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 .
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 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.
DETAILED ACTION
Status of claims
The amendment filed on 04/06/2026 is acknowledged. Claims 2-5, 8, 9, and 12 have been canceled, claims 13 and 14 have been withdrawn, and new claims 16-25 have been added.
Newly submitted claims 18-25 directed to an invention that is independent or distinct from the invention of claims 1, 6, 7, 10, 11, and 15-17 for the following reasons: Invention I, claims 1, 6, 7, 10, 11, and 15-17 and invention II, claim 18-25, are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the process for using the product as claimed can be practiced with another materially different product: US 2007/0071704 A1 discloses a method of reducing the appearance of roughness on the skin comprising the topical administration of a silicone-in-water emulsion comprising a retinoid (claims 1 and 21).
Since applicant has received actions on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 18-25 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP 821.03.
Claims 1, 6, 7, 10, 11, and 15-17 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 04/06/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. The 35 U.S.C. 103(a) rejections of claims 1, 6, 7, 10, 11, and 15 over Lambers (US 2003/0059447 A1) and Serizawa et al. (US 2011/0078311 A1) and of claims 1, 6, 7, 10, 11, and 15 over Lambers (US 2003/0059447 A1), Serizawa et al. (US 2011/0078311 A1), or alternatively, and Akinori Nakano (JP 2018-021009 A) and Serizawa et al. (US 2011/0078311 A1) from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New ground of rejections
Upon reconsideration the following rejections of the claims are applied.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6, 7, 10, 11, 15, and 17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lambers (US 2003/0059447 A1) in view of Serizawa et al. (US 2011/0078311 A1).
Lambers teaches a topical (abstract) emulsion (dispersion according to the definition in the instant specification paragraph 65) (paragraph 50) comprising
a ceramide
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extracted from a natural source or synthetic (paragraph 21-23) corresponds in stereochemical configuration to a ceramide isolatable from mammalian skin (claim 3), i.e., same as a natural ceramide:
in sphingoid: A being C(H)OH-CH2 (1 -OH from A and total 3 -OH → “t” in the formula), and R being a straight C13 alkyl group with 0 double bond (claim 1) (total C18 in sphingoid) → t18:0 (“P” in the “AP”) is claimed in claim 1 by Lambers,
in fatty acid: R' being a C17-44 alkyl group (C18-45 fatty acid) with 1 -OH (“h” in the right part of the formula, also as h(1) and (“A” in the “AP”)) and 0 double bond: 24:0h is claimed in claim 1 by Lambers; and
a ceramide expressed as: t18:0-24:0h with total C42 (C18 + C24 = C42) (100% by weight of free ceramide AP) is claimed in claim 1 by Lambers. MPEP 2131.02 III:
If one of ordinary skill in the art is able to “at once envisage” the specific compound within the generic chemical formula, the compound is anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula before any of the compounds can be “at once envisaged.”
The emulsion further comprising
a surfactant such as polyglyceryl-2 isostearate (the claimed non-ionic surfactant in the instant claim 1) (paragraph 66);
lecithin (paragraph 74 and 75) (phosphatidylcholine and thus 100 mass% of phosphatidylcholine, thus glycerophospholipid in the instant claim 7 and ≥50 mass% of phosphatidylcholine in the instant claim 1);
cholesterol (the claimed sterol in the instant claim 10) and stearic acid (C18 fatty acid, the instant claim 11) (paragraph 30); and
a solvent such as propylene glycol and butylene glycol (C2-6 diol in the instant claims 1, 6, 15, and 17) (paragraph 77); and
exemplified a cream IV in paragraph 100 comprising
1.7% by weight of ceramide, 6% by weight of propylene glycol and butylene glycol, 2.0% by weight of Biophilic S (containing lecithin → >0% and <2% by weight of lecithin), 2.0% by weight of polyglyceryl-3 methyl glucose distearate, cholesterol and stearic acid.
The mass ratio between ceramide and butylene glycol is calculated to be 1:9.4 (1.7%:6%=1:3.53). The mass ratio between polyglyceryl-3 methyl glucose distearate and ceramide is calculated to be 1.17:1 (2%:1.7%=1.17:1). The mass ratio between lecithin and polyglyceryl-3 methyl glucose distearate is calculated to be >0 and <1:1 (2%/2%=1).
The ceramide taught by Lambers does not have sugar or phosphoric acid attached, i.e., the claimed free ceramide according to the instant specification paragraph 17.
The claimed ceramide being ≥90% by mass AP has phytosphingosine (P) and a fatty acid containing 1 -OH in fatty acid (h in the formula) according to the paragraph 23 in the instant specification, thus is taught by Lambers’ teaching of t18:0-24:0h.
Lambers does not the same mass ratios between polyglyceryl-3 methyl glucose distearate and ceramide (1.17:1 vs the claimed 2.5-4:1 in the instant claim 1).
This deficiency is cured by the rationale that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties.
The claimed range of mass ratio is 2.5-4:1 and the range of mass ratio in the prior art is 1.17:1 and therefor, do not overlap but are close enough that one skilled in the art would have expected them to have the same properties while mass ratio of 0.1-30 is disclosed as suitable according to the instant specification paragraph 46; thus, the criticality of now claimed 2.5-4:1 mass ratio over 1.17:1 taught by Lambers is not established. Please refer to MPEP 2144.05.II.A:
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.
Lambers does not the same mass ratios between ceramide and butylene glycol (1:3.53 vs the claimed 1:8-20 in the instant claim 1).
This deficiency is cured by the rationale that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties.
The claimed range of mass ratios is 1:8-20 and the range of mass ratio in the prior art is 1:3.53 and therefor, do not overlap but are close enough that one skilled in the art would have expected them to have the same properties while mass ratio of 1:3-25 is disclosed as suitable according to the instant specification paragraph 11 item 1 and previously claimed (dated 06/17/2021 and 04/22/2024); thus, the criticality of now claimed 1:8-20 mass ratio over 1:3.53 taught by Lambers is not established. Please refer to MPEP 2144.05.II.A.
Lambers does not the same mass ratios between lecithin and polyglyceryl-3 methyl glucose distearate (>0 and <1:1 vs the claimed 0.25-2:1 in the instant claim 1).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition overlaps with the range disclosed in the prior art, such as in the instant rejection.
The claimed range of mass ratios is 0.25-2:1 and the range of mass ratios taught in the prior art is >0 and <1:1 and therefor, overlaps with the claimed range.
Lambers does not specify the particle size of the cream (the instant claim 1).
This deficiency is cured by Serizawa et al. who teach natural ceramide dispersion having particle size of 0.5-100 nm (abstract).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Lambers and Holt et al. to specify particle size of the topical cream taught by Lambers being 0.5-100 nm. Topical cream particle having size of 0.5-100 nm was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Claims 1, 6, 7, 10, 11, 15, and 17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lambers (US 2003/0059447 A1) in view of Serizawa et al. (US 2011/0078311 A1), or alternatively, in view of Akinori Nakano (JP 2018-021009 A) and Serizawa et al. (US 2011/0078311 A1).
The teachings of Lambers and Serizawa et al. are discussed above and applied in the same manner.
The reference of Lambers is described in detail above and that discussion is hereby incorporated by reference. It is recognized that the teachings of t18:0-24:0h natural ceramide by Lambers were deemed to anticipate the claimed ceramide in the preceding ground of rejection. The instant ground of rejection applies an alternative interpretation of the ceramide taught by Lambers, which alternative interpretation is in expectation of an argument that applicant could make regarding whether Lambers specify t18:0-24:0h natural ceramide or not, i.e. that the teachings of natural ceramide is not explicit enough to support an anticipation determination with regard to the t18:0-24:0h natural ceramide. The Examiner does not agree with such a view, but nonetheless, this alternative ground of rejection is set forth to provide an alternative rationale as to Lambers’ teaching of natural ceramide, even if they do not anticipate the claimed ceramide, nonetheless provide ample disclosure, suggestion and motivation for one of ordinary skill in the art to have arrived at t18:0-24:0h natural ceramide, the claimed ceramide.
Lamber teaches ceramides 100% by weight of t18:0-(18-45):0h (total C36-63) (claim 1). A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection.
The claimed range of t18:0-24:0h, t18:1-24:0h, and/or t20:0-24:0h ceramides is ≥50% by mass and the range of t18:0-(18-45):0h ceramides taught by Lambers is 100% by mass and therefor, includes the claimed range of ceramides and mass%.
The claimed range of number of carbons in fatty acid is 24 and the range of number of carbons in fatty acid taught in the prior art is 18-45 and therefor, includes the claimed range.
The claimed range of total number of carbons in ceramide is ≥40 and ≥42 (and also C40-44 or C44 or C45) and the range of total number of carbons in ceramide taught in the prior art is 36-63 and therefor, includes the claimed ranges.
Alternatively, mere purity of a product, by itself, does not render the product unobvious. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. In the instant case, Lambers teaches ceramide for skin conditions associated with an impaired barrier function(abstract) while the instant specification paragraph 7 discloses ceramides for skin barrier formation. Absent some demonstration of unexpected results, it would have been obvious to one of ordinary skill in the art to purify 100% by mass of C36-63 and t18:0-(18-45):0h ceramides taught by Lambers to be 100% t18:0-24:0h, i.e., the claimed ≥95% by weight of C≥40 and ≥85% by weight of C≥42 (and also C40-44 or C44 or C45) and ≥50% by mass of t18:0-24:0h, and/or t18:1-24:0h, and/or t20:0-24:0h with predictable results to one of ordinary skill in the art at the time of the invention. Please refer to MPEP 2144.04 VII:
pure materials are novel vis-à-vis less pure or impure materials because there is a difference between pure and impure materials. Therefore, the issue is whether claims to a pure material are unobvious over the prior art.
Factors to be considered in determining whether a purified form of an old product is obvious over the prior art include whether the claimed chemical compound or composition has the same utility as closely related materials in the prior art, and whether the prior art suggests the particular form or structure of the claimed material or suitable methods of obtaining that form or structure.
Alternatively, chemical compounds having “very close” structural similarities and similar utilities, without more a prima facie case may be made. It would have been prime facie obvious at the time of the invention to a person of ordinary skill in the art to replace the C36-63 and t18:0-(18-45):0h ceramides other than t18:0-24:0h taught by Lambers with t18:0-24:0h, the claimed ≥95% by weight of C≥40 and ≥85% by weight of C≥42 (and also C40-44 or C44 or C45) and ≥50% by mass of t18:0-24:0h, t18:1-24:0h, and/or t20:0-24:0h. Please refer to MPEP 2144.09 II:
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Alternatively, Akinori Nakano provides teaching of Genuine ceramide WSS (the same claimed ceramide according to the instant specification paragraph 101-105) (paragraph 5 and Examples 12-16) being dispersed in stable transparent or translucent cosmetic emulsion with excellent moisturizing function and excellent percutaneous absorption of a medicine (abstract and paragraph 9).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Lambers and Akinori Nakano to specify Genuine ceramide WSS being a preferred and readily available ceramide species among the genus taught by Lambers. Genuine ceramide WSS being a suitable species of ceramide for topical application was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Applicant’s arguments with regard to Lambers teaching 6% by weight of C2-6 diol and the amount of lecithin being unknow have been fully considered but they are moot in view of new ground of rejections.
Applicant’s argument of the examples demonstrating a higher skin care effect is basically the same as the previous argument, thus the response discussed previously applies here as well and is not persuasive for reason discussed.
Claims 1, 6, 7, 10, 11, and 15-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lambers (US 2003/0059447 A1) in view of Serizawa et al. (US 2011/0078311 A1) and Imoto et al. (US 2015/0202586 A1).
The teachings of Lambers are discussed above and applied in the same manner.
Lambers does not specify emulsifiers including decaglycerol monoisostearate (polyglyceryl-10 isostearate) in the new claim 16.
This deficiency is cured by Imoto et al. who teach both polyglyceryl-2 isostearate and polyglyceryl-10 isostearate are suitable nonionic surfactants.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Lambers and Imoto et al. to replace polyglyceryl-2 isostearate and taught by Lambers with polyglyceryl-10 isostearate. Both polyglyceryl-2 isostearate and polyglyceryl-10 isostearate are suitable nonionic surfactants was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for replacing polyglyceryl-2 isostearate and taught by Lambers with polyglyceryl-10 isostearate flows from both having been used in the prior art, and from both being recognized in the prior art as useful for the same purpose.
Claims 1, 6, 7, 10, 11, and 15-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lambers (US 2003/0059447 A1) in view of Serizawa et al. (US 2011/0078311 A1) and Imoto et al. (US 2015/0202586 A1), or alternatively, in view of Akinori Nakano (JP 2018-021009 A), Serizawa et al. (US 2011/0078311 A1), and Imoto et al. (US 2015/0202586 A1).
The teachings of Lambers are discussed above and applied in the same manner.
Lambers does not specify emulsifiers including decaglycerol monoisostearate (polyglyceryl-10 isostearate) in the new claim 16.
This deficiency is cured by Imoto et al. who teach both polyglyceryl-2 isostearate and polyglyceryl-10 isostearate are suitable nonionic surfactants.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Lambers and Imoto et al. to replace polyglyceryl-2 isostearate and taught by Lambers with polyglyceryl-10 isostearate. Both polyglyceryl-2 isostearate and polyglyceryl-10 isostearate are suitable nonionic surfactants was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for replacing polyglyceryl-2 isostearate and taught by Lambers with polyglyceryl-10 isostearate flows from both having been used in the prior art, and from both being recognized in the prior art as useful for the same purpose.
Response to Arguments
Applicant’s arguments, filed on 04/06/2026, have been fully considered but they are moot in view of new ground of rejections.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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/HONG YU/
Primary Examiner, Art Unit 1614
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