DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
The amendments filed on November 12, 2025 have been acknowledged and entered. Claims 1, 4, 5, 8-10, 12, and 13 are pending. Claims 2, 3, 6, 7, and 11 are cancelled.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/JP2021/009075, filed on March 8, 2021. This application also claims the benefits of foreign priority to JP2020-040142, filed on March 9, 2020.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of applicant’s amendments and/or remarks.
Claim Objections
Claim 12 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. Claim 12 differs from claim 1 only in that the structure of “ceramide NDS” is expressly defined. Since the instant specification already describes the scope of the “ceramide NDS” structure (see pg. 8, para. 0032), this expressed definition is implicit in claim 1 and does not impose an additional limitation. Therefore, claim 12 is not further limiting claim 1 and is a substantial duplicate of claim 1.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 5, 8, 9, 12, and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
In evaluating the enablement question, several factors are to be considered. According to In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988), these factors include:
1) The nature of the invention,
2) the state of the prior art,
3) the predictability or lack thereof in the art,
4) the amount of direction or guidance present,
5) the presence or absence of working examples,
6) the breadth of the claims, and
7) the quantity of experimentation needed, and
8) the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
The nature of the invention
The nature of the invention claims a method for growing and/or supplementing at least one ceramide species selected from the group consisting of ceramide EOS, ceramide NS and a first ceramide NDS in a skin stratum corneum, the method comprising topically applying a ceramide growth promoting agent on skin and/or hair of a human subject in need thereof, said ceramide growth promoting agent comprising a second ceramide NDS.
State of the prior art
According to the prior art, demonstration of ceramide growth or increased ceramide levels in the skin stratum corneum of a human is typically established through topical application studies conducted on human subjects or, at minimum, on human epidermal equivalents, rather than solely on cultured human keratinocytes (as is the case for the instant application; see instant specification, pg. 16, Test example 2 starting on line 18).
For example:
Di Marzio demonstrates increased ceramide levels in the stratum corneum following topical application of a sonicated Streptococcus thermophilus preparation to human subjects (abstract);
Di Marzio, L. et al. Int. J. Immunopathol. Pharmacol. 2008, 21, 137-143.
Ishikawa discloses that the “[t]opical application of the Eucalyptus extract on the dry skin of human subjects induced by acetone and diethylether treatment resulted in a significant increase in ceramide level in the stratum corneum” (abstract);
Ishikawa, J. et al. International Journal of Cosmetic Science 2012, 34, 17-22.
Takeda discloses how “[s]trawberry seed extract and its major component, tiliroside, promote ceramide synthesis in the stratum corneum of human epidermal equivalents” (title).
Takeda, S. et al. PLoS ONE 2018, 13, e0205061.
The level of the skill in the art
The level of ordinary skill in the art is relatively high. A person of ordinary skill would typically have formal training in medicinal (specifically, dermatological) chemistry and would be familiar with standard methods for evaluating the effects of topical agents on epidermal lipid composition, including ceramide synthesis and accumulation in the skin stratum corneum.
The presence or absence of working examples
The instant specification does not provide working examples that enable the full scope of the claimed method. Although claim 1 recites a method for growing and/or supplementing ceramides in a skin stratum corneum of a human subject by topical application of a ceramide growth promoting agent onto the skin and/or hair of the human subject, the specification only discloses in vitro experiments using cultured human keratinocytes (see instant specification, pg. 16, Test example 2 starting on line 18). The application does not include any working examples demonstrating topical application of a ceramide growth promoting agent to skin and/or hair of a human subject, nor does it provide examples using human epidermal equivalents that more accurately model the skin stratum corneum of a human compared to cultured human keratinocytes. As such, the data from the in vitro study using cultured human keratinocytes cannot enable a method for growing and/or supplementing ceramide species in the skin stratum corneum of a human subject as recited in the instant claims.
The amount of direction or guidance present and quantity of experimentation necessary
The instant specification provides insufficient direction and guidance to enable the claimed method without undue experimentation. Claim 1 recites a method for growing and/or supplementing ceramides in a skin stratum corneum by topical application of a ceramide growth promoting agent on skin and/or hair of a human subject. However, the specification does not disclose parameters for topical application to the skin of a human subject such as dosage, frequency, duration, or application site, nor does it describe methods for measuring or confirming ceramide growth in the stratum corneum following application.
Although the specification includes data obtained from in vitro studies using cultured human keratinocytes, it does not disclose experimental protocols for assessing ceramide levels in the stratum corneum of a human subject. As a result, a person of ordinary skill in the art would be required to engage in undue experimentation to determine whether and how the claimed method achieves the recited result.
Claims 4, 5, 8, 9, 12, and 13, which are dependent on claim 1, are also rejected for further requiring and/or reciting non-enabling elements of claim 1 as explained above.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 4, 5, 8-10, 12, and 13 are 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 1 recites a method for “growing and/or supplementing at least one ceramide species… in a skin stratum corneum,” while further reciting that the method comprises topically applying a ceramide growth promoting agent on “skin and/or hair” of a human subject. However, hair does not include a skin stratum corneum, and it is therefore unclear how topical application to hair alone would result in growth or supplementation of ceramides in a skin stratum corneum. Accordingly, the claim is rendered indefinite.
As stated above, claim 1 recites “a method for growing and/or supplementing” at least one ceramide species in a skin stratum corneum. However, the claim further recites that the ceramide growth promoting agent comprising a second ceramide NDS “thereby promoting the growth of the ceramide species.” As written, the claim is internally inconsistent. At the outset, the claim appears to encompass methods directed to (i) promoting growth, (ii) promoting growth and supplementation, or (iii) supplementation alone without growth of the ceramide species in a skin stratum corneum. In contrast, the concluding “thereby” clause limits the result of the method solely to promotion of growth. Accordingly, it is unclear whether Applicant intended the claim to be directed only to methods that promote growth of the ceramide species, or whether the claim is also intended to encompass methods that merely supplement at least one of the ceramide species without promoting growth. Since the claim does not clearly define the intended scope of the method, claim 1 is further rendered indefinite.
Claim 8 recites the limitation "wherein a diameter of dispersed particles of the ceramide NDS." There is insufficient antecedent basis for this limitation in the claim. Claim 1 (in which claim 8 is depended on) does not recite or define the ceramide NDS in the growth promoting agent as being present in the form of dispersed particles. It would be clearer if claim 8 was amended as follows:
“The method according to claim 1, wherein the ceramide NDS in the growth promoting agent is in a form of dispersed particles having a diameter of 0.45 µm or less.”
Claims 10 and 12 recite “a ceramide in which a non-hydroxy fatty acid having 14 to 24 carbon atoms is amide-bonded to a dihydrosphingosine base possessing a monovalent saturated hydrocarbon chain of 16 to 24 carbon atoms.” As currently written, the claim is ambiguous and subject to more than one reasonable interpretation. Specifically, it is unclear whether the recited “16 to 24 carbon atoms” refers to (i) the dihydrosphingosine base as a whole or (ii) the monovalent saturated hydrocarbon (i.e., excluding the amino-diol skeleton) chain associated with the dihydrosphingosine base. Although Applicant’s remarks (filed November 12, 2025) indicate that the recited carbon-atom range is intended to include the amino-diol skeleton of the dihydrosphingosine base, this clarification is not reflected in the claim language. To resolve this ambiguity, the claim should be amended, for example, by reciting:
“…a ceramide in which a non-hydroxy fatty acid having 14 to 24 carbon atoms is amide-bonded to a dihydrosphingosine base, possessing a monovalent saturated hydrocarbon chain, of 16 to 24 carbon atoms.”
The addition of the commas clarifies that the 16 to 24 carbon-atom limitation applies to the dihydrosphingosine base as a whole, thereby removing the ambiguity present in the original claim.
Claims 4, 5, 8, 9, 12, and 13 which are dependent on claim 1, are also rejected for further requiring and/or reciting the indefinite limitation of claim 1.
Note on 35 USC § 102 and § 103 Rejections
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Rejection part 1:
Claims 1, 4, 5, 9, 10, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Ishida et al. (WO2004098557A1; published November 18, 2004)
Ishida discloses a skin formulation (i.e., example 15) that is supplemented (i.e., added by spreading) on the skin of 10 experienced panelists (i.e., human subjects) as a way to evaluate the spreadability of the formulation on skin, as well as the moistness and smoothness of the panelists’ skin after topical application of the formulation onto the skin of the panelists (pg. 29, lines 10-23; See table 4 on pg. 30 for evaluation results).
The skin formulation of example 15 comprises (pg. 27, lines 15-22 and pg. 28, lines 1-2):
Component (i): the lipid composition of example 8 (pg. 27, lines 5-8)
Example 8 of Ishida (pg. 26, lines 11-17 and pg. 27, table 2) is a mixture of (2S,3R)-2-octadecanoylaminooctadecane-1,3-diol (i.e., a type of “ceramide NDS” as stated in instant claim 13; In Ishida, this ceramide is referred to as “optically active ceramide 2”; pg. 25, lines 25-27 and pg. 26, lines 1-2), cholesterol, and cetanol
Component (ii): decaglycerin monostearate, 1,3-butylene glycol, glycerin, phenoxyethanol
Component (iii): water
In other words, Ishida discloses a skin formulation comprising (2S,3R)-2-octadecanoylaminooctadecane-1,3-diol (i.e., a ceramide NDS as stated in instant claim 13) that can be used in a method for supplementing (i.e., adding) ceramide NDS in a human skin stratum corneum by topical application of the skin formulation (comprising a ceramide NDS) onto the skin of a human subject (i.e., the 10 experienced panelists). Thus, Ishida reads on instant claims 1, 4, 5, 9, 10, 12, and 13.
Rejection part 2:
Claims 1, 4, 5, 8, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Akatsuka et al. (JP2006176410A; published July 6, 2006)
Akatsuka teaches a composition (i.e., cosmetic preparation 1: “a slightly cloudy solution of vesicles with an average particle size of 215 nm”; see para. 0020) comprising the following ingredients (para.0021):
Dimethyl distearyl ammonium chloride 2% by mass ("Arcade 2HP" manufactured by Lion Akzo Co., Ltd.)
"Phytosterol S" 1% by mass
"Ceramide TIC-001" (manufactured by Takasago International Corporation as stated in para. 0009) 0.2% by mass
Note: ceramide TIC-001 is synonymous to ceramide NG which is classified as a ceramide NDS according to the instant specification (pg. 8, para. 0032) and instant claims 10 and 12.
Ceramide NG has the following structure (from PubChem; CID: 5283573, first inputted January 13, 2006):
PNG
media_image1.png
250
1592
media_image1.png
Greyscale
Glycerin 10% by mass
Water 86.8% by mass
Cosmetic preparation 1 was subjected to a usability test (see para. 0024) which involves a group of 10 panelists (i.e., human subjects) evaluating the cosmetic preparation (in the form of a rinse) by topically applying the cosmetic preparation on their skin, thereby supplementing their skin (specifically, the skin stratum corneum) with a ceramide NDS since the cosmetic preparation comprises ceramide TIC-001, a ceramide NDS.
In other words, Akatsuka teaches a method for supplementing (i.e., adding) ceramide species in a skin stratum corneum of humans, wherein the method comprises topically applying a ceramide growth promoting composition containing a ceramide NDS on skin of a human subject in need thereof and wherein the composition is made up of particles with an average particle size of 215 nm which encompasses instant claims 1, 4, 5, 8, 10, and 12.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 5, 9, 10, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-14 of U.S. Patent Application No. US6355232B1 (‘232B1).
‘232B1 claims a protective agent for skin or hair which comprises ceramide-II (note: according to the instant specification on pg. 8, para. 0032, ceramide-II is classified as a ceramide NDS) and a method for treating skin or hair comprising applying ceramide-II to the surface of skin or hair.
The claims of the instant application recite:
a method for growing and/or supplementing ceramide EOS, ceramide NS, and/or ceramide NDS in a skin stratum corneum by topically applying an agent comprising ceramide NDS on skin and/or hair of a human subject and
a skin cosmetic, a skin protective agent, a hair composition, a lip care preparation, a skin cleanser, or a bath agent, comprising ceramide NDS (which is a class of ceramides that includes ceramide-II of ‘232B1).
Accordingly, the method of the instant claims presents no patentably distinct difference from the method claims of ‘232B1 as both involve topical application of ceramide NDS to skin or hair, resulting in the addition (i.e., supplementation) of ceramide NDS in the treated skin or hair. Supplementation (i.e., addition) of ceramide NDS to skin and/or hair is an inherent and obvious consequence of the topical application of the protective agent comprising a ceramide NDS on the skin and/or hair of a human subject as disclosed and claimed in ‘232B1.
Also, claim 1 of ‘232B1 is the same as instant claim 10 since both claims are directed towards a skin protective agent comprising a ceramide NDS. Recall that according to the instant specification (pg. 8, para. 0032), the ceramide-II disclosed in claim 1 of ‘232B1 can be classified as a ceramide NDS.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624