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 .
Claim Status
Receipt of Remarks/Amendments filed on 9/3/2026 is acknowledged. Claims 1-16, 19-28, 30-32 are currently pending. Claims 1-15 are withdrawn. Accordingly, claims 16, 19-28, 30-32 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Rejection(s) not reiterated from the previous Office Action are hereby withdrawn.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.
New/Maintained Claim(s) Rejection(s) Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation “wherein the symptom is selected from”. There is insufficient antecedent basis for this limitation in the claim. Claim 20 depends from claim 16 and claim 16 does not recite or suggest there being a symptom and the recitation “wherein the symptom is selected from” makes it unclear as to what is being referred to as the symptom in claim 16. Claim 16 previously recited “a method for improving condition of an organism’s body surface” and an organism having a condition of body surface encompasses there being a symptom (see e.g. para 0041 of instant specification). As such, claim 20 previously did not lack antecedent basis. However, claim 16 has been amended to delete “condition” and claim 16 as currently amended does not recite or suggest there being a symptom.
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 28 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 28 recites wherein the ceramide NH comprises a C18:1 alkyl chain and a C18 acyl chain. Independent claim 16 recites wherein the ceramide NH comprises a C18:1 alkyl chain and a C18:0 acyl chain. “C18:0 acyl chain” in claim 16 means fully saturated 18-carbon fatty acyl chain (i.e. 0 double bonds). However, “C18 acyl chain” in claim 28 is a broader term suggesting the 18-carbon fatty acyl chain may be fully saturated or include unsaturated bonds. Therefore, claim 28 improperly broadens the scope of claim 16 and fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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, 19-28, 30-31 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) and Berkers (Topically Applied Ceramides Interact with the Stratum Corneum Lipid Matrix in Compromised Ex Vivo Skin. Pharm Res. 2018 Feb 6;35(3):48).
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, 28, 30, 31 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 (which encompasses applying one or more times). (e.g., para 0061; 0097; 0277; 0278; 0203). These teachings of Serizawa read on the claimed method of improving moisturizing capacity of an organism’s 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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Serizawa also does not expressly teach applying 1 microgram/cm2 to 100 mg/cm2 of composition comprising ceramide. However, Berkers cures this deficiency.
Berkers teaches topically applied ceramides interact with the stratum corneum lipid matrix in compromised ex vivo skin. Berkers teaches that application of a formulation comprising ceramide resulted in a denser lateral lipid packing of the stratum corneum lipids in compromised skin. Berkers teaches formulations comprising ceramide were applied in a single dose of about 5 mg/cm2 in a metal ring placed on top of the skin (see e.g. Title; Abstract; Preparation and culturing of ex vivo skin section; Material and Methods section; entire document).
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.
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 Berkers and apply the ceramide containing formulation of Serizawa in an amount of 5 mg/cm2 to the skin as disclosed by Berkers. As discussed supra, Serizawa is silent with respect to the amount of ceramide containing formulation applied to the skin. Berkers also teaches ceramide containing formulations for skin and Berkers discloses useful amount of formulation comprising ceramide for skin being 5 mg/cm2. As such, it would have been obvious to one skilled in the art to incorporate the teachings of Berkers for the amount of formulation to be applied to the skin because Serizawa is silent on this regard and Berkers teaches amounts which are known in the art to be useful for application to the skin.
“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. Further, absence any evidence of criticality or unexpected effect, it would have been obvious to one skilled in the art to determine the optimal amount through routine optimization which would depend on, for example, severity of skin condition, the type of skin (e.g. thick vs thin skin), etc. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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.
Claim 32 is 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) and Berkers (Topically Applied Ceramides Interact with the Stratum Corneum Lipid Matrix in Compromised Ex Vivo Skin. Pharm Res. 2018 Feb 6;35(3):48) as applied to claims 16, 19-28, 30-31 above and further in view of Stephens (EP1481663A1; 2004-12-01).
The teachings of the above cited references have been set forth above.
The above cited references do not expressly teach wherein the composition is applied in an amount of 1 microgram/cm2 to 0.1 mg/cm2. However, Stephens cures this deficiency.
Stephens throughout the reference teaches cosmetic compositions comprising self-tanning agent and skin care active. The skin care active comprises ceramide. Stephens teaches a method of regulating skin condition comprising topically applying the composition to the skin in an amount of from 0.1 mg/cm2 to 30 mg/cm2. The amount of 0.1 mg/cm2 overlaps the amount recited in claim 32. (see e.g. claims; para 0035; 0061; entire document).
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 Stephens and apply the ceramide containing formulation of Serizawa in an amount of 0.1 mg/cm2 to the skin as disclosed by Stephens. As discussed supra, Serizawa is silent with respect to the amount of ceramide containing formulation applied to the skin. Stephens also teaches ceramide containing formulations for skin and a method of regulating skin condition comprising topically applying the composition to the skin. Stephens discloses 0.1 mg/cm2 being a useful amount of a formulation comprising ceramide for application to skin. As such, it would have been obvious to one skilled in the art to further incorporate the teachings of Stephens for the amount of formulation to be applied to the skin because Serizawa is silent on this regard and Stephens teaches amounts which are known in the art to be useful for application to the skin. “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. Further, absence any evidence of criticality or unexpected effect, it would have been obvious to one skilled in the art to determine the optimal amount through routine optimization which would depend on, for example, severity of skin condition, the type of skin (e.g. thick vs thin skin), etc. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 priority claim and the request for a corrected filing receipt along with a corrected ADS submitted on August 3, 2023 is acknowledged by the examiner. As such, the 103 rejection utilizing Kawamoto et al. is withdrawn.
Applicant argued the ceramide exemplified by Serizawa has an acyl chain longer than that of the presently claimed C18 ceramide NH.
In response, as discussed in the 103 rejection above, the examiner directs applicant’s attention to the compound 1-4 of Serizawa which teach the ceramide having 18 carbon acyl chain and Vielhaber also teaches ceramide such as the claimed ceramide having 18 carbon acyl chain is known for being part of the epidermis.
Applicant argued that although Vielhaber identifies ceramide 8, corresponding to a ceramide having the presently claimed C18 acyl chain, Vielhaber describes ceramide 8 as one of a number of ceramides naturally occurring in the epidermis. Vielhaber discusses a diversity of naturally occurring epidermal ceramides and identifies ceramide 4 as well as ceramide 8. Vielhaber does not teach or suggest selecting ceramide 8 from among the various epidermal ceramides for topical application to skin.
In response, as discussed supra, the compound 1-4 of Serizawa teaches the ceramide having 18 carbon acyl chain. 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. 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.
Applicant argued the results demonstrate a critical and unexpected effect at C18 acyl chain length. Applicant referred to examples 1 and 2 of instant specification and 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 example 1) and a higher recovery effect of the skin condition (example 2).
In response, as discussed supra, firstly the examiner argues that the compound 1-4 of Serizawa teaches the ceramide having 18 carbon acyl chain. Further, the examiner argues that while the C18 ceramide does show much higher count of maltese cross, the results do not appear to commensurate in scope with the claims because claim 16 recites applying 1 microgram/cm2 to 100 mg/cm2 of a composition comprising ceramide NH comprising a C18 acyl chain to the skin wherein the ceramide NH comprises a C18:1 alkyl chain and a C18:0 acyl chain. The data provided by applicant in example 1 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. Further, claim 16 recites applying 1 microgram/cm2 to 100 mg/cm2 of a composition comprising ceramide NH and example 1 does not teach what amount is applied per cm2 and/or what the 10.01 mg of ceramide equates to in terms of amount per cm2 applied to skin. Thus, the results in example 1 are not commensurate in scope with instant claims. Further, while the C18 ceramide does show higher recovery effect in example 2, the results of example 2 also do not appear to commensurate in scope with the claims. Example 2 discloses 3 microgram/cm2 was spread to the skin sample, however, claim 16 recites 1 microgram/cm2 to 100 mg/cm2 and claim 32 recites 1 microgam/cm2 to 0.1 mg/cm2, and both of these ranges in claim 16 and 32 are much broader in scope than 3 microgram/cm2 disclosed in example 2. It is unclear if 0.1 mg/cm2 (i.e. 100 microgram/cm2) amount in claim 32 would provide a similar effect (i.e. a higher recovery effect compared to other ceramides) as 3 microgram/cm2 amount in example 2. Therefore, the examiner argues that while the C18 ceramide in the example appears to provide higher recovery effect at 3 microgram/cm2, this result is not commensurate in scope with the claims because both claims 16 and 32 recite amounts which are much broader in scope.
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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/ALI S SAEED/ Examiner, Art Unit 1616
