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 .
In view of applicant’s argument, previous 102(a)(2) and 103 rejections over Bartosiewicz et al (WO 2019/155389 A1) are withdrawn. Thus, applicant’s argument with respect to those rejections is now moot.
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.
Claim(s) 1, 2, 5, 6, 9, 10, 15-17, 56, 60, 61 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Buehler et al (US 2008/0014275 A1) in view of Piper (“Potential Safety Issues Surrounding the Use of Benzoate Preservatives”, Beverages, vol.4(33) (2018), pg.1-7) and Cock et al (WO 2018/145159 A1).
In Example 2, Buehler teaches a multi-symptom cold/flu suspension formulation as shown below:
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As shown above, Buehler’s formulation contains xanthan gum (instant one or more natural polymers known to be a substrate for microbial growth – see [0005] of present specification), glycerin and sorbitol (instant two or more natural polyols of claims 16 and 17), dextromethorphan hydrobromide, chloropheniramine maleate, phenylephrine hydrochloride and acetaminophen (instant one or more active pharmaceutical ingredients). Buehler’s above formulation is for oral administration (see [0002]-[0003] and [0034]).
With respect to the newly added limitation of claims 1, 2, 5 and 6 “wherein the two or more natural polyols are present in a combined amount of at least 50% w/v of the composition;”, Buehler’s Example 2 cold/flu suspension formulation does not teach such limitation. However, Buehler gives a general teaching ([0013] and claim 34) that the amount for the sorbitol solution can range from 20% w/v to 70% w/v, and the amount for the glycerin can range from 1% w/v to 20% w/v, which means that Buehler’s cold/flu suspension formulation can contain 14% w/v - 49% w/v of sorbitol (because Buehler’s sorbitol solution is 70% solution) and 1% w/v - 20% w/v of glycerin. Thus, Buehler’s cold/flu suspension formulation can contain sorbitol and glycerin (instant two mor more natural polyols) in the combined amount of 15% w/v – 69% w/v. Such range overlaps with instant range at least 50% w/v for the amount of the two or more natural polyols in a combined amount, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, Buehler teaches the newly added limitation of claims 1, 2 5 and 6.
With respect to instant limitation “wherein the aqueous-based composition does not comprise any pharmaceutical antimicrobial preservatives or any artificial antimicrobial preservatives”, Buehler’s formulation above contains sodium benzoate (an artificial antimicrobial preservative) and thus does not meet instant limitation “wherein the aqueous-based composition does not comprise any pharmaceutical antimicrobial preservatives or any artificial antimicrobial preservatives”. Piper teaches (abstract) that sodium benzoate have long been used for beverage preservation and that benzoate can cause drinks to contain traces of the carcinogen benzene. Piper further teaches that dietary benzoate can have neuromodulatory (mood, learning and personality) effects and can influence child hyperactivity disorders. Cock teaches ([0025]) that chemical preservatives may cause respiratory problems, aggravate attention deficit hyperactivity disorder and cause anaphylactic shock in susceptible individuals. Cock teaches that due to greater consumer awareness and the negative perceptions of artificial preservatives, consumers are increasingly avoiding foods containing preservatives of chemical origin and that natural antimicrobial preservatives are increasingly being sought to increase the shelf life and safety of processed foods. Based on the teachings of Piper and Cock, (i) it would have been obvious to one skilled in the art to replace the sodium benzoate in Buehler’s formulation of Example 2 with a natural antimicrobial preservative (that is as effective as sodium benzoate) in order to avoid all the potential health issues discussed in Piper and Cock. Thus, Buehler in view of Piper and Cock teaches instant limitation.
As to instant limitation “wherein the composition as a whole inhibits microbial growth when subjected to an Antimicrobial Effectiveness Test”, Buehler’s formulation of Example 2 shown above, as modified by the teaching of Piper and Cock to contain a natural antimicrobial preservative (that is as effective as sodium benzoate), would inherently or naturally satisfy instant limitation.
Buehler’s formulation shown above does not contain those compounds listed (as being excluded) in claims 2 and 6.
Thus, Buehler in view of Piper and Cock renders obvious instant claims 1, 2, 5, 6, 9, 10, 60, 61 and 63 (the sucrose contained in Buehler’s formulation is a natural sweetener, and thus Buehler’s formulation teaches instant limitation of claim 60).
With respect to instant claims 15-17, Buehler’s formulation shown above contains 0.14% (w/v) of xanthan gum. However, Buehler’s formulation also contains 0.70% (w/v) of microcrystalline cellulose and carboxymethylcellulose sodium, and Buehler teaches ([0055]-[0056]) the equivalence of microcrystalline cellulose, carboxymethylcellulose (and its derivatives), guar gums, pectin, tragacanth, alginate, chitosan and gum Arabic. Thus, it would have been obvious to one skilled in the art to use 0.70% (w/v) of guar gums, pectin, tragacanth, alginate, chitosan, gum Arabic or a combination thereof (all of which are instant polysaccharides of claim 10) (instead of 0.70% (w/v) of microcrystalline cellulose and carboxymethylcellulose sodium) in Buehler’s formulation above with a reasonable expectation of success. Buehler’s formulation modified in such a way would contain 0.84% (w/v) of one or more instant natural polymers. Thus, Buehler in view of Piper and Cock renders obvious instant claims 15-17.
With respect to instant claim 56, Buehler’s Example 2 formulation contains flavoring agents. In [0047], Buehler teaches that the flavoring agents include natural or artificial flavors. It would have been obvious to one skilled in the art to use natural flavors (such as mints, menthol, cinnamon, natural vanilla, etc.) as the flavoring agents in Buehler’s Example 2 formulation with a reasonable expectation of success. Thus, Buehler in view of Piper and Cock renders obvious instant claim 56.
Claim(s) 58 is rejected under 35 U.S.C. 103 as being unpatentable (i) over Buehler et al (US 2008/0014275 A1) in view of Piper (“Potential Safety Issues Surrounding the Use of Benzoate Preservatives”, Beverages, vol.4(33) (2018), pg.1-7) and Cock et al (WO 2018/145159 A1) as applied to claim 1 above, and further in view of Mizushima et al (US 2019/0350234 A1).
Buehler’s formulation shown above contains dyes. As evidenced by Mizushima et al ([0002]), it is already known in the art that natural colorants are considered safer than artificial colorants. It would have been obvious to one skilled in the art to use natural dyes in Buehler’s formulation for the health safety reason. Thus, Buehler in view of Piper and Cock renders obvious instant claim 58.
Claim(s) 1, 2, 5, 6, 9, 10, 15-17, 56, 58, 60, 63 and 97 are rejected under 35 U.S.C. 103 as being unpatentable over Fiebrig (EP 2 740 467 A1) in view of Silberstein et al (US 10,064,881 B2) and Barr et al (“A Study of the Inhibitory Concentrations of Glycerin-Sorbitol and Propylene Glycol-Sorbitol Combinations on the Growth of Microorganisms”, Journal of the American Pharmaceutical Association (Scientific ed.), vol.46 (4) (April 1957), pg.217-218).
Fiebrig teaches (claims 1 and 4) a foamable, rinse-off cosmetic composition having ≥ 50 wt.% and ≤ 95 wt.% of at least one low molecular weight polyol. Fiebrig teaches ([0005] and [0008[) that because its compositions have high polyol and low water content, there is very low water activity, and this leads to a self-preserving system. Thus, there is no need for preservatives. Specifically in its Example 1, Fiebrig teaches a shaving foam composition containing 12 wt.% of sodium cocoyl glycinate, 3 wt.% of potassium palmitoyl hydrolyzed wheat protein, 50 wt.% of glycerol (glycerin) and 35 wt.% of water.
Fiebrig’s Example 1 composition does not contain instant one or more natural polymers. However, Fiebrig teaches (claim 1, [0018]) that its foamable, cosmetic composition can contain > 0 wt.% and ≤ 10 wt.% of at least one auxiliary substance, such as viscosity-adjusting agent, which examples include carrageenan, pectin, tragacanth, guar gum, gum arabic, xanthan gum and chitosan. Furthermore, as evidenced by Silberstein et al (see claims 1 and 11), it is well known in the art that natural polymers such as xanthan gum, carrageenan, gum arabic and guar gum are often used as thickeners (viscosity-adjusting agent) in a shaving foam. Thus, it would have been obvious to one skilled in the art to use natural polymers such as xanthan gum, carrageenan, gum arabic and/or guar gum as the viscosity-adjusting agent in Fiebrig’s Example 1 shaving foam composition with a reasonable expectation of success.
Fiebrig’s Example 1 composition contains only one natural polyol (glycerin). However, Fiebrig teaches ([0020]) that polyols such as erythritol, xylitol, mannitol and sorbitol may also be used as its at least one low molecular weight polyol. Furthermore, Barr (see pg.218, right-hand column, item #3) teaches that a combination of 20 – 30 % w/v of glycerin and 10 % w/v of sorbitol is necessary (at the minimum) to inhibit the growth of bacteria while a combination of 50% w/v of glycerin and 10% w/v of sorbitol is necessary (at the minimum) to inhibit molds. Since Fiebrig’s Example 1 already contains 50% w/v of glycerin, it would have been obvious to further add 10% w/v of sorbitol into Fiebrig’s Example 1 composition to ensure that both bacteria and molds are inhibited. Thus, Fiebrig in view of Bar renders obvious instant two or more natural polyols that are present in a combined amount of at least 50% w/v of the composition.
With respect to instant limitation as to the composition as a whole inhibiting microbial growth wen subjected to an Antimicrobial Effectiveness Test, since Fiebrig in view of Silberstein and Barr teaches instant components of claim 1, such composition would inherently meet instant limitation. Besides, Fiebrig teaches that its compositions are self-preserving
Fiebrig’s Example 1 composition does not contain any pharmaceutical antimicrobial preservatives or any artificial antimicrobial preservatives, as instantly recited. Besides, as discussed above, Fiebrig teaches that its compositions have high polyol and low water content resulting in very low water activity, which leads to a self-preserving system and no need for preservatives.
Thus, Fiebrig in view of Silberstein and Barr renders obvious 1, 2, 9, 10, 56, 58, 60 and 97.
With respect to instant claims 15-17, Fiebrig teaches (claim 1) that its auxiliary substance (which teaches instant one or more natural polymers as discussed above) can be present in the amount of ≥ 0 wt.% and ≤ 10 wt.%. Such range overlaps with instant range 0.5 % w/v – 1% w/v of claim 15 for the amount for the one or more natural polymers, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Fiebrig in view of Silberstein and Barr renders obvious instant claims 15-17.
With respect to instant claims 5 and 6, Fiebrig further teaches (claim 1) that its composition may contain ≥ 0 wt.% and ≤ 10 wt.% of at least one therapeutic active agent, such as anti-acne agent (see [0017]). Based on such teaching, it would have been obvious to one skilled in the art to further add an anti-acne agent into Fiebrig’s Example 1 composition with a reasonable expectation of treating acne while shaving. Thus, Fiebrig in view of Silberstein and Barr renders obvious instant claims 5 and 6.
With respect to instant claim 63, Fiebrig’s Example 1 composition is a shaving foam which is applied to the skin. Thus, Fiebrig teaches instant cutaneous composition. Thus, Fiebrig in view of Silberstein and Barr renders obvious instant claim 63.
Response to Arguments
With respect to instant 103 rejections over Buehler in view of Piper and Cock, applicant argue that the cited prior arts do not teach instant two or more natural polyols being present in the combined amount of at least 50% w/v of the composition (as newly added). The Examiner believes that applicant’s such argument has already been addressed above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
April 4, 2026