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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's Request for Continued Examination (RCE) filed November 6, 2025, with the submission filed on October 30, 2025, that includes a response to the Final Office Action mailed June 5, 2025, has been entered. Claim 13 has been amended; and claims 1-12 and 14-24 have been canceled. Claim 13 is pending in the application and is currently under examination.
Claim Objections
Claim 13 is objected to because of the following:
1. Claim 13 recites “a method of enhancing skin defense by promoting expression of anti-microbial peptides in the skin…to promote the expression of the anti-microbial peptides in the skin; and promoting the expression of the anti-microbial peptide LL-37 in the skin”, which is awkward and redundant.
Appropriate correction is required.
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.
Claim 13 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 13, as now amended, stipulates that the composition being applied comprises “0.001 to 0.1 wt%” of N-(1-oxodecyl) serine methyl ester. Applicant does not appear to point specifically to where they find support for this new limitation in the original specification and claims. Adequate support cannot be found. Paragraph [0018] provides that the active is present in the amount of 0.001 to 5 wt%. Paragraph [0051] provides that the active is present in the amount of 0.001 to 5 wt%, preferably in an amount of, specifically, 0.001 to 3 wt %, and more specifically, 0.01 to 1 wt %. There is thus insufficient support establishing that Applicant contemplated at the time of filing the present application the narrower range now being claimed of 0.001 to 0.1 wt%.
This constitutes new matter.
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.
Claim 13 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 13 is directed to “a method of enhancing skin defense” and then states “by promoting expression of anti-microbial peptides in the skin”, then, further on, stipulates “promoting the expression of the anti-microbial peptide LL-37 in the skin”, which renders the claim indefinite for the following reasons:
1. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of “enhancing skin defense”. Indeed, “enhancing skin defense” is very broad and generic, and is generally accomplished by application of just about any cosmetic formulation to skin in one manner or another, depending on how “enhancing skin defense” is defined and limited. Hence, this appears to be an arbitrary and relative expression, and is not clearly defined by the claim. “Enhanced” relative to what reference or standard? Enhanced in what way and in what capacity?
2. Claim 13 first provides for “promoting the expression of anti-microbial peptides in the skin”, and then later stipulates “promoting the expression of the anti-microbial peptide LL-37 in the skin”. As one of ordinary skill in the art would generally understand, the phrase “anti-microbial peptides”, being plural, necessarily means two or more anti-microbial peptides. Yet, “the anti-microbial peptide LL-37” is but one anti-microbial peptide. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter. Is the expression of two or more anti-microbial peptides, or just the one anti-microbial peptide LL-37, necessarily being promoted?
3. One of ordinary skill in the art cannot definitively ascertain whether or not “promoting skin defense” is broad and generic, encompassing all manner of “promoting skin defense”, but necessarily including a component aspect provided by “promoting expression of anti-microbial peptides”. Or, on the other hand, is “promoting skin defense” narrowly limited exclusively to the specific aspect of “promoting skin defense” provided by whatever anti-microbial peptide(s) whose expression is actually promoted by the active step of the method. Or, on the other hand, is “promoting skin defense” narrowly limited exclusively to the specific aspect of “promoting skin defense” provided by at least one of the anti-microbial peptide(s) whose expression is actually promoted by the active step of the method. In the latter scenario, because the claim first provides for “promoting expression of anti-microbial peptides in the skin”, i.e. two or more anti-microbial peptides, and then later stipulates “promoting the expression of the anti-microbial peptide LL-37”, one of ordinary skill in the art cannot definitively ascertain whether the “enhancing skin defense” is necessarily limited to the effect provided by LL-37.
***For examination at this time, the claim is being interpreted as “enhancing skin defense” is broad and generic, and includes a component aspect provided by ““promoting expression of anti-microbial peptides in the skin”.
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 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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Candau (U.S. Patent No. 6,509,008).
Applicant Claims
Applicant’s elected subject matter is directed to a method of “enhancing” skin defense” comprising applying to skin a cosmetic composition comprising N-(1-oxodecyl) serine methyl ester; wherein the N-(1-oxodecyl) serine methyl ester is present in the amount of 0.001-0.1 wt%.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Candau discloses a method for protecting the skin comprising applying to skin a cosmetic composition comprising N-acyl amino acid ester, wherein the N-acyl amino acid ester can be e.g. N-(1-oxodecyl) serine methyl ester, and can be present in the amount of 0.1-30 wt% (abstract; Col 2, lines 1-67; Col. 3, lines 1-53; Col. 9, lines 28-32; Col. 13, lines 30-33; Col. 14, lines 10-13).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Candau does not anticipate the claimed subject matter with one specific example or preferred embodiment. However, the Candau disclosure is sufficient to render the claimed subject matter prima facie obvious within the meaning of 35 USC 103.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Candau, outlined supra, to devise Applicant’s presently claimed cosmetic composition.
Candau discloses a method for protecting the skin comprising applying to skin a cosmetic composition comprising N-acyl amino acid ester, wherein the N-acyl amino acid ester can be present in the amount of 0.1-30 wt%. Since Caudau disclose that the acyl group can be derived from capric acid, that the amino acid can be serine, and that the ester group can be derived from methanol, i.e. such that a suitable N-acyl amino acid ester is thus N-(1-oxodecyl) serine methyl ester, one of ordinary skill in the art would thus be motivated to employ N-(1-oxodecyl) serine methyl ester as the N-acyl amino acid ester, with the reasonable expectation that the resulting cosmetic composition, when applied to skin, will enhance the protection/defense of the skin, particularly against UV radiation.
Moreover, since the same compound is being applied to the skin in the same amount, the effect naturally generated in the skin from this active step must occur as well, including promoting expression of LL-37, whether or not the cited prior art expressly disclosed this natural effect.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that 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 was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed October 30, 2025 have been fully considered but they are not persuasive.
i) Applicant contends that “Candau…concerns an external protective sunscreen composition” but “does not specifically disclose N-(1-oxodecyl) serine methyl ester…nor amounts of his N-acylamino acid ester derivative binder which overlap the claimed range”; that “the minimum amount of Candau’s N-acylamino acid ester derivative…ranging from 0.1 to 50%, preferably 1% to 30%” which is “an amount significantly greater from the range claimed herein”; that “the Examiner further asserted that…the effect, such as promotion of LL-37 expression in the skin…would have been readily predictable from Candau” but “Candau is silent as the effect of promoting expression of anti-microbial peptides in the skin”; and that “isopropyl lauroyl sarcosinate claimed (claim 12) in Candau (0.1%) showed no effect whatsoever” on “the expression of the skin barrier factor (filaggrin) that had been damaged by ultraviolet (UV) light”.
The Examiner, however, would like to point out the following:
1. As already discussed, supra, “enhancing skin defense” is broad and generic. Candau discloses “protecting the skin from UV damage”. As anyone of ordinary skill in the art would recognize, “protecting the skin from UV damage” falls under the broad and generic umbrella of “enhancing skin defense”.
2. In contrast to Applicant’s assertion, Candau does, in fact, disclose N-(1-oxodecyl) serine methyl ester. Indeed, Candau expressly and repeatedly discloses that an N-acyl amino acid ester is a requisite component of their composition. Candau goes through the various options for the N-acyl amino acid ester, including that the acyl can be e.g. oxodecyl, that the amino acid can be e.g. serine, and that the ester can be e.g. a methyl ester.
3. As Applicant has pointed out, Candau discloses that their N-acyl amino acid ester compound, e.g. N-(1-oxodecyl) serine methyl ester, can be present in the amount of 0.1 wt% to 50 wt%. This amount, in fact, under U.S. Patent law, is not patentably distinct from the claimed amount of 0.001 wt% to 0.1 wt%. The ranges overlap.
4. In stark contrast to Applicant’s assertion, the Examiner has never stated that Candau discloses the anti-microbial peptide LL-37. Candau, however, does disclose protecting the skin by applying a composition containing an N-acyl amino acid ester, e.g. N-(1-oxodecyl) serine methyl ester. This is not patentably distinct from enhancing skin defense by applying a composition containing N-(1-oxodecyl) serine methyl ester. Candau is also applying the N-acyl amino acid ester in an amount that is not patentably distinct from the claimed amount. Hence, if Applicant is applying e.g. 0.1 wt% of N-(1-oxodecyl) serine methyl ester to the skin and promoting the expression of LL-37, then Candau, by applying e.g. 0.1 wt% of N-(1-oxodecyl) serine methyl ester to the skin, must also be promoting the expression of LL-37, even if Candau does not explicitly disclose this mechanistic effect, or even knew about it. Candau discloses the purpose of the method, i.e. protecting skin from UV damage, which falls under the broad umbrella of “enhancing skin defense”, and Candau also discloses the requisite active step of the method that actually must be performed by the hand of man, i.e. applying N-(1-oxodecyl) serine methyl ester to the skin, and in an amount that is not patentably distinct from the claimed amount being applied. This is sufficient to preclude the patentability of the claimed method. Candau need not disclose the mechanistic process that plays out by which application of N-(1-oxodecyl) serine methyl ester to the skin leads to the protection of the skin, including by promoting expression of LL-37.
5. The claimed method is rendered obvious in view of Candau for reasons just discussed, and this is not overcome by showing that isopropyl lauroyl sarcosinate does not affect the expression of the skin barrier factor (filaggrin). Indeed, the claims don’t even say anything about promoting the expression of the skin barrier factor filaggrin.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617