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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/30/25 has been entered.
Receipt of amendment and response dated 7/30/25 and Declaration of Jason Sondgeroth dated 8/08/25 is acknowledged.
Claim Status
Claims 1-10 have been examined.
Claims 11-20 are preliminary withdrawn from further consideration pursuant to 37 CFR 1.42(b) as being nonelected invention. It is suggested that claims 11-20 be denoted as withdrawn claims.
Claim Interpretation
Claim 1 recites the limitation “Aqueous carriers” has been interpreted to require a liquid medium composed primarily of water in which other ingredients are dissolved or suspended. In view of applicant remarks filed on August 8th, 2024.
Specification
The use of the term Carbopol, which is a trade name or a mark used in commerce, has been noted in this application. 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.
Upon further search, and consideration of Applicants’ arguments dated 7/30/25 and Declaration of Jason Sondgeroth dated 8/08/25, the previous rejections of record have been withdrawn and replaced with the following new rejection:
Claim Rejections - 35 USC § 112
Claim 7 is 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.
Instant claim recites the composition is “substantially free of anionic compounds”, which is indefinite because the specification does not provide any definition of the term “substantially free” or describe what amounts of anionic compounds in the composition renders the composition “substantially free”. Absent any definition or description, it is unclear as what are the meets and bounds of the limitation “substantially free of anionic compounds” with respect to the compounds and the amounts being excluded. Clarification and correction is needed.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
2. Claims 1-5, 7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over CA 2399229 to Wilmott et al., in view of US 5585398 to Ernst and US 9011934 to Hauser et al.
Wilmott teaches a surfactant free topical composition comprising a base composition, and at least one dispersion comprising suspended particles of a hydrophobic active agent, a hydrophobic adjuvant, or a combination thereof. The base composition comprises a rheology modifying agent and water (abstract, pager 6, l 21-29). Table 16 of Wilmott describes a lotion base comprising 0.75% sclerotium gum, 0.75% carrageenan, 1% glycerin, 1.5% Germazide MPB and 95% deionized water, and a gum base comprising 1.5% sclerotium gum, 1.5% carrageenan, 2% glycerin, 1.5% Germazide MPB, 2% propylene glycol and 87.5% deionized water.
The amounts of water and sclerotium gum in the gum base meet the instant ranges of claim 1. The term “about” recited with the weight percentages of all the ingredients allows for approximation and therefore, 95% water in the lotion base meet the instant claimed amounts of an aqueous carrier.
Instant claim 1 recites 0.5% to 4.0% lidocaine or lidocaine hydrochloride, 0.1% to 0.5% benzethonium chloride.
Wilmott teaches incorporation of antimicrobial agent benzethonium chloride on page 16, l 17. Further, Wilmott teaches analgesics including lidocaine (p 17, 5-8).
Wilmott does not teach the claimed amounts of lidocaine or other active agents. However, Wilmott teaches that the dispersion includes active agent in amounts between 0.1% to 70% by weight, mixed with about 30% to 99.9% by weight of aqueous phase (p 15, 18-21). For claim 5, Wilmott teaches anti-inflammatory agents (see p 16, last full paragraph) and other skin care active agents such as skin protectants, antiaging agents etc (p 16, l 1-9), but does not explicitly teach the amounts of the same.
In this regard, Ernst teaches a topical anesthetic includes about 1-10% by weight lidocaine hydrochloride, about 0.01-0.10% by weight adrenaline, and about 0.25-4% by weight tetracaine hydrochloride, preferably in an aqueous base with about 2% benzyl alcohol or in a gel including about 3% hydroxyethyl cellulose (abstract). In a preferred embodiment Ernst teaches 1% lidocaine hydrochloride (col. 3, l37-46). Col.7, l 5-11 describes 4% lidocaine, 1% tetracycline, 2% benzyl alcohol, added to a water base to 100 cc.
Further, Hauser teaches a formulation of a transdermal skin treatment effective in inhibition of itch sensation, comprising a solvent mixture of alcohols, glycols and water, at least one local anesthetic, and the solvent mixture having pH exceeding 8.0, with a thixotropic flow characteristic accomplished by an organic gellant (abstract and col. 3, l 38-59). The composition is in the form of a gel or a cream and on dry skin as a moistener and teaches a variety of gelling agents, that provide a thixotropic flow characteristics to the skin (col. 6, l 20-36) and also adjusting the viscosity of the composition based on the final consistency of the composition i.e., a solution has a low viscosity and a cream or gel has high viscosity (lines bridging col. 6-7). Table 1 of the reference describes 0.05-3% lidocaine as an anesthetic and up to 0.5% benzethonium chloride, and further teaches 2-20% of NSAID (anti-inflammatory agent). Table 1 further teaches 0.5-5% oat colloid meal (reads on skin moisturizer).
Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the topical composition of Wilmott by including lidocaine, benzethonium chloride and acetyl salicylate as active agents, because while Wilmott desires including the claimed active agents active agents in the range of 0.1 to 70%, the analogous teachings of Ernst and Hauser also suggests lidocaine in the claimed ranges for providing topical anesthetic effect teaches, Hauser further suggests a range of amounts of benzethonium chloride and acetyl salicylate, that overlap with the claimed amounts for providing antimicrobial effect and anti-inflammatory effect. Therefore, one of an ordinary skill in the art would have expected to that the modification of filing date of the instant invention to prepare the topical composition of Wilmott by including additional active agents such as anti-inflammatory agent, skin protectants, antiaging etc., depending on the effect desired.
For claim 2, Wilmott teaches that the composition comprises two rheology modifying agents (p 14, l 3-14) such as celluloses including hydroxyethylcellulose, sclerotium gum, (p 11, l 319), and further exemplifies a composition with equal amounts of polysaccharides i.e., carrageenan gum and sclerotium gum (Table 16). Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to substitute 1.5% carrageenan gum with 1.5% hydroxyethyl cellulose in the topical composition of Wilmott, and still expect to provide the same or equivalent viscosity to the composition. For claim 7, Wilmott does not specifically teach including anionic compounds such as carbomer in the examples. Moreover, as explained in the previous section, it is unclear what amounts of anionic compounds are being excluded. Moreover, Wilmott teaches several alternatives for the rheology modifying agents and active agents and therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to employ a suitable amount compound as active agent or a rheology modifying agent such that the composition is suitable for topical application. Claim 3 recites a ratio of sclerotium gum thickening agent to the hydroxyethylcellulose is between about 0.85 to 1.15, which includes equal amounts of both rheology modifiers. For claim 4, Wilmott teaches the composition in the form of a gel (page 8, l 26-27). For claims 9 and 10, Wilmott teaches peppermint and balm mint (see table 10 and page 46, l 4-7), which read on the instant claimed cold sore mitigating ingredients. Instant claim 9 recites “up to about 6%” and Table 10 teaches 0.2%. Even though Wilmott does not teach the exact amount of balm mint, the reference suggests 0.2% of peppermint that is within the upper limit of 6% and therefore one of an ordinary skill in the art would have been able to optimize the amounts of balm mint with an expectation to provide the desired mint flavor.
3. Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over CA 2399229 to Wilmott et al., in view of US 5585398 to Ernst and US 9011934 to Hauser et al., as applied to claims 1-5, 7 and 9-10, and further in view of Gupta (US 20060110415 A1).
Wilmott, Ernst and Hauser references fail to teach the viscosity of instant claims 6 and 8.
Gupta is drawn to topical delivery system for cosmetic and pharmaceutical agents including lidocaine [0041] and teaches that the viscosity of a gel is preferably in the range 1,000 to about 40,000 cps [0039] and for jellies 50,000 to about 500,000.
Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the topical composition of Wilmott, modified by Ernst and Hauser, having a viscosity of 100,000 or a polysaccharide for adjusting the rheology, Hauser suggests adjusting the viscosity of the composition based on the final consistency of the composition i.e., a solution has a low viscosity and a cream or gel has high viscosity (lines bridging col. 6-7), and in this regard Gupta suggests topical compositions in the form of gels, jellies, etc., have a viscosities between 1-500000 centipoise. Therefore, a prima facie case of obviousness exists where the claimed ranges or amounts do overlap with the prior art. See MPEP 2144.05(I). In this case, the general conditions of gelling agents and viscosity overlap those with the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of the viscosity.
Response to Arguments
Applicant’s arguments dated 7/30/25 and Declaration of Jason Sondgeroth dated 8/8/25 have been considered.
Applicants argue that Carbopol is used properly in the instant specification and that carbomer and Carbopol are properly designated or are used generically. This argument is not persuasive because a proper use of Carbopol is to refer the compound with ™, 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.
Applicants’ arguments regarding Robinson (US 20030049212 A1) and Hind (US 5411738 A) references (pages 1-6), and the Declaration (pages 3-6) have been considered and persuasive. Upon further consideration and search, claims 1-10 have been rejected over a new combination of references.
The present rejection relies on the teachings of Gupta reference in combination with a new combination of references i.e., CA 2399229 to Wilmott et al., in view of US 5585398 to Ernst and US 9011934 to Hauser et al., as applied to claims 1-5, 7 and 9-10, and further in view of Gupta (US 20060110415 A1). Hence, the argument that the combination of Gupta with Robinson or Hind references is not found persuasive.
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/LAKSHMI S CHANNAVAJJALA/Primary Examiner, Art Unit 1611