 27-31, as presented in the Nonfinal Rejection mailed August 4, 2025, is withdrawn as a result of Applicant’s amendment filed on February 4, 2026.
Claim Rejections - 35 USC § 103
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.
Claims 27-31 are rejected under 35 U.S.C. § 103 as being unpatentable over Anastassov et al. (U.S. PGPub. No. 2016/0374958 A1; December 29, 2016) in view of Oláh et al. (J. Clin. Invest., 2014, 124(9:3713-3724) and Hansenne et al. (U.S. PGPub. No. 2015/0320867 A1; November 12, 2015).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Regarding instant claims 27-31, Anastassov et al. teach “an anti-microbial liquid comprising: at least one cannabinoid at 5% to 10% by weight of the total composition selected from the group consisting of cannabidiol.” See e.g., paragraphs [0032]-[0033]. Anastassov et al. further teach that the “composition may be a gel or cream for topical application” such as treating “general topical infections on human skin.” See e.g., paragraphs [0090] and [0123]. Anastassov et al. further teach “applying a[] therapeutically effective amount of [the] composition ... to the skin.” See e.g., paragraph [0066]. Anastassov et al. further teach “dissolving at least one solid cannabinoid into an alcohol to form a solution.” See e.g., paragraph [0047]. Anastassov et al. further teach that the composition comprises “ethanol and isopropyl alcohol” (i.e., low molecular weight alcohol). See e.g., paragraph [0109]. Anastassov et al. further teach suitable skin conditioning agents such as octyldodecanol which reads on the instant requirements for a residual solvent (i.e., fatty alcohol) that is less volatile than either hexamethyldisiloxane or octamethyltrisiloxane. See e.g., paragraph [0105].
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claim 27, Anastassov et al. does not specifically teach a method for treating acne in a patient in need of such treatment. However, Oláh et al., in a similar field of endeavor, teach cannabidiol (CBD) “has potential as a promising therapeutic agent for the treatment of acne vulgaris” and “exert[s] a unique ‘trinity of cellular anti-acne actions.’” See e.g., pages 3713 and 3719.
Regarding instant claim 27, Anastassov et al. does not teach a composition comprising hexamethyldisiloxane, octamethyldisiloxane or combinations thereof. However, Hansenne et al., in a similar field of endeavor, teach the topical delivery of active agents provided in volatile alkyl siloxane diluents such as hexamethyldisiloxane and octamethyltrisiloxane for the treatment of numerous skin conditions, including acne. See e.g., paragraphs [0030]-[0033] and [0060]-[0061]. Hansenne et al. further teach “methods for the delivery of active agents via the skin with reduced discomfort caused by drying, irritation and/or inflammation of the skin and surrounding tissues.” See e.g., paragraph [0002].
Regarding instant claim 27, Anastassov et al. does not specifically teach 37.5-225 mg of cannabidiol being administered daily to a patient. However, Anastassov does teach compositions comprising 5% to 10% cannabidiol by weight of the total composition which is encompassed by the instantly claimed %w/w range.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
It would, therefore, have been obvious to one of ordinary skill in the art to combine the teachings of Anastassov et al. and Oláh et al. to arrive at the instantly claimed method of topically administering a therapeutically effective amount of a cannabinoid to a patient with acne. Oláh et al. teaches that “[m]ultiple human studies have already investigated the safety of CBD...[and the] most effective anti-acne agent, isotretinoin, is known to cause serious side effects. See e.g., pages 3721. Considering that Oláh et al. teach CBD “is already in use in many countries in clinical practice without any significant side effects (see e.g., page 3721), one of ordinary skill would be motivated to utilize a composition comprising CBD as an anti-acne agent to treat the acne vulgaris patient population. See e.g., page 3721.
It would also have been obvious to one of ordinary skill in the art to combine the teachings of Anastassov et al. and Hansenne et al. and arrive at the instantly claimed pharmaceutical composition comprising cannabidiol and volatile siloxanes, such as hexamethyldisiloxane and octamethyltrisiloxane. Hansenne et al. teach volatile silicones “have an elegant, light-weight ‘feel’ on the skin.” See e.g., paragraph [0048]. Therefore, at least in the interest of “reduc[ing] discomfort caused by drying, irritation and/or inflammation” (see e.g., paragraph [0002]) and improving the product “feel” on the patient’s skin, a person of ordinary skill would be motivated to include volatile silicones, such as hexamethyldisiloxane and octamethyltrisiloxane, in the CBD-composition taught by Anastassov et al.
Furthermore, it would have been obvious to arrive at the instantly claimed daily CBD dosage range (i.e., 37.5-225 mg) based on the teachings of Anastassov et al. The optimization of result-effective variables, i.e., variables that achieve a recognized result, such as dosage ranges, are considered to be within the ability of the skilled artisan. Considering that Anastassov et al. teach the instantly required %w/w range of cannabidiol, it would be within the ability of a skilled artisan to determine- via routine experimentation- the optimum dose of cannabidiol required to obtain the desired effects in a patient (i.e., obvious to vary amount/dose of cannabidiol composition as a whole being administered to patient). “[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). Therefore, at least in the interest of determine the optimum cannabidiol dose, a skilled artisan would have been motivated to employ the instantly claimed method.
Conclusion
No claims are allowed.
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 mailing date of this final action.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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