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 .
Information Disclosure Statement
The IDS filed on 1/28/2026 has been considered. See the attached PTO 1449 form.
Claim Status
Receipt of Remarks/Amendments filed on 2/25/2026 is acknowledged. Claims 1-30 are currently pending. Claims 1-15 are withdrawn. Accordingly, claims 16-30 are currently under examination.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Note: This is a second non-final office action, that is prompted by applicant’s remarks filed on 2/25/2026.
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-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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 16-30 are rejected under 35 U.S.C. 103 as being unpatentable over Serizawa et al. (US 2011/0076311 A1) in view of Kawamoto et al. (Journal of Dermatological Science 110 (April 2023) 35-38) and Vielhaber (Journal of Investigative Dermatology, volume 117, Issue 5, November 2001, pages 1126-1136).
Serizawa throughout the reference teaches ceramide dispersion which includes at least a natural ceramide containing particles that are dispersed in an aqueous phase as an oil phase component. (e.g., Abstract; Entire document).
Regarding claim 16, 17, 18, 28-30 Serizawa teaches a composition comprising a natural ceramide wherein compound (1-9) referred to as ceramide 8 (see below) is taught as one of the ceramide compound that can be included in the composition. (see e.g., para 0041; page 3-4).
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The ceramide dispersion has excellent emollient/moisturizing, anti-aging and anti-oxidation effects for the skin due to the natural ceramide and used as a skin care cosmetic such as skin lotion which is applied to the skin. (e.g., para 0061; 0097; 0277; 0278; 0203). These teachings of Serizawa read on the claimed method of improving condition of an organism’s body surface (skin) by application of a composition comprising ceramide NH to the skin, wherein the composition provides emollient/moisturizing effect.
Regarding claims 19 and 20, Serizawa teaches the ceramide dispersion composition provide emollient/moisturizing effect and thus would be able to treat dry skin due to its moisturizing effect.
Regarding claim 21, as discussed supra, Serizawa teaches the ceramide dispersion is used as a cosmetic product.
Regarding claims 22-27, Serizawa teaches the ceramide dispersion composition include cholesterol (e.g., example 6). A lecithin may also be used in the composition and Serizawa specifically teaches an example of lecithin that can be used includes phosphatidylethanolamine (e.g., para 0174-0179). The ceramide dispersion also includes, as a surfactant, a fatty acid such as lauric acid, myristic acid, palmitic acid, stearic acid and oleic acid. (e.g., para 0146).
The difference between the ceramide 8 compound taught by Serizawa and the claimed ceramide compound is the chain length (specifically the acyl chain length) wherein ceramide 8 of Serizawa has a longer chain length than the claimed ceramide compound. However, this deficiency is cured by Kawamoto and Vielhaber.
Kawamoto discusses chain length of covalently bound ceramides correlates with skin barrier function in healthy subjects. Kawamoto teaches chain length of covalently bound ceramides play an important role in barrier function at least in sun protected skin of healthy subjects. Corneocyte lipid envelope (CLE) thickness is thought to act as a bridge between protein-enriched corneocytes and extracellular lipid lamellae, which may contribute to stabilizing the lamellar structure. Therefore, the changes in CLE thickness, which are closely associated with the carbon length of covalently bound CERs, were speculated to influence the stability of the lamellar structure, which may in turn be attributed to individual variations in barrier function. The current study is the first to provide evidence that the chain length of covalently bound CERs plays a role in the skin barrier function of healthy subjects. (see entire document).
Vielhaber teaches the epidermis is marked by a unique diversity of ceramides and to date, eight ceramides are known, the structure of which vary in the degree of hydroxylation of the sphingosine backbone and of the fatty acid. Vielhaber discloses one of the ceramide is ceramide 8 which is represented by the structure below, which is the same as the claimed ceramide compound. (see e.g. Figure 1; abstract; pages 1126-1127; entire document).
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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 Serizawa to incorporate the teachings of Kawamoto and Vielhaber and have the chain length (specifically the acyl chain length) of ceramide 8 of Serizawa to be C18 as disclosed by Vielhaber. Serizawa teaches the length of the alkyl chain may have any structure (para 0042). As discussed supra, Kawamoto teaches the current study is the first to provide evidence that the chain length of covalently bound CERs plays a role in the skin barrier function of healthy subjects. the changes in CLE thickness, which are closely associated with the carbon length of covalently bound CERs, were speculated to influence the stability of the lamellar structure, which may in turn be attributed to individual variations in barrier function. Vielhaber teaches the epidermis is marked by a unique diversity of ceramides and to date, eight ceramides are known, the structure of which vary in the degree of hydroxylation of the sphingosine backbone and of the fatty acid. Vielhaber discloses one of the ceramide is ceramide 8 which is the same as the claimed ceramide compound. The claimed ceramide compound was known to be a ceramide of the epidermis as taught by Vielhaber and the chain length of ceramides were known to play a role in the skin barrier function and stability of the lamellar structure. Therefore, it would have been obvious to one skilled in the art to manipulate the carbon chain length and determine the chain length which provides skin barrier function and stability of the lamellar structure. One would have been especially motivated to pick the carbon 18 chain length because Vielhaber teaches this type of ceramide (i.e. claimed ceramide with 18 carbon chain length) was known to be a ceramide of the epidermis.
Further, while Serizawa does not expressly teach an example which comprises the claimed ceramide in combination with cholesterol, phosphatidylethanolamine and the fatty acids, Serizawa teaches cholesterol, phosphatidylethanolamine and the fatty acids can all be included in the ceramide dispersion composition which can include ceramide 4. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 16-30 are rejected under 35 U.S.C. 103 as being unpatentable over Serizawa et al. (US 2011/0076311 A1) in view of Vielhaber (Journal of Investigative Dermatology, volume 117, Issue 5, November 2001, pages 1126-1136).
Serizawa throughout the reference teaches ceramide dispersion which includes at least a natural ceramide containing particles that are dispersed in an aqueous phase as an oil phase component. (e.g., Abstract; Entire document).
Regarding claim 16, 17, 18, 28-30 Serizawa teaches a composition comprising a natural ceramide wherein compound (1-4) referred to as ceramide 2 (see below) is taught as one of the ceramide compound that can be included in the composition. (see e.g., para 0041; page 3-4).
(1-4)
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The ceramide dispersion has excellent emollient/moisturizing, anti-aging and anti-oxidation effects for the skin due to the natural ceramide and used as a skin care cosmetic such as skin lotion which is applied to the skin. (e.g., para 0061; 0097; 0277; 0278; 0203). These teachings of Serizawa read on the claimed method of improving condition of an organism’s body surface (skin) by application of a composition comprising ceramide NH to the skin, wherein the composition provides emollient/moisturizing effect.
Regarding claims 19 and 20, Serizawa teaches the ceramide dispersion composition provide emollient/moisturizing effect and thus would be able to treat dry skin due to its moisturizing effect.
Regarding claim 21, as discussed supra, Serizawa teaches the ceramide dispersion is used as a cosmetic product.
Regarding claims 22-27, Serizawa teaches the ceramide dispersion composition include cholesterol (e.g., example 6). A lecithin may also be used in the composition and Serizawa specifically teaches an example of lecithin that can be used includes phosphatidylethanolamine (e.g., para 0174-0179). The ceramide dispersion also includes, as a surfactant, a fatty acid such as lauric acid, myristic acid, palmitic acid, stearic acid and oleic acid. (e.g., para 0146).
The difference between the ceramide 2 compound taught by Serizawa and the claimed ceramide compound is that the ceramide 2 of Serizawa lacks a hydroxyl (OH) on C6 of the alkyl chain. Serizawa does teach that more preferable embodiments of the natural ceramide are those each having three or more hydroxyl groups in a molecular structure thereof (para 0022; 0038). Vielhaber further addresses this deficiency.
Vielhaber teaches the epidermis is marked by a unique diversity of ceramides and to date, eight ceramides are known, the structure of which vary in the degree of hydroxylation of the sphingosine backbone and of the fatty acid. Vielhaber discloses one of the ceramide is ceramide 8 which is represented by the structure below, which is the same as the claimed ceramide compound. (see e.g. Figure 1; abstract; pages 1126-1127; entire document).
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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 Serizawa to incorporate the teachings of Vielhaber and further add a hydroxyl group on carbon 6 of the alkyl chain as taught in Vielhaber. As discussed supra, Serizawa teaches more preferable embodiments of the natural ceramide are those each having three or more hydroxyl groups in a molecular structure thereof. Serizawa teaches other ceramide compound structure (e.g. compound 1-9) which have the hydroxyl group on carbon 6. Vielhaber teaches the epidermis is marked by a unique diversity of ceramides and to date, eight ceramides are known, the structure of which vary in the degree of hydroxylation of the sphingosine backbone and of the fatty acid. Vielhaber discloses one of the ceramide is ceramide 8, which is the same as the claimed ceramide compound having hydroxyl group on carbon 6 of the alkyl chain. The claimed ceramide compound was known to be a ceramide of the epidermis as taught by Vielhaber. Therefore, it would have been obvious to one skilled in the art to include a hydroxyl group on carbon 6 of the alkyl chain because Serizawa teaches to add at least 3 hydroxyl groups and the ceramides having the hydroxyl group on the carbon 6 was known in the art as taught by Vielhaber. As such, the claimed ceramide compound in the composition of Serizawa would have been prima facie obvious to one skilled in the art.
Further, while Serizawa does not expressly teach an example which comprises the claimed ceramide in combination with cholesterol, phosphatidylethanolamine and the fatty acids, Serizawa teaches cholesterol, phosphatidylethanolamine and the fatty acids can all be included in the ceramide dispersion composition which can include ceramide 4. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant’s arguments regarding compound 1-3 of Serizawa not reading the claimed ceramide are persuasive and as such, the new/modified 103 rejection above does not rely on compound 1-3 of Serizawa.
Applicant argued the C18 acyl chain length of the claimed ceramide having unexpected effect because compared to C14, C16 or C22, the C18 ceramide having 18 carbon chain length shows a remarkably high count of maltese cross.
In response, the examiner argues that while the C18 ceramide does shows much higher count of maltese cross, the results do not appear to commensurate in scope with the claims because the claim broadly recites the composition comprising ceramide NH comprising a C18 acyl chain and does not recite any particular amount of C18 ceramide. The data provided by applicant includes one specific amount of ceramide 18, which is 10.01 mg, and it is not apparent that similar effect would occur when ceramides are used in other amounts as well.
The examiner further directs applicant’s attention to the compound 1-4 of Serizawa which teach the ceramide having 18 carbon chain and Vielhaber also teaches ceramide such as the claimed ceramide having 18 carbon chain is known for being part of the epidermis. Thus, applicant’s use of ceramide with 18 carbon chain does not appear to be non-obvious to one of ordinary skill in the art.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616
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