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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-3, 19, 36, 40, 65, 76, and 89-92 in the reply filed on 11 March 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Accordingly, claims 109-110, 114-115, 120-124, and 136-137 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 19, 36, 40, 65, 76, and 89-92 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a first penetration enhancer. The claim is indefinite because the scope of the claim is unclear. It is not clear what compounds/substances are encompassed by the term “first penetration enhancer.” At best, para. [0007] of the instant Specification discloses wherein the first penetration enhancer can comprise at least one terpene; para. [0070] discloses amphiphilic or comprise hexadecenoic acid ([0070]); para. [0136] discloses a list of structurally dissimilar compounds; para. [0137]-[0142], [0144], [0146]-[0150], and so on, all disclose what a first penetration enhancer can be. Therefore, it is unclear which compounds/substances from the exemplary listings is considered a “first penetration enhancer” as encompassed by claim 1, such that one of ordinary skill in the art would know when a compound/substance infringes on the claimed invention. Clarification is requested.
The same applies in the instance of claim 1 reciting a “second penetration enhancer.” Clarification is requested.
Claims 2-3, 19, 36, 40, 65, 76, and 89-92 are rejected as they depend from claim 1 and do not further clarify the scope of claim 1.
Claim 36 recites an additional penetration enhancer. The claim is indefinite because the scope of the claim is unclear. It is not clear what compounds/substances are encompassed by the term “additional penetration enhancer.” At best, para. [0148] of the instant Specification discloses wherein the additional penetration enhancer can comprise a terpene. However, para. [0151] discusses where the additional penetration enhancer can be one or more of several substances. Therefore, it is not clear which compounds/substances from the exemplary listings is considered an “additional penetration enhancer” as encompassed by claim 36 such that one of ordinary skill in the art would know when a compound/substance infringes on the claimed invention. Clarification is requested.
Claim 40 recites the penetration enhancer in the penultimate line of the claim. The claim is indefinite because the scope of the claim is unclear. It is not clear whether “the penetration enhancer” refers to the first penetration enhancer, the second penetration enhancer, or the combination of a first and second penetration enhancer. Clarification is requested.
Claim 40 recites the limitation "the penetration additive" in the last two lines of the claim. There is insufficient antecedent basis for this limitation in the claim. Neither claim 40 or claim 1, from which it depends, recites a penetration additive. Clarification is requested.
Claim 65 recites a secondary active agent. The claim is indefinite because it is unclear what is encompassed by the term “secondary active agent.” At best, para. [0165] lists exemplary secondary active agents. However, para. [0168]-[0188] also lists exemplary secondary active agents. Moreover, para. [0164] discloses wherein the first penetration enhancer, the second penetration enhancer, or both can comprise or otherwise act or behave as a secondary active agent. Thus it is not clear which compounds/substances are encompassed by the recitation of “secondary active agent” of claim 65, such that one of ordinary skill in the art would know when a compound/substance infringes on the claimed invention. Clarification is requested.
Claim 91 recites wherein the topical composition is formulated as a suppository. The claim is indefinite because the scope of the claim is unclear. It is unclear how a suppository, being a vaginal or rectal formulation (i.e. internal use), qualifies as a topical composition. Clarification is requested.
Claim 92 recites a biocompatible polymer. The claim is indefinite because it is not clear what is encompassed by the term “biocompatible polymer.” At best, para. [0234] of the instant Specification lists several classifications of what the “biocompatible polymer” may be. However, it is not clear which polymers from the exemplary listings is encompassed by claim 92 such that one of ordinary skill in the art would know when a polymer infringes on the claimed invention. Clarification is requested.
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 1-3, 19, 36, 40, 65, 76, and 89-92 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2016/0303039 A1, 10/20/2016, ISR reference) (hereinafter Smith).
Smith discloses a transdermal composition comprising a pharmaceutically effective amount of one or more cannabinoids including cannabidiol, and one or more permeation/penetration enhancers including terpene/terpenoids such as myrcene or menthol; the effects of the cannabinoids are synergized by addition of particular terpenes/terpenoids (abs, [0007], [0008], [0035], [0038], [0097]). The composition may comprise one or more additional penetration enhancers including octanol (i.e. octan-1-ol) ([0035]). The penetration enhancer may be included between about 1-40% weight of the composition ([0036]). The terpenes/terpenoids may be about 0.01-20% by weight ([0056]).
As noted by para. [0119] and Table A of the instant Specification, myrcene and menthol are both terpenes suitable as a penetration enhancer. Therefore the myrcene and menthol of Smith meet the limitation of a penetration enhancer as instantly claimed.
The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claim 1 and 3 reciting a synergistic ratio or a ratio of the first and second penetration enhancers, respectively, para. [0034] of the instant Specification notes that “synergistic” means more than the additive effect of the individual components of a composition. As discussed above, Smith teaches wherein addition of particular terpenes/terpenoids synergize the effect of cannabinoids. Smith further discloses wherein each terpene/terpenoid may alternatively be included in amounts of between about 0.1-3% by weight ([0056]). Accordingly, it would have been obvious to one of ordinary skill in the art to have selected an amount of a terpene and an amount of additional terpene such that the amounts selected would have equated to a ratio that overlaps with the claimed ratio, thus making the claimed ratio obvious. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claims 1 and 92 reciting a pharmaceutically acceptable carrier, Smith further discloses wherein the composition may comprise Carbopol® polymers (i.e. homo- and copolymers of acrylic acid) ([0024]). As evidenced by para. [0234] of the instant Specification, acrylic polymers are biocompatible polymers. Thus the polymers of Smith meet the limitation of a biocompatible polymer suitable as a pharmaceutically acceptable carrier as instantly claimed.
Regarding claim 2, Smith further discloses wherein the cannabinoids may be about 0.01-5% by weight of the composition ([0089]). Accordingly, it would have been obvious to one of ordinary skill in the art to have selected an amount of cannabinoids and an amount of terpenes from the disclosed weight ranges, such that the amounts selected would have equated to a ratio that overlaps with the claimed ratio, thus making the claimed ratio obvious. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 19, as evidenced by Table B of the instant Specification, octan-1-ol has a cLogP of 2.7769 and a polar surface area of 20.23. Thus the octanol of Smith meets the limitation of the first or second penetration enhancer as instantly claimed.
Regarding claim 36, Smith further discloses wherein the permeation enhancer may include isopropyl myristate ([0007]). As evidenced by para. [0136] of the instant Specification, isopropyl myristate is a penetration enhancer. Thus the isopropyl myristate of Smith meets the limitation of an additional penetration enhancer as instantly claimed.
Regarding claim 40, as discussed above, Smith discloses wherein effects of the cannabinoids are synergized by addition of particular terpenes/terpenoids. Smith further discloses wherein cannabis’ other components, such as terpenoids, may act in synergy to contribute to its effects ([0097]). Accordingly, although Smith does not explicitly disclose an amount of potency increase for the cannabinoids, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed increase in potency (i.e. at least 10%) through routine experimentation based on the amount of synergy desired. "[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." See MPEP § 2144.05(II)(A).
Regarding claim 65, as discussed above, Smith discloses wherein the composition comprises myrcene. As evidenced by para. [0170] and [0172] of the instant Specification, myrcene acts as an anti-inflammatory agent suitable as a secondary active agent. Therefore, the myrcene of Smith meets the limitation of a secondary active agent as instantly claimed.
Regarding claim 76, Smith further discloses wherein the composition may include one or more pharmaceutically acceptable excipients including emollients ([0059]).
Regarding claim 89, as discussed above, Smith discloses wherein the composition is a transdermal formulation. Accordingly, although Smith does not explicitly disclose a pH range, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed pH range through routine experimentation based on pH ranges desired to allow transdermal delivery. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 90 and 91, Smith further discloses wherein the composition may be in the form of suspensions, creams, oils, or gels ([0093]). Accordingly, although Smith does not explicitly disclose a viscosity range, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed ranges of viscosity (i.e. about 1 to 1000 cP) through routine experimentation based on the desired formulation of composition. "[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." See MPEP § 2144.05(II)(A).
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lampach (US 2021/0251949 A1, 08/19/2021), directed to compositions comprising cannabinoids and terpenes in desired synergistic ratios.
Aung-Din (US 2019/0274969 A1, 09/12/2019), directed to topical therapy with terpenes acting in synergy with cannabinoids.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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