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 .
Applicant’s arguments, filed 06/30/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-10 are pending and under examination.
Claim Objections
Claim 5 is objected to because of the following informalities: the period “.” following “25 deg C” should be removed. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-4, and 6-10, stand rejected under 35 U.S.C. 103 as being unpatentable over Min (KR 20160082054 A, cited on IDS dated 06/21/2024), in view of Arditty (US 20100055062 A1, cited on IDS dated 06/21/2024).
Min teaches an oil-in-water D phase emulsion comprising a D phase comprising water, a polyol, sodium dilauramidoglutamide lysine, and an oil (¶¶ 6, 37). The oil is selected from silicone oils, ester-based synthetic oils, hydrocarbon-based oils, etc. (¶ 35). The oil content is 10-20 wt% (¶ 30). The polyol content is 5-20 wt% (¶ 29). Also disclosed is a method of preparing an oil-in-water D phase emulsion comprising preparing a D phase comprising oil, fatty alcohol, and sodium dilauramidoglutamide lysine to form an O/D emulsion, and adding an aqueous phase to the O/D phase and emulsifying it (¶¶ 29, 36-39). The compositions are emulsifier free (¶ 1).
Min does not teach the inclusion of N-acyl proline or a salt thereof, nor the viscosity of the oil-in-water emulsion.
Arditty teaches cosmetic compositions that may be oil-in-water emulsions, wherein the emulsions comprise an emulsifying system comprising at least one proline derivative or a salt thereof (abs, ¶ 58). The proline derivative and salts thereof constitute the main surfactant system, and includes sodium palmitoyl proline (¶¶ 40, 44).
Regarding claim 1, it would have been obvious to substitute a proline derivative or a salt thereof, such as sodium palmitoyl proline (an n-acyl proline derivative, see claim 2), as taught by Arditty, for the sodium dilauramidoglutamide lysine of Min, where both were known lipoamino acid based surfactants used in emulsifying systems for oil-in-water emulsions.
Regarding claim 2, it would have been obvious to select from sodium palmitoyl proline as the proline derivative or salt thereof, for the same reasons discussed above.
Regarding claim 3, it would have been obvious to select from the suitable oils taught by Min, such as silicone oils, ester-based synthetic oils, and hydrocarbon-based oils.
Regarding claim 4, it would have been obvious to include the oil in a content of 10-20 wt%, as taught by Min, falling within the claimed range.
Regarding claim 6, where the composition made obvious above appear to be free of solid emulsifiers or solid emulsification aids, it appears the limitation of comprising 5 wt% or less of a solid emulsifier or a solid emulsification aid is met.
Regarding claim 7, the composition made obvious above further comprises a polyol, as taught by Min.
Regarding claim 8, it would have been obvious to include the polyol in a content of 5-20 wt%, as taught by Min, falling within the claimed range.
Regarding claim 9, it would have been obvious to prepare the oil-in-water D phase emulsion made obvious above comprising preparing a D phase, mixing the D phase with an oil phase including an oil, and mixing the mixture with an aqueous phase, as taught by Min.
Regarding the N-acyl pyrrolidone or a salt thereof of claim 9, it would have been obvious to substitute a proline derivative or a salt thereof, such as sodium palmitoyl proline (an n-acyl proline derivative, see claim 2), as taught by Arditty, for the sodium dilauramidoglutamide lysine of Min, for the same reasons discussed above.
Regarding claim 10, it would have been obvious to include the oil in a content of about 10-20 wt%, as taught by Min for the same reasons discussed above.
Response to Arguments
First, Applicants assert the skilled artisan would not have been motivated to combine the teaching of Min and Arditty, where Arditty’s proline derivatives are used in conventional emulsification systems, which is different from Min’s D-phase emulsification. Applicants assert Arditty provides no guidance on whether proline derivatives would function in or be beneficial to that system.
Second, Applicants assert the present examples confirms that the use of sodium palmitoyl proline provides superior emulsification stability compared to the use of other types of lipoamino acids, particularly sodium stearoyl glutamate, and that even for sodium palmitoyl proline, D-phase emulsification provides better stability than conventional emulsification. Specifically, Applicants assert sodium palmitoyl proline was compared with other types of lipoamino acids in preparation example 1 and example 1, and when D-phase emulsion was prepared, example 1 showed excellent stability, whereas the compositions of comparative examples 1 to 4 exhibited poor stability with phase separation or precipitation. In addition, Applicants assert through preparation example 3 and experimental example 4, D-phase emulsification and conventional emulsification were compared using sodium palmitoyl proline and sodium stearoyl glutamate, and it was confirmed that example 1, which used sodium palmitoyl proline in D-phase emulsification exhibited superior stability compared to comparative example 5 (conventional emulsification with sodium palmitoyl proline, separated after 2 weeks at 50 deg C), comparative example 6 (D-phase emulsification using sodium stearoyl glutamate, separated 2 days at 50 deg C), and comparative example 7 (conventional emulsification using sodium stearoyl glutamate, separated after 1 day at 50 deg C). Applicants assert table 4 shows examples 1-5 demonstrated stability across multiple oil types, including caprylic/capric triglyceride, coco-caprylate/caprate, triethylhexanoin, hydrogenated polydecane, and mixtures thereof, all with viscosities of 800-1900 cps. Applicants assert this demonstrates that the unexpected results are present across the claimed oil genus.
Third, Applicants assert sodium dilauramidoglutamate lysine of Min, which contains a glutamic acid group, is similar to sodium stearoyl glutamate, which is used in comparative example 6. Applicants assert table 6 shows comparative example 6 confirms that glutamate-based lipoamino acid exhibits different behavior from sodium palmitoyl proline in D-phase emulsification.
Fourth, Applicants assert that since Arditty merely discloses a conventional emulsification system, it only corresponds to comparative example 5, which used sodium palmitoyl proline with conventional emulsification and separated after 2 weeks at 50 deg C. Applicants assert substituting sodium palmitoyl proline into Min’s D-phase system would not have been straightforward and the skilled artisan would not have had a reasonable expectation of the stability of the claimed composition.
First, respectfully, this argument is not persuasive. Min and Arditty are both directed to oil in water emulsions in the field of cosmetics, where both teach the use of surfactants. While Min may be formulated by a different process, both are still oil in water emulsions, and the skilled artisan could reasonably look to other known surfactants that were taught to be suitable for the same purpose.
Second, respectfully, this argument is not persuasive. The examiner agrees that example 1 appears to show improved stability when compared to comparative examples 1-4, which appear to differ only in the particular surfactant used. Assuming purely arguendo that unexpected results have been established, it does not appear that the results are commensurate in scope with the instant claims. The results are limited to specific formulations comprising only one N-acyl proline (1 wt% sodium palmitoyl proline) in combination with specific polyols (9 wt% glycerin, 3 wt% butylene glycol, 1.5 wt% 1,2-hexanediol), and a single oil (15 wt% caprylic/capric triglyceride), in a particular amount. Claim 1 allows for any oil-in-water D-phase emulsion comprising any N-acyl proline or salt thereof and any oil, in any amounts, and allows for the inclusion of additional components. The skilled artisan would have reasonably expected that the stability of the oil-in-water emulsions would be effected by the particular selection of N-acyl proline or a salt thereof, the particular oil, the presence of polyols, the amounts of components and their particular ratios, etc. Accordingly, it does not appear that the stability results can be reasonably extended to the full scope of the instant claims. See MPEP 716.02(b) I-II and 716.02(d).
Regarding production example 3 and experimental example 4, the examiner agrees that that the D-phase emulsification of sodium palmitoyl proline appears to be more stable under with the tested embodiments under the tested conditions than comparative examples 5-7. Assuming purely arguendo that unexpected results have been established, the results do not appear to be commensurate in scope with the instant claims for the same reasons discussed above.
Regarding table 4, in examples 1-5, the results for the specific embodiments tested with sodium palmitoyl proline appear to be stable in caprylic/capric triglyceride, coco-caprylate/caprate, triethylhexanoin, hydrogenated polydecane, and the mixture of all four at a total of 15 wt%. While various oils were tested, claim 1 is directed to any oil in any amount, combined with any N-acyl proline in any amount, and it is currently not clear if the same stability would be achieved across the full scope of the claims. The examiner notes that claim 3 recites a Markush group of oil classes, including silicone oil, and where it appears that no silicone oil was tested, it is not clear if the emulsion would be stable in silicone oil.
Third, respectfully, this argument is not persuasive. From tables 5 and 6, the results appear to show increased stability in the specific embodiments comprising sodium palmitoyl proline compared to sodium stearoyl glutamate, both using D-phase emulsification, appearing to suggest that the selection of sodium palmitoyl proline is critical to stability. However, even assuming purely arguendo that unexpected results have been established, the results do not appear to be commensurate in scope with the instant claims for the same reasons discussed above.
Fourth, respectfully, this argument is not persuasive. Min was cited as the primary reference for teaching D-phase emulsification of an oil in water emulsion where it was known to use a lipoamino acid based surfactant, and it would have been obvious for the skilled artisan to look to other known lipoamino acid based surfactants that were taught to be suitable for oil in water emulsions, such as sodium palmitoyl proline, as taught by Arditty, with a reasonable expectation of success where both were known to be suitable for the same purpose. Regarding the results, while it does appear that the particular selection of sodium palmitoyl proline in the particular embodiments tested showed greater stability, even assuming purely arguendo that unexpected results have been established, the results do not appear to be commensurate in scope with the instant claims for the same reasons discussed above.
Claim 5 stands rejected under 35 U.S.C. 103 as being unpatentable over Min (KR 20160082054 A, cited on IDS dated 06/21/2024) and Arditty (US 20100055062 A1, cited on IDS dated 06/21/2024), as applied to claims 1-4, and 6-10 above, and further in view of Park et al (US 20130011454 A1, hereinafter “Park”).
Min and Arditty are discussed above but do not teach the specific viscosity of the oil-in-water emulsions.
Park teaches oil-in-water cosmetic emulsions with a high oil content and excellent stability, where it was known to formulate the emulsion compositions comprising a viscosity of less than 4000 cps (abs, ¶¶ 16-18, 34). The oils include silicone oils, ester oils, hydrocarbon oils, and a polyol (¶¶ 23, 27, claim 7). Embodiments with viscosities of 5000 cps or higher had poor storage stability, and required additional surfactants which cause skin irritation, and thus could not be used in practice (¶ 31).
It would have been obvious to formulate the oil-in-water emulsion composition made obvious above by Min and Arditty, with known viscosities suitable for oil-in-water cosmetic emulsions with high oil content, such as less than 4000 cps, as taught by Park.
Regarding the Brookfield viscometer with an LV #3 (63) spindle limitation, while the claim recites a product by process limitation of a viscosity as measured by a Brookfield viscometer with an LV #3 (63) spindle at 12 rpm and 25 deg C, where Park teaches that viscosities of 5000 cps or higher had poor storage stability, it would have been well within the relative skills of the skilled artisan to formulate the oil-in-water emulsions with viscosities falling within the disclosed ranges, as measured by any method, in order to achieve desired and optimal viscosity properties. Purely arguendo, even if there would be slight variations in viscosity between measurement techniques, the general motivation provided by the prior art is that viscosities less than 5000 cps are more stable, and it would have been obvious to formulate emulsions with viscosities less than 5000 cps as measured by any method.
Further, it would have been well within the relative skills of the skilled artisan to routinely optimize the viscosity of the compositions in order to achieve optimal and desired viscosities for desired uses. See MPEP 2144.05(II)(A).
Response to Arguments
Applicants assert Park does not cure the deficiencies of Min and Arditty above.
Respectfully, this argument is not persuasive. The claims stand rejected for the same reasons discussed above and of record.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Min (KR 20160082054 A, cited on IDS dated 06/21/2024) and Arditty (US 20100055062 A1, cited on IDS dated 06/21/2024), as applied to claims 1-4, and 6-10 above, and further in view of Park et al (US 20130011454 A1, hereinafter “Park”) and Lee (KR 0170571 B1).
Min, Arditty, and Park are discussed above, and purely arguendo, if somehow the measurement technique is required, the following applies.
Lee teaches oil-in-water D-phase emulsions can result in emulsion with viscosities of less than 100 cps, wherein it was known to measure D-phase emulsion viscosity using a Brookfield viscometer LVT #3 spindle at 12 rpm for 2 minutes (pg 2, 3).
It would have been obvious to formulate the emulsion made obvious above with known viscosities suitable for oil-in-water cosmetic emulsions with high oil content, such as less than 4000 cps, as taught by Park, for the same reasons discussed above. Further, it would have been obvious to use a known viscosity measurement device suitable for measuring viscosity of D-phase emulsions, such as a Brookfield viscometer LVT #3 spindle at 12 rpm, as taught by Lee. Regarding the temperature and 1-minute stabilization, it would have been well within the relative skills of the skilled artisan to have routinely adjusted the measurement temperature and stabilization time to measure viscosity under different standard conditions.
Further, it would have been well within the relative skills of the skilled artisan to routinely optimize the viscosity of the compositions in order to achieve optimal and desired viscosities for desired uses. See MPEP 2144.05(II)(A).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jaynes et al (WO 2009115428 A1) teaches it was known to measure viscosity of oil-in-water emulsions at 25 deg C using a Brookfield viscometer with an LVT #3 spindle at 12 rpm.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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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.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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