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 .
Status of the Claims
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/09/2026 has been entered.
Claims 1-27 and 31-32 are cancelled.
Claims 37-38 are withdrawn.
Claims 39-40 are newly added
Claims 28-30, 33-36, and 39-40 are under current examination. The claims were read in view of the species elections of a combination of 2,3-octanediol and caprylhydroxamic acid and an active substance for a cosmetic composition the reply filed on 09/12/2023.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Objections
Claim 39 is objected to because of the following informalities: it is believed that “Stephulococcus” in line 2 is a misspelling of Staphylococcus. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 28-30, 33-36, and 39-40 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 28 recites the limitation "the microbes" and “the microbe” in line 13, respectively. There is insufficient antecedent basis for these limitations in the claim. Claim 28 previously recites that “the composition has antimicrobial efficacy”, but does not recite “microbes” or a “microbe”. It is unclear if the claim requires that the composition have antimicrobial efficacy against one or a plurality of microbes. Claims 39 and 40 recite “the microbe is selected from…”, raising similar issues of indefiniteness. It is suggested that Applicant can recite in claim 28, “wherein the composition has antimicrobial efficacy at least 2 days after exposure of a microbe to the composition, and wherein the microbe is selected from…”
Claims 29-30 and 33-36 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 28 and failure to cure the deficiency noted above.
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 28-30, 33-36, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Winn (US 2015/0148421 A1, published May 28, 2015; of record) in view Ciccognani et al. (US 2006/0057175 A1, published March 16, 2006; of record), hereafter “Ciccognani”.
Regarding instant claim 28, Winn teaches a composition for and methods of preserving a topical cosmetic, toiletry or pharmaceutical formulation against microbiological contamination or growth, in which the compositions include at least one hydroxamic acid, salt or complex thereof (see entire document, particularly the abstract). Winn also teaches compositions further including alkanediols and/or solubilizing agents in blends with hydroxamic acid (abstract). The most preferred hydroxamic acid is caprylohydroxamic acid (paragraphs [0024]-[0025]), a synonym for caprylhydroxamic acid. Winn teaches that various diols may be used in the composition, but vicinal diols are preferred (paragraphs [0026]-[0027]); further, alkane vicinal diols have been known in the art for use in anti-microbial compositions (paragraph [0012]). The preferred vicinal diol is caprylyl glycol (also known as 1,2-octanediol) (paragraph [0027]). Winn further teaches that in preferred cosmetic, toiletry, or pharmaceutical compositions, the hydroxamic acid is present from 0.01-10% by weight (paragraph [0038]). The ratio of the alkanediol (alkane vicinal diol) of Winn is suggested at 1:1 (per paragraph [0038]), thus the amount of the vicinal diols is also suggested at 0.01-10% by weight. An example skin care emulsion formulation of Winn demonstrates microbial efficacy against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger at day 7 (at least 2 days) (paragraphs [0044]-[0046], Tables 1-2). Further exemplified formulations demonstrate reduced microbial counts from Day 2 to Day 28 (Examples 2-5, paragraphs [0047]-[0060] including Tables).
Regarding instant claims 29 and 33-34, Examples 1-5 of Winn are directed to cosmetic formulations (a skin care emulsion, a body wash, a lotion, and sunscreen lotions) that comprise a blend of caprylhydroxamic acid and 1,2-octanediol. These formulations further comprise active substances for cosmetic compositions; as just one example, Example 1 of Winn comprises glyceryl stearate and PEG-100 stearate, which is known in the art as an emulsifier. Additional additives for personal care and pharmaceutical formulations are provided in paragraph [0041].
Regarding instant claims 35-36, Winn teaches that the compositions may be an aqueous/alcoholic or glycolic solution based product (paragraph [0042]).
Regarding instant claims 39-40, as noted above, example formulations of Winn demonstrate microbial efficacy against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger from at least 2 days (paragraphs [0044]-[0060], including Tables).
Winn does not expressly teach a composition that comprises both caprylhydroxamic acid and 2,3-octanediol, as recited in instant claim 28. Winn also does not teach that the composition further comprises at least one additional antimicrobial agent, selected from those recited in instant claim 30.
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 (see entire document, particularly the abstract). Preferred capryl glycol analogs are alkanediols where the hydroxyl groups are vicinally substituted; expressly disclosed analogs of capryl glycol include 2,3-octanediol (paragraphs [0013]). The preservative blends are particularly useful in personal care or cosmetics formulations (paragraphs [0026] to [0029]). Ciccognani teaches that the use of caprylyl glycol or one or more analogs thereof in combination with a preservative in cosmetic formulations results in broad anti-microbial protection against bacteria and fungi, in particular against species such as Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Candida albicans, Aspergillus niger and the like, and that the anti-microbiological activity can be synergistic (paragraphs [0044]-[0045]). Ciccognani exemplifies preservative blends against microbes after 8 days (at least 2 days) (paragraphs [0048]-[0051], including Tables) and their use in personal care formulations (see Examples at paragraphs [0052]-[0076]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date instant invention to substitute the 1,2-octanediol with its analog 2-3-octanediol into the composition of Winn and to add other known preservatives, such as the chloroxylenol taught by Ciccognani, to reach the instantly claimed invention.
Winn teaches that 1,2-octanediol is preferred in the composition, but that “medium-chain length, linear vicinal diols that demonstrate antimicrobial activity at relatively low use-levels” are expected to be similarly suitable (paragraph [0027]). Ciccognani further teach that 2,3-octanediol is an analog of 1,2-octanediol useful in compositions having effective broad spectrum preservation activity (paragraph [0013]) and can be used in emulsions and cosmetic formulations (paragraphs [0041] and [0044]). Simple substitution of one vicinal octanediol known to have use in antimicrobial cosmetic compositions for its known analog, similarly known for use in cosmetic compositions having effective broad spectrum preservation activity, is within the purview of the skilled artisan and would yield predictable results (see MPEP 2143 I. B.). This substitution would predictably result in a composition having broad spectrum antimicrobial properties that is suitable for use in cosmetic compositions.
A person of ordinary skill in the art would have been motivated to add in further antimicrobial agents such as chloroxylenol with a reasonable expectation of success as Ciccognani teaches that blends of 1,2-octanediol or analogs thereof with preservatives such as chloroxylenol have effective broad spectrum preservation activity against a wide spectrum of microorganisms for a sustained period of time (paragraphs [0012] and [0024]-[0025]). There is a reasonable expectation of success as the compositions of Winn and Ciccognani are both taught to have use for preserving cosmetic emulsion compositions, as described above. Winn further teaches that other preservatives may be include in the formulations (paragraph [0041]).
As to the particular amount of 2,3-octanediol and caprylhydroxamic acid, the claimed ranges overlap the ranges disclosed in the prior art. 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, 54.1 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. In any event, it is noted that the claims do not require both octanediol and caprylhydroxamic acid, only either one, and the amount taught by the Winn of 0.01-10% by weight of alkanediol (alkane vicinal diol) read on the claimed amount.
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 28-30, 33-36, and 39-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 15-18, and 19-21 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 having a carbon chain of 5 to 14 carbon atoms, which is selected from the group including 2,3-octanediol, in an overlapping amount by weight. The composition further comprises at least one antimicrobial component, which is selected from the group including caprylhydroxamic acid, in in an overlapping amount by weight, and optionally at least one cosmetically or pharmaceutically active substance and/or additive. Both the instant claims and the claims of ‘312 further recite a cosmetic or pharmaceutical preparation that is a dispersion, a liquid surfactant formulation, a solid surfactant formulation, or an aqueous or aqueous/alcoholic or aqueous/glycolic solution.
While the claims of copending Application ‘312 do not explicitly recite that the composition further comprises at least one additional antimicrobial agent, it would be obvious to include in the composition as claim 15 of copending Application ‘312 recites mixtures of two or more antimicrobial components.
The claims of copending Application ’312 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘312 render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 28-30, 33-36, and 39-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 17, 19, 24, and 29 of copending Application No. 18/009,291 in view of Winn (US 2015/0148421 A1, published May 28, 2015; of record).
Claims 28-30, 33-36, and 39-40 are directed to an invention not patentably distinct from claims 2, 17, 19, 24, and 29 of commonly assigned Application No. 18/009,291.
Both the instant claims and those of copending Application ‘291 are directed to a cosmetic or pharmaceutical composition comprising at least one linear alkanediol having a carbon chain of 5 to 14 carbon atoms, which is selected from the group including 2,3-octanediol in overlapping amounts by weight. The composition of ‘Application 291 optionally comprises at least one antimicrobial compound and optionally at least one active substance for a cosmetic or pharmaceutical composition. While the claims of copending Application ‘291 do not explicitly recite that the composition further comprises at least one additional antimicrobial agent required by the instant claims, claim 2 recites “at least one antimicrobial compound”; the specification of copending Application ‘291 defines “at least one antimicrobial compound” to include mixtures of two (paragraph [0034]). The claims of copending Application ‘291 further recite a cosmetic product in the form of a hydrodispersion gel; the instant claims also recite a dispersion in the form of a gel.
The claims of copending Application ‘291 do not recite that the composition comprises caprylhydroxamic acid in an amount of 0.01 to 6.0% by weight, as recited in the instant claims.
Winn teaches a composition for and methods of preserving a topical cosmetic, toiletry or pharmaceutical formulation against microbiological contamination or growth; the compositions include at least one hydroxamic acid, salt or complex thereof, and further include alkanediols and/or solubilizing agents in blends with hydroxamic acid (abstract). Winn further discloses that alkane vicinal diols have been known in the art as liquid antimicrobial agent (paragraph [0012]). The most preferred hydroxamic acid is caprylhydroxamic acid (paragraph [0025]). Various diols may be used, but vicinal dials are preferred (paragraph [0026]). Winn further discloses that the hydroxamic acid is present from 0.01-10% by weight (paragraph [0038]). The ratio of the alkanediol (alkane vicinal diol) of Winn is suggested at 1:1 (per paragraph [0038]), thus the amount of the vicinal diols is also suggested to comprise 0.01-10% by weight.
It would have been prima facie obvious to one of ordinary skill in the art to use weight percentage of caprylhydroxamic acid, as taught by Winn, in the composition of copending Application ‘291. One would have been motivated to do so as Winn teaches that when effective amounts of alkylhydroxamic acids are added to topical cosmetic, toiletry, and pharmaceutical formulations, it results in a non-toxic, broad pH, and effective preservative method against a range of bacteria, yeast, and fungi (paragraph [0033]). The instant claims recite that the caprylhydroxamic acid in an amount which overlaps with the range taught by Winn, and is thus rendered obvious by the prior art.
The claims of copending Application ’291 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘291 in view of Winn render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 18/009,291, 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 28-30, 33-36, and 39-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 16-19, 21, and 37-39 of copending Application No. 18/009,288 in view of Winn (US 2015/0148421 A1, published May 28, 2015; of record).
Claims 28-30, 33-36, and 39-40 are directed to an invention not patentably distinct from claims 2, 16-19, 21, and 37-39 of commonly assigned Application No. 18/009,288.
Both the instant claims and the claims of copending Application ‘288 are directed to a cosmetic or pharmaceutical composition or homecare product comprising at least one linear alkanediol selected from the group including 2,3-octanediol, in overlapping amounts by weight. The composition further comprises at least one antimicrobial compound selected from the group including caprylhydroxamic acid, and optionally at least one active substance for a cosmetic, or pharmaceutical composition or a homecare product and/or additive. While the claims of copending Application ‘288 do not explicitly recite that the composition further comprises at least one additional antimicrobial agent, as required by the instant claims, it would be obvious to include in the composition as claim 17 recites “mixtures of two or more the aforesaid antimicrobial agents”. The instant claims and those of copending Application ‘288 further recite a cosmetic or pharmaceutical composition or homecare product that is a dispersion, a liquid surfactant formulation, or an aqueous or aqueous/alcoholic or aqueous/glycolic solution.
The instant claims recite the caprylhydroxamic acid in an amount of 0.01 to 6.0% by weight, which is not recited in the claims of copending Application ‘288.
Winn teaches a composition for and methods of preserving a topical cosmetic, toiletry or pharmaceutical formulation against microbiological contamination or growth; the compositions include at least one hydroxamic acid, salt or complex thereof, and further include alkanediols and/or solubilizing agents in blends with hydroxamic acid (abstract). The most preferred hydroxamic acid is caprylhydroxamic acid (paragraph [0025]); Winn further discloses that the hydroxamic acid is present from 0.01-10% by weight (paragraph [0038]).
It would have been prima facie obvious to one of ordinary skill in the art to use weight percentage of caprylhydroxamic acid, as taught by Winn, in the composition of copending Application ‘288. One would have been motivated to do so as Winn teaches that when effective amounts of alkylhydroxamic acids are added to topical cosmetic, toiletry, and pharmaceutical formulations, it results in a non-toxic, broad pH, and effective preservative method against a range of bacteria, yeast, and fungi (paragraph [0033]). The instant claims recite that the caprylhydroxamic acid in an amount which overlaps with the range taught by Winn, and is thus rendered obvious by the prior art.
The claims of copending Application ’288 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘288 in view of Winn render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 18/009,288, 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 28-30, 33-36, and 39-40 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 Winn (US 2015/0148421 A1, published May 28, 2015; of record) and Ciccognani et al. (US 2006/0057175 A1, published March 16, 2006; of record), hereafter “Ciccognani”.
Claims 28-30, 33-36, and 39-40 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 2,3-alkanediol having a carbon chain of 5 to 13 carbon atoms, which is selected from the group including 2,3-octanediol, in an overlapping amount by weight, the same at least one active substance for a cosmetic product and/or additive, and the inclusion of antimicrobial compounds. Both sets of claims further recite a cosmetic product that is aqueous (see copending claim 25 which recites micellar water).
The instant claims recite the inclusion of caprylhydroxamic acid in an amount of 0.01 to 6.0% by weight, which is not recited in the claims of copending Application ‘090.
Winn teaches a composition for and methods of preserving a topical cosmetic, toiletry or pharmaceutical formulation against microbiological contamination or growth; the compositions include at least one hydroxamic acid, salt or complex thereof, and further include alkanediols and/or solubilizing agents in blends with hydroxamic acid (abstract). The most preferred hydroxamic acid is caprylhydroxamic acid (paragraph [0025]); Winn further discloses that the hydroxamic acid is present from 0.01-10% by weight (paragraph [0038]).
It would have been prima facie obvious to one of ordinary skill in the art to use weight percentage of caprylhydroxamic acid, as taught by Winn, in the composition of copending application copending Application ‘090. One would have been motivated to do so as Winn teaches that when effective amounts of alkylhydroxamic acids are added to topical cosmetic, toiletry, and pharmaceutical formulations, it results in a non-toxic, broad pH, and effective preservative method against a range of bacteria, yeast, and fungi (paragraph [0033]). The instant claims recite that the caprylhydroxamic acid in an amount which overlaps with the range taught by Winn, and is thus rendered obvious by the prior art.
The claims of copending Application ‘090 do not teach an antimicrobial agent selected from those in instant claim 30.
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). Preferred capryl glycol analogs are alkanediols where the hydroxyl groups are vicinally substituted; expressly disclosed analogs of capryl glycol include 2,3-octanediol (paragraphs [0013]). The preservative blends are particularly useful in personal care or cosmetics formulations (paragraphs [0026] to [0029]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition of copending Application ‘090 to include antimicrobial agents such as the chloroxylenol taught by Ciccognani. One would have been motivated to do so as Ciccognani teaches that blends of 1,2-octanediol or analogs thereof, such as 2,3-octanediol, with preservatives such as chloroxylenol have effective broad spectrum preservation activity against a wide spectrum of microorganisms for a sustained period of time (paragraphs [0012] and [0024]-[0025]).
The claims of copending Application ’090 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘090 in view of Winn and Ciccognani render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 18/301,090, 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 28-30, 33-36, and 39-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, and 8 of U.S. Patent No. 11,911,347 B2 in view of Winn (US 2015/0148421 A1, published May 28, 2015; of record) and Ciccognani et al. (US 2006/0057175 A1, published March 16, 2006; of record), hereafter “Ciccognani”.
Claims 28-30, 33-36, and 39-40 are directed to an invention not patentably distinct from claims 1, 5-6, 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 having a carbon chain of 5 to 14 carbon atoms, which is selected from the group including 2,3-octanediol, in overlapping amounts by weight. The composition further comprises the same at least one cosmetically or pharmaceutically active substance and/or additive. Both the instant claims and the claims of U.S. Patent No. 11,911,347 B2 further recite a cosmetic or pharmaceutical preparation that is a dispersion, a liquid surfactant formulation, a solid surfactant formulation, or an aqueous or aqueous/alcoholic or aqueous/glycolic solution.
The instant claims recite the inclusion of caprylhydroxamic acid in an amount of 0.01 to 6.0% by weight, which is not recited in the claims of U.S. Patent No. 11,911,347 B2.
Winn teaches a composition for and methods of preserving a topical cosmetic, toiletry or pharmaceutical formulation against microbiological contamination or growth; the compositions include at least one hydroxamic acid, salt or complex thereof, and further include alkanediols and/or solubilizing agents in blends with hydroxamic acid (abstract). The most preferred hydroxamic acid is caprylhydroxamic acid (paragraph [0025]); Winn further discloses that the hydroxamic acid is present from 0.01-10% by weight (paragraph [0038]).
It would have been prima facie obvious to one of ordinary skill in the art to use weight percentage of caprylhydroxamic acid, as taught by Winn, in the composition of U.S. Patent No. 11,911,347 B2. One would have been motivated to do so as Winn teaches that when effective amounts of alkylhydroxamic acids are added to topical cosmetic, toiletry, and pharmaceutical formulations, it results in a non-toxic, broad pH, and effective preservative method against a range of bacteria, yeast, and fungi (paragraph [0033]). The instant claims recite that the caprylhydroxamic acid in an amount which overlaps with the range taught by Winn, and is thus rendered obvious by the prior art.
The claims of U.S. Patent No. 11,911,347 B2 do not teach an antimicrobial agent selected from those in instant claim 30.
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). Preferred capryl glycol analogs are alkanediols where the hydroxyl groups are vicinally substituted; expressly disclosed analogs of capryl glycol include 2,3-octanediol (paragraphs [0013]). The preservative blends are particularly useful in personal care or cosmetics formulations (paragraphs [0026] to [0029]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition of U.S. Patent No. 11,911,347 B2 to include antimicrobial agents such as the chloroxylenol taught by Ciccognani. One would have been motivated to do so as Ciccognani teaches that blends of 1,2-octanediol or analogs thereof, such as 2,3-octanediol, with preservatives such as chloroxylenol have effective broad spectrum preservation activity against a wide spectrum of microorganisms for a sustained period of time (paragraphs [0012] and [0024]-[0025]).
The claims of U.S. Patent No. 11,911,347 B2 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of U.S. Patent No. 11,911,347 B2 in view of Winn and Ciccognani render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
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 28-30, 33-36, and 39-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 18-19, and 22 of copending Application No. 18/009,324 in view of Winn (US 2015/0148421 A1, published May 28, 2015; of record) and Ciccognani et al. (US 2006/0057175 A1, published March 16, 2006; of record), hereafter “Ciccognani”.
Claims 28-30, 33-36, and 39-40 are directed to an invention not patentably distinct from claims 2, 18-19, and 22 of commonly assigned Application No. 18/009,324.
Both the instant claims and those of copending Application ‘324 are directed to a composition comprising at least one linear alkanediol having a carbon chain of 5 to 14 carbon atoms, which is selected from the group including 2,3-octanediol, in an overlapping amount by weight, the same at least one active substance for a cosmetic product and/or additive, and the inclusion of antimicrobial agents. Both the instant claims and the claims of copending Application ‘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 instant claims recite the inclusion of caprylhydroxamic acid in an amount of 0.01 to 6.0% by weight, which is not recited in the claims of copending Application ‘324.
Winn teaches a composition for and methods of preserving a topical cosmetic, toiletry or pharmaceutical formulation against microbiological contamination or growth; the compositions include at least one hydroxamic acid, salt or complex thereof, and further include alkanediols and/or solubilizing agents in blends with hydroxamic acid (abstract). The most preferred hydroxamic acid is caprylhydroxamic acid (paragraph [0025]); Winn further discloses that the hydroxamic acid is present from 0.01-10% by weight (paragraph [0038]).
It would have been prima facie obvious to one of ordinary skill in the art to use weight percentage of caprylhydroxamic acid, as taught by Winn, in the composition of copending Application ‘324. One would have been motivated to do so as Winn teaches that when effective amounts of alkylhydroxamic acids are added to topical cosmetic, toiletry, and pharmaceutical formulations, it results in a non-toxic, broad pH, and effective preservative method against a range of bacteria, yeast, and fungi (paragraph [0033]). The instant claims recite that the caprylhydroxamic acid in an amount which overlaps with the range taught by Winn, and is thus rendered obvious by the prior art.
The claims of copending Application ‘324 do not teach an antimicrobial agent selected from those in instant claim 30.
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). Preferred capryl glycol analogs are alkanediols where the hydroxyl groups are vicinally substituted; expressly disclosed analogs of capryl glycol include 2,3-octanediol (paragraphs [0013]). The preservative blends are particularly useful in personal care or cosmetics formulations (paragraphs [0026] to [0029]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition of copending Application ‘324 to include antimicrobial agents such as the chloroxylenol taught by Ciccognani. One would have been motivated to do so as Ciccognani teaches that blends of 1,2-octanediol or analogs thereof, such as 2,3-octanediol, with preservatives such as chloroxylenol have effective broad spectrum preservation activity against a wide spectrum of microorganisms for a sustained period of time (paragraphs [0012] and [0024]-[0025]).
The claims of copending Application ’324 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘324 in view of Winn and Ciccognani render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 18/009,324, 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 28-30, 33-36, and 39-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 16, 19, and 22 of copending Application No. 18/009,289 in view of Winn (US 2015/0148421 A1, published May 28, 2015; of record) and Ciccognani et al. (US 2006/0057175 A1, published March 16, 2006; of record), hereafter “Ciccognani”.
Claims 28-30, 33-36, and 39-40 are directed to an invention not patentably distinct from claims 2, 16, 19, and 22 of commonly assigned Application No. 18/009,289.
Both the instant claims and those of copending Application ‘289 are directed to a composition comprising at least one linear alkanediol having a carbon chain of 5 to 14 carbon atoms, which is selected from the group including 2,3-octanediol, in an overlapping amount by weight, the same at least one active substance for a cosmetic product and/or additive, and the inclusion of antimicrobial agents. Both the instant claims and the claims of copending Application ‘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 instant claims recite the inclusion of caprylhydroxamic acid in an amount of 0.01 to 6.0% by weight, which is not recited in the claims of copending Application ‘289.
Winn teaches a composition for and methods of preserving a topical cosmetic, toiletry or pharmaceutical formulation against microbiological contamination or growth; the compositions include at least one hydroxamic acid, salt or complex thereof, and further include alkanediols and/or solubilizing agents in blends with hydroxamic acid (abstract). The most preferred hydroxamic acid is caprylhydroxamic acid (paragraph [0025]); Winn further discloses that the hydroxamic acid is present from 0.01-10% by weight (paragraph [0038]).
It would have been prima facie obvious to one of ordinary skill in the art to use weight percentage of caprylhydroxamic acid, as taught by Winn, in the composition of copending Application ‘289. One would have been motivated to do so as Winn teaches that when effective amounts of alkylhydroxamic acids are added to topical cosmetic, toiletry, and pharmaceutical formulations, it results in a non-toxic, broad pH, and effective preservative method against a range of bacteria, yeast, and fungi (paragraph [0033]). The instant claims recite that the caprylhydroxamic acid in an amount which overlaps with the range taught by Winn, and is thus rendered obvious by the prior art.
The claims of copending Application ‘289 do not teach an antimicrobial agent selected from those in instant claim 30.
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). Preferred capryl glycol analogs are alkanediols where the hydroxyl groups are vicinally substituted; expressly disclosed analogs of capryl glycol include 2,3-octanediol (paragraphs [0013]). The preservative blends are particularly useful in personal care or cosmetics formulations (paragraphs [0026] to [0029]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition of copending Application ‘289 to include antimicrobial agents such as the chloroxylenol taught by Ciccognani. One would have been motivated to do so as Ciccognani teaches that blends of 1,2-octanediol or analogs thereof, such as 2,3-octanediol, with preservatives such as chloroxylenol have effective broad spectrum preservation activity against a wide spectrum of microorganisms for a sustained period of time (paragraphs [0012] and [0024]-[0025]).
The claims of copending Application ’289 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘289 in view of Winn and Ciccognani render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 18/009,289, 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.
Claims 28-30, 33-36, and 39-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17-18, and 21-23 of copending Application No. 18/009,295 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Both the instant claims and those of copending Application ‘295 are directed to compositions comprising at least one antimicrobial component selected from caprylhydroxamic acid, 2,3 octanediol and mixtures thereof, in overlapping amounts by weight, and optionally at least one active substance for a food, a cosmetic, or pharmaceutical composition or a homecare product and/or additive. The composition further comprises at least one additional antimicrobial agent selected from the same group of agents. Both the instant claims and the claims of ‘295 further recite a food, cosmetic, or pharmaceutical preparation and a cosmetic or pharmaceutical preparation that is a dispersion, a liquid surfactant formulation, a solid surfactant formulation, or an aqueous or aqueous/alcoholic or aqueous/glycolic solution.
The claims of copending Application ’295 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘295 render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 28-30, 33-36, and 39-40 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 Winn (US 2015/0148421 A1, published May 28, 2015; of record) and Ciccognani et al. (US 2006/0057175 A1, published March 16, 2006; of record), hereafter “Ciccognani”.
Claims 28-30, 33-36, and 39-40 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 those of copending Application ‘004 are directed to a composition comprising at least one linear alkanediol having a carbon chain of 5 to 14 carbon atoms, which is selected from the group including 2,3-octanediol, in an overlapping amount by weight, the same at least one active substance for a cosmetic product and/or additive, and the inclusion of antimicrobial agents. Both the instant claims and the claims of copending Application ‘004 further recite a cosmetic composition preparation 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 instant claims recite the inclusion of caprylhydroxamic acid in an amount of 0.01 to 6.0% by weight, which is not recited in the claims of copending Application ‘004.
Winn teaches a composition for and methods of preserving a topical cosmetic, toiletry or pharmaceutical formulation against microbiological contamination or growth; the compositions include at least one hydroxamic acid, salt or complex thereof, and further include alkanediols and/or solubilizing agents in blends with hydroxamic acid (abstract). The most preferred hydroxamic acid is caprylhydroxamic acid (paragraph [0025]); Winn further discloses that the hydroxamic acid is present from 0.01-10% by weight (paragraph [0038]).
It would have been prima facie obvious to one of ordinary skill in the art to use weight percentage of caprylhydroxamic acid, as taught by Winn, in the composition of copending Application ‘004. One would have been motivated to do so as Winn teaches that when effective amounts of alkylhydroxamic acids are added to topical cosmetic, toiletry, and pharmaceutical formulations, it results in a non-toxic, broad pH, and effective preservative method against a range of bacteria, yeast, and fungi (paragraph [0033]). The instant claims recite that the caprylhydroxamic acid in an amount which overlaps with the range taught by Winn, and is thus rendered obvious by the prior art.
The claims of copending Application ‘004 do not teach an antimicrobial agent selected from those in instant claim 30.
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). Preferred capryl glycol analogs are alkanediols where the hydroxyl groups are vicinally substituted; expressly disclosed analogs of capryl glycol include 2,3-octanediol (paragraphs [0013]). The preservative blends are particularly useful in personal care or cosmetics formulations (paragraphs [0026] to [0029]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition of copending application ‘004 to include antimicrobial agents such as the chloroxylenol taught by Ciccognani. One would have been motivated to do so as Ciccognani teaches that blends of 1,2-octanediol or analogs thereof, such as 2,3-octanediol, with preservatives such as chloroxylenol have effective broad spectrum preservation activity against a wide spectrum of microorganisms for a sustained period of time (paragraphs [0012] and [0024]-[0025]).
The claims of copending Application ’004 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘004 in view of Winn and Ciccognani render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 18/301,004, 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 28-30, 33-36, and 39-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 18-19, 22-24, 26, 28-29, and 32-34 of copending Application No. 18/009,314 in view of Winn (US 2015/0148421 A1, published May 28, 2015; of record) and Ciccognani et al. (US 2006/0057175 A1, published March 16, 2006; of record), hereafter “Ciccognani”.
Claims 28-30, 33-36, and 39-40 are directed to an invention not patentably distinct from claims 1, 13, 18-19, 22-24, 26, 28-29, and 32-34 of commonly assigned Application No. 18/009,314.
Both the instant claims and those of copending Application ‘314 are directed to a composition (formulation) comprising at least one linear 2,3-alkanediol having a carbon chain of 5 to 13 carbon atoms, which is selected from the group including 2,3-octanediol, in an overlapping amount by weight, the same at least one active substance for a cosmetic product and/or additive, and the inclusion of antimicrobial agents. Both sets of claims further recite a cosmetic product that is aqueous (see copending claim 13 which recites micellar water).
The instant claims recite the inclusion of caprylhydroxamic acid in an amount of 0.01 to 6.0% by weight, which is not recited in the claims of copending Application ‘314.
Winn teaches a composition for and methods of preserving a topical cosmetic, toiletry or pharmaceutical formulation against microbiological contamination or growth; the compositions include at least one hydroxamic acid, salt or complex thereof, and further include alkanediols and/or solubilizing agents in blends with hydroxamic acid (abstract). The most preferred hydroxamic acid is caprylhydroxamic acid (paragraph [0025]); Winn further discloses that the hydroxamic acid is present from 0.01-10% by weight (paragraph [0038]).
It would have been prima facie obvious to one of ordinary skill in the art to use weight percentage of caprylhydroxamic acid, as taught by Winn, in the composition of copending Application ‘314. One would have been motivated to do so as Winn teaches that when effective amounts of alkylhydroxamic acids are added to topical cosmetic, toiletry, and pharmaceutical formulations, it results in a non-toxic, broad pH, and effective preservative method against a range of bacteria, yeast, and fungi (paragraph [0033]). The instant claims recite that the caprylhydroxamic acid in an amount which overlaps with the range taught by Winn, and is thus rendered obvious by the prior art.
The claims of copending Application ‘314 do not teach an antimicrobial agent selected from those in instant claim 30.
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). Preferred capryl glycol analogs are alkanediols where the hydroxyl groups are vicinally substituted; expressly disclosed analogs of capryl glycol include 2,3-octanediol (paragraphs [0013]). The preservative blends are particularly useful in personal care or cosmetics formulations (paragraphs [0026] to [0029]).
It would have been prima facie obvious to one of ordinary skill in the art to modify the composition of copending Application ‘314 to include antimicrobial agents such as the chloroxylenol taught by Ciccognani. One would have been motivated to do so as Ciccognani teaches that blends of 1,2-octanediol or analogs thereof, such as 2,3-octanediol, with preservatives such as chloroxylenol have effective broad spectrum preservation activity against a wide spectrum of microorganisms for a sustained period of time (paragraphs [0012] and [0024]-[0025]).
The claims of copending Application ’314 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘314 in view of Winn and Ciccognani render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 18/009,314, 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 28-30, 33-36, and 39-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-6, and 8-11 of copending Application No. 19/499,536 in view of Winn (US 2015/0148421 A1, published May 28, 2015; of record).
Claims 28-30, 33-36, and 39-40 are directed to an invention not patentably distinct from claims 1, 3, 5-6, and 8-11 of commonly assigned Application No. 19/499,536.
Both the instant claims and those of copending Application ‘536 are directed to a composition (mixture) comprising one or more antimicrobial agents selected from the group including 2,3-octanediol, caprylhydroxamic acid, and those consistent with instant claim 30 (see copending claim 3). Both the instant claims and the claims of copending Application ‘536 further recite a pharmaceutical preparation comprising an oil component (an active component consistent with those recited in instant claim 29) 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 compositions of both sets of claims are taught to have an antimicrobial effect.
The instant claims recite the inclusion of caprylhydroxamic acid in an amount of 0.01 to 6.0% by weight and 2,3-octanediol in an amount of 0.0001 to 5% by weight, which is not recited in the claims of copending Application ‘536.
Winn teaches a composition for and methods of preserving a topical cosmetic, toiletry or pharmaceutical formulation against microbiological contamination or growth; the compositions include at least one hydroxamic acid, salt or complex thereof, and further include alkanediols and/or solubilizing agents in blends with hydroxamic acid (abstract). The most preferred hydroxamic acid is caprylhydroxamic acid (paragraph [0025]); Winn further discloses that the hydroxamic acid is present from 0.01-10% by weight (paragraph [0038]). The ratio of the alkanediol (alkane vicinal diol) of Winn is suggested at 1:1 (per paragraph [0038]), thus the amount of the vicinal diols is also suggested at 0.01-10% by weight.
It would have been prima facie obvious to one of ordinary skill in the art to use weight percentage of caprylhydroxamic acid and vicinal diol, as taught by Winn, in the composition of copending Application ‘536. One would have been motivated to do so as Winn teaches that when effective amounts of alkylhydroxamic acids are added to topical cosmetic, toiletry, and pharmaceutical formulations, it results in a non-toxic, broad pH, and effective preservative method against a range of bacteria, yeast, and fungi (paragraph [0033]), and that vicinal diols are known to be effective against bacteria and yeast (paragraph [0027]). The instant claims recite that the caprylhydroxamic acid and vicinal diol are in an amount which overlaps with the ranges taught by Winn, and are thus rendered obvious by the prior art. Per MPEP 2144.05, “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, 54.1 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
The claims of copending Application ’536 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘536 in view of Winn render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 19/499,536, 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. 19/499,536, 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 28-30, 33-36, and 39-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12-15, and 17-19 copending Application No. 19/100,574 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 28-30, 33-36, and 39-40 are directed to an invention not patentably distinct from claims 1, 12-15, and 17-19 of commonly assigned Application No. 19/100,574.
Both the instant claims and those of copending Application ‘574 are directed to compositions comprising at least one antimicrobial component selected from caprylhydroxamic acid, 2,3 octanediol, those consistent with instant claim 30 (see copending claims 12 and 14), and mixtures thereof, in overlapping amounts by weight, and at least one active substance for a food, a cosmetic, or pharmaceutical composition, or a homecare product. Both the instant claims and the claims of ‘574 further recite a food, cosmetic, or pharmaceutical preparation that is a dispersion, a liquid surfactant formulation, a solid surfactant formulation, or an aqueous or aqueous/alcoholic or aqueous/glycolic solution.
The claims of copending Application ’574 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘574 render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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. 19/100,574, 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 28-30, 33-36, and 39-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, 11-12, 17, and 22 of copending Application No. 18/858,297 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 28-30, 33-36, and 39-40 are directed to an invention not patentably distinct from claims 1, 4-7, 11-12, 17, and 22 of commonly assigned Application No. 18/858,297.
Both the instant claims and those of copending Application ‘297 are directed to compositions comprising at one antimicrobial component selected from caprylhydroxamic acid, 2,3 octanediol, those consistent with instant claim 30 (see copending claims 4-5), and mixtures thereof, in overlapping amounts by weight, and at least one active substance for a food, a cosmetic, or pharmaceutical composition, or a homecare product. Both the instant claims and the claims of ‘297 further recite a food, cosmetic, or pharmaceutical preparation that is a dispersion comprising an oil component in an amount of ≥ 1% by weight, a liquid surfactant formulation, a solid surfactant formulation, or an aqueous or aqueous/alcoholic or aqueous/glycolic solution.
The claims of copending Application ’297 do not explicitly recite that the composition has antimicrobial efficacy at least 2 days after exposure of the recited microbes to the composition. However, the claims of copending Application ‘297 render obvious the structural limitations of the claimed composition, and the claimed antimicrobial properties would necessarily follow, absent evidence to the contrary.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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. 18/858,297, 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 04/09/2026 have been fully considered.
Regarding the claim rejections under 35 USC § 103, Applicant argues that the prior art neither teaches nor suggests the claimed composition, and the invention as presently claimed possesses unexpectedly superior properties that could not have been predicted from Winn and/or Ciccognani. Particularly, Applicant argues that, 2,3-octanediol in particular, and 2,3-alkanediols having an alkyl chain of more than four carbon atoms generally, do not constitute a cosmetic ingredient, and 2,3-octanediol was known to have a lower antimicrobial efficacy than its 1,2-counterpart, 1,2-octanediol (referring to the PETs of Table 47, the MIC data on pg. 8 of the Remarks, and the Further Koch Declaration filed 07/31/2025), including at the 2 day mark. Applicant argues that it cannot be concluded that the analogs have the same antimicrobial effect and can simply be swapped with predictable results; if 2,3-octanediol were simply substituted for 1,2-octanediol, this would not result in an equivalent antimicrobial effect but rather a weaker antimicrobial effect.
These arguments are unpersuasive. Regarding the argument that 2,3-octanediol generally does not constitute a cosmetic ingredient, the Examiner reiterates the position of the Office Action mailed 10/10/2025 that the prior art of Ciccognani clearly teaches a composition having broad spectrum preservation activity comprising a mixture of caprylyl glycol or one or more analogs thereof (paragraph [0009]) and that preferred analogs are alkanediols wherein the hydroxyl groups are vicinally substituted, examples of which include 2,3-octanediol (paragraph [0013]). Ciccognani further clearly envisions cosmetic formulations comprising such compositions (paragraphs [0028] and [0041]) and thus contemplates the use of 2,3-octanediol as a cosmetic ingredient.
Regarding the argument that substitution of 2,3-octanediol for 1,2-octanediol would result in a weaker antimicrobial effect, the Examiner respectfully maintains that the current evidence of record shows that both 1,2-octanediol and 2,3-octanediol demonstrate antimicrobial activity against a range of microorganisms, with comparable activity in multiple instances, particularly against PA and AB microorganisms. The Examiner reemphasizes that the instant claims do not require any particular degree of antimicrobial or preservation activity, and both analogs are shown to have an antimicrobial effect against all microorganisms tested. Further, the prior art of Ciccognani expressly disclose the compounds as analogues (paragraph [0013]). Substitution of 1,2-octanediol in the compositions of Winn for its known analog of 2,3-octanediol would predictably result in compositions with effective broad spectrum preservation activity.
Applicant further argues that the present invention achieved unexpected superior results that could not have been predicted from the prior art that adding 2,3-octanediol enhances/improves the antimicrobial efficacy of caprylhydroxamic acid at least 2 days after exposure of the microbes to the composition (referring to Table 24). In particular, by using only half the original concentration of caprylhydroxamic acid, an even better effect is achieved, and the composition provides improved antimicrobial efficacy while enabling a considerable reduction in the concentration of the caprylhydroxamic acid. Applicant argues that the prior art does not teach or suggest that an antimicrobial effect can be obtained at least 2 days after exposure of the microbes to the composition (as recited in the claims as presently pending), and that the concentration of the antimicrobial component can be considerably reduced by the addition of 2,3-alkanediol.
In response, the Examiner first notes that the limitation of “at least 2 days after” is inclusive of times 2 days and later (e.g., 7 days, 14 days, etc.). As set forth in the above rejections, example formulations of Winn demonstrate microbial efficacy against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, Aspergillus niger from at least 2 days (paragraphs [0044]-[0060], including Tables); Ciccognani similarly exemplifies preservative blends against microbes after 8 days (at least 2 days) (paragraphs [0048]-[0051], including Tables).
The Examiner further respectfully maintains the position set forth in the Office Action mailed 10/10/2025 that the evidence of alleged unexpected results is not commensurate in scope with independent claim 28, which is drawn to a composition comprising 2,3-octanediol or 2,3-heptanediol in an amount of 0.0001 to 5% by weight and caprylhydroxamic acid or glyceryl caprylate in an amount of 0.01 to 6.0%. 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 example provided in Table 24 is limited to a composition comprising 0.1 wt.% 2,3-octanediol and 0.2 wt.% caprylhydroxamic acid (corresponding to a 1:2 ratio of 2,3-octanediol:caprylhydroxamic acid). From this one example, 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 the full range of concentrations claimed in any ratio of the claimed components.
Further, 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 2,3-octandiol and caprylhydroxamic acid 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. At 7 days and beyond (at least 2 days), the combination achieves the same results as 0.4% caprylhydroxamic acid alone for PA, SA, EC, and CA, and no significant improvement against AB is observed, with the combination performing worse against AB at 2 days, 14 days, and 28 days than caprylhydroxamic acid alone. It is reemphasized that 0.4% caprylhydroxamic acid is within the scope of weight percentages recited in the instant claims, and it is unclear what significant, practical advantage is achieved from the combination with 2,3-octanediol. Note that the claims do not require both octanediol and caprylhydroxamic acid, only either one, and the effect shown by applicants resulted from both ingredients. Therefore, the effects shown by applicants are not commensurate in scope with the claims.
The Examiner also respectfully maintains the position that the prior art of Ciccognani teaches that 1,2-octanediol, or analogs thereof, has synergistic effects in preservative blends, particularly with regard to anti-microbiological activity (paragraph [0044]). 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)”.
The Examiner further reiterates that obviousness does not require absolute predictability; per MPEP 2145, “Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. The Federal Circuit concluded that "[g]ood science and useful contributions do not necessarily result in patentability." Id. at 1364, 83 USPQ2d at 1304.” Further, the test for obviousness is what the combined teachings of the references would have suggested to those of ordinary skill in the art, In re Keller, 642 F. 2d 413, 208 USPQ 871 (CCPA 1981).
As set forth in the above rejection, Winn teaches compositions for preserving a topical cosmetic formulation against microbiological contamination or growth comprising hydroxamic acid (particularly caprylhydroxamic acid) and vicinal diols (particularly 1,2-octanediol), and Ciccognani reasonably suggest to one of ordinary in the art that 2,3-octanediol is a known analog of 1,2-octanediol useful in compositions having broad spectrum preservation activity which can be used in cosmetic formulations. The Examiner maintains that the teachings of the prior art establish a reasonable expectation of success in achieving a composition having antimicrobial properties that is suitable for use in a cosmetic composition by substituting 2,3-octanediol for the 1,2-octandiol exemplified by Winn. Particularly, an ordinary skilled artisan is made aware from the teachings of Ciccognani that both caprylyl glycol and its analogs (clearly defined to include 2,3-octanediol, see paragraph [0013]) result in broad spectrum preservation activity with preservative compositions. Claim 1, and paragraphs [0044]-[0045] of Ciccognani clearly suggest to an ordinary skilled artisan that caprylyl glycol or analog thereof with preservative blends results in antimicrobial activity.
In view of the foregoing, and as further detailed in the above rejections, the Examiner maintains that the preponderance of evidence suggests that the instant claims are obvious over the prior art of Winn in view of Ciccognani.
Regarding the nonstatutory double patenting claim rejections, Applicant argues that the amended claims are not patentably indistinct from the recited claims as set forth in the provisional nonstatutory type double patenting rejections.
These arguments are unpersuasive. 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 No. 11,911,347 B2.
Conclusion
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/Isis A Ghali/Primary Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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