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 and under current examination.
Priority
This application is a DIV of Application 17/415,875 (now abandoned), filed 06/18/2021, which was a national stage entry of PCT/EP2019/086365, filed 12/19/2019. Foreign priority has been claimed to FR18 73902, filed 12/21/2018. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 in Application 17/415,875.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/08/2024 and 09/10/2025 are in
compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have
been considered by the Examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: it is suggested that “Method preparing a stable composition” in line 1 should read “Method of preparing a stable composition”.
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.
Claims 1-16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1 and 9 contains the trademark/trade name Vaseline. 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 petrolatum (also known in the art as petroleum jelly and white petrolatum) and, accordingly, the identification/description is indefinite.
Claims 1 and 9 recite the limitation “at least two gelling agents of which one is a polyacrylamide type gelling agent”. The term “polyacrylamide type” is not defined by the claim, the specification does not provide a standard for ascertaining the characteristics a gelling agent must possess to satisfy being “polyacrylamide type”, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination and applying prior art, the Examiner interprets a “polyacrylamide type gelling agent” as a gelling agent comprising a polymer that contains acrylamide monomers.
The term “crosslinked polymers of acrylic acid of high molecular weight” in claims 1 and 9 is a relative term which renders the claims indefinite. The term “high molecular weight” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what molecular weights satisfy being “high”, and the metes and bounds of the claim are uncertain.
Claim 9 recites the limitation "the addition of at least two gelling agents improves the stability of the composition over time" in lines 13-14. There is insufficient antecedent basis for “the composition” in the claim, as no composition is previously recited, and it is unclear what is intended to be included in the composition. Similarly, the recitations of “the composition” in claims 11, 12, 13, 14, and 15, respectively, lack antecedent basis. For purposes of examination and applying prior art, the Examiner interprets that the composition is one which comprises an oil in water or water in oil emulsion comprising glycerol, Vaseline, liquid paraffin, at least one preservative different from parabens, and at least two gelling agents as previously set forth in claim 9.
Claims 2-8 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 1 and failure to cure the deficiencies noted above. Claims 10-16 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 9 and failure to cure the deficiencies noted above.
Claims 5, 7, 13, and 15 are rejected under 35 U.S.C. 112(b) as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the conditions for measuring the “consistency at manufacture” and “consistency value”. As evidenced by Stable Micro Systems (“How to measure consistency”), many factors affect consistency measurement, including temperature, humidity, test speed, sample container and volume, and probe/attachment geometries (“Key factors affecting consistency measurement”). As further evidenced by Anton Paar (“Consistency measurement”), for some substances, a decrease of 1 °C can cause a consistency increase of 10% (pg. 1). Without reciting the measurement conditions, one of ordinary skill in the art would not be reasonably apprised of the scope of compositions having “a consistency at manufacture comprised between 70 and 230 g” (instant claims 5 and 13) or a “consistency value comprised between 40 and 210 g at room temperature” (instant claims 7 and 15).
Claim Rejections - 35 USC § 103
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 invention(s) 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.
Claims 1, 3, 5-9, 11, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mallard et al. (US 2009/0318550 A1, published December 24, 2009), hereafter “Mallard”, in view of Fabre et al. (US 2011/0071226 A1, published March 24, 2011), hereafter, “Fabre”.
Regarding instant claims 1 and 9, Mallard teaches physically, chemically, and rheologically stable dermatological/cosmetic emulsions comprising a retinoid and benzoyl peroxide, and a process of formation (see entire document, particularly Abstract, claim 1, and claim 25), in the form of and oil-in-water or water-in-oil emulsion (paragraphs [0031]-[0032]). The emulsions comprise up to 20% of humectants and/or emollients (claim 24, paragraph [0151]), with glycerol as an exemplary humectant and/or emollient (paragraph [0141]; glycerol is also exemplified in Examples 1-4 beginning at paragraph [0244]). The emulsions comprise from 2% to 50% a fatty phase (claim 24) which can comprise mineral oils; exemplary mineral oils are liquid paraffins (paragraphs [0122]-[0123]). Mallard teaches that the emulsions can be in forms with various consistencies, including semiliquid or semisolid cream type (paragraph [0044]), and that creams are known to have absorbent bases such as petrolatum (generic term for vaseline) (paragraph [0032]). The emulsions comprise up to 3% of preservatives (claim 24), and exemplary preservatives include those different from parabens, such as benzalkonium chloride, bronopol, chlorhexidine, chlorocresol and its derivatives, ethyl alcohol, phenethyl alcohol, phenoxyethanol, potassium sorbate, diazolidinylurea, and benzyl alcohol (paragraph [0140]).
Mallard teaches that the emulsions comprise one or more gelling agents and/or pH-independent gelling agents (claim 24); preferred gelling agents include polyacrylamides such as Simulgel 600 or Sepigel 305, “electrolyte-insensitive” carbomers such as Carbopol ETD2020 NF, polysaccharides, such as xanthan gum, and cellulose derivatives such as hydroxypropylmethylcellulose or hydroxyethylcellulose (paragraph [0136]). As defined in the instant specification, carbomers are synthetic hydrophilic polymers of acrylic acid, of high molecular weight (pg. 16, lines 21-22). Mallard teaches the preparation of the emulsions; gelling agents are included in the aqueous phase, and polyacrylamide and other additives are introduced following emulsification (see processes for preparation beginning at paragraph [0189], particularly paragraphs [0192], [0198], [0209], and [0218]-[0221]). Mallard teaches that many gelling agents are destabilized by benzoic acid released during the decomposition of benzoyl peroxide (paragraph [0034]), but compositions comprising pH-independent gelling agents have good physical and chemical stability over time and do not exhibit a drop in viscosity over time (paragraph [0040]); it is interpreted that the addition of the gelling agents in the method of Mallard provides stability to the emulsions over time and that the method of Mallard meets the preamble limitation of claim 9 of “Method for improving the stability over time of an oil in water or water in oil emulsion comprising…”.
Regarding instant claims 3 and 11, Mallard teaches that the emulsions comprise from 30% to 95%, preferably from 50 to 85% water (paragraph [0145]). The emulsions comprise from 0.1% to 20%, preferably from 2% to 15%, of one or more humectants and/or emollients (paragraph [0151]) with glycerol as an exemplary humectant and/or emollient (paragraph [0141]). The emulsions comprise from 2% to 50%, preferably from 5% to 30%, of fatty phase (paragraph [0148]) with liquid paraffin as an exemplary fatty mineral oil (paragraphs [0122]-[0123]). Per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding instant claims 5 and 13, Mallard teaches that the emulsions can be provided in various consistencies such as liquid, semiliquid, or semisolid (paragraph [0044]; claims 22-23), and the emulsions can be cream or lotion type (paragraph [0039]). Mallard further teaches that neutralization of the gelling agent can be used to adjust the pH and consistency (paragraph [0217]). A skilled artisan would be motivated from the teachings of Mallard to routinely adjust the consistency of the emulsions to reach the range claimed in order to achieve a desired application form. Per MPEP 2144.05 II. A., “"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Regarding instant claims 6 and 14, Mallard teaches that the compositions can take the form of a cream or fluid emulsion of lotion type with a variety of consistencies (paragraphs [0039] and [0044]), and that it is considered a cream if the viscosity is greater than 30,000 cP (1 cp = 1 mPa·s) and a lotion if the viscosity is less than 30,000 cP (paragraphs [0238]-[0240]), exemplifying a lotion with a starting viscosity of 21,283 cP (Example 5 beginning at paragraph [0261]). One of ordinary skill in the art would be motivated from the teachings of Mallard to routinely optimize the viscosity in order to reach a desired physical form of the emulsion (such as a cream or lotion). Per MPEP 2144.05 II. A., “"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Regarding instant claims 7 and 15, as noted above, Mallard suggest the routine optimization of the consistency and viscosity of the emulsions in order to reach a desired physical form of the emulsion (such as a cream or lotion). Mallard further teaches that the emulsions are physically, chemically and rheologically stable (see claim 1) and do not exhibit a drop in viscosity over time and at temperatures of from 4 °C to 40 °C (paragraph [0040]), exemplifying storage for 3 months at 40 °C (see Examples beginning at paragraph [0243]). Therefore, Mallard suggests that a desired consistency and viscosity can be both selected and maintained upon extended storage. Per MPEP 2144.05 II. A., “"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Further, as the structural components of the composition of the instant claims is rendered obvious by the teachings of Mallard, absent evidence to the contrary, they will exhibit the same physical properties upon storage (see MPEP 2112.01, II. “A chemical composition and its properties are inseparable.”).
Regarding instant claims 8 and 16, as set forth above, Mallard teaches preferred gelling agents include polyacrylamides such as Simulgel 600 (paragraph [0136]), which is the trademark of the sodium acryloyldimethyltaurate copolymer/isohexadecane/polysorbate 80 mixture (paragraph [0135]).
Mallard does not teach a method of stabilizing an emulsion comprising glycerol, petrolatum, liquid paraffin, and at least one preservative different from parabens with sufficient specificity to anticipate the instant claims. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to combine the prior art elements taught Mallard according to known methods to yield predictable results. Here, as described above, Mallard teaches the preparation of stable emulsions comprising glycerol as a preferred humectant and/or emollient, liquid paraffin as an exemplary fatty mineral oil, and exemplary preservatives including those different from parabens; Mallard further teaches that petrolatum is a known absorbent base in creams, and the emulsions can take various forms including semiliquid or semisolid cream type. Mallard teaches the inclusion of pH-independent gelling agents, and that such compositions have good physical, rheological, and chemical stability over time. The stable emulsions of Mallard are used for the treatment of various dermatological conditions such as acne vulgaris, ichthyoses, psoriasis, eczema, etc. (paragraphs [0157]-[0168]). Rearrangement of the prior art elements taught by Mallard to reach the stabilization of the emulsion of the instant claims is within the purview of a person of ordinary skill in the art who is not an automaton, and would predictably result in a physically, chemically, and rheologically stable dermatological/cosmetic emulsion useful for treating a variety of dermatological conditions.
Further, the prior art of Fabre teaches that oil-in-water or water-in-oil emulsions comprising glycerol, Vaseline, and liquid paraffin can be used in compositions which treat a variety of skin conditions including ichthyosis conditions, psoriasis, and eczema (see entire document, particularly Abstract). Fabre further teaches that gelling agents and non-paraben preservatives can be included in such emulsions (paragraphs [0037], and [0047]). Per MPEP 2141 I., "[I]n Sakraida v. AG Pro, Inc., the Court derived . . . the conclusion that when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417, 82 USPQ2d at 1395-96 (Internal quotations omitted.)”.
While Mallard teaches the inclusion of from 2% to 50% of a fatty phase and suggests the inclusion of petrolatum as a known absorbent base in creams, Mallard does not specifically teach the inclusion of petrolatum at a concentration of between 3 and 20% by weight, as required by instant claims 3 and 11.
However, as noted above, the prior art of Fabre teaches that oil-in-water or water-in-oil emulsions comprising glycerol, Vaseline, and liquid paraffin can be used in compositions which treat a variety of skin conditions including ichthyosis conditions, psoriasis, and eczema (see entire document, particularly Abstract). Fabre further teaches that gelling agents and non-paraben preservatives can be included in such emulsions (paragraphs [0037], and [0047]). Fabre teaches that the concentration of Vaseline is between 3% and 20% by weight (paragraph [0031]), and that advantageously, water is between 30% and 80% by weight, and the composition comprises approximately 15% glycerol, approximately 8% Vaseline, and approximately 2% liquid paraffin (paragraphs [0032]-[0033]), consistent with the amounts recited in instant claims 3 and 11.
It would have been prima facie obvious to one of ordinary skill in the art to modify the emulsion in the method of Mallard to comprise petrolatum between 3 and 20% by weight, as suggested by Fabre. One of ordinary skill would have been motivated to do so in order to use an amount of petrolatum known to be advantageous in emulsions for the treatment of a variety of skin conditions such as ichthyosis conditions, psoriasis, and eczema. There is a reasonable expectation of success as the emulsions in the method of Mallard are similarly taught to be used to treat various dermatological conditions such as ichthyoses, psoriasis, eczema, etc. (paragraphs [0157]-[0168]), and similarly comprise water, glycerol, liquid paraffin, preservatives, and gelling agents. Further, per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)” and per MPEP 2144.05 II. A., “"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mallard in view of Fabre as applied to claims 1, 3, 5-9, 11, and 13-16 above, and further in view of Langsrud et al. (“Ethylhexylglycerin Impairs Membrane Integrity and Enhances the Lethal Effect of Phenoxyethanol” PLOS ONE 2016, 11(10), e0165228), hereafter “Langsrud”.
The teachings of the modified Mallard are described above.
The combination of Mallard and Fabre does not teach the limitation of instant claims 2 and 10 that the at least one preservative different from parabens is selected from the group consisting of hexanediol, ethylhexyl glycerin, pentylene glycol, butylene glycol, 1,2 octanediol (caprylyl glycol) and mixtures thereof.
Langsrud teaches that it is desirable to keep the concentration of preservatives in cosmetic formulations as low as possible to reduce exposure of consumers, and that this can be achieved by adding potentiating agents (see entire document, particularly “Abstract” and “Introduction”, paragraph 1). Combining preservatives with potentiating agents can provide benefits such as a wider spectrum of activity, enhanced activity at lower concentrations and reduced likelihood of allergic reactions or irritation of the skin for the end user (pg. 2, paragraph 4). Langsrud teaches that ethylhexylglycerin shows a synergistic effect on the viability of a range of different microorganisms with 2-phenoxyethanol, a widely used compound used for antimicrobial protection of cosmetics (pg. paragraphs 2-4; “Results”, paragraph 1; “Discussion”, paragraph 1).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant invention to modify the composition in the method Mallard in view of Fabre to incorporate ethylhexyl glycerin, as suggested by Langsrud. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to incorporate a potentiating agent that has a synergistic antimicrobial effect with phenoxyethanol which can keep the concentration of preservative low and reduce the likelihood of allergic reaction or skin irritation, as suggested by Langsrud. There is a reasonable expectation of success Mallard as teaches the inclusion of a phenoxyethanol preservative (paragraph [0140]) and that emulsions are used for the treatment of dermatological conditions (paragraphs [0157]-[0168]).
Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mallard in view of Fabre as applied to claims 1, 3, 5-9, 11, and 13-16 above, and further in view of Liu et al. (WO 96/07396 A2, published March 14, 1996), hereafter “Liu”.
The teachings of the modified Mallard are described above.
The combination of Mallard and Fabre does not teach the limitation of instant claims 4 and 12 that the composition has a pH comprised between pH 7.1 and pH 8.9.
Liu teaches skin care compositions possessing good physical and chemical stability comprising an oil-in-water emulsion base containing retinoids (see entire document, particularly Abstract and claims 1 and 23). Liu teaches that the pH of the composition is from about 6 to about 9 (claim 28); in compositions having a pH of about 6 or more, the retinoid is more stable than at pH of less than 6 and the stability is less dependent on the actual materials used in the formulation (pg. 8, lines 11-22).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant invention to modify the composition in the method Mallard in view of Fabre to have a pH of about 6 to about 9, overlapping the claimed range, as suggested by Liu. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to adjust the pH to avoid degradation of retinoids in emulsion skincare compositions. There is a reasonable expectation of success as Mallard teaches that the dermatological emulsions comprise at least one retinoid (abstract), and that pH can be adjusted as necessary until a desired pH is achieved (paragraph [0217]). Further, per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Conclusion
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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