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 Claims and Arguments/Remarks filed 21 May 2026, in response to the Office Correspondence dated 24 February 2026, are acknowledged.
The listing of Claims filed 21 May 2026, have been examined. Claims 1, and 3-12 are pending. Claim 1 is amended, claims 2 and 13 are canceled, and no new claims have been added.
Response to Amendment
The applicant’s Remarks and the amendment to claim 1 have been fully considered. To the extent that the applicant’s arguments are directed to the previous rejections under 35 U.S.C. § 102 (anticipation by Korevaar) and the withdrawn obviousness rejections, those arguments are moot as those rejections have been withdrawn. However, the applicant’s arguments regarding the newly amended claims and the outstanding §103 rejection over Weber, Casey, Oh, and Maula are not persuasive for the reasons set forth below in the Response to Arguments.
The applicant has not identified any newly added matter or newly amended limitations that would necessitate a new ground of rejection beyond the outstanding §103 rejection. The amendment to claim 1, adding the acyl chain length limitation for each of (A), (B), and (C), does not avoid the prior art combination because Weber, Casey, and Oh each teach acyl chain lengths within C14-C26. The prior rejection of claims 1, and 3-12 under 35 U.S.C. § 103 remains fully applicable to the amended claim, and accordingly, is maintained.
Further, amendment to claim 1 necessitates new grounds of objection, as detailed below.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 24 February 2026, since the art which was previously cited continues to read on the amended/newly cited 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.
New Rejections
The following new rejections are made from the previous Office Correspondence dated 24 February 2026, as the applicant's amendment necessitated the new grounds of rejection presented below based on the amended/newly cited limitations.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 now recites "phytosphyngosine", which is misspelled and should be cottected to "phytosphingosine". Further, it is noted that claim 1 recites acyl chain length limitations for (A), (B), and (C) but does not specify that the acyl chain is the fatty acid moiety (as opposed to the sphingosine moiety). It is suggested that the applicant clarifying the claim language to recite, "wherein the fatty acid acyl chain of phytoceramide (A) has a length of C14 to C26…", etc.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 21 May 2026, have been fully considered and are not persuasive for the reasons set forth below.
The applicant argues that Weber and Casey disclose ceramides having esterified fatty acid moieties and therefore fail to teach or suggest the presently claimed phytoceramides having non-esterified acyl chains of C14-C26. This argument is not persuasive. Amended claim 1 recites wherein the phytoceramide (A), (B), and (C) have an acyl chain having a length of C14-C26. The claim does not exclude esterified ω-hydroxy fatty acid-containing ceramides nor require any particular acyl-chain substitution pattern beyond chain length. Weber expressly teaches phytosphingosine-based ceramide analogs derived from ω-hydroxy alkanoic acids and further teaches that the ω-hydroxy alkanoic acid can be provided with any chain length that is desirable, and discloses acyl-chain lengths encompassing the presently claimed range.
Moreover, Casey expressly teaches ceramide structures containing fatty acid chains ranging from approximately C14-C26. The newly added limitation merely places a numerical restriction on acyl chain length that is already encompassed by the teachings of Weber and Casey. The applicant has not identified any structural limitation in claim 1 excluding the specific ceramide classes disclosed by Weber and Casey. Accordingly, the amendment does not distinguish the claims from the applied prior art (see MPEP § 2111.01 and § 2111.04).
However, even if the claim were construed to require non-esterified acyl chains, Weber teaches such structures. Weber expressly discloses phytosphingosine-based ceramides wherein the fatty acid moiety is an ω-hydroxy alkanoic acid, which may be esterified or non-esterified depending on the embodiment. Moreover, the skilled artisan would have recognized that substituting a non-esterified acyl chain for an esterified chain is a routine chemical modification that does not alter the fundamental properties of the molecule in a manner rendering the combination non-obvious. The applicant’s own specification discloses phytoceramides with esterified acyl chains (in the broad definition of phytoceramide), undermining any contention that the claims exclude such structures.
The applicant next argues that Oh concerns variation in fatty-acid chain length rather than variation in phytosphingosine chain length and does not teach or suggest mixtures of phytoceramides having different phytosphingosine alkyl chain lengths. The examiner agrees that Oh primarily addresses fatty acyl chain diversity, however, this does not render the claimed combination non-obvious. Thus, the argument is not persuasive.
The rejection does not rely upon Oh for teaching variation of sphingoid-base chain length. Rather, the rejection relies upon the combination of Weber, Casey, Oh, and Maula. It relies on Weber and Casey for teaching phytoceramide species encompassing C16, C18, and C20 phytosphingosine backbones, Oh for teaching that mixtures of phytoceramide species having differing chain-length characteristics provide improved skin barrier functionality and that optimization of relative ratios of chain-length-diverse ceramide species was known and desirable, and Maula for specifically teaching that sphingoid-base chain length is an important structural variable affecting membrane organization and barrier properties.
Maula supplies the missing link in teaching that sphingoid base length itself affects membrane properties, including lipid order, sterol affinity, and phase transition temperatures (Abstract; Figure 3). Maula demonstrates chain-length-dependent effects for C16, C18, and C20 bases, the exact lengths claimed. A person of ordinary skill seeking to optimize a phytoceramide mixture for skin barrier function would therefore have been motivated to vary the sphingoid base length among known species (C16, C18, C20) with a reasonable expectation of success, rendering it obvious under KSR International Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
The applicant fails to address the teachings of the references in combination. A rejection under §103 is based upon the collective teachings of the references and not whether any single reference independently discloses the entire claimed invention. The examiner's rationale remains that Oh teaches the desirability of chain-length diversity within phytoceramide systems, while Maula identifies sphingoid-base length as a recognized result-effective variable. Accordingly, the applicant's criticism of Oh does not overcome the combination.
The applicant argues that Maula merely studies model membrane systems and does not disclose phytosphingosine ceramides of the type presently claimed, nor does Maula disclose compositions containing mixtures of phytoceramides having different phytosphingosine chain lengths. This argument is not persuasive. Maula is not relied upon as a direct disclosure of the claimed mixture, rather, it is relied upon as motivation to combine known elements. Maula expressly investigates the influence of sphingoid-base chain length on membrane properties and demonstrates systematic effects attributable to chain length variation. Specifically, Maula teaches that sphingoid-base length significantly influences lipid ordering, sphingoid-base length significantly influences sterol interactions, sphingoid-base length significantly influences phase-transition behavior, and longer-chain ceramides produce progressively different membrane effects.
These teachings establish sphingoid-base chain length as a recognized result-effective variable. Where the prior art recognizes a parameter affecting the desired result, optimization of that parameter is ordinarily obvious (see In re Aller, 220 F.2d 454 (CCPA 1955)). Oh taught that chain-length diversity improves barrier function, and Maula taught that base length matters, the step of combining multiple base lengths (C16, C18, C20) is an obvious extension of known principles. A single reference need not explicitly disclose the claimed combination to render it obvious, it is sufficient that the reference provides a reason to combine other known elements. The applicant has not rebutted the finding that Maula would have motivated a skilled artisan to investigate mixtures incorporating differing sphingoid-base lengths.
The applicant relies upon lower melting-point data, improved lamellar structure formation data, and reduction in TEWL measurements for enhanced skin barrier recovery as evidence of unexpected results (unexpectedly superior properties). The evidence has been considered but is insufficient to outweigh the strong prima facie case of obviousness for the following reasons:
Claim 1 encompasses a vast genus of compositions. The claim covers any C16 phytoceramide A, any C18 phytoceramide B, any C20 phytoceramide C, any acyl chain from C14-C26, and any ratio satisfying the recited limitations. The experimental evidence, however, appears limited to a small number of specific phytoceramide species and specific formulations. The applicant has not established that all compositions encompassed by the claims exhibit the alleged advantages. Evidence of unexpected results must be reasonably commensurate in scope with the claims (see In re Grasselli, 713 F.2d 731 (Fed. Cir. 1983)).
The submitted data compare certain mixtures against a single ceramide species. However, the closest prior art identified in the rejection is not a single-species phytoceramide composition (e.g., “Ceramide III (C18:0-PHS18:0)”). The closest teachings are the mixed phytoceramide systems of Weber, Casey, and Oh.
The applicant has not demonstrated superiority over compositions representing the closest prior-art mixtures. The applicant must demonstrate that the results are unexpected relative to the closest prior art (see MPEP § 716.02(e) and In re Geiger, 815 F.2d 686 (Fed. Cir. 1987)). The applicant has provided no data comparing the claimed composition to, for example, a mixture of C18 phytoceramides with varying acyl chain lengths, as taught by Oh, or a mixture of C16, C18, and C20 sphingosines, as suggested by Maula.
The TEWL data in Figure 1 compares only a single phytoceramide (C18:0-PHS18:0) to the claimed mixture. The single species showed no significant reduction while the mixture did. The prior art combination teaches mixtures, not single species. The proper comparison would be between the claimed C16/C18/C20 sphingoid base mixture and, for example, a C18 sphingoid base mixture with varying acyl chains, as in Oh. The applicant has provided no such comparison. Without evidence that the claimed mixture performs unexpectedly better than the closest prior art mixture (varying acyl chains on a fixed C18 base), the TEWL data do not rebut obviousness.
The applicant has not provided any comparative data showing that the claimed specific weight percentage ranges (X:65-90, Y:5-30, Z:1-20 in claim 11) produce unexpectedly superior results compared to other ratios within the broad ranges (e.g., X:50, Y:30, Z:20). Where a claim recites a broad range of result-effective variables without demonstrating criticality, the range is obvious.
The applicant has not established that the results are unexpectedly superior to what the prior art would have suggested. The results appear consistent with prior-art expectations. Oh teaches improved barrier performance through chain-length diversity and that Maula teaches chain-length-dependent membrane behavior. Accordingly, observations that changing sphingoid-base length influences melting behavior, membrane organization, or barrier properties would have been expected from the combined teachings of the prior art. The applicant has not demonstrated that the magnitude of the observed effects would have been truly surprising to a person of ordinary skill in the art.
The alleged differences in melting points and lamellar structure are predictable, not unexpected. Maula explicitly teaches that varying sphingoid base length produces predictable, chain-length-dependent progressive changes in membrane properties (Figures 1-2). Lower melting points and altered lamellar packing are exactly the types of predictable physical changes one would expect when mixing molecules of different chain lengths, as taught by Maula. Maula demonstrates that mixtures with different base lengths exhibit distinct phase behavior as a teaching, therefore it is not an unexpected result.
The applicant also alleges that the rejection is based upon impermissible hindsight reconstruction. This argument is not persuasive. The rejection is based on four prior art references, each of which predates the applicant’s effective filing date and identifies explicit teachings from the prior art. Weber teaches phytoceramide compositions for cosmetic/pharmaceutical use, phytosphingosine moieties with chain lengths encompassing C16-C20, and the optional use of multiple phytoceramide species. Casey teaches mixtures of phytosphingosine-containing ceramides with C16-C20 chain lengths, including explicit examples of mixtures. Oh teaches advantages of combining phytoceramide species with differing chain-length characteristics to improve skin barrier function and that optimizing ratios is routine. Maula teaches that sphingoid base length (C12-C20) is a critical variable affecting membrane properties and behavior, with chain-length-dependent effects for C16, C18, and C20, and is therefore a variable worthy of optimization.
The motivation to combine is therefore derived from the prior art itself rather than applicant's disclosure- it is a straightforward application of the principle that when prior art teaches a class of compounds (phytoceramides with C16-C20 bases) and teaches that varying a structural parameter (chain length) affects a desired property (barrier function), selecting specific members of that class for a mixture is obvious. The obviousness analysis need not identify an express teaching to combine when market forces, design incentives, and known scientific principles would have prompted the combination (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007)). Accordingly, the rejection is not based on hindsight.
Although the applicant amended claim 1 to incorporate the former claim 13 limitation regarding acyl-chain length, the amendment and arguments do not overcome the established prima facie case of obviousness and the outstanding rejection. The newly added limitation merely narrows the acyl-chain length to C14-C26. As discussed above Casey teaches C14-C26 fatty-acid chains. Weber teaches overlapping chain-length ranges. Oh teaches phytoceramide species having chain lengths within the claimed range. Selection of an overlapping range from a prior-art disclosed range is ordinarily obvious absent evidence of criticality (see In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)). The applicant has not demonstrated that the entire claimed C14-C26 range is critical. Therefore, amended claim 1 remains obvious.
Conclusion
No claims are allowed.
The 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 (87 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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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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