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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 6-7, and 9-10 in the reply filed on 21 May 2026 is acknowledged. Accordingly, claims 21-24, 26, 28-32, and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 1 is objected to because of the following informalities: immediately prior to each of the two recitations of “preservative agent” in the penultimate line, there should be recited --- at least one ---. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: in lines 3 and 4, immediately prior to each recitation of “preservative agent”, there should be recited --- at least one ---. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: immediately prior to “preservative agent” in line 2 of the claim there should be recited --- at least one ---. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: immediately prior to “preservative agent” in line 2 of the claim there should be recited --- at least one ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6-7, and 9-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “increase the efficacy” in claims 1 and 2 is a relative term which renders the claim indefinite. The terms “increase” and “efficacy” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what extent of increase are considered an “increase”, or how the “efficacy” is determined (e.g., increased time on shelf, lack of bacterial presence, retardation of chemical degradation, retardation of physical separation, etc.), such that one of ordinary skill in the art would know when an efficacy parameter, and/or a change thereof, infringe on the claimed invention.
Claims 3, 6-7, and 9-10 are included as they depend from claim 1 but does not further clarify the subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6-7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Eggensperger et al. (DE 2311675 A1, 09/26/1974, IDS reference) (hereinafter Eggensperger).
Regarding claims 1-3 and 10, Eggensperger discloses wherein esters of certain ketocarboxylic acids show a high antimicrobial effectiveness and are ideal for use in disinfectants and particularly advantageous for cosmetic preparations. The ketocarboxylic acids include levulinic acid. The esters include a radical of a primary or secondary aliphatic alcohol with 1-16 carbon atoms, a cycloaliphatic alcohol with 6-12 carbon atoms, an araliphatic alcohol, or an unsubstituted or substituted phenoxyethanol. The ketocarboxylic acid esters show an increased effect of synergy when contained with additional antimicrobial agents (i.e. preservative agents). (p.2, ¶ 2, 4, 8, and 10). Exemplary antimicrobial agents include carboxylic acids and their derivatives (p. 2, ¶ 14). Exemplary carboxylic acid includes sorbic acid (p. 3, Table 1).
Together these would provide a composition as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claim 1 reciting wherein the at least one levulinic acid derivative being present in an amount sufficient to increase the efficacy of the preservative agent as compared to the preservative agent alone, as discussed above, Eggensperger discloses wherein esters of levulinic acid show an increased effect of synergy when contained with additional antimicrobial agents such as sorbic acid (i.e. an instantly claimed carboxylic acid). Accordingly, one of ordinary skill in the art would reasonably conclude the compositions, comprising substantially the same esters of levulinic acid in presence with sorbic acid, to have an improved efficacy compared to compositions comprising sorbic acid alone. As such, the disclosure of Eggensperger meets the limitations as instantly claimed.
Regarding claim 2 reciting a pH range of cosmetic compositions, although Eggensperger does not explicitly disclose a pH range, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed pH range (i.e. from 4 to 9) through routine experimentation based on desired pH ranges for cosmetic preparations. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claims 6 and 7, as discussed above, Eggensperger discloses wherein the esters of levulinic acid include those formed from primary or secondary aliphatic alcohol with 1-16 carbon atoms. As such, the claimed C1-8 alkyl, or C1-5 alkyl, levulinic acid esters, respectively, would have been obvious.
Regarding claim 9 reciting a list of levulinic acid ketals, it is not necessary for Eggensperger to disclose the recited levulinic ketal since the claim, as currently recited, does not require the at least one levulinic acid derivative to be a levulinic ketal. The claim recites wherein the at least one levulinic acid derivatives may be a levulinic acid ester, which Eggensperger discloses by disclosing wherein the composition comprises esters of levulinic acid ester with a C1-16 radical.
Regarding claim 10 reciting a weight ratio of the at least one levulinic acid derivative and sorbic acid, although Eggensperger does not explicitly disclose a claimed weight ratio, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed weight ratio (i.e. 500:1 to 1:10 of at least one levulinic acid derivative and sorbic acid) through routine experimentation based on the level of increased effect of synergy desired. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Claims 1-3, 6, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Behler et al. (US 2019/0209451 A1, 07/11/2019) (hereinafter Behler).
Regarding claims 1-3 and 10, Behler discloses use of levulinic acid esters with a fatty alcohol as solubilizing agents for dissolving organic UV filters in cosmetically acceptable products/compositions ([0001]). The organic UV filters have a poor oil-solubility at a certain concentration and tend to crystallize, leading to decrease in UV protection efficacy ([0005]). The fatty alcohol includes those having 6-22 carbon atoms ([0016]). The compositions may further comprise preservatives including dehydroacetic acid ([0109]). Suitable pH values for the composition includes 6.1-6.5 (Ex. A25), or 5.6-6.5 (Ex. A26).
Together these would provide a composition as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claims 1 and 2 reciting wherein the at least one levulinic acid derivative being present in an amount sufficient to increase the efficacy of the preservative agent as compared to the preservative agent alone, or at a certain pH range, respectively, as discussed above, Behler discloses wherein the levulinic acid esters act to solubilize organic UV filters in cosmetically acceptable compositions, so that the UV filters do not crystallize and exhibit decreased efficacy. Accordingly, one of ordinary skill in the art would reasonably conclude the compositions, comprising levulinic acid derivative in presence with the preservative, to have an improved efficacy compared to compositions comprising the preservative alone, or at a pH value range that overlaps with the instantly claimed ranges. As such, the disclosure of Behler meets the limitations as instantly claimed.
Regarding claim 6, as discussed above, Behler discloses wherein the levulinic acid ester may be formed from a C6 fatty alcohol (i.e. instantly claimed C1-8 alkyl levulinic acid ester).
Regarding claim 9 reciting a list of levulinic acid ketals, it is not necessary for Behler to disclose the recited levulinic ketal since the claim, as currently recited, does not require the at least one levulinic acid derivative to be a levulinic ketal. The claim recites wherein the at least one levulinic acid derivatives may be a levulinic acid ester, which Behler discloses by disclosing wherein the composition comprises levulinic acid ester with a fatty alcohol 6-22 carbon atoms.
Regarding claim 10 reciting a weight ratio of the at least one levulinic acid derivative and dehydroacetic acid, although Behler does not explicitly disclose a claimed weight ratio, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed weight ratio (i.e. 300:1 to 1:10 of at least one levulinic acid derivative and dehydroacetic acid) through routine experimentation based on the level of solubilization and preservative effects desired. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bigorra Llosas et al. (US 2012/0214669 A1, 08/23/2012), directed to stable compositions comprising ketocarboxylic acid esters and biocides.
Koehl et al. (US 2019/0124921 A1, 05/02/2019, IDS reference), directed to chemically and physically stable solution of levulinic acid and sorbic acids providing improved antibacterial protection.
Selifonov (US 2008/0242721 A1, 10/02/2008), directed to ketal compounds of levulinic acid, and use of such compounds in cosmetic and personal care products.
Yontz et al. (US 2016/0044914 A1, 02/18/2016), directed to compositions comprising an antibacterial and a ketal.
Salama et al. (US 2024/0298646 A1, priority 03/07/2021), directed to antimicrobial compositions comprising levulinic acid esters thereof or derivatives thereof.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights