DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Amendments to the Specification Title, Amendments to the Claims and Arguments/Remarks filed 03 December 2025, in response to the Office Correspondence dated 04 September 2025, are acknowledged.
The listing of Claims filed 03 December 2025, have been examined. Claims 1 and 3-13 are pending. Claims 1 and 10-13 are amended and are supported by the originally-filed disclosure. Claim 2 is canceled and no new claims have been added.
Information Disclosure Statement
The Information Disclosure Statement (IDS), filed 03 December 2025, is acknowledged and has been considered.
Response to Amendment
The applicant has amended the specification title in accordance with the Examiner’s suggestion and requests withdrawal of the objection. The amendment to the title has been reviewed and is found to be clearly indicative of the subject matter of the claims. Accordingly, the objection to the title is withdrawn.
Claims 2 and 10-13 were previously rejected under 35 U.S.C. § 112(b) for indefiniteness, primarily due to internal inconsistency regarding the recited percentages X, Y, and Z. The applicant has cancelled claim 2 and its subject matter incorporated into claim 1. The clause “each of X, Y, and Z is less than 100” corrects a mistranslation and is supported by paragraph ¶[0046] of the specification. As amended, claim 1 now clearly recites, “X, Y, and Z as independent weight percentages relative to the total amount of phytoceramides (A), (B), and (C); and that each of X, Y, and Z is less than 100.”, without reciting an impossible summation requirement. Thus, the amended language removes the logical inconsistency identified in the prior Office Action and as such the dependent claims 10-13 no longer perpetuate the defect previously noted and the rejection of claim 2 is moot and the rejection of claims 10-13 under 35 U.S.C. § 112(b) is withdrawn.
Regarding the rejection of claims 12 and 13 under 35 U.S.C. § 112(d), the applicant argues that “phytosphingosine moiety” as defined in the specification includes both saturated and unsaturated species, such that claim 12 (reciting C16:0, C18:0, and C20:0) provides a narrowing limitation and claim 13 properly limits claim 1 by specifying acyl chain lengths, which are not recited in claim 1. Upon reconsideration of ¶[0038] of the specification, the examiner agrees that the term “phytosphingosine moiety,” as expressly defined by the applicant, encompasses both saturated and unsaturated variants. Accordingly, claim 12, which specifies saturated C16:0, C18:0, and C20:0 phytosphingosine moieties, imposes a further structural limitation and does not merely restate an inherent property. Claim 13 now properly depends from claim 1, which does not specify acyl chain length. The recited C14-C26 acyl chain range constitutes an additional narrowing limitation that is fully consistent with the scope of claim 1. Accordingly, the rejection of claims 12 and 13 under 35 U.S.C. § 112(d) is withdrawn.
Regarding the rejection of claims 1, 3-7, and 9-13 under 35 U.S.C. § 102 (anticipation by Korevaar), the applicant contends that the prior rejection improperly conflated alkyl chain length of the sphingoid base (C16, C18, C20 phytosphingosine moieties), as required by the claims; with acyl (fatty acid) chain length, as disclosed in Korevaar. The applicant further argues that Korevaar consistently employs C18 sphingoid bases and varies only the fatty acid chain length, and therefore fails to disclose a mixture of phytoceramides having different phytosphingosine backbone lengths.
Upon reconsideration of the disclosure of Korevaar in light of Applicant’s clarification and the structural distinctions emphasized in the remarks, the examiner agrees with the applicant. Korevaar discloses ceramide mixtures wherein variation resides in the acyl (fatty acid) chain length, while the phytosphingosine (sphingoid) base is consistently C18. Korevaar does not expressly or inherently disclose a composition comprising two or more phytoceramides having different phytosphingosine backbone lengths selected from C16, C18, and C20, as now required by amended claim 1. Because anticipation requires that each and every limitation of the claim be disclosed in a single reference, Korevaar does not anticipate amended claim 1 or its dependent claims. Accordingly, the rejection of claims 1, 3-7, and 9-13 under 35 U.S.C. § 102 is withdrawn.
Regarding rejection of claims 1, 4, 5 and 8 under 35 U.S.C. § 103, the applicant asserts that the rejection relied on the same misunderstanding regarding sphingoid base versus acyl chain length and since claim 2 (previously relied upon) has been incorporated into claim 1, and Korevaar does not disclose or suggest varying phytosphingosine backbone length, the rejection cannot stand.
The examiner agrees that the previously articulated rationale for obviousness was premised on Korevaar allegedly teaching mixtures of phytoceramides differing in phytosphingosine chain length. As discussed above, Korevaar does not disclose or suggest this feature. Absent a teaching or suggestion in the prior art to modify Korevaar to employ multiple phytosphingosine backbone lengths (C16, C18, C20), the examiner finds that a prima facie case of obviousness has not been established on the current record. Accordingly, the rejection of claims 1, 4, 5, and 8 under 35 U.S.C. § 103 is withdrawn. However, based on the applicant’s clarification and amended claim 1, a new ground of rejection under 35 U.S.C. § 103, detailed below in this Office action.
New Rejections
The following new rejections are made from the previous Office Correspondence dated 04 September 2025, as the applicant's clarification necessitated the new grounds of rejection presented below based on the amended limitations.
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-AlA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AlA) 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 and 3-13 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Weber et al. (US-6054599-A; published 25 April 2000, hereinafter referred to as “Weber”) in view of Casey et al. (US-5627056-A; published 06 May 1997, hereinafter referred to as “Casey”) and in further view of Oh et al. (Novel phytoceramides containing fatty acids of diverse chain lengths are better than a single C18-ceramide N-stearoyl phytosphingosine to improve the physiological properties of human stratum corneum. Clin Cosmet Investig Dermatol. 2017 Sep 13;10:363-371; hereinafter referred to as “Oh”) and Maula et al. (Importance of the sphingoid base length for the membrane properties of ceramides. Biophys J. 2012 Nov 7;103(9):1870-9; hereinafter referred to as “Maula”).
Weber discloses compositions comprising ceramides and phytoceramides for dermatological cosmetic (column 2, lines 3-15) and pharmaceutical use (column 5, lines 54-57), including phytosphingosine-based ceramides, wherein, “The compositions of the present invention may optionally contain more than one of the herein described phytosphingosine-based ceramide I analogs.” (column 5, lines 50-53). Casey discloses compositions containing multiple sphingolipids, including ceramides, for skin barrier repair (column 3, lines 49-56). Thus, compositions comprising mixtures of multiple ceramide/phytoceramide species is taught.
Weber teaches phytosphingosines and ceramides having alkyl chain lengths ranging from C15-35, specifically mentioning 6 different C18 phytosphingosine moiety phytoceramide with C16 and C20 phytosphingosine moiety phytoceramides being encompassed in the 11-26 carbons in the tail as an "analog" of the preferred structure as, “"...it should also be understood that the value of in the phytosphingosine moiety, is preferably 13, but is intended to include analogs wherein the saturated alkyl chain tail, which extends from the 4-OH position, is from 11 to 26 carbons in total length..." (column 3, lines 39-65) and expressly teaches variation in alkyl base chain length as, “In this way, the ω-hydroxy alkanoic acid can be provided with any chain length that is desirable.” (column 5, lines 4-5). Casey also discloses sphingoid bases with different carbon chain lengths from about C16-24, including phytosphingosine derivatives (column 4, lines 7-45; structures 5-10; Examples 3-16), mention that the fermentation product is a mixture of C16-20 chain lengths (column 3, lines 49-55), thus the prior art teaches sphingoid/phytosphingosine alkyl chain length variability that encompasses individual C16, C18, and C20 phytosphingosine moieties.
Weber teaches, “The compositions of the present invention may optionally contain more than one of the herein described phytosphingosine-based ceramide I analogs.” (column 5, lines 50-53), wherein mixtures necessarily include non-zero amounts of at least two species, and wherein the two species may be chosen from a sphingoid base length of C16, C18 and C20, and the choice of these specific components would necessarily result in “at least two of X, Y, and Z are more than 0” and “each of X, Y, and Z is less than 100”.
Weber teaches a phytoceramide having a C18 (t18:0) phytosphingosine moiety in examples 6 and 8 (i.e., N-(27-stearoyloxy-heptacosanoyl)-phytosphingosine) and examples 7 and 9 (i.e., N-(23-stearoyloxy-tricosanoyl)-phytosphingosine) (columns 22 and 23), but does not explicitly teach a mixture of at least two different phytoceramides.
Casey teaches the amount of the phytosphingosine-containing ceramide one present in the composition according to the invention is from 0.00001 to 50% (column 6, lines 32-34) and in Example 12 a formulation containing both phytosphingosine-containing ceramide structure (7) at 0.05% w/w and phytosphingosine-containing ceramide structure (8) at 0.05% w/w (column 17, lines 1-19; wherein the structures can be found in column 6, lines 7-19), wherein the two species may alternatively be chosen from a sphingoid base length of C16, C18 and C20 according to the invention (column 5, lines 21-56), which would meet the instant claim 1 limitation of “at least two of X, Y, and Z are more than 0” and “each of X, Y, and Z is less than 100” and the instant claim 10 limitation of “wherein X is 0-90, Y is 0-95, and Z is 0-50” (in Casey’s Example 12, X= 0, Y=50, and Z=50). In fact, any mixture of two or more the phytoceramides would unequivocally and necessarily meet the instant claim 1 limitation of “wherein at least two of X, Y, and Z are more than 0, and each of X, Y, and Z is less than 100”.
Neither Weber nor Casey explicitly discloses a composition consisting of exactly three phytoceramides limited to C16, C18, and C20 phytosphingosine moieties with defined relative weight percentages to each other.
Oh teaches formulations comprising multiple phytoceramides and relative proportions of ceramide species in mixtures (page 366, ¶3 and Table 1) and demonstrates comparative performance of mixtures versus single ceramide species showing improved epidermal recovery rate and skin hydration with mixed ceramide formulations with different ratios to varying degrees (page 368, Figures 3 and 4), motivating intentional selection of multiple chain-length species and combining multiple phytoceramide chain-length species in controlled ratios. In Table 1, Oh shows phytoceramide fatty acyl chain length percent weights analyzed in various oil-derived ceramide samples using GC, wherein calculated weight ratios of C16:C18:C20 based on the total weight of the sum of C16, C18 and C20 species calculated (rounded to the nearest whole number) are 15:20:4 for human SC (face), 41:60:0 for human SC (leg), 0:100:0 for C18-ceramide NP, 40:60:0 for Phytocera-H (natural oil), 46:54:0 for Phytocera-H (synthetic), 30:66:4 for Phytocera-M (natural oil), 30:65:5 for Phytocera-M (synthetic), 6:93:1 for Phytocera-SB (natural oil) and Phytocera-SB (synthetic), 10:89:0 for Phytocera-SF (natural oil), 8:92:0 for Phytocera-SF (synthetic), 12:68:20 for Phytocera-Mix (natural oil), and 12:65:23 for Phytocera-Mix (synthetic), exemplifying the variability of the unique ratios.
Further supporting the obviousness of combining the teachings of Weber and Casey with the importance of phytoceramide chain diversity taught by Oh (i.e., combining multiple different species with different chain lengths in specific ratios), Maula directly provides an explicit motivation and scientific rationale for varying the sphingoid base chain length itself. Maula recites reporting on “…the importance of the sphingoid base length in regulating the properties of ceramide bilayers…”, noting great variation in the length of some sphingoid bases has been observed (page 1870, right column, ¶1). Thus, establishing that it was known at the time of the instant invention that the scientific community recognized that great variation in sphingoid base length existed, and there was a clear, identified need to understand its importance.
Maula demonstrates that varying the sphingoid base length from C12 to C20 produces predictable, chain-length-dependent progressive changes in its biophysical properties and effects on membrane properties like lipid order (page 1871, Figure 1), sterol affinity (page 1875, Figure 5), and in mixtures with sphingomyelin they observed a chain-length-dependent increase in the main phase transition temperature for bases from C12 to C20 (page 1872, Figure 2). Maula explicitly shows that in mixtures with POPC (a model phospholipid), ceramides with C16, C18, and C20 sphingoid bases induced ordered- or gel-phase formation, while shorter ones did not (page 1873, Figure 3). In combination with the teaching of Oh that chain-length diversity improves skin barrier function and modifying the specific ratios of each chain length provides variable results, one of ordinary skill in the art would have been motivated to also diversify the sphingoid base chain length (e.g., to C16, C18, and C20) and optimize the relative ratios of each with the reasonable expectation of success in further optimizing these membrane properties for skin care applications. Therefore, a person of ordinary skill in the art seeking to optimize a ceramide mixture would then be directly motivated to investigate mixtures with varying base lengths (known to encompass C16, C18 and C20 bases as taught by Weber and Casey) because the Maula taught that this was a key structural variable affecting membrane properties.
Weber expressly teaches wherein the compositions are cosmetic (column 2, lines 3-15) or pharmaceutical (column 5, lines 54-57). Weber also teaches wherein compositions may further comprise cosmetic or pharmaceutical ingredients (claims 9 and 10; column 5, lines 21-30) including the lipids Lanette O, White Vaseline, Paraffin liquor (Examples 6 and 8) and the fatty acid stearic acid (Example 8) and indirectly terpenoids anhydrous lanolin (Example 8). Casey teaches additives including lipid and fatty acid additives (column 10, lines 1-18), cholesterol specifically (column 10, line 14). Oh also prepares formulations including the phytoceramide, phytosphingosine, cholesterol, medium-chain triglyceride (MCT; C8–C12,), lecithin 95 (a phosphatidylethanolamine), stearic acid, oleic acid (a building block of triolein), linoleic acid, and distilled water (page 364, right column, ¶3). Thus, the limitations of instant claims 3-9 are taught by the prior art.
Weber teaches the use of from 0.001% to 25% of at least one compound by Weber (claim 9) and ceramide concentrations are taught broadly by Casey as 0.00001 to 50% (column 6, lines 32-34), but neither teach relative ratios of phytoceramide species.
Oh shows variable percentage ranges for various chain lengths in ceramide mixtures (Table 1), thus rendering it obvious to optimize the specific ratios of ceramides with C16, C18, and C20 sphingoid bases in the mixture to 0-90%, 0-95%, and 0-50%, respectively, or 65-90%, 5-30%, and 1-20%, respectively, as they are known to be result-effective variables by the teachings of Maula, and given the wide range of known optimization of ceramide chain length ratios for barrier function taught by Oh for the acyl chain (pages 366-369). Determining the specific effective ratios of a mixture of C16, C18, and C20 phytoceramides would be a routine optimization for a person of ordinary skill, achieved through standard experimentation without undue burden. The ranges claimed are broad and encompass mixtures that would result from simply combining the teachings of Oh and Casey. Furthermore, optimizing the specific relative amounts of the components is a routine matter of trial and optimization for a person of ordinary skill, and in the absence of evidence of criticality, such optimization is considered obvious. The applicant has not provided data demonstrating that these specific numerical ranges produce unexpectedly superior results compared to other ranges or the prior art mixtures.
Weber describes the phytosphingosine as saturated (column 3, lines 53-58), encompassing saturated C16:0, C18:0, C20:0 phytosphingosine of instant claim 12. Weber teaches C5-C25 acyl chain lengths (column 3, lines 36-37), Casey teaches the fatty acid (acyl) chain can vary from C14-26 (column 2, lines 60-65), and Oh teaches C12-26 acyl chain lengths (Table 1; see also Introduction). Therefore, the limitations of instant claims 12 and 13 are fully met by the prior art combination.
In summary, the subject matter of claims 1 and 3-13 as a whole it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date. Weber was known to formulate cosmetic compositions with ceramides/phytoceramides, Weber and Maula teach all species individually, Casey teaches that phytosphingosines exist naturally in a range of chain lengths, including C16, C18, C20 as mixtures of the species. Oh teaches it was routine for those skilled in the art to optimize ceramide mixtures for barrier function by selecting multiple known ceramide species with variable chain lengths in mixtures at different relative ratios of species, motivating intentional selection and combination of multiple chain-length species in controlled ratios. Maula directly provides an explicit motivation varying the sphingoid base chain length itself, for the importance of the sphingoid base length in regulating the properties of ceramide bilayers (page 1870, right column, ¶1).
Maula demonstrates that varying the sphingoid base length from C12 to C20 produces predictable, chain-length-dependent progressive changes in its biophysical properties and membrane effects and in combination with the teaching of Oh that chain-length diversity improves skin barrier function and modifying the specific ratios of each chain length provides variable results, one of ordinary skill in the art would have been motivated to also diversify the sphingoid base chain length (e.g., to C16, C18, and C20) and optimize the relative ratios of each with the reasonable expectation of success in further optimizing these membrane properties for skin care applications.
Therefore, a person of ordinary skill in the art seeking to optimize a ceramide mixture would then be directly motivated to investigate mixtures with varying base lengths, known to encompass C16, C18 and C20 bases as taught by Weber and Casey, because the Maula taught that this was a key structural variable affecting membrane properties in combination with Oh's teaching on the importance of fatty acyl chain diversity in phytoceramides would have led naturally to the instant claimed compositions of alternative sphingoid base chain lengths.
Thus, blending ceramides with different sphingoid base lengths for a topical composition would have been obvious at the effective filing date. The instant claimed ratios represent routine optimization of known variables and the additional limitations of the dependent claims are either explicitly taught by the prior art or represent obvious routine optimizations. It would have been obvious to one of ordinary skill in the art at the time of the invention to formulate a cosmetic or pharmaceutical composition comprising a mixture of C16, C18, and C20 phytoceramides in optimized ratios, as taught and suggested by Weber and Casey, in view of the performance-based motivation articulated by Oh and the importance of the sphingoid base chain lengths in barrier function parameters taught by Maula.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 03 December 2025, have been fully considered and are persuasive. Accordingly, the prior Office Action objection and rejections have been withdrawn.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615