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 .
Withdrawn Objections/Rejections
The objections to claim 1 and 18 are withdrawn as the amended claims have addressed the informalities.
The rejection of claim 23 under 35 USC § 112(d) is withdrawn in view of the claim amendments.
Claim Status
Applicants' amendments and arguments filed 01/21/2026 have been fully considered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application.
Claims 2-16, 20, and 24-26 are cancelled.
Claims 27-28 are withdrawn.
Claims 1, 17-19, and 21-23 are under current examination. The claims were read in view of the species election of glyceryl caprylate as the antimicrobial component, the inclusion of an active substance of antioxidants, ascorbic acid and salts thereof as the additional antimicrobial agent, a cosmetic preparation as the type of preparation, and dispersions as the form of the preparation in the reply filed on 06/03/2024.
Rejections Maintained
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, 17, 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Tsushima et al. (EP 3695827 A1, published August 19, 2020; of record), hereafter “Tsushima” in view of Premachandran et al. (US 2018/0092357 A1, published April 5, 2018, included on IDS submitted 01/13/2023), hereafter “Premachandran”.
Tsushima teaches an antimicrobial composition containing a component (A) that is at least one selected from the group consisting of 1,2-alkanediols having an alkyl group having 6 to 8 carbons and monoalkyl glyceryl ethers having an alkyl group having 6 to 8 carbons (claim 1). 1,2-alkanediols having an alkyl group having 6 to 8 carbons can be exemplified by 1,2-alkanediols having a straight-chain alkyl group having 6 to 8 carbons, for example, 1,2-heptanediol (paragraph [0011]) (instant claim 1 (a)). As the antimicrobial composition of Tsushima is taught to exhibit significantly high antimicrobial activity (abstract), it is considered that the 1,2-heptanediol is present in an effective amount.
The antimicrobial composition can be advantageously used in applications, such as cosmetics (instant claim 22), where direct contact with the human body occurs (paragraph [0017]); the cosmetic may contain antioxidants (paragraphs [0021] and [0049]) (instant claims 1 (c) and 17).
The content of component (A), with reference to the total mass of the cosmetic, is preferably 0.001 to 10 mass% (paragraph [0020]) (instant claim 19). 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)”.
Tsushima does not teach that the composition comprises an effective amount of glyceryl caprylate (instant claim 1 (b)) present in an amount of 0.01 to 25.0% by weight based on the total weight of the composition (instant claim 21).
Premachandran teaches (claim 19) a synergistic preservation composition capable of providing broad spectrum antimicrobial activity comprising:
about 0.1 wt. % to about 99.9 wt. % of propylene carbonate;
about 0.1 wt. % to about 99.9 wt. % of one or more organic compounds selected from the group consisting of diols, alkane diols, glycerins, alkyl glycerins, esters of glycerins, organic acids and their salts, fatty acids and their salts, and/or esters of long chain fatty acids; and
optionally about 0.1 wt. % to 20.0 wt. % of one or more preservatives.
The organic compounds are taught to include glyceryl caprylate (claim 20, paragraph [0076]). Premachandran further teaches a cosmetic product comprising the preservation composition in the range of from about 0.01 wt. % to 5.0 wt.% (paragraph [0077]-[0078]). The glyceryl caprylate of Premachandran would therefore be present in the cosmetic product from about 0.00001 to 4.995 wt.%, overlapping the range of instant claim 21.
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 modify the cosmetic composition of Tsushima with the synergistic preservation composition comprising glyceryl caprylate in an amount overlapping instant claim 21, as suggested by Premachandran.
One of ordinary skill in the art would have been motivated to do so as Premachandran teaches that an effective composition capable of demonstrating cumulative synergism and a reduction in use or required level of organic/preservative compounds can be achieved by the inclusion of propylene carbonate with one or more organic compounds and/or one or more preservative compounds (paragraph [0037]). There is a reasonable expectation of success as Premachandran teaches alkane diols, particularly 1,2-alkane diols can be used in combination with glyceryl caprylate in such synergistic mixtures (see Premachandran claim 19, paragraphs [0044]-[0047]), and both Tsushima and Premachandran teach cosmetic compositions comprising antimicrobial mixtures.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Tsushima and Premachandran as applied to claims 1, 17, 19, and 21-22 above, and further in view of Tutino et al. (US 2007/0154532 A1, published July 5, 2007; of record), hereafter “Tutino”.
The teachings of Tsushima and Premachandran are described above. Additionally, the cosmetic of Tsushima can include chelating agents (paragraph [0021]). Examples of chelating agents include ascorbic acid (paragraph [0038]).
However, the combination of Tsushima and Premachandran do not teach the inclusion of ascorbic acid as an additional antimicrobial agent, as recited in instant claim 18.
Tutino teaches that L-ascorbic acid has important biological functions for the skin including chelating action with respect to ferric ions (paragraphs [0011] and [0017]). Tutino further teaches that L-ascorbic acid, i.e., vitamin C, is known as an antimicrobial and anti-oxidant additive for nutritional foods or as a disinfectant for pharmaceutical preparations such as cosmetics (paragraph [0002]), and that compositions comprising L-ascorbic acid can by advantageously employed in the cosmetic treatment of skin (paragraph [0001]).
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 use the ascorbic acid taught by the modified Tsushima as both a chelating agent and additional antimicrobial agent, as suggested by Tutino. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to take advantage of the known benefits of ascorbic acid as both a ferric ion chelating agent and disinfecting agent in cosmetic preparations, particularly in cosmetic treatment of the skin, as taught by Tutino. There is a reasonable expectation of success as the cosmetic compositions of Tsushima are taught to be those where direct contact with the human body occurs (paragraph [0017]), including lotions and creams (paragraph [0019]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Tsushima and Premachandran as applied to claims 1, 17, 19, and 21-22 above, and further in view of Weiner et al. (US 2005/0232894 A1, published October 20, 2005; of record), hereafter “Weiner”.
The teachings of Tsushima and Premachandran are described above. Additionally, the cosmetic of Tsushima can be in various forms including an emulsion, hair liquid, lotion, cleansing milk, and creams (paragraph [0019]); the cosmetic can include liquid or solid oils and fats (paragraph [0021]). Premachandran further teaches that preservative compositions can be aqueous or non-aqueous and can be delivered through different formulations techniques including dispersions (paragraph [0072]).
The combination of Tsushima and Premachandran do not teach the limitation of instant claim 23 of an oil component in an amount of ≥ 1% by weight.
Weiner teaches that antimicrobial skin treatment compositions (abstract) can include emollients and moisturizers to maintain healthy skin and replenish any skin that is irritated by antimicrobial agents; examples include oils such as cod liver oil, olive oil, coconut oil, avocado oil, castor oil, peanut oil, sesame oil, almond oil, light mineral oil, and vegetable oil (paragraph [0057]). The emollient and moisturizer component can be included at varying amounts depending upon the desired level of moisturization and the treatment composition can comprise 1 wt.% to about 3 wt.% or about 1.5 wt.% to about 2.5 wt.% emollient and/or moisturizer (paragraph [0058]). The treatment compositions can be provided as a crème or lotion (paragraph [0049]).
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 modify the cosmetic composition of Tsushima in view of Premachandran with an oil component in an amount ≥ 1%, as suggested by Weiner. One of ordinary skill in the art would have been motivated to do so to achieve an antimicrobial composition with the desired level of moisturization to maintain healthy skin and replenish any skin that is irritated by antimicrobial agents, as taught by Weiner. There is a reasonable expectation of success as the cosmetic compositions of Tsushima are taught to be those where direct contact with the human body occurs (paragraph [0017]), including lotions and creams (paragraph [0019]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 17-19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-30 and 33-36 of copending Application No. 18/301,051 in view of Ciccognani et al. (US 2006/0057175 A1, published March 16, 2006; of record), hereafter “Ciccognani”.
Both the instant claims and those of copending Application ‘051 are directed to compositions comprising a linear alkanediol, in overlapping amounts by weight. The compositions further comprise glyceryl caprylate, in overlapping amounts by weight, and at least one active substance for a food, a cosmetic, or pharmaceutical composition or a homecare product and/or additive of antioxidants. The composition further comprises at least one additional antimicrobial agent of ascorbic acid. Both the instant claims and the claims of ‘051 further recite a food, cosmetic, or pharmaceutical preparation and a cosmetic or pharmaceutical preparation that is a dispersion comprising an oil component in an amount of ≥ 1% by weight wherein the cosmetic composition is in the form of an emulsion, a liquid, a lotion, a suspension, a milk, an ointment, a paste, a gel, a cream based formulation, an oil based formulation, or a liposome-based formulation.
The claims of copending application ‘051 differ from the instant claims in that the linear alkane diol is taught to be 2,3-heptanediol or 2,3-octanediol rather than the 1,2-heptanediol of the instant claims.
Ciccognani teaches a composition having effective broad spectrum preservation activity comprising capryl glycol (1,2-octanediol), or one or more analogs thereof, and other known preservatives, such as chloroxylenol (abstract). Expressly disclosed analogs of capryl glycol include 2,3-octanediol and 1,2-heptanediol (paragraphs [0013]). The preservative blends are particularly useful in personal care or cosmetics formulations, and particularly emulsion formulations (paragraphs [0026] to [0029]).
It would have been prima facie obvious to one of ordinary skill in the art to substitute the 2,3-octanediol claimed in copending application ‘051 with the 1,2-heptanediol taught by Ciccognani. Both are linear alkanediols taught to be analogs of caprylyl glycol which are useful in compositions having effective broad spectrum preservation activity and which can be used in cosmetic formulations. Simple substitution of one linear alkanediol known to have use in antimicrobial cosmetic compositions for its known analog is within the purview of the skilled artisan and would yield predictable results (see MPEP 2141 III).
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending application ‘051, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 17-19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 15-16, 18, and 20-21 of copending Application No. 18/009,312 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Both the instant claims and the claims of copending application ‘312 are directed to a composition comprising at least one linear alkanediol of 1,2-heptanediol, in an amount of 0.001 to 15.0% by weight. The composition further comprises at least one antimicrobial component, which is selected from the group including glyceryl caprylate and ascorbic acid and salts thereof, in overlapping amounts, and at least one cosmetically or pharmaceutically active substance and/or additive of antioxidants. Both the instant claims and the claims of ‘312 further recite a cosmetic composition preparation that is a dispersion comprising an oil component in an amount of ≥ 1% by weight wherein the cosmetic composition is in the form of an emulsion, a liquid, a lotion, a suspension, a milk, an ointment, a paste, a gel, a cream based formulation, an oil based formulation, or a liposome-based formulation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 17-19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 19, and 24 of copending Application No. 18/009,291 in view of Tsushima et al. (EP 3695827 A1, published August 19, 2020; of record), hereafter “Tsushima”, Premachandran et al. (US 2018/0092357 A1, published April 5, 2018, included on IDS submitted 01/13/2023), hereafter “Premachandran”, Tutino et al. (US 2007/0154532 A1, published July 5, 2007; of record), hereafter “Tutino”, and Weiner et al. (US 2005/0232894 A1, published October 20, 2005; of record), hereafter “Weiner”.
Claims 1, 17-19, and 21-23 are directed to an invention not patentably distinct from claims 2, 19, and 24 of commonly assigned Application No. 18/009,291.
Both the instant claims and those of copending Application ‘291 are directed to a cosmetic composition comprising at least one linear alkanediol of 1,2-heptanediol, at least one antimicrobial compound, and at least one active substance for a cosmetic product and/or additive of antioxidants. Both sets of claims further recite a cosmetic dispersion in the form of a gel.
The claims of copending application ‘291 do not recite that the composition comprises 1,2-heptanediol in an amount of 0.001 to 15.0% by weight.
Tsushima teaches an antimicrobial composition containing a component (A) that is at least one selected from the group consisting of 1,2-alkanediols having an alkyl group having 6 to 8 carbons and monoalkyl glyceryl ethers having an alkyl group having 6 to 8 carbons (claim 1). 1,2-alkanediols having an alkyl group having 6 to 8 carbons can be exemplified by 1,2-alkanediols having a straight-chain alkyl group having 6 to 8 carbons, for example, 1,2-heptanediol (paragraph [0011]). The antimicrobial composition can be advantageously used in applications, such as cosmetics (instant claim 22), where direct contact with the human body occurs (paragraph [0017]); the content of component (A), with reference to the total mass of the cosmetic, is preferably 0.001 to 10 mass% (paragraph [0020]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘291 with the wt.% of 1,2-heptanediol suggested by Tsushima. One would have been motivated to do so to achieve a cosmetic composition with a high antimicrobial activity and level of safety for the human body with a reduction in the amount of paraben or paraben replacement used (Tsushima, abstract, paragraphs [0002]-[0003]).
The claims of copending application ‘291 do not recite that the composition comprises glyceryl caprylate in an amount of 0.01 to 25.0% by weight, as recited in the instant claims.
Premachandran teaches (claim 19) a synergistic preservation composition capable of providing broad spectrum antimicrobial activity comprising:
about 0.1 wt. % to about 99.9 wt. % of propylene carbonate;
about 0.1 wt. % to about 99.9 wt. % of one or more organic compounds selected from the group consisting of diols, alkane diols, glycerins, alkyl glycerins, esters of glycerins, organic acids and their salts, fatty acids and their salts, and/or esters of long chain fatty acids; and
optionally about 0.1 wt. % to 20.0 wt. % of one or more preservatives.
The organic compounds are taught to include glyceryl caprylate (claim 20). Premachandran further teaches a cosmetic product comprising the preservation composition in the range of from about 0.01 wt. % to 5.0 wt.% (paragraph [0077]-[0078]). The glyceryl caprylate of Premachandran would therefore be present in the cosmetic product from about 0.00001 to 4.995 wt.%, overlapping the range of instant claim 21.
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘291 with the synergistic preservation composition comprising glyceryl caprylate in an amount overlapping instant claim 21, as suggested by Premachandran. One of ordinary skill in the art would have been motivated to do so to achieve a cosmetic composition comprising an effective preservative composition capable of demonstrating cumulative synergism and a reduction in use or required level of organic/preservative compounds (Premachandran, paragraph [0037]).
The claims of copending application ‘291 do not recite that the composition further comprises an additional antimicrobial component of ascorbic acid and salts thereof, as recited in the instant claims.
Tutino teaches that L-ascorbic acid has important biological functions for the skin including chelating action with respect to ferric ions (paragraphs [0011] and [0017]). Tutino further teaches that L-ascorbic acid, i.e., vitamin C, is known as an antimicrobial and anti-oxidant additive for nutritional foods or as a disinfectant for pharmaceutical preparations such as cosmetics (paragraph [0002]), and that compositions comprising L-ascorbic acid can by advantageously employed in the cosmetic treatment of skin (paragraph [0001]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘291 with ascorbic acid as suggested by Tutino. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to take advantage of the known benefits of ascorbic acid as both a ferric ion chelating agent and disinfecting agent in cosmetic preparations, particularly in cosmetic treatment of the skin, as taught by Tutino.
The claims of copending application ‘291 do not recite that the composition comprises an oil component in an amount of ≥ 1% by weight, as recited in the instant claims.
Weiner teaches that antimicrobial skin treatment compositions (abstract) can include emollients and moisturizers to maintain healthy skin and replenish any skin that is irritated by antimicrobial agents; examples include oils such as cod liver oil, olive oil, coconut oil, avocado oil, castor oil, peanut oil, sesame oil, almond oil, light mineral oil, and vegetable oil (paragraph [0057]). The emollient and moisturizer component can be included at varying amounts depending upon the desired level of moisturization and the treatment composition can comprise 1 wt.% to about 3 wt.% or about 1.5 wt.% to about 2.5 wt.% emollient and/or moisturizer (paragraph [0057]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the claims of copending application ‘291 with an oil component in an amount of ≥ 1% by weight, as suggested by Weiner. One of ordinary skill in the art would have been motivated to do so to achieve an antimicrobial composition with the desired level of moisturization to maintain healthy skin and replenish any skin that is irritated by antimicrobial agents, as taught by Weiner.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending application ‘291, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application No. 18/009,291, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1, 17-19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 16-18, and 21 of copending Application No. 18/009,288 in view of Premachandran et al. (US 2018/0092357 A1, published April 5, 2018, included on IDS submitted 01/13/2023), hereafter “Premachandran” and Tutino et al. (US 2007/0154532 A1, published July 5, 2007; of record), hereafter “Tutino”.
Claims 1, 17-19, and 21-23 are directed to an invention not patentably distinct from claims 2, 16-18, and 21 of commonly assigned Application No. 18/009,288.
Both the instant claims and the claims of copending application ‘288 are directed to a composition comprising at least one linear alkanediol of 1,2-heptanediol, in overlapping amounts by weight. The composition further comprises at least one antimicrobial component, which is selected from the group including glyceryl caprylate, and at least one cosmetically or pharmaceutically active substance and/or additive of antioxidants. Both the instant claims and the claims of ‘288 further recite a cosmetic composition preparation that is a dispersion comprising an oil component in an amount of ≥ 1% by weight wherein the cosmetic composition is in the form of an emulsion, a liquid, a lotion, a suspension, a milk, an ointment, a paste, a gel, a cream based formulation, an oil based formulation, or a liposome-based formulation.
The claims of copending application ‘288 do not recite that the composition comprises glyceryl caprylate in an amount of 0.01 to 25.0% by weight, as recited in the instant claims.
Premachandran teaches (claim 19) a synergistic preservation composition capable of providing broad spectrum antimicrobial activity comprising:
about 0.1 wt. % to about 99.9 wt. % of propylene carbonate;
about 0.1 wt. % to about 99.9 wt. % of one or more organic compounds selected from the group consisting of diols, alkane diols, glycerins, alkyl glycerins, esters of glycerins, organic acids and their salts, fatty acids and their salts, and/or esters of long chain fatty acids; and
optionally about 0.1 wt. % to 20.0 wt. % of one or more preservatives.
The organic compounds are taught to include glyceryl caprylate (claim 20). Premachandran further teaches a cosmetic product comprising the preservation composition in the range of from about 0.01 wt. % to 5.0 wt.% The glyceryl caprylate of Premachandran would therefore be present in the cosmetic product from about 0.00001 to 4.995 wt.% (paragraph [0077]-[0078]), overlapping the range of instant claim 21.
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘288 with the synergistic preservation composition comprising glyceryl caprylate in an amount overlapping instant claim 21, as suggested by Premachandran. One of ordinary skill in the art would have been motivated to do so to achieve a cosmetic composition comprising an effective preservative composition capable of demonstrating cumulative synergism and a reduction in use or required level of organic/preservative compounds (Premachandran, paragraph [0037]).
The claims of copending application ‘288 do not recite that the composition further comprises an additional antimicrobial component of ascorbic acid and salts thereof, as recited in the instant claims.
Tutino teaches that L-ascorbic acid has important biological functions for the skin including chelating action with respect to ferric ions (paragraphs [0011] and [0017]). Tutino further teaches that L-ascorbic acid, i.e., vitamin C, is known as an antimicrobial and anti-oxidant additive for nutritional foods or as a disinfectant for pharmaceutical preparations such as cosmetics (paragraph [0002]), and that compositions comprising L-ascorbic acid can by advantageously employed in the cosmetic treatment of skin (paragraph [0001]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘288 with ascorbic acid as suggested by Tutino. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to take advantage of the known benefits of ascorbic acid as both a ferric ion chelating agent and disinfecting agent in cosmetic preparations, particularly in cosmetic treatment of the skin, as taught by Tutino.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending application ‘288, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application No. 18/009,288, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1, 17-19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16, 18, 21-23, and 25 of copending Application No. 18/301,090 in view of Premachandran et al. (US 2018/0092357 A1, published April 5, 2018, included on IDS submitted 01/13/2023), hereafter “Premachandran”, Tutino et al. (US 2007/0154532 A1, published July 5, 2007; of record), hereafter “Tutino”, and Weiner et al. (US 2005/0232894 A1, published October 20, 2005; of record), hereafter “Weiner”.
Claims 1, 17-19, and 21-23 are directed to an invention not patentably distinct from claims 16, 18, 21-23, and 25 of commonly assigned Application No. 18/301,090.
Both the instant claims and those of copending Application ‘090 are directed to a composition comprising at least one linear 1,2-alkanediol of 1,2-heptanediol in an amount of 0.001 to 15.0%, and at least one active substance for a cosmetic product and/or additive of antioxidants and antimicrobial compounds. Both sets of claims further recite a cosmetic dispersion in the form of a gel.
The claims of copending application ‘090 do not recite that the composition comprises glyceryl caprylate in an amount of 0.01 to 25.0% by weight, as recited in the instant claims.
Premachandran teaches (claim 19) a synergistic preservation composition capable of providing broad spectrum antimicrobial activity comprising:
about 0.1 wt. % to about 99.9 wt. % of propylene carbonate;
about 0.1 wt. % to about 99.9 wt. % of one or more organic compounds selected from the group consisting of diols, alkane diols, glycerins, alkyl glycerins, esters of glycerins, organic acids and their salts, fatty acids and their salts, and/or esters of long chain fatty acids; and
optionally about 0.1 wt. % to 20.0 wt. % of one or more preservatives.
The organic compounds are taught to include glyceryl caprylate (claim 20). Premachandran further teaches a cosmetic product comprising the preservation composition in the range of from about 0.01 wt. % to 5.0 wt.% (paragraph [0077]-[0078]). The glyceryl caprylate of Premachandran would therefore be present in the cosmetic product from about 0.00001 to 4.995 wt.%, overlapping the range of instant claim 21.
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘090 with the synergistic preservation composition comprising glyceryl caprylate in an amount overlapping instant claim 21, as suggested by Premachandran. One of ordinary skill in the art would have been motivated to do so to achieve a cosmetic composition comprising an effective preservative composition capable of demonstrating cumulative synergism and a reduction in use or required level of organic/preservative compounds (Premachandran, paragraph [0037]).
The claims of copending application ‘090 do not recite that the composition further comprises an additional antimicrobial component of ascorbic acid and salts thereof, as recited in the instant claims.
Tutino teaches that L-ascorbic acid has important biological functions for the skin including chelating action with respect to ferric ions (paragraphs [0011] and [0017]). Tutino further teaches that L-ascorbic acid, i.e., vitamin C, is known as an antimicrobial and anti-oxidant additive for nutritional foods or as a disinfectant for pharmaceutical preparations such as cosmetics (paragraph [0002]), and that compositions comprising L-ascorbic acid can by advantageously employed in the cosmetic treatment of skin (paragraph [0001]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘090 with ascorbic acid as suggested by Tutino. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to take advantage of the known benefits of ascorbic acid as both a ferric ion chelating agent and disinfecting agent in cosmetic preparations, particularly in cosmetic treatment of the skin, as taught by Tutino.
The claims of copending application ‘090 do not recite that the composition comprises an oil component in an amount of ≥ 1% by weight, as recited in the instant claims.
Weiner teaches that antimicrobial skin treatment compositions (abstract) can include emollients and moisturizers to maintain healthy skin and replenish any skin that is irritated by antimicrobial agents; examples include oils such as cod liver oil, olive oil, coconut oil, avocado oil, castor oil, peanut oil, sesame oil, almond oil, light mineral oil, and vegetable oil (paragraph [0057]). The emollient and moisturizer component can be included at varying amounts depending upon the desired level of moisturization and the treatment composition can comprise 1 wt.% to about 3 wt.% or about 1.5 wt.% to about 2.5 wt.% emollient and/or moisturizer (paragraph [0057]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the claims of copending application ‘090 with an oil component in an amount of ≥ 1% by weight, as suggested by Weiner. One of ordinary skill in the art would have been motivated to do so to achieve an antimicrobial composition with the desired level of moisturization to maintain healthy skin and replenish any skin that is irritated by antimicrobial agents, as taught by Weiner.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending application ‘090, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application No. 18/301,090, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1, 17-19, and 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, and 8 of U.S. Patent No. 11,911,347 B2 in view of Premachandran et al. (US 2018/0092357 A1, published April 5, 2018, included on IDS submitted 01/13/2023), hereafter “Premachandran” and Tutino et al. (US 2007/0154532 A1, published July 5, 2007; of record), hereafter “Tutino”.
Claims 1, 17-19, and 21-23 are directed to an invention not patentably distinct from claims 1, 4-6, and 8 of commonly assigned U.S. Patent No. 11,911,347 B2.
Both the instant claims and those of U.S. Patent No. 11,911,347 B2 are directed to a composition comprising at least one linear alkanediol of 1,2-heptanediol, in an amount of 0.001 to 15.0% by weight. The composition further comprises an antioxidant and at least one cosmetically or pharmaceutically active substance and/or additive of anti-microbial agents. Both the instant claims and the claims of U.S. Patent No. 11,911,347 B2 further recite a cosmetic composition preparation that is a dispersion comprising an oil component in an amount of ≥ 1% by weight wherein the cosmetic composition is in the form of an emulsion, a liquid, a lotion, a suspension, a milk, an ointment, a paste, a gel, a cream based formulation, an oil based formulation, or a liposome-based formulation.
The claims of U.S. Patent No. 11,911,347 B2 do not recite that the composition comprises glyceryl caprylate in an amount of 0.01 to 25.0% by weight, as recited in the instant claims.
Premachandran teaches (claim 19) a synergistic preservation composition capable of providing broad spectrum antimicrobial activity comprising:
about 0.1 wt. % to about 99.9 wt. % of propylene carbonate;
about 0.1 wt. % to about 99.9 wt. % of one or more organic compounds selected from the group consisting of diols, alkane diols, glycerins, alkyl glycerins, esters of glycerins, organic acids and their salts, fatty acids and their salts, and/or esters of long chain fatty acids; and
optionally about 0.1 wt. % to 20.0 wt. % of one or more preservatives.
The organic compounds are taught to include glyceryl caprylate (claim 20). Premachandran further teaches a cosmetic product comprising the preservation composition in the range of from about 0.01 wt. % to 5.0 wt.% (paragraph [0077]-[0078]). The glyceryl caprylate of Premachandran would therefore be present in the cosmetic product from about 0.00001 to 4.995 wt.%, overlapping the range of instant claim 21.
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in U.S. Patent No. 11,911,347 B2 with the synergistic preservation composition comprising glyceryl caprylate in an amount overlapping instant claim 21, as suggested by Premachandran. One of ordinary skill in the art would have been motivated to do so to achieve a cosmetic composition comprising an effective preservative composition capable of demonstrating cumulative synergism and a reduction in use or required level of organic/preservative compounds (Premachandran, paragraph [0037]).
The claims of U.S. Patent No. 11,911,347 B2 do not recite that the composition further comprises an additional antimicrobial component of ascorbic acid and salts thereof, as recited in the instant claims.
Tutino teaches that L-ascorbic acid has important biological functions for the skin including chelating action with respect to ferric ions (paragraphs [0011] and [0017]). Tutino further teaches that L-ascorbic acid, i.e., vitamin C, is known as an antimicrobial and anti-oxidant additive for nutritional foods or as a disinfectant for pharmaceutical preparations such as cosmetics (paragraph [0002]), and that compositions comprising L-ascorbic acid can by advantageously employed in the cosmetic treatment of skin (paragraph [0001]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in U.S. Patent No. 11,911,347 B2 with ascorbic acid as suggested by Tutino. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to take advantage of the known benefits of ascorbic acid as both a ferric ion chelating agent and disinfecting agent in cosmetic preparations, particularly in cosmetic treatment of the skin, as taught by Tutino.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of U.S. Patent No. 11,911,347 B2, the instant claims are rejected on the ground of nonstatutory double patenting.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 11,911,347 B2, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1, 17-19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27 and 36 of copending Application No. 18/301,004 in view of in view of Premachandran et al. (US 2018/0092357 A1, published April 5, 2018, included on IDS submitted 01/13/2023), hereafter “Premachandran” and Tutino et al. (US 2007/0154532 A1, published July 5, 2007; of record), hereafter “Tutino”.
Claims 1, 17-19, and 21-23 are directed to an invention not patentably distinct from claims 27, and 36 of commonly assigned Application No. 18/301,004.
Both the instant claims and the claims of copending application ‘004 are directed to a composition comprising at least one linear alkanediol of 1,2-heptanediol present in overlapping % by weight. The composition further comprises at least one cosmetically or pharmaceutically active substance and/or additive of anti-microbial agents and antioxidants. Both the instant claims and the claims of ‘004 further recite a cosmetic composition preparation that is a dispersion comprising an oil component in an amount of ≥ 1% by weight wherein the cosmetic composition is in the form of an emulsion, a liquid, a lotion, a suspension, a milk, an ointment, a paste, a gel, a cream based formulation, an oil based formulation, or a liposome-based formulation.
The claims of co-pending application ‘004 do not recite that the composition comprises glyceryl caprylate in an amount of 0.01 to 25.0% by weight, as recited in the instant claims.
Premachandran teaches (claim 19) a synergistic preservation composition capable of providing broad spectrum antimicrobial activity comprising:
about 0.1 wt. % to about 99.9 wt. % of propylene carbonate;
about 0.1 wt. % to about 99.9 wt. % of one or more organic compounds selected from the group consisting of diols, alkane diols, glycerins, alkyl glycerins, esters of glycerins, organic acids and their salts, fatty acids and their salts, and/or esters of long chain fatty acids; and
optionally about 0.1 wt. % to 20.0 wt. % of one or more preservatives.
The organic compounds are taught to include glyceryl caprylate (claim 20). Premachandran further teaches a cosmetic product comprising the preservation composition in the range of from about 0.01 wt. % to 5.0 wt.% (paragraph [0077]-[0078]). The glyceryl caprylate of Premachandran would therefore be present in the cosmetic product from about 0.00001 to 4.995 wt.%, overlapping the range of instant claim 21.
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition of co-pending application ‘004 with the synergistic preservation composition comprising glyceryl caprylate in an amount overlapping instant claim 21, as suggested by Premachandran. One of ordinary skill in the art would have been motivated to do so to achieve a cosmetic composition comprising an effective preservative composition capable of demonstrating cumulative synergism and a reduction in use or required level of organic/preservative compounds (Premachandran, paragraph [0037]).
The claims of copending application ‘004 do not recite that the composition further comprises an additional antimicrobial component of ascorbic acid and salts thereof, as recited in the instant claims.
Tutino teaches that L-ascorbic acid has important biological functions for the skin including chelating action with respect to ferric ions (paragraphs [0011] and [0017]). Tutino further teaches that L-ascorbic acid, i.e., vitamin C, is known as an antimicrobial and anti-oxidant additive for nutritional foods or as a disinfectant for pharmaceutical preparations such as cosmetics (paragraph [0002]), and that compositions comprising L-ascorbic acid can by advantageously employed in the cosmetic treatment of skin (paragraph [0001]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘004 with ascorbic acid as suggested by Tutino. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to take advantage of the known benefits of ascorbic acid as both a ferric ion chelating agent and disinfecting agent in cosmetic preparations, particularly in cosmetic treatment of the skin, as taught by Tutino.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending application ‘004, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application No. 18/301,004, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1, 17-19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 13, 16, 18-19, and 21-22 of copending Application No. 18/009,324 in view of in view of Tutino et al. (US 2007/0154532 A1, published July 5, 2007; of record), hereafter “Tutino”.
Claims 1, 17-19, and 21-23 are directed to an invention not patentably distinct from claims 1-2, 13, 16, 18-19, and 21-22 of commonly assigned Application No. 18/009,324.
Both the instant claims and the claims of copending application ‘324 are directed to a composition comprising at least one linear alkanediol of 1,2-heptanediol, in an amount of 0.001 to 15.0% by weight. The composition further comprises glyceryl caprylate in overlapping amounts, and at least one cosmetically or pharmaceutically active substance and/or additive of anti-microbial agents and antioxidants. Both the instant claims and the claims of ‘324 further recite a cosmetic composition preparation that is a dispersion comprising an oil component in an amount of ≥ 1% by weight wherein the cosmetic composition is in the form of an emulsion, a liquid, a lotion, a suspension, a milk, an ointment, a paste, a gel, a cream based formulation, an oil based formulation, or a liposome-based formulation.
The claims of copending application ‘324 do not recite that the composition further comprises an additional antimicrobial component of ascorbic acid and salts thereof, as recited in the instant claims.
Tutino teaches that L-ascorbic acid has important biological functions for the skin including chelating action with respect to ferric ions (paragraphs [0011] and [0017]). Tutino further teaches that L-ascorbic acid, i.e., vitamin C, is known as an antimicrobial and anti-oxidant additive for nutritional foods or as a disinfectant for pharmaceutical preparations such as cosmetics (paragraph [0002]), and that compositions comprising L-ascorbic acid can by advantageously employed in the cosmetic treatment of skin (paragraph [0001]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘324 with ascorbic acid as suggested by Tutino. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to take advantage of the known benefits of ascorbic acid as both a ferric ion chelating agent and disinfecting agent in cosmetic preparations, particularly in cosmetic treatment of the skin, as taught by Tutino.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending application ‘324, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application No. 18/009,324, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1, 17-19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 18-19, and 22-24 of copending Application No. 18/009,314 in view of Premachandran et al. (US 2018/0092357 A1, published April 5, 2018, included on IDS submitted 01/13/2023), hereafter “Premachandran”, Tutino et al. (US 2007/0154532 A1, published July 5, 2007; of record), hereafter “Tutino”, and Weiner et al. (US 2005/0232894 A1, published October 20, 2005; of record), hereafter “Weiner”.
Claims 1, 17-19, and 21-23 are directed to an invention not patentably distinct from claims 1, 13, 18-19, and 22-24 of commonly assigned Application No. 18/009,314.
Both the instant claims and those of copending Application ‘314 are directed to a composition comprising at least one linear 1,2-alkanediol of 1,2-heptanediol in an amount of 0.001 to 15.0%, and at least one active substance for a cosmetic product and/or additive of antioxidants and antimicrobial compounds. Both sets of claims further recite a cosmetic dispersion in the form of a gel.
The claims of copending application ‘314 do not recite that the composition comprises glyceryl caprylate in an amount of 0.01 to 25.0% by weight, as recited in the instant claims.
Premachandran teaches (claim 19) a synergistic preservation composition capable of providing broad spectrum antimicrobial activity comprising:
about 0.1 wt. % to about 99.9 wt. % of propylene carbonate;
about 0.1 wt. % to about 99.9 wt. % of one or more organic compounds selected from the group consisting of diols, alkane diols, glycerins, alkyl glycerins, esters of glycerins, organic acids and their salts, fatty acids and their salts, and/or esters of long chain fatty acids; and
optionally about 0.1 wt. % to 20.0 wt. % of one or more preservatives.
The organic compounds are taught to include glyceryl caprylate (claim 20). Premachandran further teaches a cosmetic product comprising the preservation composition in the range of from about 0.01 wt. % to 5.0 wt.% (paragraph [0077]-[0078]). The glyceryl caprylate of Premachandran would therefore be present in the cosmetic product from about 0.00001 to 4.995 wt.%, overlapping the range of instant claim 21.
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘314 with the synergistic preservation composition comprising glyceryl caprylate in an amount overlapping instant claim 21, as suggested by Premachandran. One of ordinary skill in the art would have been motivated to do so to achieve a cosmetic composition comprising an effective preservative composition capable of demonstrating cumulative synergism and a reduction in use or required level of organic/preservative compounds (Premachandran, paragraph [0037]).
The claims of copending application ‘314 do not recite that the composition further comprises an additional antimicrobial component of ascorbic acid and salts thereof, as recited in the instant claims.
Tutino teaches that L-ascorbic acid has important biological functions for the skin including chelating action with respect to ferric ions (paragraphs [0011] and [0017]). Tutino further teaches that L-ascorbic acid, i.e., vitamin C, is known as an antimicrobial and anti-oxidant additive for nutritional foods or as a disinfectant for pharmaceutical preparations such as cosmetics (paragraph [0002]), and that compositions comprising L-ascorbic acid can by advantageously employed in the cosmetic treatment of skin (paragraph [0001]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘314 with ascorbic acid as suggested by Tutino. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to take advantage of the known benefits of ascorbic acid as both a ferric ion chelating agent and disinfecting agent in cosmetic preparations, particularly in cosmetic treatment of the skin, as taught by Tutino.
The claims of copending application ‘314 do not recite that the composition comprises an oil component in an amount of ≥ 1% by weight, as recited in the instant claims.
Weiner teaches that antimicrobial skin treatment compositions (abstract) can include emollients and moisturizers to maintain healthy skin and replenish any skin that is irritated by antimicrobial agents; examples include oils such as cod liver oil, olive oil, coconut oil, avocado oil, castor oil, peanut oil, sesame oil, almond oil, light mineral oil, and vegetable oil (paragraph [0057]). The emollient and moisturizer component can be included at varying amounts depending upon the desired level of moisturization and the treatment composition can comprise 1 wt.% to about 3 wt.% or about 1.5 wt.% to about 2.5 wt.% emollient and/or moisturizer (paragraph [0057]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the claims of copending application ‘314 with an oil component in an amount of ≥ 1% by weight, as suggested by Weiner. One of ordinary skill in the art would have been motivated to do so to achieve an antimicrobial composition with the desired level of moisturization to maintain healthy skin and replenish any skin that is irritated by antimicrobial agents, as taught by Weiner.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending application ‘314, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application No. 18/009,314, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1, 17-19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5 of U.S. Patent No. 12,303,468 B2 (formerly Application No. 18/009,298) in view of Premachandran et al. (US 2018/0092357 A1, published April 5, 2018, included on IDS submitted 01/13/2023), hereafter “Premachandran” and Tutino et al. (US 2007/0154532 A1, published July 5, 2007; of record), hereafter “Tutino”.
Claims 1, 17-19, and 21-23 are directed to an invention not patentably distinct from claims 1-3 and 5 of commonly assigned U.S. Patent No. 12,303,468 B2.
Both the instant claims and those of U.S. Patent No. 12,303,468 B2 are directed to a composition comprising 1,2-heptanediol in an amount of 0.001 to 15.0% by weight. The composition further comprises an antioxidant and at least one cosmetically or pharmaceutically active substance and/or additive of anti-microbial agents. Both the instant claims and the claims of U.S. Patent No. 12,303,468 B2 further recite a cosmetic composition preparation that is a dispersion comprising an oil component in an amount of ≥ 1% by weight wherein the cosmetic composition is in the form of an emulsion, a liquid, a lotion, a suspension, a milk, an ointment, a paste, a gel, a cream based formulation, an oil based formulation, or a liposome-based formulation.
The claims of U.S. Patent No. 12,303,468 B2 do not recite that the composition comprises glyceryl caprylate in an amount of 0.01 to 25.0% by weight, as recited in the instant claims.
Premachandran teaches (claim 19) a synergistic preservation composition capable of providing broad spectrum antimicrobial activity comprising:
about 0.1 wt. % to about 99.9 wt. % of propylene carbonate;
about 0.1 wt. % to about 99.9 wt. % of one or more organic compounds selected from the group consisting of diols, alkane diols, glycerins, alkyl glycerins, esters of glycerins, organic acids and their salts, fatty acids and their salts, and/or esters of long chain fatty acids; and
optionally about 0.1 wt. % to 20.0 wt. % of one or more preservatives.
The organic compounds are taught to include glyceryl caprylate (claim 20). Premachandran further teaches a cosmetic product comprising the preservation composition in the range of from about 0.01 wt. % to 5.0 wt.% (paragraph [0077]-[0078]). The glyceryl caprylate of Premachandran would therefore be present in the cosmetic product from about 0.00001 to 4.995 wt.%, overlapping the range of instant claim 21.
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition of U.S. Patent No. 12,303,468 B2 with the synergistic preservation composition comprising glyceryl caprylate in an amount overlapping instant claim 21, as suggested by Premachandran. One of ordinary skill in the art would have been motivated to do so to achieve a cosmetic composition comprising an effective preservative composition capable of demonstrating cumulative synergism and a reduction in use or required level of organic/preservative compounds (Premachandran, paragraph [0037]).
The claims of U.S. Patent No. 12,303,468 B2 do not recite that the composition further comprises an additional antimicrobial component of ascorbic acid and salts thereof, as recited in the instant claims.
Tutino teaches that L-ascorbic acid has important biological functions for the skin including chelating action with respect to ferric ions (paragraphs [0011] and [0017]). Tutino further teaches that L-ascorbic acid, i.e., vitamin C, is known as an antimicrobial and anti-oxidant additive for nutritional foods or as a disinfectant for pharmaceutical preparations such as cosmetics (paragraph [0002]), and that compositions comprising L-ascorbic acid can by advantageously employed in the cosmetic treatment of skin (paragraph [0001]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in U.S. Patent No. 12,303,468 B2 with ascorbic acid as suggested by Tutino. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to take advantage of the known benefits of ascorbic acid as both a ferric ion chelating agent and disinfecting agent in cosmetic preparations, particularly in cosmetic treatment of the skin, as taught by Tutino.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of U.S. Patent No. 12,303,468 B2, the instant claims are rejected on the ground of nonstatutory double patenting.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 12,303,468 B2, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1, 17-19, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 16, 19, and 22 of copending Application No. 18/009,289 in view of Premachandran et al. (US 2018/0092357 A1, published April 5, 2018, included on IDS submitted 01/13/2023), hereafter “Premachandran” and Tutino et al. (US 2007/0154532 A1, published July 5, 2007; of record), hereafter “Tutino”.
Claims 1, 17-19, and 21-23 are directed to an invention not patentably distinct from claims 1-2, 16, 19, and 22 of commonly assigned Application No. 18/009,289.
Both the instant claims and those of copending application ‘298 are directed to a composition comprising at least one linear alkanediol of 1,2-heptanediol in an amount of 0.001 to 15.0% by weight. The composition further comprises an at least one cosmetically or pharmaceutically active substance and/or additive of anti-microbial agents and antioxidants. Both the instant claims and the claims of ‘289 further recite a cosmetic composition preparation that is a dispersion comprising an oil component in an amount of ≥ 1% by weight wherein the cosmetic composition is in the form of an emulsion, a liquid, a lotion, a suspension, a milk, an ointment, a paste, a gel, a cream based formulation, an oil based formulation, or a liposome-based formulation.
The claims of copending application ‘289 do not recite that the composition comprises glyceryl caprylate in an amount of 0.01 to 25.0% by weight, as recited in the instant claims.
Premachandran teaches (claim 19) a synergistic preservation composition capable of providing broad spectrum antimicrobial activity comprising:
about 0.1 wt. % to about 99.9 wt. % of propylene carbonate;
about 0.1 wt. % to about 99.9 wt. % of one or more organic compounds selected from the group consisting of diols, alkane diols, glycerins, alkyl glycerins, esters of glycerins, organic acids and their salts, fatty acids and their salts, and/or esters of long chain fatty acids; and
optionally about 0.1 wt. % to 20.0 wt. % of one or more preservatives.
The organic compounds are taught to include glyceryl caprylate (claim 20). Premachandran further teaches a cosmetic product comprising the preservation composition in the range of from about 0.01 wt. % to 5.0 wt.% (paragraph [0077]-[0078]. The glyceryl caprylate of Premachandran would therefore be present in the cosmetic product from about 0.00001 to 4.995 wt.%, overlapping the range of instant claim 21.
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition of copending application ‘289 with the synergistic preservation composition comprising glyceryl caprylate in an amount overlapping instant claim 21, as suggested by Premachandran. One of ordinary skill in the art would have been motivated to do so to achieve a cosmetic composition comprising an effective preservative composition capable of demonstrating cumulative synergism and a reduction in use or required level of organic/preservative compounds (Premachandran, paragraph [0037]).
The claims of copending application ‘289 do not recite that the composition further comprises an additional antimicrobial component of ascorbic acid and salts thereof, as recited in the instant claims.
Tutino teaches that L-ascorbic acid has important biological functions for the skin including chelating action with respect to ferric ions (paragraphs [0011] and [0017]). Tutino further teaches that L-ascorbic acid, i.e., vitamin C, is known as an antimicrobial and anti-oxidant additive for nutritional foods or as a disinfectant for pharmaceutical preparations such as cosmetics (paragraph [0002]), and that compositions comprising L-ascorbic acid can by advantageously employed in the cosmetic treatment of skin (paragraph [0001]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition claimed in copending application ‘289 with ascorbic acid as suggested by Tutino. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to take advantage of the known benefits of ascorbic acid as both a ferric ion chelating agent and disinfecting agent in cosmetic preparations, particularly in cosmetic treatment of the skin, as taught by Tutino.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending application ‘289, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application No. 18/009,289, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
Applicant’s arguments filed 01/21/2026 have been fully considered.
Regarding the claim rejections under 35 U.S.C. 103, Applicant argues that the conclusion that the claims are obvious over the cited prior art is ill-founded, as none of the cited prior art references suggest the addition of 1,2-heptanediol to an antimicrobial component, such as glyceryl caprylate, to boost the antimicrobial effect synergistically. Applicant argues that the present application provides experimental data showing that combining 1,2-heptanediol with an antimicrobial results in a synergistic efficiency against specific bacteria, yeasts, and fungi/molds which is superior to the effect of the substances individually (referring to PET data from Table 53). Applicant argues that a large number of antimicrobial components are exemplified and tested, and the synergistic efficiency demonstrated, that one of ordinary skill in the art would understand that this boosting effect of using 1,2-heptanediol with an antimicrobial component is generally applicable to the antimicrobial components recited in claim 1, and that a surprising effect has been demonstrated for the full scope of the claims.
These arguments are unpersuasive. Regarding synergism, MPEP 716.02(a) states, “Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991)”. Here, it is unclear that the effect of the combination of 1,2-heptanediol and the elected species of glyceryl caprylate has achieved an effect that is “greater than the sum of each of the effects taken separately” or that the results are of a significant, practical advantage. The evidence in the specification (see Example 7.3 at [0492]) demonstrates that at 7 days and beyond, the combination achieves the same results as 0.4% 1,2-heptanediol alone for PA, SA, and EC and seemingly shows worse results for CA. The instant specification further notes that 1,2-heptanediol shows significant efficacy against AB (paragraphs [0406]-[0407]), and it is unclear what significant, practical advantage is achieved from the combination with glyceryl caprylate, particularly as independent claim 1 recites “an effective amount of 1,2-heptanediol” with no further limitation on the amount.
The Examiner further respectfully maintains the position of the Office Action mailed 10/21/2025 that the evidence of alleged unexpected results is not commensurate in scope with independent claim 1, drawn to compositions comprising 1,2-heptanediol and at least one of several antimicrobial components in any amounts and any ratios. MPEP 716.02(d) states that unexpected results must be commensurate in scope with the claimed invention. However, “[t]he nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979)”.
The combinations exemplified in Table 53 (and their corresponding tables in the specification) are limited to a narrow concentration range (0.1-0.4%) of 1,2-heptanediol in combination with specific amounts of a subset of the claimed antimicrobial components. As noted in the instant specification, the antimicrobial activity of 1,2-heptanediol is concentration dependent (paragraph [0407]). Further the combinations in Table 53 do not show a predictable “boost” in antimicrobial effect across the tested microbes, with some combinations effective against bacteria, yeast, and fungi/mold, and others only effective against a subset of these. From the evidence of record, one of ordinary skill in the art would not be able to determine a trend in the in the exemplified data to reasonably extend to any combination of claimed components in any concentration and any ratio.
Applicant further argues that none of the cited prior art references teach or suggest that 1,2-heptanediol boosts the antimicrobial effect of antimicrobial components according to the presently claimed invention in a synergistic way when combined with them. Regarding Tsushima, Applicant argues that 1,2-heptanediol is not described as a preferred alkanediol and is not described as having a high antimicrobial activity; Tsushima also fails to describe 1,2-heptanediol as enhancing the antimicrobial efficacy of an antimicrobial component, rather describing that component (B) enhances the effect of (A), but that 1,2-heptane diol does not enhance any efficacy of component (B). Applicant argues that one of ordinary skill in the art would be unlikely to select 1,2-heptanediol as a starting point toward the development of antimicrobial compositions, or at the very least could not have predicted that it would boost the antimicrobial effect of an antimicrobial component.
Regarding Premachandran, Applicant argues that 1,2-heptanediol is not specifically mentioned, and that, while glyceryl caprylate is taught as an organic compound, Premachandran provides an extensive “laundry list” of option to choose from with no guidance as to which to select and no indication of a reasonable expectation by making particular selections. Applicant further argues that Premachandran teaches a synergy that is quite different from that achieved in the present invention, demonstrating that propylene carbonate underlies the synergy observed, even in combination with just one organic compound (i.e., a single 1,2-alkanediol); propylene carbonate is not a required component in the composition of the present invention, which exhibits unexpected synergy in view of the cited art.
These arguments are unpersuasive. The evidence of alleged unexpected results is addressed above. The Examiner further notes that the instant claims broadly recite the open “comprising” language and recite “an effective amount” of 1,2-heptanediol and at least one antimicrobial component. The claims do not recite an effect that must be achieved, that the components act synergistically, or that 1,2-heptanediol boosts the antimicrobial effect of the at least one antimicrobial component, and the claims do not exclude the propylene carbonate taught by Premachandran. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Further, per MPEP 2144 IV, “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)”.
Regarding Tsushima, the Examiner notes that, per MPEP 2123 I., “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)”. Here, in claiming a component (A) that is at least one selected from the group consisting of 1,2-alkanediols having an alkyl group having 6 to 8 carbons (claim 1) and exemplifying 1,2-heptanediol (paragraph [0011]), Tsushima reasonably suggests to one of ordinary skill in the art that 1,2-heptanediol is a suitable diol for use in the antimicrobial composition of Tsushima.
Regarding Premachandran, the Examiner maintains that in claiming the combination of alkane diols and glycerin esters (claim 19) and specifically glyceryl caprylate (claim 20), Premachandran reasonably suggests to one of ordinary skill in the art the inclusion of glyceryl caprylate in antimicrobial compositions capable of providing broad spectrum antimicrobial activity, specifically those containing alkane diols. Further, a reference that "discloses a multitude of effective combinations does not render any particular formulation less obvious." Merck & Co., Inc. V. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).
The Examiner further respectfully maintains that Premachandran reasonably suggests that alkane diols and glyceryl caprylate are capable of demonstrating synergy; Premachandran teaches that one or more organic compounds can be used in preservative compositions and (emphasis added), “inclusion of each additional organic compound is capable of demonstrating cumulative synergy” (paragraph [0016]). Alkane diols and glyceryl caprylate are taught as examples of such organic compounds (claims 19-20). The alkane diols of Premachandran are inclusive of 1,2-heptanediol (paragraph [0047]). Therefore, based on the teachings of the prior art, a skilled artisan would have expected the claimed combination to result in a synergistic effect, and Applicants have not shown how the synergy of the working examples is unexpected. From MPEP 716.02(c) "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967)”.
In view of the forgoing, and as further detailed in the above rejections, the Examiner maintains
that the instant claims are rendered obvious over the prior art of the modified Tsushima.
Regarding the nonstatutory double patenting claim rejections, Applicant argues that the
amended claims are patentably distinct over the reference claims and that the presently pending claims offer distinguishing features not present in the reference applications/patents. For the reasons noted above, it would not have been obvious to modify the compositions of the reference applications/patents based on the teachings of the cited prior art.
These arguments are unpersuasive. The arguments regarding the prior art are addressed above. As detailed above in the non-statutory double patenting rejections, the amended claims are still found to be patentably indistinct from the co-pending applications provided above and U.S. Patent Nos. 11,911,347 B2 and 12,303,468 B2.
Conclusion
Applicant’s arguments are considered unpersuasive. Accordingly, THIS ACTION IS MADE FINAL. 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 JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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