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 .
In view of applicant’s argument, previous 103 rejections over Stepniewski et al’672 in view of Shioya et al (JP 5-39208) are hereby withdrawn. Thus, applicant’s arguments with respect to the previous 103 rejections are now moot.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Stepniewski et al (US 2015/0320672 A1) in view of a report titled “Amended Safety Assessment of Salicylic Acid and Salicylates as Used in Cosmetics” (“ASASS”) (published on June 5, 2019 and obtained from the website: https://www.cir-safety.org/sites/default/files/salicy042019FAR.pdf ), Elder et al (“Antimicrobial Preservatives Part Two: Choosing a Preservative”, American Pharmaceutical Review, an internet article published on October 15, 2017 and obtained from the website: https://www.americanpharmaceuticalreview.com/Featured-Articles/343543-Antimicrobial-Preservatives-Part-Two-Choosing-a-Preservative/ ) and Albericio Palomera et al (US 2016/0185819 A1).
Stepniewski teaches (Example 1) a water-in-oil emulsion lash composition which contains the following ingredients:
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As shown above, Stepniewski’s water-in-oil emulsion lash composition contains: 0.20 wt.% of magnesium salicylate (instant salicylic acid (a) – present specification states that instant term “salicylic acid” includes salicylic acid and salts thereof); 4.12 wt.% of quaternium-90 bentonite (instant (b) 0.1 to 5.0% by mass of an organically modified clay material); 7.70 wt.% of sorbitan olivate and 2.20 wt.% of sorbitan tristearate and 0.98 wt.% of iron oxide (instant (d) 0.1 to 40% by mass of a coloring material).
With respect to instant range “0.5% by mass or more and 20% by mass or less” for the amount of salicylic acid (a), Stepniewski’s magnesium salicylate is present in the amount of 0.20 wt.% in its lash composition shown above. However, as evidenced by a report titled “Amended Safety Assessment of Salicylic Acid and Salicylates as Used in Cosmetics” (“ASASS” hereinafter), salicylic acid and its salts such as magnesium salicylate are known to be used as preservatives in ready-for-use cosmetic preparations (see 3rd paragraph on the 4th page of the report). ASASS further teaches (5th paragraph on the 4th page) that for products such as eye shadow, mascara, eyeliner and lipstick, salicylic acid (as preservative) is safe when used at a concentration of 0.5 %. Furthermore, as taught by Elder et al (see 1st paragraph under “Chemical Stability of Preservatives”), preservative levels during product shelf life need to remain within limits that ensure acceptable antimicrobial efficacy. Elder further states (see the paragraphs under “Factors that Compromise Preservative Efficacy”) that reduction in microbial efficacy can occur during manufacture, throughout the product’s shelf life or during the in-use period due to interactions with other components within the product, chemical instability of the preservative and physical looses or changes preservative levels in solution. Since Elder teaches that preservatives need to remain within limits that ensure acceptable antimicrobial efficacy during product shelf life and that the possibilities for chemical degradation are manifold as described above, it would have been obvious to one skilled in the art to raise the level of magnesium salicylate (Stepniewski’s preservative as pointed out by applicant - see the last paragraph on pg.5 in applicant’s REMARKS filed on December 4, 2025) in Stepniewski’s lash composition from 0.20 wt.% to 0.5 wt.% (maximum safe level as taught by ASASS) so that the preservative remains within limits that ensure acceptable antimicrobial efficacy during the product shelf life as taught by Elder. Thus, Stepniewski in view of ASASS and Elder renders obvious instant (a) 0.5 to 20% by mass of salicylic acid.
With respect to instant “0.1 to 4.0% by mass” of a sorbitan fatty acid ester, which is selected from sorbitan monoisostearate or sorbitan sesquiisostearate”, in Stepniewski’s lash composition shown above, sorbitan olivate and sorbitan tristearate are being used in the amount of 9.90 wt.% in total, which lies outside of instant range 0.1 to -4.0% by mass. However, Stepniewski gives a general teaching (claim 4) that its water-in-oil composition can contain a mixture of sorbitan tristearate, sorbitan olivate and polyisobutene in the amount that ranges from 1 to 15 wt.%. Subtracting the amount (1.85 wt.%) of polyisobutene present in the lash composition shown above from the range 1-15 wt.% gives the amount for the sum of sorbitan tristearate and sorbitan olivate to be 13.15 wt.% or less. Such range overlaps with instant range 0.1 - 4.0 % by mass for the amount of sorbitan fatty acid ester, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, in re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, Stepniewski renders obvious instant range 0.1 to 4.0% by mass of for instant sorbitan fatty acid ester. As to instant sorbitan fatty acid ester being chosen from sorbitan monoisostearate or sorbitan sesquiisostearate, although Stepniewski’s sorbitan olivate and sorbitan tristearate do not teach instant sorbitan fatty acid esters, as evidenced by Albericio Palomera (see [0100]), sorbitan olivate, sorbitan tristearate, sorbitan isostearate (instant sorbitan monoisostearate) and sorbitan sesquiisostearate are all known in the art as equivalent sorbitan ester-type emulsifiers used in cosmetic compositions. It would be obvious to one skilled in the art to replace sorbitan olivate and sorbitan tristearate with sorbitan monoisostearate and sorbitan sesquiisostearate with a reasonable expectation of success. Thus, Stepniewski in view of Albericio Palomera renders obvious instant (c) 0.1 - 4.0% by mass of a sorbitan fatty acid ester selected from the group consisting of sorbitan monoisostearate and sorbitan sesquiisostearate.
Thus, Stepniewski in view of ASASS, Elder and Albericio Palomera renders obvious instant claims 1, 5 and 6.
With respect to instant claim 2, as shown above, Stepniewski’s lash composition contains quaternium-90 bentonite (instant organically modified clay mineral (b)) in the amount of 4.12 wt.%, which falls within instant range 1.5-5.0% by mass, thus teaching instant range. Thus, Stepniewski in view of ASASS, Elder and Albericio Palomera renders obvious instant claim 2.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Stepniewski et al (US 2015/0320672 A1) in view of a report titled “Amended Safety Assessment of Salicylic Acid and Salicylates as Used in Cosmetics” (“ASASS”), published on June 5, 2019 and obtained from the website: https://www.cir-safety.org/sites/default/files/salicy042019FAR.pdf ), Elder et al (“Antimicrobial Preservatives Part Two: Choosing a Preservative”, American Pharmaceutical Review, an internet article published on October 15, 2017 and obtained from the website: https://www.americanpharmaceuticalreview.com/Featured-Articles/343543-Antimicrobial-Preservatives-Part-Two-Choosing-a-Preservative/ ) and Albericio Palomera et al (US 2016/0185819 A1), as applied to claim 1 above, and further in view of Kuroda et al (US 2006/0222615 A1).
Stepniewski in view of ASASS, Elder and Albericio Palomera does not teach instant polyether-modified silicone. However, as evidenced by Kuroda ([0023]-[0024]), it is well known in the art that polyether-modified silicone is an emulsifier useful in forming a stable water-in-oil type emulsion cosmetic. It would have been obvious to one skilled in the art to use a polyether-modified silicone in Stepniewski’s water-in-oil emulsion cosmetic composition with a reasonable expectation of forming a stable water-in-oil emulsion cosmetic composition.
Thus, Stepniewski in view of ASASS, Elder and Albericio Palomera, and further in view of Kuroda renders obvious instant claim 3.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Stepniewski et al (US 2015/0320672 A1) in view of a report titled “Amended Safety Assessment of Salicylic Acid and Salicylates as Used in Cosmetics” (“ASASS”), published on June 5, 2019 and obtained from the website: https://www.cir-safety.org/sites/default/files/salicy042019FAR.pdf ), Elder et al (“Antimicrobial Preservatives Part Two: Choosing a Preservative”, American Pharmaceutical Review, an internet article published on October 15, 2017 and obtained from the website: https://www.americanpharmaceuticalreview.com/Featured-Articles/343543-Antimicrobial-Preservatives-Part-Two-Choosing-a-Preservative/ ) and Albericio Palomera et al (US 2016/0185819 A1), as applied to claim 1 above, and further in view of Mohammadi et al (WO 2009/052239 A2) or Sakuta et al (US 2009/0232859 A1).
Stepniewski’s water-in-oil emulsion cosmetic composition does not contain polyethylene glycol. However, it is known in the art to use polyethylene glycols as humectants or moisture retention agents in a cosmetic composition for skin or eyelashes, as evidenced by Mohammadi (pg.23, lines 17-26 and claim 7) or Sakuta ([0080] and [0072]). It would have been obvious to one skilled in the art to add polyethylene glycol (as a humectant) to Stepniewski’s water-in-oil emulsion cosmetic composition shown above (for lashes) with a reasonable expectation of achieving the effect of moisture retention. Thus, Stepniewski in view of ASASS, Elder and Albericio Palomera, and further in view of Mohammadi or Sakuta renders obvious instant claim 4.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
January 24, 2026
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