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 .
Detailed Action
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/26/2026 has been entered.
Status of Application
The Examiner acknowledges receipt of amendments filed on 06/26/2026 wherein claims 1, 8, 9, and 16 have been amended, claims 2, 15, 17, 18, and 20-23 have been cancelled, and claim 24 has been added.
Claims 1, 3-14, 16, 19, and 24 are presented for examination on the merits. The following rejections are made.
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 16, 19, and 24 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.
Regarding claim 16, the statement of “…a ratio of the second weight percentage of the composition to the amount of hydroxyacteophenone is greater than 2.5” renders the claim indefinite. For clarity, claim should state the ratio of “caprylyl glycol to hydroxyacteophenone is greater than 2.5”. Claims 19 and 24 are rejected by virtue of their dependency on rejected claim 16.
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.
Claim(s) 1, 3-6, and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Pesaro (US 20190282478 A1) in view of Kaneko (JP2019014765A).
Regarding claims 1, 3-6, and 8-13, Pesaro teaches a preservation mixture comprising components (a) an antimicrobial agent, (b) a second antimicrobial agent, such as 4-hydroxy acetophenone (para. [0105]), and (c) a hydroxyl compound such as 1,2-octanediol (i.e. caprylyl glycol) and methyl propanediol (i.e. first glycol with less than 6 carbons, para. [0106]). Pesaro further teaches that the composition may comprise nonionic surfactants (para. [0326]), such as polysorbate-80 (para. [0268]), implying the inclusion of the surfactant is optional. As such, it would have been obvious to one of ordinary skill in the art that the composition of Pesaro may be free of surfactants. Pesaro teaches that when the nonionic surfactants are present in an amount of 0.1-90 wt.% (para. [0348]). Component (c) of Pesaro (i.e. 1,2-octanediol, 1,2-pentanediol, para, [0106]) can be in an amount from 1-25 wt.% (para. [0116]). The antimicrobial agents of Pesaro (i.e. hydroxyacetophenone) is present in an amount of 0.01-10 wt.% (para. [0119]). The percent composition of the hydroxyacetophenone of instant claim 1 overlaps with that taught in Pesaro, and as such it is obvious. See MPEP § 2144.05(I).
Regarding the ratios of instant claims 1, 8, and 9, the ratio of the non-ionic surfactant to the hydroxyacetophenone can be greater than 1, and within the range of 9:10-25:10, when the amount of the surfactant is 20 wt.%, and hydroxyacetophenone is present in the amount of 10 wt.%. These concentrations fall within the ranges taught in Pesaro, and as such the ratios of surfactant to hydroxyacetophenone taught in instant claims 1 and 8 are obvious, unless Applicant can demonstrate criticality of ranges. "…differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical" MPEP § 2144.05(II)(a). Regarding the ratio of the nonionic surfactant to the first glycol, Pesaro teaches the ratio of instant claim 1 and 9, when the amount of surfactant is 8 wt.%, and the concentration of the methyl propanediol is 4 wt.%. Again both concentrations are taught in Pesaro, and the ratios of instant claims 1 and 9 are obvious, unless criticality of range is established by Applicant. MPEP § 2144.05(II)(a). While Pesaro does not explicitly state the ratios of instant claim 1, the concentration ranges of each component are disclosed in Pesaro. These are optimizable parameters, inviting one skilled in the art to experiment, and it would be obvious to test ratios and concentrations described in Pesaro before arriving at a composition that is stable.
Pesaro teaches that the composition is stable (para. [0007]) and that stability testing can be done to determine antimicrobial performance of the composition (para. [0034]). However, Pesaro fails to teach the specific method of testing the composition's long-term stability at 5 ºC, as disclosed in amended claims 1, 9, and 16. Kaneko teaches an antimicrobial composition with a glycol and nonionic surfactant (see claim 1). The composition of Kaneko further comprises isopropyl methylphenyl, which has the same function as the hydroxyacetophenone of instant invention, to act as an antibacterial agent (para. [0012]). Kaneko discloses a method for mixing the antimicrobial agent, glycol, and surfactant to obtain a homogenous solution (para. [0026]). The composition is prepared by combining the components and stirring at a temperature of 40-90 ºC (para. [0027]). Kaneko teaches that the order of addition of the antimicrobial agent, glycol, and nonionic surfactant is not limited, and they can be added at once or sequentially (para. [0027]). Kaneko describes that a temperature of 40 ºC or higher allows the nonionic surfactant to be melted more efficiently, and when it is at 90 ºC, the target product can be obtained more economically (para. [0027]). Further, Kaneko teaches a method of evaluating the stability of the composition, describing that after the composition was prepared it was stored at room temperature or -5 ºC for one month, and the composition's stability was evaluated by observing whether it remained homogenous, and if precipitation occurred (para. [0034]). Kaneko described that if the physical appearance of the composition remained the same, the stability of the composition was sufficient (para. [0034]). Kaneko teaches that the glycol and nonionic surfactant composition demonstrates stability both at room temperature and at -5 ºC, therefore it is obvious that the composition would also demonstrate stability at 5 ºC, which falls between these temperatures.
Pesaro and Kaneko are considered to be analogous to the claimed invention because they are in the same field of antimicrobial compositions with antimicrobials, glycols, and non-ionic surfactants. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to use the preparation method taught in Kaneko, to prepare the composition taught in Pesaro. Kaneko teaches a method that is effective to prepare a homogenous mixture comprising glycols and nonionic surfactants. One would have reasonable expectation of success to add in the hydroxyacetophenone after the other components have dissolved because Kaneko teaches that the different elements, such as the antimicrobial agent, can be added individually. MPEP § 2143(I)(g). Kaneko also discloses a range of 40-90 ºC while combining these components, as 40 ºC or higher allows the surfactant to be melted efficiently, and 90 ºC allows the product can be obtained more economically (para. [0027]). One of ordinary skill in the art would be motivated to stir the components of Pesaro at a temperature between 40-90 ºC (i.e. 50 ºC) because, as above, Kaneko teaches the benefits of both the low and high ends of the range. MPEP § 2143(I)(g). It further would have been obvious to utilize the stability testing taught in Kaneko to evaluate the long-term stability of the composition of Pesaro, because Kaneko teaches this method to be effective in optimizing the composition to determine which glycols and other components allow for greater stability over one month. Kaneko teaches that the composition’s long-term stability can be evaluated after storing the composition at either room temperature or -5 ºC for one month. One of ordinary skill in the art would have a reasonable expectation of success in storing the composition of Pesaro at 5 ºC because this falls between room temperature and -5 ºC, temperatures that Kaneko teaches in its stability testing. As such it would be obvious to store the composition at this temperature for one month to evaluate long-term stability. MPEP § 2143(I)(g). While Pesaro does not teach that the composition is stable after one month stored in 5 ºC, the composition of Pesaro has the same components in overlapping concentrations and as such would have similar properties such as long-term stability. Further, while Pesaro teaches glycols with varying carbon chain lengths, Kaneko specifically teaches isopentyl diol (i.e. glycol with less than 6 carbons), that has long-term stability in the antimicrobial composition. As such, one of ordinary skill in the art would have a reasonable expectation of success in optimizing the composition of Pesaro to comprise glycols with less than 6 carbons, as Kaneko teaches a composition with a 5-carbon glycol that has long-term stability at both room temperature and -5 ºC (i.e. including temperatures between such as 5 ºC). MPEP § 2143(I)(g).
Claim(s) 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pesaro (US 20190282478 A1) in view of Kaneko (JP2019014765A), in further view of Li (US 20160007594 A1).
While Pesaro and Kaneko teach the claimed invention as above, they fail to teach that the composition comprises polysorbate-20 as the nonionic surfactant.
Regarding claim 7 and 14, Li teaches an antimicrobial composition that comprises a non-ionic surfactant (see claim 1) such as polysorbate-20 (para. [0037]).
Pesaro, Kaneko, and Li are considered to be analogous to the claimed invention because they are in the same field of antimicrobial compositions with glycols and nonionic surfactants. Li teaches that polysorbate-20 is effective as a surfactant in antimicrobial compositions. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to substitute the nonionic surfactant taught in Pesaro, with the specific non-ionic surfactant, polysorbate-20, that is taught in Li, to yield predictable results. MPEP § 2143(I)(b).
Response to Applicants’ Arguments
Applicant’s amendment filed 06/26/2026 overcomes the rejection of claims 1, 9, 16, and 17 112(b) made by the Examiner under 35 U.S.C. 112(b). This rejection is withdrawn.
While the amendments to claims 1, 9, and 16 regarding the stability test overcomes previous 103 rejections, new prior art Kaneko obviates the newly added claim amendments.. Amendments to the claims resulted in new prior art being applied, as above. Examiner thanks Applicant for amendments, and after careful consideration maintains the 103 rejection of instant claims 1 and 3-14. In regards to the 103 rejections, Applicant asserts the following:
As shown in instant specification, unexpected results were discovered that demonstrated that the glycols with a carbon chain length with less than 6 carbons provided stability in the composition, whereas glycols with a carbon chain length of greater than 6 carbons did not demonstrate long-term stability. Applicant argues that no case of obviousness exists because there is no suggestion or motivation in Pesaro or Li to provide a composition that has a glycol containing less than 6 carbons, and criticality of carbon chain length is established in specification.
Pesaro and Li fail to appreciate the combination of a first glycol, a nonionic surfactant, and hydroxyacetophenone with the importance of the specified ratio of the nonionic surfactant to the hydroxyacetophenone being from 9:10 to 25:10, and the specified ratio of the nonionic surfactant to the first glycol being from 9:20 to 25:10 in achieving the stability of the composition, as stated in instant claim 1. Applicant asserts that one of ordinary skill in the art would not select a first glycol with a carbon chain length of less than 6 carbons, as well as the particular ratios of the nonionic surfactant to the hydroxyacetophenone and the nonionic surfactant to the first glycol.
Applicant asserts that amended claim 1 is commensurate in scope with the unexpected results of stability demonstrated in original specification. The Office Action mailed 01/26/2026 claims code L of Table 1 does not provide a stable result, but code L further does not comprise a nonionic surfactant, so it cannot be considered in regards to the composition taught in instant claim 1.
There is no prima facie case of obviousness for amended claim 9 because here is no suggestion in Pesaro or Li to provide a composition with a first glycol comprising a carbon chain with less than 6 carbons, a second glycol, a nonionic surfactant, and hydroxyacteophenone, where the ratios of the nonionic surfactant to the hydroxyacetophenone being from 9:10 to 25:10, and the specified ratio of the nonionic surfactant to the first glycol being from 9:20 to 25:10 is necessary to achieve the stability of the composition, as stated in instant claim 9.
Prior art of record fails to present a prima facie case of obviousness for amended claim 16 because Pesaro and Li fail to teach all claim limitations and there is no reasonable expectation of success. Applicant states Pesaro and Li fail to teach a composition with a first and second glycol, where the composition does not include a nonionic surfactant and the ratio of the total glycol weight percentage to the amount of hydroxyacetophenone is greater than 4.0, the ratio of the second weight percentage of the composition to the amount of hydroxyacetophenone is greater than 2.5, and composition is stable according to the stability testing. Pesaro teaches wide ranges of the second glycol and hydroxyacetophenone, and one of ordinary skill in the art might configure a composition with a total glycol weight percentage to hydroxyacetophenone that is less than 4.0, and is not stable according to Applicant's stability testing. Further, Applicant asserts that the data in original specification Table 4 demonstrates a criticality of ranges for the ratio of total glycol weight to hydroxyacetophenone to be greater than 4.
Pesaro and Li fail to teach a composition that does not include a nonionic surfactant, and they do not demonstrate the importance of the second weight percentage of the composition to the amount of hydroxyacetophenone to be greater than 2.5 to achieve stability. Applicant states that Table 4 of instant specification demonstrates the criticality of this ratio in obtaining a composition that has long-term stability at low temperatures.
Applicant asserts that claim 24 is allowable pursuant of chain of dependency from claim 16.
In response to A, this argument is overcome by Kaneko, which teaches that isopentyl diol (i.e. glycol with less than 6 carbons) is preferred because it demonstrates antimicrobial activity that is maintained in a composition with nonionic surfactants, and has particularly long-term storage stability at low temperatures (para. [0008]). Kaneko also teaches that the composition may further contain a lower alcohol or a polyhydric alcohol other than isopentyl diol (para. [0019]). Applicant argues that unexpected results were discovered that demonstrated that glycols with less than 6 carbons provide a stable composition. However, Kaneko teaches that the antimicrobial can further contain propanediol and butanediol while maintaining stability at low temperatures over a month. As such, optimizing the composition of Pesaro to comprise a glycol with less than 6 carbons to improve long-term stability is obvious in view of Kaneko. One of ordinary skill in the art would have a reasonable expectation of success in optimizing the composition of Pesaro to comprise glycols with less than 6 carbons, as Kaneko teaches a composition with a 5-carbon glycol that has antimicrobial activity and long-term stability at both room temperature and -5 ºC (i.e. including temperatures between these values such as 5 ºC). Further, the specific glycol that allows for long term stability at low temperatures is an optimizable parameter, inviting one skilled in the art to experiment. While Pesaro and Li alone do not explicitly acknowledge the importance of the combination of a first glycol with less than 6 carbons, a nonionic surfactant, and hydroxyacetophenone, one of ordinary skill in the art would be motivated in light of Kaneko to include glycols that contribute to greater stability using the stability testing taught in Kaneko. Applicant claims unexpected results, but Kaneko teaches lower carbon glycols provide greater long-term stability so the result appears to be expected, burden is on applicant to demonstrate any other unexpected data in view of the teachings of the prior art.
In response to B and D as above, Kaneko teaches that lower alcohols allow for more long-term stability. As such, one would be motivated to optimize the ratios within the concentrations taught in Pesaro using glycols with 5 carbons (as taught in Kaneko), and evaluate stability of the compositions using the testing of Kaneko. Each concentration taught in Pesaro overlaps with the ratios of instant claim 1 and 9, and as such a case of obviousness exists. MPEP 2144.05(I). Applicant can overcome this rejection by providing evidence that indicates such concentration is critical, which Applicant does not satisfy. MPEP 2144.05(II)(a). Regarding the ratio of the surfactant to hydroxyacetophenone of instant claim 1 and 9, Applicant does not demonstrate the criticality because they only provide compositions with concentrations within this claimed ratio, which does not prove a ratio within said range is necessary for stability at these temperatures as no examples ‘outside’ this ratio are provided. Further, Applicant does not demonstrate criticality of the ratio of the surfactant to the first glycol of instant claim 1 and 9, because Applicant only reports compositions with concentrations within this ratio. This does not establish that concentrations outside this ratio will be less stable. The ratios of instant claims 1 and 9 are optimizable parameters, and one of ordinary skill in the art would be motivated to optimize within the concentrations taught in Pesaro, then further use the stability testing taught in Kaneko to determine which specific glycols and nonionic surfactants with which concentrations have the most stability over time. As described in the 103 rejection above, the ratios of the nonionic surfactant to the hydroxyacetophenone and the ratio of the nonionic surfactant to the first glycol is obvious in view of Pesaro. Pesaro teaches concentrations of the surfactant and first glycol, that overlap with the ratios of instant claims 1 and 9, and these can be optimized for long-term stability at 5 ºC. Applicant does not provide criticality of ranges, and as such of the ranges are obvious in the absence of such datas.
In response to C, Applicant's argument that Code L of Table 4 of original specification does not demonstrate any contradiction to claim 1 is accepted, as code L of Table 1 in instant specification cannot be drawn to a composition with a first glycol, hydroxyacetophenone, and nonionic surfactant. However, as described above in response to B and D, applicant did not provide examples of compositions with concentrations outside this ratio, thus criticality of these ratios was not established.
In response to E and G, Applicant's argument was found to be persuasive, as criticality of the ratio of total glycol to hydroxyacetophenone is demonstrated in original specification Table 4. Regarding Code R and S of Table 4, the only factor to differentiate the compositions is the ratio being less than or greater than 4.0. A precipitate only forms when the ratio does not exceed 4.0. As such, criticality of ranges was established and claim 16 is free of prior art. MPEP § 2144.05(II)(a).
In response to F, Pesaro teaches the concentrations that overlap with the ratio, as discussed in the 103 rejection. Applicant asserts that the criticality of this ratio is demonstrated in Table 4 of instant specification, however Applicant does not demonstrate an example on Table 4 where this is the only ratio not met, and a precipitate forms, therefore does not demonstrate the criticality of this ratio. Codes Q and R demonstrate compositions with a ratio of the second weight percentage to hydroxyacetophenone that is greater than 2.5, and are stable compositions. Code O demonstrates a composition that does not meet this requirement; however this composition also does not meet the requirement of the composition to have a total glycol to hydroxyacetophenone ratio of greater than 4.0. Therefore no conclusions can be drawn that the reason for Code O forms precipitate is because of the second weight percentage to hydroxyacetophenone ratio, therefore no criticality of the range for this ratio is established.
Applicant's argument has been fully considered but the rejection of instant claims 1 and 3-14 under 35 U.S.C. 103 is maintained. Claims 16, 19, and 24 maintain unallowable under new 112(b) rejection.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sharif (CA 3011975 A1) teaches a cleansing formulation that comprises hydroxyacetophenone, propanediol (i.e. glycol with less than 6 carbons), caprylyl glycol, and no nonionic surfactants (see example 1, para. [0025]). While Sharif teaches most components of instant claim 16, it does not disclose concentrations that teach that the ratio of the totally glycol weight percentage to the amount of hydroxyacetophenone is greater than 4.0. Therefore, while Sharif is analogous to instant claim 16 and is considered relevant prior art, no case of obviousness exists because it does not teach a ratio of totally glycol weight percentage to the amount of hydroxyacetophenone to be greater than 4.0.
Conclusion
Claim(s) 1, 3-14, 16, 19, and 24 are rejected.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
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