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
Claims 1, 3-7, 10, 12, 13, 15, 18, 20-25, 28, 30 and 62 are pending.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, claims 1, 3-7, 10, 12, 13, 15, 18, 20-24 and 62, and the species of a) squalene and b) presence of palmitic acid, in the reply filed on 12/29/25 is acknowledged.
Claims 25, 28 and 30 are withdrawn as being drawn to a nonelected invention.
Claims 10 and 23 are withdrawn as not being directed to the elected species.
Claims 1, 3-7, 12, 13, 15, 18, 20-22, 24, and 62 are under consideration to the extent that composition comprises the elected species.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 11/20/23 and 12/29/25. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claims 3, 6, 7, 13, 18, 20, 24 are objected to because of the following informalities:
In claims 3, 6, 7, 13, 18, 20, 24, “comprising” should be replaced with “further comprising” to clarify that the ingredient is in addition to the components recited in Claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 depends from claim 3 and recites “about 20% by weight to about 40% by weight of a first diol… and from about 2% by weight to about 10% by weight of a second diol”. This broadens the range of claim 3. The upper limit of claim 3 is 40 wt%, but claim 4 allows for as much as 50 wt% of one or more diols.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 13, 20-22 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Okubo et al. (US 2005/0163742; cited previously).
Okubo et al. teach a water-in-oil emulsified composition containing a sphingosine, a C6-30 fatty acid, and an oil component (e.g. abstract). Example 8 is an emulsion comprising 1.0 wt% sphingosine, 1.5 wt% palmitic acid, and water (e.g. Table 2). Example 3 is an emulsion comprising 0.25 wt% palmitic acid and 62.55 wt% water. Okubo et al. more broadly teach water in amounts of 1-80 wt%, palmitic acid in amounts of 0.001 to 10 wt%, and sphingosine in amounts of 0.001 to 10 wt%, which overlap the claimed ranges (e.g. paragraphs 0035, 0040 and 0066).
Regarding Claims 1, 13, 21, 22, and 62, it would have been obvious to one of ordinary skill in the art at the time of filing to vary the concentrations of the water, palmitic acid, and sphingosine of Okubo et al. It would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the concentrations through routine experimentation to arrive at the claimed concentrations in order to optimize the resulting product. It is obvious to optimize within prior art conditions or through routine experimentation. In addition, 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, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding Claims 3-6 and 20, Okubo et al. further teach the inclusion of a humectant comprising 1,3-butylene glycol, propylene glycol, and/or glycerin (e.g. paragraph 0067), but do not teach a general concentration thereof. Okubo exemplify 20 wt% humectants in Examples 1, 2, 4 and 5. It would have been obvious to one of ordinary skill in the art at the time of filing to vary the concentrations of the individual humectants through routine experimentation to arrive at the claimed concentrations in order to optimize the resulting product. It is obvious to optimize within prior art conditions or through routine experimentation. In addition, 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, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Claims 7, 12 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Okubo et al. (US 2005/0163742; cited previously) as applied to claims 1, 3-6, 13, 20-22 and 62 above, and further in view of Bouwstra et al. (US 2011/0165203).
Regarding Claims 1, 3-6, 13, 20-22 and 62, the teachings of Okubo et al. are described supra. Okubo et al. teach that the compositions prevent moisture loss from the skin by forming a film on the skin surface, so that they can protect the skin from drying or give treatment effects to the skin (e.g. paragraph 0003) and further teach the inclusion of hydrocarbon oils such as squalane (e.g. paragraph 0043). They do not teach the inclusion of squalene. This is made up for by the teachings of Bouwstra et al.
Bouwstra et al. teach composition which mimics some of the benefits of natural Vernix, and may particularly be used to promote skin barrier recovery (e.g. paragraph 0009). Bouwstra et al. teach that the composition comprises water, palmitic acid, ceramides and 0.1-10 wt% squalene (e.g. paragraph 0022 and 0025; Examples; Claim 1 and 14).
Regarding Claims 7, 12 and 24, it would have been obvious to one of ordinary skill in the art at the time of filing to include the squalene of Bouwstra et al. in the compositions of Okubo et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of the compositions are useful as skin moisturizing and protecting compositions comprising several of the same ingredients, and one of ordinary skill would have been motivated in order to provide the benefits of skin barrier recovery as taught by Bouwstra et al. In addition, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Regarding the concentration of squalene and palmitic acid, the concentrations taught by Okubo and Bouwstra overlap the claimed ranges. 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, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Okubo et al. (US 2005/0163742; cited previously) as applied to claims 1, 3-6, 13, 20-22 and 62 above, and further in view of Seppic (Simulgel EG <https://www.ulprospector.com/en/na/ PersonalCare/Detail/1432/46887/SIMULGEL-EG> 2015).
Regarding Claims 1, 3-6, 13, 20-22 and 62, the teachings of Okubo et al. are described supra. Okubo et al. teach that the compositions may further comprise a thickener (e.g. paragraph 0067). They do not teach the inclusion of polysorbate 80 or sodium acrylate and sodium acryloyldimethyl taurate copolymer. This is made up for by the teachings of Seppic.
Seppic teaches that Simulgel EG is INCI Name: Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (and) Isohexadecane (and) Polysorbate 80, and thickens and stabilizes skin composition emulsions (e.g. pages 1 and 2). Seppic teaches that Simulgel improves the texture and provides supple formulations (e.g. page 1). Simulgel EG is used at concentrations of 0.5-4.0 wt% (e.g. page 2).
Regarding Claims 15 and 18, it would have been obvious to one of ordinary skill in the art at the time of filing to include the Simulgel EG of Seppic, which comprises Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer and Polysorbate 80, for use in the composition of Okubo et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as Okubo et al. suggest the inclusion of thickeners, and one of ordinary skill would have been motivated in order to provide the benefits of skin improved texture and supple formulation, as taught by Seppic.
Regarding the concentration of Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer and Polysorbate 80, the concentrations taught by Seppic overlaps the claimed range the claimed ranges. 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, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I). In addition, it would have been obvious to one of ordinary skill in the art at the time of filing to vary the concentrations of the of Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer and Polysorbate 80. It would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the concentrations through routine experimentation to arrive at the claimed concentrations in order to optimize the resulting product. It is obvious to optimize within prior art conditions or through routine experimentation.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619