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 .
Claim Status
Claims 1-16 are pending.
Claims 1-5 and 12-16 are withdrawn as they are directed to a non-elected group(s).
Claims 6-11 are currently under consideration.
Claims 6-11 are rejected.
Acknowledgement of Receipt
Applicants’ election without traverse of Group II., claims 6-11 drawn to a solid lipid nanoparticulate stock formulation in the reply filed 09/05/2025 is acknowledged. This Office Action is in response to Applicants’ elections, amendments and remarks filed 09/05/2025.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 08/22/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this IDS has been considered by the Examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the terms “triglyphix sense” (see Spec., [0006]), “Transcutol” (see Spec., [00055]) and “Myaderm” (see Spec., [00064]), which are trade names or a marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 7-8 and 10 are objected to because of the following informalities: the species are capitalized. One would only capitalize if it was the start of a sentence or part of a proper noun, such as “Thai basil” (where “Thai” is a proper adjective). Appropriate correction is required.
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.
Claims 6- 11 and all dependent claims thereof 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 7, line 3; claim 11 lines 2-3, contain the trademarks/trade names “Precirol® ATO”, “Span”; “Tween 80”, “TranscutolP”, respectively. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a lipid matrix forming agent or a surfactant and, accordingly, these identifications/descriptions are indefinite. For the purposes of this office action prior art teaching any emulsifying agent, lipid matrix forming agent and surfactant will be considered to be read on the claims 7 and 11 respectively.
Claims 6 and all dependent claims thereof 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 6 recites the phrase, “solid lipid nanoparticulate stock formulation,” in line 1 renders the claim unclear because it is unclear which structural part(s) of the claim (i.e., the last 6 lines), if any, relate to "a solid lipid nanoparticulate". None of the lines appear to require an actual particulate. The lines do not recite anything that would clearly indicate a solid phase. The recitation of “a surfactant solution” in the last line of the claim indicates an emulsion; further not supporting the meaning of the phrase “a solid lipid nanoparticulate”. In paragraph [0020] of the instant specification, Applicants state that physiological lipids remain in a solid state but this does not provide any clarity to the phrase “solid lipid nanoparticulate stock formulation”. In said paragraph there is no mention of the term “stock” anywhere.
When reading the preamble in the context of the entire claim, the recitation "a solid lipid nanoparticulate" is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. Considering the totality of all the limitations of the claim and their interaction with each other, the body of the claim does not sustain the preamble so that the claim apprises one of ordinary skill in the art of its scope. See MPEP 2173.02(II.). Additionally, the phrase "for the preparation of a topical cream formulation" also adds uncertainty to the interpretation of the claim because the phrase suggests that the claimed emulsion could be a "stock" component to be combined with nanoparticles later, and then used to make a topical cream formulation. As such, the claim here is suggesting a method step.
Thus, claim 6 and all dependent claims thereof are also rejected for being indefinite as they are dependent on an indefinite claim.
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rahmani (WO 2022/040773 A1).
Rahmani discloses compositions comprising an oil-in-water nano-emulsion dispersed in an external oil phase, methods for the preparation of such compositions as well as uses of such compositions, for example, for delivery of active ingredients to a subject (abstract, [0001]). The methods comprise combining a first mixture comprising a liquid oil and a charged lipid with a second mixture that is an aqueous mixture comprising a film-forming thermoreversible emulsifier to prepare an oil-in-water nano-emulsion; and combining the oil-in-water nano-emulsion with a third mixture comprising a combination of solid lipids to prepare the composition (abstract, claim 1). Rahmani focuses on providing a compounding base for the treatment or management of inflammation and/or pain that has the flexibility to enhance the delivery of both hydrophilic and lipophilic active ingredients ([005]). The Nano-Emulsion SR Cream is composed of an oil-in-water (O/W) nano-emulsion core stabilized in an external oil phase to prolong the release of lipophilic and hydrophilic active ingredients ([0010]).
Rahmani teaches the internal oil phase comprises a liquid oil in combination with a charged lipid; the external oil phase comprises a combination of solid lipids ([0011-0012]). Rahmani discloses that solid lipids comprising the external oil phase comprise glyceryl dibehenate, petrolatum (e.g. petrolatum white USP), hydrogenated castor oil, cetyl alcohol, glyceryl stearate and PEG-100 stearate ([0067], [00119]); third mixture comprising the combination of solid lipids comprises: the liquid emollient isopropyl lauroyl sarcosinate; the penetration enhancer ethoxy diglycol; and the antioxidant butylated hydroxytoluene ([0120], [00124], claim 50).
Regarding the first and second lipid matrix forming agents, Rahmani discloses that the hydrogenated vegetable oil or combination thereof can be useful to create a stable matrix ([0067]). The same one lipid could be the first or second matrix forming agent and read on the limitation as one skilled in the art could reasonable envision using the same lipid for cost-effectiveness and ease of use and/or formulating. Applicants have yet to compare the difference of the two (first vs. second lipid matrix forming agent) to show criticality. See MPEP §2144.04.
Regarding permeability enhancer, Rahmani provides an exemplary embodiments in which the CBD/THC in medium chain triglyceride (MCT) oil, THC Distillate (i.e., concentrate), and CBD isolate is formulated with the said cream with menthol and or spearmint essential oil ([0172], Example 8; [0174], Example 9). Here the prior art reads on the limitation as menthol is a species recited as a permeability enhancer in instant claim 8.
Regarding the natural analgesic limitation, Rahmani discloses the Nano-Emulsion SR Cream as being able to deliver THC distillate and CBD oil (i.e., concentrate and isolate) with no oxidative discoloration of the cannabinoids being observed under the conditions used ([0010], [0093], [00102]) and suggests an immediate release of the active from the external phase for immediate local pain relief, followed by sustained release of the drug from the internal oil phase ([0096]). As THC distillate and CBD oil are concentrate and isolate as taught by Rahmani, and the teaching meets the limitation of instant claim 9, as such, the natural analgesic limitation is met of the base claim.
Regarding the solubilizer limitation, Rahmani teaches that liquid emollient, penetration enhancers, can be polar or non-polar and suitably has the ability to dissolve soluble and poorly water-soluble active ingredients, respectively ([00120-00121]). Rahmani presents ethoxy diglycol as a penetration enhancer, solubilizing agent and indicates natural penetration enhancers such as cineol, eucalyptol limonene, linalool and menthol ([0071], [00122], [00142], see Phase D under I. Materials).
Regarding the surfactant and water limitation, Rahmani discloses purified water and poloxamer (i.e., nonionic surfactant) as the film-forming thermoreversible emulsifier amphoteric tri-block copolymer in Phase A of I. Materials ([0142], claims 9, 43) where the poloxamers enhance the viscosity of the water phase ([0064]).
Regarding claim 8, Rahmani teaches menthol ([0071], [00122]) and provides embodiments thereof ([00172-00174])
Regarding claim 9, Rahmani teaches cannabinoid isolate by disclosing and providing formulations employing CBD isolate ([00100-00100]; [00174], Example 9).
Regarding claim 11, Rahmani teaches that in an embodiment the composition further comprises a multifunctional polymer comprising polysorbate 80 (i.e. Tween 80, nonionic surfactant) ([0069]) further described as being well-hydrated by combining with the first mixture prior to combination with the third mixture so as to obtain a homogeneous composition to stabilize the oil phase, provide a gel cream texture and create a pseudo-emulsion system ([0127]).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to apply the composition taught by Rahmani with expected results. One would be motivated to do so with a reasonable expectation of success because Rahmani provides a compositions can entrap lipophilic active ingredients in both the internal and external oil phase ([0096]). Rahmani teaches that a person skilled in the art would appreciate that the use of the composition will depend on the active ingredient or combination of active ingredients to be delivered to the subject for local analgesic effect ([00109]). Further, Rahmani provides a nano-emulsion cream base (NanoEmulsion SR Cream) that was prepared that is a white cream that can, for example, be readily spread on an affected area without leaving a tacky or sticky feeling, readily removed if not tolerated, and would be readily mixed with compounding AP is at the pharmacy level ([0010]) would contribute to the improvement of delivering natural active for pain relief, absent a clear showing of evidence to the contrary.
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rahmani as applied to claims 6-9 and 11 above, and further in view of Woo (US 6,428,821 B2) evidenced by Oronsky (US 9511016 B2).
The teachings of Rahmani above are incorporated herein.
Regarding claim 7, Rahmani teaches nonionic emulsifier, Span; amphoteric emulsifier, phospholipids, lecithin, saponin and their derivatives as being used in the art to make nano-emulsions ([0064]) but does not exemplify this with embodiments.
Regarding claim 10, Rahmani discloses polyethylene glycol as part of the structure of poloxamer ([0064]).
Woo discloses an micro-emulsion composition of Carduus marianus containing a major amount of silybin as the active ingredient in a stable emulsion from that requires a co-surfactant (col. 1, line 15).
Woo discloses that the composition further comprises a surfactant which promotes the wetting of the active ingredient in an aqueous medium (col. 2, line 35). Representative examples of the surfactant include polyoxyethylene-sorbitan-fatty acid esters (Tween®), polyoxyethylene-polyoxypropylene block copolymer (Poloxamer®), phospholipids, trans-esterification products of natural vegetable oil triglycerides, sorbitan fatty acid esters such as sorbitan monolauryl, sorbitan monopalmityl and sorbitan monostearyl esters (Span®), and sterols or derivatives thereof such as cholesterol, phytosterol and sitosterol (col. 2, no. (1) - col. 3, no. (12)). Here, Woo not only teaches cholesterol, but also teaches components taught in Rahmani.
Regarding claim 7, Woo discloses sterols or derivatives thereof such as cholesterol as the surfactant (col. 3, no. (12); claim 4). While embodiments are not provided explicitly using cholesterol, Oronsky provides evidence that cholesterol can serve both as an emollient and an emulsifier in topical compositions (see Oronsky, col. 4, line 23 and 49).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to incorporate the cholesterol taught by Woo in the oil-in-water nano-emulsion dispersed in an external oil phase composition taught by Rahmani with expected results. One would be motivated to do so with a high expectation of success because Woo achieved a greatly increased level of in vivo bioavailability of silybin, the level being at least 4-fold higher than that achievable by conventional formulations (col. 2, line 9). One skilled in the art would recognize, in addition, that the composition of Woo being an oral composition would meet the safety expectations as a topical composition such as the one disclosed by Rahmani. Further, as evidenced by Oronsky, incorporating the natural and readily available cholesterol (e.g., Lanolin, see Oronsky col. 8, line 56) and with its dual properties (emollient and emulsifier, see above), complements the affinities of Rahmani for natural components (see Rahmani, natural oils and active agents (claims 4, 29, 38 and 58).
Regarding claim 10, Woo discloses that the co-surfactant that may be used is ethanol, propylene glycol (1,2-dihydroxypropane), polyethylene glycol, transcutol (diethylene glycol monoethyl ether) (col. 2 line 25; claim 3). Woo provides exemplary embodiments in which polyethylene glycol 200 is used (col. 5, line 20, Example 4).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to substitute one known ethoxy diglycol of Rahmani with the polyethylene glycol of Woo for a similar purpose of solubilizing the active. Simple substitution of one solubilizer for another is within the purview of the skilled artisan and would yield predictable results. In addition, one skilled in the art would recognize the variable polymer chain length and more electronegative oxygen atoms of polyethylene glycol (PEG) and as such, would expect that PEG would be a more powerful solubilizer than ethoxy diglycol, primarily due to its these characteristics which would allow PEG to create a more extensive and effective solubilizing environment, particularly for a wide range of poorly water-soluble compounds (i.e., Carduus marianus, cannabidiol (CBD)).
Conclusion
Claims 6-11 are rejected; no claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614