DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-2, 4, 9-11, and 14-20 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 08/03/2026 has been entered.
Claims 1 and 16 were amended. Claims 13 and 21 were canceled. No new material was added.
The previous rejections of claims 13 and 21 are moot, because the claims were canceled.
Applicant’s amendments overcome the previous rejections of claims 1-2, 4, 9-11, and 14-20 under 35 U.S.C. 103.
Claims 1-2, 4, 9-11, and 14-20 are newly rejected under 35 U.S.C. 103 due to the amendment.
Claim 11 is newly rejected under 35 U.S.C. 112 due to the amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/03/2026, with respect to the rejection(s) of claim(s) 1-2, 4, 9-11, and 14-21 under U.S.C. 103 have been fully considered and are persuasive due to the amendment. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, KR‘913 (KR 101433913 B1), and Kahraman. The references were cited previously by the Examiner.
New 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 11 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 11 does not include all of the limitations of the independent claim 1, because claim 1 requires a tetraacetylphytosphingosine, while claim 11 requires one selected from sphingosine, phytosphingosine, tetraacetylphytosphingosine, and spinganine. 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.
New 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.
Claims 1-2, 4, 11, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee ‘579 (US 20160213579 A1; IDS reference, 09/27/2024), further in view of Lee ‘756 (US 2015335756 A1; IDS reference, 09/27/2024), Kotaka (JP 2008297301 A), Youm (Translation of KR 20180092256 A; IDS reference, 04/04/2023), Cope (US 6572868 B1), and KR‘913 (KR 101433913 B1). The references were cited previously by the Examiner.
Regarding claim 1, Lee ‘579 teaches a liquid crystal emulsion (i.e., composition) with an oil phase and an aqueous (i.e., water) phase (Lee ‘579, abstract). Lee ‘579 teaches the oil phase comprises lipid ingredients, a non-ionic surfactant (i.e., a suitable emulsifier as defined by the instant specification, page 7, paragraph 0035), and an oil (Lee ‘579, claim 1), wherein the lipids can be ceramides, cholesterol, and fatty acids (i.e., skin lipids; Lee ‘579, claim 2). Lee ‘579 teaches a mixture of lecithin, sorbitan, and glucoside surfactants as the non-ionic surfactant (Lee ‘579, page 3, paragraphs 0034-0035) resulting in an amount of surfactant (i.e., emulsifier) ranging from 0.25-11% by weight (Lee ‘579, page 3, paragraph 0036), which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Lee ‘579 teaches the liquid crystal emulsion has a multilayer lamellar structure (Lee ‘579, abstract), but does not specify a hexagonal system structure. Lee ‘756 teaches a composition wherein the emulsion layers are in a structure which can be hexagonal or lamellar (Lee ‘756, page 1, paragraph 0004). Lee ‘579 also teaches a non-ionic surfactant (i.e., a suitable emulsifier as defined by the instant specification, page 7, paragraph 0035), but does not teach a specific emulsifier with a hydrophile-lipophile balance as claimed. Lee ‘756 teaches emulsifiers with a suitable HLB value to include hydrogenated lecithin (Lee ‘756, page 2, paragraph 0017), which is known in the art to have an HLB value of about 4-9 according to the instant specification (page 8, paragraph 0036).
Lee ‘579 teaches intercellular lipids may include for example ceramides and phytosphingosine (Lee ‘579, page 3, paragraph 0030), and exemplifies the composition comprises phytosphingosine in 0.3% by weight (Lee ‘579, page 4, table 1), which lies within the claimed range, but does not specify a tetraacetylphytosphingosine. Kotaka teaches a solution for dermatological use comprising a ceramide which can be a ceramide or a ceramide derivative (Kotaka, claim 2), and teaches ceramides to include phytosphingosine and ceramide derivatives to include tetraacetylphytosphingosine (Kotaka, claim 3). Kotaka further teaches a composition having about 76.7% water (Kotaka, page 11, example 3), which lies within the claimed range.
Lee ‘579 and Lee ‘756 both teach a composition comprising a ceramide, a cholesterol, and stearic acid (i.e., a fatty acid; Lee ‘579, page 4, paragraph 0052, example 1; Lee ‘756, page 4, example 17), but does not teach a molar ratio of the skin lipid ingredients. Youm teaches a liquid crystal emulsion (Youm, abstract) comprising a mixture of a ceramide, a cholesterol, and fatty acids in a molar ratio of 1:1:1 (Youm, page 6, paragraph 0040), which lies within the claimed range.
Lee ‘579 teaches at least one selected from the group comprising ceramide-3 and ceramide-6 as possible embodiments of natural ceramides (Lee ‘579, page 3, paragraph 0031), but does not teach a specific combination of the two ceramides. Cope teaches a skin restructuring cosmetic complex comprising ceramide 3 and ceramide 6 (Cope, abstract) and teaches specific optimized ratios of the two ceramides with preferred weight ratios of 0.1-0.2% for each (Cope, column 4, lines 2-14), resulting in a potential weight ratio ranging from 1:2 to 2:1, overlapping the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Lee ‘579 teaches at least one selected from the group comprising natural and pseudo ceramides (Lee ‘579, page 3, paragraph 0031), but does not specifically teach glucosylceramide. KR‘913 teaches a pseudo ceramide which is a glycosyl ceramide (KR‘913, page 3, paragraph 0003), and teaches the glucosyl ceramide is most preferably in an amount of 0.01-20% by weight (KR‘913, page 6, paragraph 0075), which lies within the claimed range.
Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and KR‘913 are all considered to be analogous to the claimed invention, because all are in the same field of ceramide-containing topical compositions. It would have been prima facie obvious to one of ordinary skill in the art to have utilized an emulsifier that is preferable as taught by Lee ‘756, thereby arriving at the claimed invention, because Lee ‘756 teaches hydrogenated lecithin as a preferable emulsifier and teaches an HLB value of the compound should be suitable for crystal formation (Lee ‘756, page 2, paragraph 0017), and it would have obvious to one of ordinary skill in the art to have expected the structure taught by Lee ‘756 to be formed, because Lee ‘756 teaches the geometric structure is determined based on the lipid components present (Lee ‘756, page 1, paragraph 0004). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition taught by Lee ‘579 to utilize tetraacetylphytosphingosine in place of phytosphingosine as taught by Kotaka in the same amount, because Kotaka teaches the two compounds to be reasonable alternatives, and therefore it would have been obvious to substitute. It would have been obvious to utilize the amount of water taught by Kotaka, because Lee ‘579 teaches an ingredient which is water, but does not specify a range, and teaches the composition can be formulated as a gel (Lee ‘579, page 4, paragraph 0045), while Kotaka teaches a gel solution having a specific amount of water (Kotaka, page 11, example 3). It would have been obvious to one of ordinary skill in the art to have modified the composition taught by Lee ‘579 and ‘756 to utilize the molar ratio of the same ingredients taught by Youm, because Lee ‘579 teaches the lipid ingredients of the topical composition play a particularly important role in the stratum corneum (Lee, page 1, paragraph 0002) and Youm teaches a molar ratio such as 1:1:1 between the claimed ingredients is necessary for strong skin barrier function (Youm, page 6, paragraph 0040). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition taught by Lee ‘579 to utilize the specific ceramides in the relative amounts taught by Cope, because Lee ‘579 teaches the lipid ingredients of the topical composition, including ceramides, play a particularly important role in the stratum corneum (Lee, page 1, paragraph 0002), while Cope teaches ceramides 3 and 6 have a high capacity for improving the water-retaining capacity of the skin and penetration of the stratum corneum (Cope, column 3, lines 58-67). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified to the composition taught by Lee ‘579 to utilize a glucosylceramide as taught by KR‘913, because Lee ‘579 teaches the composition can comprise pseudo ceramides (Lee ‘579, page 3, paragraph 0031), and KR‘913 teaches a specific pseudo ceramide used in similar compositions to have a regenerating effect on the skin cells (KR‘905, page 4, paragraph 0047).
Regarding claim 2, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and KR‘913 together teach all the elements of the current invention as applied to claim 1. Lee ‘579 teaches the composition comprises ceramide-3 in 0.5% by weight, cholesterol in 0.5% by weight, and stearic acid (i.e., a fatty acid) in 1.0% by weight (Lee ‘579, page 4, paragraph 0052, example 1), resulting in a total of 2% by weight of the composition, which lies within the claimed range.
Regarding claim 4, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and KR‘913 together teach all the elements of the current invention as applied to claim 1. Lee ‘579 teaches the composition comprises oils in a total of 14% by weight by weight of the composition (Lee ‘579, page 4, paragraph 0052-0053, example 1), which lies within the claimed range.
Regarding claim 11, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and KR‘913 together teach all the elements of the current invention as applied to claim 1. As above, Lee ‘579 teaches the composition further comprises phytosphingosine (Lee ‘579, page 4, paragraph 0052, example 1).
Regarding claim 14, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and KR‘913 together teach all the elements of the current invention as applied to claim 1. As above, Lee ‘579 teaches a liquid crystal emulsion (i.e., has an emulsion formulation; Lee ‘579, abstract).
Regarding claim 15, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and ‘913 together teach all the elements of the current invention as applied to claim 1. Lee ‘579 teaches the emulsion has a particle size of 5-15 micrometers (Lee ‘579, page 2, paragraph 0022), which lies within the claimed range of the average particle size.
Regarding claim 16, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and KR‘913 together teach all the elements of the current invention as applied to claim 1. Lee ‘579 teaches the liquid crystal emulsion is a cosmetic composition (Lee ‘579, page 2, paragraph 0009), which can have an anti-wrinkle or whitening function (i.e., examples of ameliorating skin conditions; Lee ‘579, page 2, paragraph 0018), suggesting the composition is capable of ameliorating skin conditions as claimed.
Regarding claim 17, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and KR‘913 together teach all the elements of the current invention as applied to claim 16. As above, Lee ‘579 teaches the liquid crystal emulsion is a cosmetic composition (Lee ‘579, page 2, paragraph 0009), which can have an anti-wrinkle (i.e., amelioration of skin wrinkles) or whitening function (Lee ‘579, page 2, paragraph 0018).
Regarding claim 18, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and KR‘913 together teach all the elements of the current invention as applied to claim 1. As above, Lee ‘579 teaches the liquid crystal emulsion is a cosmetic composition (Lee ‘579, page 2, paragraph 0009).
Regarding claim 19, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and ‘913 together teach all the elements of the current invention as applied to claim 18. Lee ‘579 teaches the composition further comprises polyols and a preservative (Lee ‘579, page 4, paragraph 0053, example 1).
Regarding claim 20, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and KR‘913 together teach all the elements of the current invention as applied to claim 18. Lee ‘579 teaches the composition may have a formulation selected from the group comprising a lotion, a cream, and a foundation (Lee ‘579, page 4, paragraph 0045).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee ‘579 (US 20160213579 A1; IDS reference, 09/27/2024), Lee ‘756 (US 2015335756 A1; IDS reference, 09/27/2024), Kotaka (JP 2008297301 A), Youm (Translation of KR 20180092256 A; IDS reference, 04/04/2023), Cope (US 6572868 B1), and KR‘913 (KR 101433913 B1), as applied to claims 1-2, 4, 11, and 14-20, further in view of Kahraman (Cosmetics, 2019). The references were cited previously by the Examiner.
Regarding claim 9, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and KR’913 together all the elements of the current invention as applied to claim 1. Lee ‘579 teaches the ceramide can be at least one selected from a group of natural ceramides comprising ceramide-1, ceramide-2, ceramide-3, ceramide-4, ceramide-5, ceramide-6, ceramide-7, ceramide-8, or the like (Lee ‘579, page 3, paragraph 0031), but does not specifically teach ceramide-9. Kahraman teaches the use of ceramides for topical application to benefit the skin (Kahraman, abstract). Kahraman teaches ceramides found naturally in the human skin to include ceramides 1-12 (Kahraman, page 5, figure 4).
Lee ‘579, Lee ‘756, Youm, and Kahraman are all considered to be analogous to the claimed invention, because all are in the same field of ceramide-containing topical compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition taught by Lee ‘579 to utilize any of the ceramides taught by Kahraman, because Lee ‘579 teaches the use of other natural ceramides (Lee ‘579, page 3, paragraph 0031), while Kahraman teaches there are 12 known natural ceramides known to be useful in replacing decreased ceramide levels associated with skin diseases as part of a topical composition (Kahraman, page 6, “2. Topical Applications of Ceramides”).
Regarding claim 10, Lee ‘579, Lee ‘756, Kotaka, Youm, Cope, and KR’913 together all the elements of the current invention as applied to claim 1. Lee ‘579 teaches the ceramide can be at least one selected from a group of natural ceramides comprising ceramide-1, ceramide-2, ceramide-3, ceramide-4, ceramide-5, ceramide-6, ceramide-7, ceramide-8, or the like (Lee ‘579, page 3, paragraph 0031), but does not specifically teach ceramide-9, ceramide-10, or ceramide-11. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition taught by Lee ‘579 to utilize any combination of the ceramides taught by Kahraman, because Lee ‘579 teaches the use of other natural ceramides (Lee ‘579, page 3, paragraph 0031), while Kahraman teaches there are 12 known natural ceramides known to be useful in replacing decreased ceramide levels associated with skin diseases as part of a topical composition (Kahraman, page 6, “2. Topical Applications of Ceramides”).
Conclusion
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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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