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
This application does not claim benefit to any previously filed application, and has an effective filing date of November 6, 2023.
Claim Rejections - 35 USC § 112(d)
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 2-7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. The compositions of claims 2-7 describe substituting coconut oil, vanilla oil, thymol, beeswax, camphor, and menthol, respectively, with compounds possessing similar characteristics. Dependent claims must incorporate all limitations from the claim which they depend. As stated in MPEP §608.01(n)(III), “… if claim 1 recites the combination of elements A, B, C, and D, a claim reciting the structure of claim 1 in which D was omitted or replaced by E would not be a proper dependent claim, even though it placed further limitations on the remaining elements or added still other elements.” For examination purposes, claims 2-7 will be interpreted as the substitutions of the corresponding claim limitations in claim 1. Applicant may cancel the claims 2-7, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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.
Claims 1-3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Drennan (US Publication No. US20220226241A1, Published July 21, 2022), in view of Garland (US Publication No. US20250018043A1, Effectively Filed July 10, 2023).
Drennan teaches that cannabidiol (CBD) is one of the most widely used herbs for medicinal purposes including lotions and topicals to improve symptoms of various conditions via applications to the skin (¶ 0003 and 0004) along with terpenes, essential oils, carrier oils, and enhancers that can be included in said topicals. The teachings explicitly point out that the issues with CBD, terpenes, and flavonoids are their lipophilic nature which causes low solubility in aqueous environments. Furthermore, to overcome poor solubility and to achieve desirable dosage forms of an active agent, one may encapsulate or disperse the desired lipophilic substance, for example CBD, using additives or modifiers such as micelles or liposomes (¶ 0205). More specifically, a desired topical formulation (¶ 0161, lines 1-6) may comprise terpenes, essential oils, and carrier oils. The compositions may include terpenes such as methyl salicylate (¶ 164, second column, line 5, Para. 165, lines 1-5, range 0.05 - 80%, wherein the therapeutic oil blend may comprise 30% w/w of a terpene), menthol (¶ 164, second column, line 3, ¶ 165, lines 1-5, range 0.05 - 80%, wherein the therapeutic blend may comprise 3% w/w of a terpene), camphor (¶ 164, second column, line 1; ¶ 165, lines 1-5, range 0.05 - 80%, wherein the therapeutic oil blend may comprise 6% w/w of a terpene), thymol (¶ 126, line 50; ¶ 128, lines 1-4, range 0.05 – 80%, wherein the composition may comprise 0.1% w/w of a terpene), carvacrol (¶ 126, line 9; ¶ 128, range 0.05 – 80%, wherein the composition may comprise 0.1% w/w of a terpene), and eucalyptol oil by way of eucalyptol (¶ 164, second column, line 5; ¶ 165, lines 1-5, range 0.05 - 80%, wherein the therapeutic oil blend may comprise 0.1% - 50% w/w of a terpene). Carrier oils such as coconut oil (¶ 135, line 3; ¶ 136, range 0.5 – 99.5%, wherein the carrier oil in the composition may comprise about 40% - 45% w/w of a carrier oil) are also discussed as being part of a desired topical formulation.
As mentioned previously, Drennan also teaches that essential oils may be part of a CBD topical formulation. The compositions may include essential oils such as vanilla oil (page 12, ¶ 130, line 35; ¶ 131, line 1 range 0.1 - 10%, wherein in some embodiments the topical composition may comprise about 0.3% - 2.0% w/w of an essential oil), linalool oil (¶ 129, Line 4; ¶ 131, range 0.1 - 10%, wherein in some embodiments the topical composition may comprise about 0.3% - 2.0% w/w of an essential oil), limonene oil (¶ 129, line 4; ¶ 131, range 0.1 - 10%, wherein in some embodiments the topical composition may comprise about 0.3% - 2.0% w/w of an essential oil), eucalyptus (¶ 129, line 44; ¶ 131, range 0.1% – 10%, wherein the composition may comprise 0.1% w/w of an essential oil), and cinnamon oil extracted from cinnamon leaf (¶ 130, second column, lines 19-21; ¶ 131, range 0.1 - 10%, wherein in some embodiments the topical composition may comprise about 0.3% - 2.0% w/w of an essential oil).
While Drennan’s teachings are broad and state the concept of encapsulating CBD in liposomes to achieve enhanced drug delivery, Drennan fails to teach the explicit formulation of CBD hemp microspheres in the weight percent range instantly claimed.
However, Garland teaches CBD hemp microspheres (¶ 0009 & 0010; ¶ 0162; ¶ 0164, lines 1 – 8, wherein the dry weight % in the composition may comprise between 0.005% - 0.01% of one or more active agents) along with various other formulations that include terpenes, essential oils, carrier oils, and permeation enhancers. The microspheres are utilized for hydrophobic compounds to treat, prevent, or cure disease and conditions that have been shown to have drawbacks due to low bioavailability as a result of low solubility in aqueous solution (¶ 003). More specifically, Garland teaches that CBD hemp microspheres (¶ 0162; ¶ 0164, lines 1 – 8, wherein the dry weight % in the composition may comprise between 0.005% - 0.01% of one or more active agents) can be generated to incorporate into topical formulations.
Garland also teaches that a topical composition may contain various types of carriers for the active agent. The carriers include organic beeswax (page 21, ¶ 0233, line 3; ¶ 0290, range 5% – 60%, wherein the topical formulation may include 15% - 20% of a carrier for the active agent), lavender oil (page 21, ¶ 0233, Line 46-47; ¶ 0290, range 5% – 60%, wherein the topical formulation may include 40% - 50% of a carrier for the active agent), shea butter (page 21, second column, ¶ 0233, line 18; ¶ 0290, range 5% – 60%, wherein the topical formulation may include 40% - 50% of a carrier for the active agent), avocado oil (page 21, ¶ 0233, line 2; ¶ 0290, range 5% – 60%, wherein the topical formulation may include 40% - 50% of a carrier for the active agent), almond oil (page 21, second column, ¶ 0233, line 28; ¶ 0290, range 5% – 60%, wherein the topical formulation may include 40% - 50% of a carrier for the active agent), sunflower oil (page 21, second column, ¶ 0233, line 27; ¶ 0290, range 5% – 60%, wherein the topical formulation may include 40% - 50% of a carrier for the active agent), seed oil (page 21, second column, ¶ 0233, line 27; ¶ 0290, range 5% – 60%, wherein the topical formulation may include 40% - 50% of a carrier for the active agent), paraffin (page 21, ¶ 0233, line 58; ¶ 0290, range 5% – 60%, wherein the topical formulation may include 15% - 20% of a carrier for the active agent) and soy wax by way of hydrogenated soybean oil (page 21, ¶ 0233, lines 34-35; ¶ 0290, range 5% – 60%, wherein the topical formulation may include 15% - 20% of a carrier for the active agent).
Drennan and Garland are both considered to be analogous art to the claimed invention because they are in the same field of optimizing topical compositions with cannabidiol being at least one of the active agents. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention and following the teachings of Drennan, to have incorporated the liposomes of Garland, to form a topical ointment containing CBD encapsulated microspheres in liposomes in order to enhance drug delivery in topical formulations. Furthermore, the wt. % ranges of the teachings of Drennan and Garland overlap with the concentrations of those of in the instant claims which further bolsters a prima facie obviousness rejection (see MPEP §2144.05(I)).
With respect to claim 1, Drennan teaches a topical formulation (¶ 161) comprising: methyl salicylate, menthol, camphor, vanilla, thymol, and coconut oil in the corresponding ranges in the claimed invention (see above citations). Garland teaches CBD hemp microspheres and organic beeswax in the corresponding ranges in the claimed invention (see above citations). The Examiner notes that the specification of the instant application states that the active ingredients are methyl salicylate and CBD, however based on the scope of the prior art, especially in the teachings of Garland, a topical can have one or more active ingredients, such as CBD, and terpenes, like methyl salicylate.
With respect to claim 2, Garland teaches that a topical composition may contain lavender oil, shea butter, avocado oil, almond oil, sunflower oil, and seed oil in the corresponding ranges in the claimed invention (see above citations). The Examiner notes that neem oil was not taught by either Drennan or Garland, however by virtue of the alternative form of claim 2 which indicates neem oil is not required as a substitution, the rejection is appropriate.
With respect to claim 3, Drennan teaches a topical formulation that can include one or more essential oils including linalool oil, limonene oil, eucalyptol oil by way of eucalyptol, and cinnamon oil extracted from cinnamon leaf in the corresponding ranges in the claimed invention (see above citations). While Samaritan or “Thieves” oil is not explicitly taught by Drennan, the components that make up Samaritan oil, i.e., cinnamon, clove lemon, eucalyptus, and rosemary (¶ 129 & 130) are disclosed. It would be prima facie obvious to a PHOSITA to mix these essential oils to generate Samaritan oil for substitution of vanilla oil as stated in claim 3.
With respect to claim 5, Garland teaches paraffin and soy wax by way of hydrogenated soybean oil in the corresponding ranges in the claimed invention (see above citations).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Drennan, in view of Garland, further in view of the evidentiary reference Sadiq et al. (“Chemical and antimicrobial studies of monoterpene: Citral” Pesticide Biochemistry and Physiology (98) 89-93. Published June 9, 2010).
With respect to claim 4, Drennan teaches a topical formulation may contain at least one terpene including carvacrol and an essential oil including eucalyptus in the corresponding ranges in the claimed invention (see above citations). While citral is not taught by Drennan or Garland, it belongs to the terpene class of compounds as evidenced by Sadiq et al. (page 89, 1. Introduction, 2nd full ¶) and would have been obvious to a PHOSITA to substitute thymol with citral, a well-known fragrant terpene.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Drennan in view of Garland, further in view of Herslof (US Patent No. 10,034,943, Patent Publication Date July 31, 2018).
The teachings of Drennan and Garland are broad and do cover a plethora of embodiments for topical formulations to include an active agent (such as CBD, and methyl salicylate), terpenes (such as menthol, camphor, and thymol), essential oils (such as vanilla oil), and moisturizing agents or carriers (such as beeswax and coconut oil). While there are mentions of incorporating analgesic compounds in topical formulations containing CBD as an active agent in both Drennan and Garland, they fail to explicitly teach analgesics instantly claimed, namely salicylamide, diclofenac, ketoprofen, or nicotinate esters.
Herslof teaches a cosmetic composition for topical administration of two types: the first aiming at administering the pharmaceutically active agent onto healthy or diseased skin to produce its effect on the skin in one more layer of the skin, the second aiming to deliver the pharmaceutically active agent through the skin (column 1, lines 28 – 38). Herslof states that a pharmaceutically active agent can include species within the genus of antibacterial agents, antiseptics, antiphlogistics/analgesics, antipsoriatic, agents for treatment of eczema and atopic dermatitis, antiglaucomateous, local anasthetics, anti-dandruff, anti-acne, and wound healing agents (column 3, lines 4 – 58). Of these various genera of pharmaceutically active agents, the one of relevance is the antiphlogistics/analgesics genus. The species with the antiphlogistics/analgesic genus are salicylate (column 7, line 53), diclofenac (column 7, line 45), ketoprofen (column 7, line 48), nicotinate esters (column 7, line 49), and phenols (column 7, line 53). Furthermore, the claimed concentrations of camphor (5.9 wt. %) and menthol (2.9 wt. %), are also taught by way of overlapping ranges (column 5, lines 25 – 30, range 0.001 – 10%, more specifically of at least one pharmaceutically active agent). Moreover, the wt. % ranges of the teachings of Drennan, Garland, and Herslof overlap with the concentrations of those in the instant claims which further bolsters a prima facie obviousness rejection (see MPEP §2144.05(I)).
Drennan, Garland, and Herslof are all considered to be analogous art to the claimed invention because they are in the same field of optimizing topical compositions for administration to a subject via the stratum corneum (the outer most layer of the skin). Therefore, it would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to have modified Drennan to incorporate the teachings of Garland to form a topical ointment containing CBD encapsulated in liposomes to enhance drug delivery in topical formulations, as well as incorporate the teachings of Herslof to incorporate analgesic agents, including salicylate, diclofenac, ketoprofen, salicylamide, nicotinate esters, or phenols in said topical formulations (column 3, lines 20-25). The Examiner notes that salicylamide is not explicitly taught in Herslof, but it would be obvious to a PHOSITA to incorporate salicylamide into a topical as it is a known analgesic.
With respect to claim 6, Herslof teaches salicylate, diclofenac, ketoprofen, nicotinate esters, and phenols in the corresponding ranges in the claimed invention (see above citations), which can be substituted for camphor in the claimed concentration of 5.9 wt. % (see above citations). The Examiner notes that the terms in the body of claim 6, along with all instant claims, are given their broadest reasonable interpretation as stated in MPEP §2103(I)(C). Therefore, the terms salicylate, nicotinate esters and phenols are considered broadly and the teachings of Herslof read on these by way of: salicylic acid as the limitation salicylate, wherein salicylate and salicylic acid exist in equilibrium due to their inherent acid base relationship, methyl nicotinate as the limitation nicotinate esters, and salicylic acid, which is inherently a type of phenol.
With respect to claim 7, the same rationale applies for the substitution of menthol with the aforementioned limitations in claim 6. For clarity, the concentration claimed in the instant claims of 2.9 wt. % of menthol is taught in Herslof by way of overlapping ranges (see above citations).
Claim 8 is rejected 35 U.S.C. 103 as being unpatentable over Drennan, in view of Garland, further in view of Hanlon (US Patent No. 11,478,446, Patent Publication Date October 25, 2022).
Drennan’s topical is disclosed to be formulated according to known methods of oil blend preparation. Those methods include but are not limited to heating, cooling, mixing, serial addition, serial dilution, emulsification, homogenization, dissolution, and titration (¶ 172). Furthermore, Drennan states a method of heating the cannabinoid oil to a temperature in the range of 40°C - 80°C, including 75°C (¶ 176) in order to obtain a desired topical formulation. Garland discusses that the liposomes encapsulating the CBD promotes stability at higher temperatures, and that the composition of the nanoparticle is not susceptible to significant change (less than or equal to about 20%; ¶ 0250). Therefore, a PHOSITA would not be significantly concerned with order of adding carrier oils, essential oils, antiseptics, and active agents as long as the CBD active agent is encapsulated within the hydrophobic portion of the phospholipid bilayer. Hanlon teaches a method of preparing a topical formulation comprising steps of preparing an emulsifying wax and heating said wax in between 70°C – 75°C, adding cannabinoids suspended in oil, adding a thickening agent to form a first phase, heating distilled water with menthol crystals to form a second phase wherein the first and second phase are mixed thereafter to produce a third phase, and adding an essential oil to the third phase. These teachings are in agreement with the instant application with respect to the addition of vanilla oil at the end phase presumably because of the high vapor pressure of essential oils (column 3, lines 39 – 57).
With respect to claim 8, a PHOSITA would have known to combine the teachings of Drennan and Garland to arrive at the wt. % of the various ingredients of topical formulation and combine them in the manner presented in the instant claim. According to the MPEP, the sequence of adding ingredients is prima facie obvious in the absence of new or unexpected results (MPEP §2144.04 (IV)(C)). Notwithstanding the foregoing, Hanlon teaches that formation of the of the primary oil/emulsifying wax and addition of any specialty ingredients to said primary oil/emulsifying wax should be done prior to the addition of the CBD active agent (column 6, lines 20 – 49). Furthermore, as mentioned above the temperature range taught in Hanlon overlaps with range stated in the instant claim, rendering it prima facie obvious.
Drennan, Garland, and Hanlon are all considered to be analogous art to the claimed invention because they are in the same field of optimizing topical compositions for administration to a subject via the stratum corneum (the outer most layer of the skin). Therefore, it would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to have modified Drennan to incorporate the teachings of Garland to form a topical ointment containing CBD encapsulated in liposomes to enhance drug delivery. Moreover, a PHOSITA would have known to incorporate the method of Hanlon to optimize the preparation of the topical composition in such a way where the CBD active agent and the essential oil are added at the end due to their reported degradation after long exposure to heat and high vapor pressure, respectively. A PHOSITA would have appreciated that CBD microencapsulated in a liposome would provide aided stability to the CBD active agent at high heat, but in the same vein, would appreciate that to achieve optimal bioavailability, adding microencapsulated CBD at the end of the method steps is ideal.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Karelis (US Patent No. 12,239,628) teaches incorporation of CBD and terpenes into a topical formulation for treating sleep disorder. Aung-Din (US Publication No. US20160338974A1) teaches low dose of CBD in topical ointment. Garti (US Patent No. 11,819,491) teaches incorporation of beeswax in CBD topical formulations in the weight range claimed in the instant application. LaRosa (US Patent No. 11,439,654) and Nowak (US Publication No. US20200276256A1) teach methods of manufacturing topical formulations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHIL CHANDER AGGARWAL whose telephone number is (571)272-7755. The examiner can normally be reached 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAHIL CHANDER AGGARWAL/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623