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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/02/2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group (I) with the addition of Alcohol:ethyl alcohol, Emollient:castor oil, Denaturant:isopropyl alcohol, Cooling agent:menthol, Additional emollient: glyceryl laurate, Preservative:benzyl alcohol, Antioxidant: BHT in the reply filed on 09/03/2024 is acknowledged and maintained.
Claim Status
Claims 1, 5-19 and 29-34 are pending and are examined in accordance to the elected species. Claims 2-4 and 20-28 are canceled.
Action Summary
Claims 30-33 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, are withdrawn in light of the deletion of glycerol.
The obviousness rejections under 35 U.S.C. 103 presented in the previous Office action are withdrawn in their entirety. Upon further consideration and additional prior art, the claims are rejection under 35 U.S.C. 103 based on the following references and rationales.
Claim Objections
Claim 16 is objected to because of the following informalities: Specifically, the semicolon preceding “and the alcohol comprising ethyl alcohol” render the claim awkward and potentially confusion. 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.
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, 5-19 and 29-34 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.
Independent claims 1, 16, and 18 each initially recite “at least one C1-C3 alcohol,” which encompasses one or a plurality of alcohols. The claims subsequently recite that “the emollient in the alcohol” and further state that “the alcohol comprises ethyl alcohol.” Because the earlier recitation encompasses one or more alcohols, it is unclear whether the later recitation “the alcohol” refers to the entire alcohol component, to one or more C1-C3 alcohols, or specifically ethyl alcohol. Thus, one or ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claimed subject matter.
Dependent claim 2 recites that “the alcohol further comprising a denaturant.” Since claim 5 depends from claim 1 and incorporates the ambiguous recitation discussed above, it is likewise unclear whether the denaturant is added to the entire alcohol component or one of the C1-C3 alcohols, or ethyl alcohol specifically. Accordingly, claim 5 is indefinite for the same reason set forth above.
Claims 30, 33, and 34 recited the phrase “the emollient comprising a glyceryl ester.” This recitation renders the scope of the claim unclear. The parent claims recite an emollient comprising castor oil. However, the specification separately identifies glyceryl esters (e.g., glyceryl laurate and glyceryl stearate) as examples of other emollients and further teach that such emollient may be present as an “additional emollient.” See paragraphs [0012]-[0013] and example 1. Accordingly, it is unclear whether the dependent claims merely characterize the previously-recited castor oil emollient, replace the castor oil emollient, or instead introduce an additional glyceryl ester emollient. Therefore, the metes and bounds of the claims cannot be determined with reasonable certainty. For prior art purpose, the glyceryl ester recitation is construed to be an additional emollient.
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 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 non-obviousness.
Claims 1, 5-6, 13, 15-16, 18, 31-32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Eggers et al (US4,849,455) in view of Eutick et al. (US10,596,102 B2), and Loran et al. (Journal of American Pharmaceutical Association, Vol. XL, No. 9, 1951, pages 465-466.)
Eggers teaches a method for disinfecting and/or deactivating viruses lacking lipoid sheaths comprising applying to the skin of a patient a virucidal agent comprising at least 70% by volume of methanol, ethanol, or mixtures thereof and from 1 to 10% by volume of glycerol and further comprises up to 5% of castor oil, wherein said castor oil is present in an amount of 0.5 to 2% by volume. (See claims 7-9.) Eggers also teaches adding amounts of glycerol and/or castor oil showed that although the skin as degreased upon treatment, the skin retain, moisture. (See Example 2.) Additionally, Eggers teaches in practical application, the virucidal agents of the present invention may be used either as rinsing agents or applied to the skin by means of cotton, a cloth rag or a similar aid to the infected areas of the skin. (See lines 51-54 of col.2.) The cotton taught by Eggers represent an applicator. Furthermore, Eggers teaches the efficacy of the virucidal agent of the present invention has so far not been scientifically elucidated. The hypothesis that the activity is based alone on a dehydration effect cannot be correct, as other solvents having also a highly dehydrating effect such as propyl alcohol, isopropyl alcohol and acetone are inactive. (See lines 24-29 of col. 2.) However, the content of glycerol and, optionally, of castor oil, protects the skin from being rendered too dry and, thus, acts in a similar manner as would a per se desirable restitution of fat. Moreover, it is possible, after using the virucidal agents of the invention to treat the skin, to apply suitable skin cosmetics containing triglycerides, since the disinfection or deactivation, respectively, has been effected in the absence of triglycerides. (See lines 59-66.) Therefore, the fact that alcohol is an ineffective virucidal agent alone, does not negate its use in combination with oil such as castor oil and glycerol.
Eggers does not teach the claimed percentages as the instant specification refers to all percentages as being weight percentages in paragraph [0038]. However, Eggers teaches volume percentages.
Assuming 100 mL total volume for the Example 1 of Eggers and using standard densities:
Component volume (mL) Density (mg/mL) weight (g)
Ethanol 95 (96% by volume + 4% water) 0.789 71.96
95 x 0.96 = 91.2 mL
Castor oil 4 0.96 3.84
Glycerol 1 1.26 1.26
Water 95 x 0.04 =3.8 mL 1.00 3.8
Therefore:
Ethanol = 71.96/80.86 x 100 = 88.98 wt%
Castor oil = 3.84/80.86 x 100 = 4.75 wt%
Glycerol = 1.26/80.86 x 100 = 1.56 wt%
Water = 3.8/80.86 x 100 = 4.70 wt%
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to formulate the composition of Eggers using weight percentages instead of volume percentages and adding isopropyl alcohol and to substitute methanol with isopropanol because both concentration units are conventional measures of ingredient amounts and conversation between volume percentages and weight percentages is a routine calculation using known densities of the components and also because Eggers teaches that isopropyl alcohol is an alternative solvent choice that can be used together with ethanol, castor oil and glycerol for the purpose of exhibiting virucidal activity and further teaches methanol is a highly toxic solvent (see lines 34-36). The claimed weight percentages therefore represent no more than an obvious variation of the concentration taught by Eggers.
With respect to the limitation of a disinfecting composition disposed on the absorbent material, Eggers teaches the virucidal agents of the present invention may be used either as rinsing agents or applied to the skin by means of cotton, a cloth rag or a similar aid to the infected areas of the skin. (See lines 51-54 of col.2.) Therefore, a person of ordinary skill in the art would have understood that the application of the virucidal agents with a cotton to inherently represent the disposition of the virucidal agents on the cotton which constitutes the absorbent material.
With respect the recitation “in amount effective to reduce a stinging sensation produced by contacting a wall of a nasal passage with the alcohol.” The fact that Eggers teaches castor oil in an obvious amount of 4.8% by weight and the fact that Eggers recognizes that castor oil as a moisture retainer, the teaching of 4.8 wt% castor oil of Eggers constitutes in amount effective to reduce a stinging sensation produced by contacting a wall of a nasal passage with the alcohol.
With respect to the single-phase solution limitation recited in claim 18., Eggers teaches the claimed disinfecting composition comprising ethanol and castor oil. Eggers, however, does not expressly teach the composition is formulated in a single-phase solution. Loran teaches that pharmaceutical compositions comprising castor oil, ethanol, and water may be formulated in proportions that produce homogenous, single-phase solution and provide phase-diagrams and practical formulations identifying such compositions. (See whole document.) Accordingly, It would have been obvious to formulate Eggers’ disinfecting composition according to the teachings of Loran so that the composition exists as a homogenous single-phase solution, thereby providing formulation stability, uniform distribution of the emollient, and consistent dosing upon application.
With respect to “20-40% castor oil and 50-70% ethanol” recited in claim 15, Eggers teaches the claimed disinfecting composition comprising ethanol and castor oil. Eggers, however, does not expressly teach 20-40 wt% castor oil. Eutick teaches that emollients, e.g., castor oil are conventionally used in amounts of 10-50 wt% in topical formulation. (See lines 1-23 of col. 7.) Eutick further teaches the term “emollient” as used herein in relation to the composition, can be interchanged with moisturizer, and includes occlusive emollients, humectants emollients, anti-rub or work the composition onto and around the affected pruritic emollients and antiseptic emollients. (See lines 61-65 of col. 5.) Loran teaches several different mixtures of castor oil, ethanol, and water including 25.0 wt.% castor oil, 5.0 wt.% water, and 70.0 wt.% alcohol as a homogenous single-phase solution. (See Table IV) Accordingly, It would have been obvious to one of ordinary skill in the art at the time the invention was filed to increase the amount of castor oil in the disinfecting composition of Eggers to the 20-40 wt% range taught by Eutick because Eutick teaches that castor oil is a suitable emollient for topical formulations and teaches that emollients, including castor oil, may be present in amounts of about 10-50 wt% to provide effective moisturizing and barrier properties while remaining suitable for topical administration and because Loran reports a single-phase homogenous mixtures that contains 25.0 wt.% castor oil, 5.0 wt.% water, and 70.0 wt.% alcohol . One of ordinary skill in the art would have reasonably expected that increasing the castor oil content within the range taught by Eutick while keeping the contend of the ethanol at 70.0 wt.% would enhance the emollient and barrier functions of Egger’ s alcohol-based composition while remaining its suitable as a topical disinfecting formulation.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Eggers et al (US4,849,455) in view of Eutick et al. (US10,596,102 B2), and Loran et al. (Journal of American Pharmaceutical Association, Vol. XL, No. 9, 1951, pages 465-466.) as applied to claims 1, 5-6, 13, 15-16, 18-19, 31-32, and 34 34 in further view of Chen et al. (CN CN209696061U).
The teachings of Eggers, Eutick and Loran have been discussed in the 103 rejections above.
Eggers, Eutick and Loran collectively do not teach a swab containing an absorbent and a swab stick.
Chen teaches medical cotton stick is article more common in medical care treatment work, is mainly used for disinfection, hemostasis, debridement etc. In When curative activity, medical cotton stick usually needs to add medical antiseptic solution on cotton balls, and common cotton swab itself does not store generally disinfecting drug, sterilization could be played by needing to soak in medical fluid, inconvenient to use. (See first paragraph of page 2.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to provide the disinfecting composition taught by Eggers, as modified by Eutick and Loran, on the medical cotton swab comprising an absorbent material (cotton ball) and a swab stick taught by Chen. One would have been motivated to do so because Chen teaches that medical cotton sticks are conventional articles used in medical care for disinfection, hemostasis, and debridement and further teaches that the cotton tip receives an antiseptic solution for application to a treatment site. Incorporating the disinfecting composition of Eggers into the conventional cotton applicator taught by Chen would have merely involved using a known applicator for its known purpose of applying an antiseptic composition, thereby providing a convenient hygienic, and controlled means of delivering the disinfecting composition to the treatment site while avoiding the need to separately soak the absorbent material immedicably before use. One of ordinary skill in the art would have had a reasonable expectation of success because both Eggers and Chen are directed to the application of antiseptic/disinfecting compositions using absorbent applicators, and the substitution of one known applicator format for another represent no more than the predictable use of prior art element according to their established functions.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Eggers et al (US4,849,455) in view of Eutick et al. (US10,596,102 B2), and Loran et al. (Journal of American Pharmaceutical Association, Vol. XL, No. 9, 1951, pages 465-466.) as applied to claims 1, 5-6, 13, 15-16, 18-19, 31-32, and 34 34 in further view of Spray-Tish® Menthol (MIMS, March, 2019).
The teachings of Eggers, Eutick and Loran have been discussed in the 103 rejections above.
Eggers, Eutick and Loran collectively do not teach menthol.
Spray-Tish® Menthol teaches Spray-Tish Menthol, which contains menthol, cineole, and camnphor, is a nasal decongestant. It clears a stuffy or blocked nose by shrinking the inflamed and swollen blood vessels in the lining of the nose. Spray-Tish Menthol relieves a stuffy or blocked nose (nasal congestion) associated with the common cold, hayfever and rhinitis. Spray-Tish® Menthol teaches a nasal formulation containing menthol for relieving nasal congestion. Menthol was well-known in the art to impart a colling sensation when applied to the nasal cavity.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the disinfecting composition of Eggers as modified by Eutick and Loran, by including menthol taught by Spray-Tish® Menthol, because Spary-Tish® Menthol teaches that menthol-containing nasal formulation relieve nasal congestion and provided improved user comfort during intranasal administration. One would have reasonably expected the resulting composition to retain the disinfecting properties of Eggers while additionally provide the known cooling and decongestion effects associated with menthol.
Claims 9, 10, 17, 29-30, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Eggers et al (US4,849,455) in view of Eutick et al. (US10,596,102 B2), and Loran et al. (Journal of American Pharmaceutical Association, Vol. XL, No. 9, 1951, pages 465-466.) as applied to claims 1, 5-6, 13, 15-16, 18-19, 31-32, and 34 34, in further view of HRPA, Scientific Discussion, 12/10/2016, Grodberg (CA1,318,247C).
The teachings of Eggers, Eutick and Loran have been discussed in the 103 rejections above.
Eggers, Eutick and Loran collectively do not teach glyceryl laurate in the amount of 0.1 to 1.5% and water in an amount ranging from 1 to 15%. Additionally, Eggers, Eutick and Loran collectively do not teach menthol in the amount of 0.01 to 0.15%.
HRPA teaches the use of 0.1% Menthol in nasal spray for the relief of nasal congestion due to colds, hay fever or other allergic rhinitis, sinusitis and to aid drainage of secretions in affections of the paranasal sinuses. (See Section I and Section II.1.)
Grodberg teaches an antiseptic composition comprising ethyl alcohol in the amount of 70%, monolaurin in the amount of 0.5%, mint scent in the amount of 0.025% and water. (See Example 2.) Monolaurin is another name of glyceryl laurate. Moreover, Grodberg teaches the monolaurin in the antiseptic composition is believed to enhance the activity of and substantially decrease the time required for the ethyl alcohol to inactivate or destroy the potentially harmful skin microorganisms. (See page 7; seventh paragraph.) Grodberg also teaches the monolaurin brings about the rapid wetting and penetration of the microorganism with the ethyl alcohol active microbiocide thus causing rapid inactivation of the microorganism and also acts as a surface-active agent and emulsifying agent and effects in rapid wetting of the microorganisms contacted with the antiseptic composition. (See page 10; sixth paragraph.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify to incorporate 0.1 wt% menthol as taught by HRPA to provide the known cooling and nasal decongestion effects and to incorporate 0.5 wt% monolaurin (aka glyceryl laurate) in the amount of 0.5% as taught by Grodberg because Grodberg teaches that monolaurin functions as a surfactant/emulsifying agent, enhances wetting and penetration of microorganisms by ethanol, and enhances antimicrobial performance of the antiseptic alcohol composition.. One would have reasonably expected the resulting composition would retain the disinfecting properties of Eggers while additionally providing the known surfactant and antimicrobial-enhancing properties of glyceryl laurate together with the known colling and nasal comfort properties associated with menthol.
Furthermore, with respect to the limitation of claim 29 reciting water in an amount ranging from 1 to 15 wt%, Eggers teaches using ethanol having a concentration of 96 vol.% in example 1. Because the disclosed ethanol inherently contains approximately 4 vol.% water, conversion of Eggers’ disclosed volume percentages to weight percentages using standard component densities demonstrates that 4.7 wt.% water, which falls within the claimed range of 1-15 wt.%. Accordingly, It would have been obvious to incorporate glyceryl laurate into Egger’s composition while utilizing the conventional ethanol taught by Eggers because Grodberg teaches that glyceryl laurate enhances wetting, emulsification, and antimicrobial efficacy in alcohol-based antiseptic compositions, while the water content inherently present in 190 proof ethanol falls within the claimed range.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Eggers et al (US4,849,455) in view of Eutick et al. (US10,596,102 B2), and Loran et al. (Journal of American Pharmaceutical Association, Vol. XL, No. 9, 1951, pages 465-466.) as applied to claims 1, 5-6, 13, 15-16, 18-19, 31-32, and 34 34, in further view of Willimann (US 8,778,415 B2).
The teachings of Eggers, Eutick and Loran have been discussed in the 103 rejections above.
Eggers, Eutick and Loran collectively do not teach one or more BHT and vitamin C.
Willimann teaches an antimicrobial, antiviral and antifungal composition consisting
essentially of: ethanol in an amount of between 5.0% and 75.0% by weight of the total
composition, orange oil in an amount of between 0.05% and 60.0% by weight of the total
composition, benzalkonium chloride in an amount of between 0.05% and 0.15% by weight of
the total composition, jojoba oil in an amount of between 0.1% and 75% by weight of the total
composition and vitamin E in an amount of between 0.1% and 4.0% by weight of the total
composition. (See claim 2.). Particular preference is given to a composition comprising USP
Ethyl Alcohol (190 proof) 50%, Cocos Nucifera 3%, Citrus Sinensis 2%, Simmondsia chinensis
(jojoba) 40%, Glycine Soja 4.6%, BHT (preservative), 0.1% Benzalkonium chloride, and 0.1%
Vitamin E 0.2%. (See Example 9.)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the disinfecting composition taught by Eggers, as modified by Eutick and Loran, by including BHT as taught by Williamnn. One would have been motivated to do so because Willimann teaches BHT as a preservative/antioxidant additive in alcohol-containing antimicrobial composition. A person of ordinary skill in the art would have had a reasonable expectation of success because BHT was a known addition for improving stability of alcohol/oil-based antimicrobial compositions, and its inclusion would have been expected to provide its known preservative/antioxidant function without destroying the disinfecting properties of the composition. Because claim 12 recites “one or more BHT and vitamin C,” the teaching of BHT alone satisfies the claim limitation. BHT is not recognized by Willimann as antioxidant. However, instant specification describes BHT as an antioxidant, rendering BHT as both a preservative and antioxidant.
Claims 11, 14, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Eggers et al (US4,849,455) in view of Eutick et al. (US10,596,102 B2), Loran et al. (Journal of American Pharmaceutical Association, Vol. XL, No. 9, 1951, pages 465-466), HRPA, Scientific Discussion, 12/10/2016, Grodberg (CA1,318,247C), and Willimann (US 8,778,415 B2) as applied to 1, 5-6, 9-10, 12-13, 15-19, 29-31, and 33-34, in further view of Lane (WO2018/211333A1).
The teachings of Eggers, Eutick, Loran, HRPA, Grodberg, Willimann have been discussed in the 103 rejections above.
Eggers, Eutick, Loran, HRPA, Grodberg, Willimann collectively do not teach polyaminopropyl biguanide, fragrance, and benzyl alcohol. However, Willimann teaches orange oil. Applicant’s own specification identifies orange oil as a suitable fragrance. Accordingly, a person of ordinary skill in the art would have recognized the orange oil of Willimann as satisfying the claimed fragrance limitation.
Lane teaches preservative systems comprising xylitol ester and/or xylitol ether, capryly! glycol, ethylhexylglycerin, and 1,3-propanediol for useful in protecting various formulations, including cosmetics and personal care products, from microbial contamination. (See Abstract and page 1; lines 9-11.) Moreover, Lane teaches the preservative systems can include benzyl alcohol and polyaminopropyl biguanide. (See page 4, lines 21-24, and page 2; lines 9-14.) Furthermore, Lane teaches the preservative system can be a part of nasal decongestants. (See page 4; line 10.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the disinfecting composition taught by Eggers, as modified by Eutick, Loran, HRPA, Grodberg, and Willimann, by incorporating the preservative system taught by Lane, including benzyl alcohol and polyaminopropyl biguanide, into the alcohol-based disinfecting composition. One would have been motivated to do so because Lane teaches that such preservatives are suitable for protecting topical and nasal formulations from microbial contamination while maintaining formulation stability. A person of ordinary skill in the art would have further recognized that the orange oil taught by Willimann constitutes a fragrance, as identified by Applicant’s own specification, thereby satisfying the claimed fragrance limitation. Because each of the cited ingredients was known to perform its conventional function in alcohol-based topical or nasal formulations, combining them according to their established uses would have represented no mor than the predictable use of prior-art elements according to their established functions, with a reasonable expectation of success obtaining stable disinfecting composition comprising ethanol. Isopropanol, water, castor oil, glyceryl laurate, menthol, antioxidant, fragrance, benzyl alcohol, and polyaminopropyl biguanide.
Applicant’s argument regarding the miscible jojoba oil in the composition of Willimann have been fully considered and are not persuasive. The new rejections set forth above do not rely on Willimann to teach an emollient that is miscible with ethanol or the claimed castor oil. Rather Eggers is relied upon for the alcohol/castor oil disinfecting composition, Eutick is relied upon for the claimed castor oil high concentration, and Loran is relied upon for formulating ethanol/oil compositions as homogeneous single-phase solutions. Willimann is cited only for its teaching of BHT (and where applicable, orange oil), and Applicant’s argument directed to Jojoba oil therefore do not address the actual combination of references relied upon in the rejection.
Applicant’s arguments regarding jojoba oil are not applicable to claim 12 because the rejection does not rely on Willimann’s jojoba oil disclosure at all.
Conclusion
Claims 1, 5-19 and 29-34 are not allowed.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628
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