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 .
Status of claims
The claims filed on 07/09/2026 are hereby being considered. Claims 1, 12, and 14 are currently amended. Claims 2, 9, and 11 are original. Claims 3-8, 10, 13, and 15 are previously presented. Claims 16-19 are new. Claims 1-19 are pending and under examination.
Priority
This application is a 371 of PCT/EP2022/067655, filed on 06/28/2022. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP 21382581.3, filed on 06/30/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Rejections/Objections withdrawn
All 35 USC § 112 (b) rejections imposed in the previous correspondence are hereby withdrawn due to applicant’s amendments.
As this rejection is withdrawn, applicant’s arguments to the rejection are moot.
Claim Objections
Claim 17 is objected to because of the following informalities:
The “and” is improperly placed before “component f)” and not before the final limitation (i.e., “the nanoemulsion is alcohol-free”).
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
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.
New rejections made in view of the new claims:
Claims 16-18 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.
Claims 16-18 recite that “the total concentration of diclofenac is from 1.5% to 2.5% (w/w)”. The phrase “total concentration of diclofenac” is indefinite because it is unclear whether the claimed 1.5% to 2.5% (w/w) total is calculated by summing the actual weight percentages of diclofenac free acid and diclofenac alkali metal salt, including the mass of the alkali-metal counterion, or instead solely on a diclofenac-equivalent basis. These methods produce different values and therefore different claim boundaries.
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 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.
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 inventions absent any evidence to the contrary. Applicant is 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.
Rejections maintained in view of amendments: prior arts unchanged, prior art mappings added, and obviousness statement unchanged.
Claims 1-4, 7-9, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kandavalli et al. (US20160184431A1) in view of Tamarkin et al. (US20080299220A1).
Kandavalli et al. discloses topical compositions comprising a corticosteroid and at least one penetration enhancing agent, wherein the composition may be substantially free of propylene glycol (abstract). Kandavalli et al. teaches that the topical compositions of the present invention may be in the form of nanoemulsions (¶ 88). Kandavalli et al. teaches that the composition may be used for treating skin diseases (¶ 62). Kandavalli et al. teaches that the composition may include one or more additional active agents that are useful in the management of psoriasis and associated pathological conditions (¶ 66). Kandavalli et al. teaches that the composition may include one or more pharmaceutically acceptable excipient, which may act as carriers, emulsifiers, co-emulsifiers, solvents, co-solvents, emollients, antioxidants, preservatives, gelling or thickening agents, polymers, surfactants, soothing agents, pH modifiers, solubilizers, humectants, moisturizers, oily bases, and the like (¶ 96). Kandavalli et al. teaches that the term “solvent” refers to components that aid in the dissolution of the drug in the formulation (¶ 105), which would thus include emulsifiers. Kandavalli et al. teaches that such solvents include diethylene glycol monomethyl ether (¶ 105), which satisfies element C of present claim 1. Kandavalli et al. teaches that the composition may include polyoxyl 40 hydrogenated castor oil as an emulsifier (¶ 98), which satisfies element D of present claim 1. Kandavalli et al. teaches that the composition may include caprylic/capric triglycerides as a water immiscible solvent (¶ 105), which satisfies element E of present claim 1. Kandavalli et al. teaches that the composition may include water at concentrations of at least 60% w/w (¶ 91, claims 14-16 of Kandavalli et al.), which satisfies element F of present claim 1. Kandavalli et al. teaches that the composition may include cetrammonium chloride (¶ 110), which satisfies all required elements of present claims 8 and 9. Kandavalli et al. teaches that the composition may include solvents––previously stated to include polyoxyl 40 hydrogenated castor (has an HLB of 15) in addition to caprylic and capric triglycerides––at concentrations of 1% w/w to 30% w/w based on the total weight of the composition (¶ 106), which overlaps with the claimed concentration ranges and ratios of present claim 13, thus wholly satisfying it. Kendall allows for one or more additional active agents that are useful in management of psoriasis and associated pathological conditions (paragraph 66). In a single embodiment (¶ 137, example 2), an emulsion was made with an anti-inflammatory agent and various excipients including surfactants, providing a point of reference for modifying such compositions. Kandavalli et al. makes the inclusion of alcohol-containing compounds optional in many embodiments, thus obviating the exclusion of alcohol.
However, Kandavalli et al. fails to teach the limitations of elements A and B in present claim 1, in addition to the limitations of present claims 2-4, 7, 15.
Tamarkin et al. discloses a substantially waterless composition suitable for delivery of an active agent to a body surface or cavity (abstract). Tamarkin et al. teaches that the composition may however comprise up to 10% of water (¶ 34). Tamarkin et al. teaches that the target site of the composition may be the skin (¶ 55), and further states that the composition may be applied to the skin (¶ 125). Tamarkin et al. teaches that the composition may include surfactants to form emulsions such as oil-in-water (o/w) emulsions (¶ 236). Tamarkin et al. teaches that the composition may include therapeutic agents such as diclofenac (which is intrinsically a free acid), its salts, and mixtures thereof (¶ 667), and specifically includes Diclofenac sodium as an example (¶ 84) ––covering the active agents stated in elements A and B of present claim 1 in addition to the active agents stated in present claims 2 and 3. Tamarkin et al. teaches that the composition may include about 1% to about 5% by weight of at least one therapeutic agent (¶¶ 51, 924), which satisfies the active agent percentages stated in elements A and B of present claim 1 in addition to the active agent ratios and percentages stated in present claims 2 and 3. Tamarkin et al. states that the term “Surface-active agents” is synonymous to “surfactants” (¶ 236). Tamarkin et al. teaches that the composition may contain about 0% to about 20% of at least one surface-active agent (¶ 56-57) such as a cationic surface-active agent (¶ 245) to stabilize the two phases (¶ 131), which satisfies all required elements of present claim 4. Tamarkin et al. teaches that the composition may be substantially alcohol-free to reduce skin-irritating effects (¶ 210), which covers all required elements of present claim 7. Tamarkin et al. teaches that the therapeutic agent in the composition may include a non-steroidal anti-inflammatory agent (¶ 624) that treats or prevents a disease involving inflammation (¶ 626), thus covering all required elements of present claim 15.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the drugs, excipients, concentrations, and treatment teachings disclosed in Tamarkin et al. into the topical nanoemulsion composition of Kandavalli et al. This is because both references are directed towards topical delivery systems for administration of active agents to the skin and both references teach formulations that may be in emulsion form. Kandavalli et al. expressly teaches that its compositions may include excipients that overlap with those claimed such as nonionic surfactants, caprylic/capric triglyceride, and C8-C16-alkyl trimethylammonium salts, with caprylic/capric triglyceride and nonionic surfactants being at concentrations and ratios that overlap with those in the present claims. Additionally, Kandavalli et al. teaches that its composition may include active agents useful to treat pathological conditions, thereby suggesting addition or substitution of other well-known anti-inflammatory agents. Concurrently, Tamarkin et al. teaches diclofenac, its salt forms, and mixtures thereof, are suitable therapeutic agents for such compositions to treat inflammation topically, in addition to teaching that the cationic surfactants taught in Kandavalli et al. may be at concentrations overlapping with those in the present claims and that such composition may be alcohol-free. A person of ordinary skill in the art would therefore have been motivated to substitute or incorporate the diclofenac, cationic surfactant concentrations, and alcohol-free teachings of Tamarkin et al. into the emulsion vehicles of Kandavalli et al. to obtain a predictable topical anti-inflammatory composition, with a reasonable expectation of success because the references employ compatible formulation technologies (emulsions comprising surfactants and oils) routinely used to delivery active ingredients to the skin. Furthermore, a person of ordinary skill in the art would have understood that drugs such as diclofenac may exist in free acid and salt forms, and that inclusion of both forms can be used to balance solubility and permeability characteristics in topical formulations, rendering the presence of both forms of diclofenac (free acid and alkali metal salt) an obvious design choice. Overall, selecting concentrations and ratios of the above drugs and excipients constitutes routine optimization of result-effective variables through ordinary experimentation, which does not confer patentability. Accordingly, the claimed composition would have been obvious over the combined teachings of Kandavalli et al. and Tamarkin et al. with a reasonable expectation of success, given that both references employ conventional emulsifiable components routinely used for topical delivery of therapeutics.
Rejections maintained in view of amendments: prior art unchanged, prior art mapping unchanged, and obviousness statement unchanged.
Claims 5-6, 10-11, 14, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kandavalli et al. (US20160184431A1) in view of Tamarkin et al. (US20080299220A1) in further view of Nicolosi et al. (US20110206739A1) as evidenced by Murgia et al. (Murgia S, Fadda P, Colafemmina G, et al. Characterization of the Solutol® HS15/water phase diagram and the impact of the Δ9-tetrahydrocannabinol solubilization. J Colloid Interface Sci. 2013;390(1):129-136. doi:10.1016/j.jcis.2012.08.068).
Kandavalli et al. and Tamarkin et al. collectively teach all the limitations of present claims 1 and 4.
However, Kandavalli et al. and Tamarkin et al. fail to collectively teach the limitations of present claims 5-6, 10-11, 14, 16, and 17.
Nicolosi et al. discloses compositions and methods of forming nanoemulsions, e.g., containing an active component, in combination with lipophilic components such as oils, hydrophilic components such as water, and one or more surfactants (abstract). Nicolosi et al. teaches that nanoemulsions may contain anti-inflammatory agents (¶ 3). Nicolosi et al. teaches that the nanoemulsion compositions of the disclosure can be effective for delivery of therapeutic products to the skin (¶ 64), and may be done so topically (¶ 138). Nicolosi et al. teaches that such nano-emulsions of the invention can be developed via temperature-dependent phase inversion of a surfactant, also termed self-assembled nanoemulsions (self emulsifying) (¶ 8), which satisfies all required elements of present claim 5. Nicolosi et al. teaches such nano-emulsions to be transparent (¶ 3), which satisfies all required elements of present claim 6. Nicolosi et al. teaches that the compositions in this invention may contain a polyethylene glycol 660 hydroxystearate surfactant (e.g., Solutol® HS15) (¶ 11), also known to be polyoxyethylene esters of hydroxystearic acids (e.g., a polyoxyethylene ester of 12-hydroxystearic acid such as the surfactant sold under the tradename SOLUTOL® HS15) (¶ 81), thus satisfying all required elements of present claims 10 and 11. This is further evidenced by Murgia et al., which teaches that Solutol® HS15 consists of poly-ethylene glycol mono and di-esters of 12-hydroxystearic acid (HS) and of about 30 wt.% of free poly-ethylene glycol (PEG) (page 130, Section 2.1 - Materials). Nicolosi et al. teaches that such compositions can be delivered in kits for therapeutic use (¶ 140), with such kits containing administration (or application) instruments such as pipettes and patches (¶ 141), which thus satisfies all required elements of present claim 14.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the nanoemulsion formation techniques, surfactant selections, and delivery formats taught by Nicolosi et al. into the nanoemulsion composition collectively taught by Kandavalli et al. and Tamarkin et al. This is because all three references are directed towards topical delivery systems employing emulsified formulations for administering therapeutic agents to the skin. Nicolosi et al. expressly teaches self-assembled nano-emulsions formed via phase-inversion processes, which are conventional methods to produce stable nano-emulsions, and further teaches that such nanoemulsions may be transparent, thereby suggesting predictable formulation characteristics obtainable using known emulsification techniques. Additionally, Nicolosi et al. teaches Solutol® HS15 to function as a known surfactant suitable for nanoemulsion systems similar to those described in Kandavalli et al. and Tamarkin et al. Furthermore, Nicolosi et al. teaches delivery of nanoemulsion composition kits comprising application devices such as pipettes, thereby predicting delivery of such compositions with an applicator as recited in the present claims. A person of ordinary skill in the art would have therefore been motivated to apply the nanoemulsion preparations methods, surfactant selections, and delivery formats of Nicolosi et al. into the composition of Kandavalli et al. as modified by Tamarkin et al. to obtain a predictable topical nanoemulsion formulation with known stability, transparency, and administration characteristics. This would have been done with a reasonable expectation of success because the references employ compatible formulations technologies routinely used for topical delivery of therapeutic agents. Overall, selecting particular nanoemulsion preparation methods, surfactant species, and delivery configurations constitutes routine optimization of result-effective variables through ordinary experimentation, which does not confer patentability. Accordingly, the claimed invention would have been obvious over the combined teachings of Kandavalli et al., Tamarkin et al., and Nicolosi et al. with a reasonable expectation of success.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kandavalli et al. (US20160184431A1) in view of Tamarkin et al. (US20080299220A1) in further view of Dhingra et al. (US20180021349A1) as evidenced by Hasan (Hasan NM. Role of medium-chain fatty acids in the emulsification mechanistics of self-micro-emulsifying lipid formulations. Saudi Pharm J. 2014;22(6):580-590. doi:10.1016/j.jsps.2014.02.005).
Kandavalli et al. and Tamarkin et al. jointly teach all limitations of claim 1.
However, Kandavalli et al. and Tamarkin et al. fail to collectively teach the limitations of claim 12.
Dhingra et al. teaches formulations for drug delivery of a lipophilic therapeutic agent, providing enhanced modulation of solubility, stability, absorption, metabolism, and/or pharmacokinetic profile of the therapeutic agent (abstract). Dhingra et al. teaches that the composition may be in the form of a self-dispersing nano-emulsion (¶ 36). Dhingra et al. teaches that the administration method of the composition may be topical and transdermal (¶ 169). Dhingra et al. teaches that the composition may include diclofenac (¶ 75). Dhingra et al. teaches that the composition may include solubilizers (¶ 189) including Miglyol 812 (¶ 195), which possesses characteristics that overlap with all material and concentration elements of claim 12, thus wholly satisfying it. This is further evidenced by Hasan, which teaches that the fatty acid distribution in Miglyol 812 according to the manufacturer is: caprylic (C8): 50–65%, capric (C10): 30–45% (page 582, Section 2.1 – Materials).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the Miglyol 812 teachings of Dhingra et al. into the nanoemulsion composition collectively taught by Kandavalli et al. and Tamarkin et al. This is because all three references are directed towards topical delivery systems employing emulsified formulations for administering therapeutic agents to the skin. Kandavalli et al. and Tamarkin et al. jointly teach that the nanoemulsions in its compositions may include substances such as caprylic/capric triglycerides to aid in the dissolution of active agents, While Dhingra et al. teaches Miglyol 812 to be an example of such triglycerides used in these nanoemulsions as a solubilizer. Therefore, a person of ordinary skill in the art would have been motivated to incorporate the teachings of Dhingra et al. into the joint teachings of Kandavalli et al. and Tamarkin et al. to further enhance the dissolution characteristics of the composition. Additionally, because all three of these references, especially Dhingra et al., teach such excipients to be compatible for these formulations and delivery methods, one of ordinary skill in the art would have incorporated the Miglyol 812 teachings of Dhingra et al. into the compositions taught by Kandavalli et al. and Tamarkin et al. with a reasonable expectation of success to reach the claimed invention.
Rejection added in view of new claim 18: prior art unmodified yet rearranged to address claim 18 limitations, prior art mappings unmodified, obviousness statement added.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kandavalli et al. (US20160184431A1) in view of Tamarkin et al. (US20080299220A1) in further view of Nicolosi et al. (US20110206739A1) in further view of Dhingra et al. (US20180021349A1) as evidenced by Hasan (Hasan NM. Role of medium-chain fatty acids in the emulsification mechanistics of self-micro-emulsifying lipid formulations. Saudi Pharm J. 2014;22(6):580-590. doi:10.1016/j.jsps.2014.02.005) as further evidenced by Murgia et al. (Murgia S, Fadda P, Colafemmina G, et al. Characterization of the Solutol® HS15/water phase diagram and the impact of the Δ9-tetrahydrocannabinol solubilization. J Colloid Interface Sci. 2013;390(1):129-136. doi:10.1016/j.jcis.2012.08.068).
Kandavalli et al. and Tamarkin et al. collectively teach all required limitations of claim 1.
However, Kandavalli et al. and Tamarkin et al. fail to collectively teach all required limitations of claim 18.
Regarding Claim 18: See sections A.to D. as stated above.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate diclofenac composition of Kandavalli in view of Tamarkin with the additional excipient selections taught by Nicolosi and Dhingra. Nicolosi teaches the use of Solutol HS15-type PEG 12-hydroxystearate surfactants in nanoemulsions, with Murgia evidencing the known free-PEG content of that commercial surfactant, while Dhingra teaches caprylic/capric medium-chain triglyceride for pharmaceutical self-emulsifying systems, with Hassan evidencing the known C8/C10 composition thereof. An ordinarily skilled artisan would have been motivated to employ these known surfactant and oil-phase materials because each was conventionally used to provide and stabilize pharmaceutical emulsions/nanoemulsions and to solubilize lipophilic drug components. There would have been a reasonable expectation of success because the cited references demonstrate successful use of these same classes of pharmaceutically acceptable surfactants, triglycerides and cationic surfactants in compatible oil/water drug delivery systems, such that their combination would have involved the predictable use of known formulation components for their established functions.
Rejection added in view of new claim 19 limitation and substantial modifications (i.e., limiting the active agent of claim 1 to only diclofenac alkali metal salt and diclofenac free acid): new prior arts (i.e., Johnson and Roy) added, prior art mappings added, obviousness statement added.
Claim 19 and claim 1 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US20170281580A1) in view of Roy (US20120093882A1) as evidenced by Croda (CRODA-A001).
Johnson discloses beneficial topical pharmaceutical compositions comprising diclofenac sodium in high amounts, and methods for their use [¶abstract]. Johnson teaches that the composition may be oil-in-water (O/W) emulsion [¶¶7, 135, 144]. Johnson teaches that the composition may comprise a) 1-5% of diclofenac sodium and other alkali metal salts of diclofenac at concentrations ranging from 0.1-10% w/w [¶137-138]. Johnon teaches that additional active ingredients may be used in the composition [¶47], and further recognizes b) diclofenac free acid (distinct from its salt form) as a less soluble active used for topical/skin applications [¶¶1, 2], and teaches that the concentration of diclofenac may be included in the composition at 0.1-10% w/w [¶138]. Johnson further teaches that c) 5-25% w/w of a glycol solvent selected from the group consisting of propylene glycol and polyethylene glycol (200-20000) may be included in the composition [¶30]. Johnson further teaches that the composition may contain d) nonionic surfactants such as polyoxyl 20 cetostearyl ether (HLB=15.7 as evidenced by Croda) [¶134, claim 21 of Johnson]. Johnson teaches that the composition may contain e) caprylic/capric acid triglyceride as the liquid lipid of its oily phase [¶119]. Johnson teaches that f) water may be present in the composition as a co-solvent [¶¶15, 22, 109, 134]. Johnson further teaches that in some embodiments, no additional active pharmaceutical ingredient besides diclofenac may be included in the composition [¶47].
However, Johnson fails to teach the emulsion as a nanoemulsion.
Roy discloses a stable pharmaceutical composition of diclofenac or salts thereof comprising nano size droplets of diclofenac or salts thereof [¶abstract]. Roy teaches that the composition may be in the form of emulsion, and specifically a nano-emulsion [¶¶56, 59, 62], which may improve stability, permeability, and bioavailability [¶¶1, 49]. Roy teaches examples of topical applications of such compositions [example 4].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Johnson’s topical oil-in-water diclofenac composition according to the nano emulsion teachings of Roy. This is because Roy expressly teaches formulating diclofenac-containing emulsions to nanosized droplets for topical pharmaceutical delivery. A skilled Artisan would have been motivated to reduce the droplet size of Johnson’s emulsion to the nanoscale size of Roy to obtain the recited benefits of improved stability and permeability. Furthermore, neither reference requires anything more than diclofenac as an active agent, which obviates diclofenac alkali metal salt and diclofenac free acid as the only active pharmaceutical ingredients. There would have been a reasonable expectation of success because both are directed to developing topical diclofenac formulations via an emulsion.
Response to Arguments
Applicant's arguments filed 07/09/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument [p. 7, ¶5–p. 8, ¶1] that all claim limitations must be taught or suggested and that an obvious rejection requires articulated reasoning with rational underpinning:
The cited references need not individually disclose every limitation. Rather, the proper inquiry concerns what the combined teachings would have suggested to an ordinarily skilled artisan. This office action identifies the respective teachings relied upon from each reference and provides reasons as to why a person of ordinary skill in the art would have combined those teachings with a reasonable expectation of success.
Regarding applicant’s argument [p. 8, ¶¶2-3; p. 9, ¶1-3] that nanoemulsions and diclofenac formulations are highly unpredictable and therefore the claimed formulation cannot properly be characterized as routine optimization:
General statements that formulation development may involve difficulties do not establish that the particular modifications proposed in the rejection would have lacked a reasonable expectation of success. The cited art expressly teaches the relevant pharmaceutical emulsions/nanoemulsions, excipient classes, active agents, and overlapping concentrations. Applicant has not provided comparative evidence demonstrating that the claimed selections produced an unexpected result or that the proposed combinations would have been inoperative.
Regarding applicant’s argument [p. 9, ¶4–p. 10, ¶1] that the rejection constitutes impermissible hindsight because the references are directed to allegedly disparate subject matter:
This argument is not persuasive. The rejection does not merely rely on the fact that the individual claimed components can be located somewhere in the art. All references are directed to emulsions that are applied topically, and per the above 35 USC 103 rejections, each reference teaches a required component that can be incorporated into such compatible formulations. The references therefore provide teachings reasonably pertinent to the claimed topical pharmaceutical emulsion system, and the rejection sets forth specific reasons for combining them.
Regarding applicant’s argument [p. 10, ¶2–p. 11, ¶1] that modifying Kandavalli would require a substantial wholesale redesign because diclofenac differs physiochemically from clobetasol:
This argument is not persuasive with respect to claims 1-18. Those claims use an open-ended “comprising” language and do not require removal of Kandavalli’s corticosteroid. Kandavalli expressly permits additional active agents, while Tamarkin teaches diclofenac and its salt forms as topical anti-inflammatory agents. Thus, the proposed modification may be accomplished by incorporating diclofenac teachings into Kandavalli’s disclosed topical formulation rather than replacing its corticosteroid. Applicant’s discussion of the alleged localization of the respective diclofenac forms within the nano-micelle additionally concerns mechanistic features that are not recited in the claims.
Regarding applicant’s argument [p. 11, ¶2–p. 12, ¶1] that the proposed modification would render Kandavalli unsuitable for its intended purpose by removing clobetasol:
The argument is not persuasive for claims 1-18 because the rejection does not require removal of clobetasol. Kandevalli’s corticosteroid may remain present while the diclofenac components are incorporated, such that Kandevalli’s disclosed therapeutic function is not destroyed. New claim 19, which excludes additional APIs, is separately addressed under the Johnson/Roy rejection and therefore does not depend upon removal of Kandevalli’s corticosteroid.
Regarding applicant’s argument [12, ¶2] that Tamarkin leads away from the claimed invention because Tamarkin principally concerns substantially waterless foamable compositions:
Tamarkin does not criticize, discourage, or identify aqueous emulsions or nanoemulsions containing diclofenac as unsuitable. Rather, Tamarkin is relied upon for discrete teachings concerning topical diclofenac, diclofenac salts, therapeutic agent concentrations, and surfactants, not for wholesale incorporation of Tamarkin’s preferred waterless vehicle into Kandavalli. The fact that Tamarkin additionally teaches different preferred vehicles does not negate those expressed teachings.
Regarding applicant’s argument [p. 12, ¶3–p. 13, ¶1] that claims 3-15 are patentable for the same reasons asserted for claim 1 and because they recite additional limitations allegedly absent from the art:
This argument is not persuasive. The additional limitations of the dependent claims are separately addressed by the cited references as set forth in the rejection, including the claimed surfactant classes and concentrations, caprylic/capric triglyceride, quaternary ammonium surfactant, alcohol-free formulation, PEG hydroxy stearate surfactant, fatty acid composition, and other recited features. Applicant’s generalized assertion does not identify a specific dependent claim limitation that remains untaught by the applied combination.
Regarding applicant’s argument [p. 13, ¶2] that claim 2 is patentable because Tamarkin does not expressly recite the claimed diclofenac salt-to-free-acid ratios:
This argument is not persuasive. An expressly stated ratio is not required where the recited teachings provide the respective diclofenac forms at amounts that encompass values producing the claimed ratio. As discussed in the rejection, the cited art teaches both diclofenac forms and concentrations encompassing the presently claimed amounts; selection of approximately equal amounts, such as 1% w/w of each form, necessarily yields a 1:1 ratio and a total diclofenac concentration of 2% by weight, both within the presently claimed ranges.
Regarding applicant’s argument [p. 13, ¶3] that claims 16-19 are patentable for the same reasons as claim 1 and because they add further patentable subject matter:
Claims 16-18 principally combine limitations already separately taught by the applied references, and the present rejection expressly maps those combined limitations. Claim 19 is separately rejected over Johnson in view of Roy, wherein Johnson teaches topical diclofenac formulations, recognizes the free-acid and salt forms, and expressly contemplates embodiments devoid of other active ingredients, while Roy supplies the nanoemulsion teaching for the compositional form.
Conclusions
No claim is found to be 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARYA AHMADI BAZARGANI whose telephone number is (571)272-0211. The examiner can normally be reached Monday - Friday 11:30AM - 5:00 PM ET.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613
Prosecution Insights