DETAILED ACTION
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 .
Status of Application and Claims
Claims 1-5 are pending and under consideration in this action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (natural phenomenon) without significantly more.
The claims are evaluated below using the “Subject Matter Eligibility Test for Products and Processes: flow chart as shown in MPEP § 2106 III.
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Yes. The claims are drawn to a composition of matter, which is one of the four statutory categories.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes. The claims are directed towards a composition of matter for placement on the skin comprising niacinamide, peptides, ceramide complex, ectoine, fermented extract, and squalane. All of the components of the claimed mixture are naturally-occurring except for squalane and the fermented extract. Squalane is a hydrogenated, stabilized version of squalene. Squalane can be derived from natural plant sources like wheat germ oil, olives, and rice bran, as evidenced by Chaves, Tricia. “What’s the difference Between Squalene and Squalane? Experts Explain.” Byrdie. 2 February 2024. https://www.byrdie.com/best-products-squalane-squalene-difference-dry-skin-4799792. Fermented extracts are produced by microorganisms breaking down natural ingredients to release potent nutrients and bioactive compounds, evidenced by “Everything You Need to Know About Fermented Skincare Products.” DesignDash. 21 February 2024. https://designdash.com/wellness/self-care/everything-you-need-to-know-about-fermented-skincare-products/. The nature-based mixture is analyzed to determine whether it has markedly different characteristics from any naturally occurring products and there is no naturally occurring counterpart to the claimed combination, the combination is compared to the individual components as they occur in nature. Furthermore, where the claim in a nature-based product in combination with non-nature-based elements, the markedly differed character analysis should be applied only to the nature-based product limitation (see MPEP 2106.04© I. A.). Claim 1 of the instant application claims “a synergistic combination” of the ingredients. However, there is no evidence in the specification that shows how the ingredients work in a synergistic combination. Therefore, there is no indication in the instant application that the combination of naturally-occurring components exhibits any markedly different characteristics from any natural counterparts, and thus, is treated as a product of nature judicial exception.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No. The judicial exception is not integrated into a practical application or specific usage because there is no indication on the instant application that the inclusion of squalane or fermented extract is necessary to make the natural products configurable for placement on the skin.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. There is no data within the instant specification that supports the change in functionality when the ingredients are combined. Additionally, the use of squalane and fermented extracts are well-understood, routine and conventional, as evidenced by Chaves, Tricia. “What’s the difference Between Squalene and Squalane? Experts Explain.” Byrdie. 2 February 2024. https://www.byrdie.com/best-products-squalane-squalene-difference-dry-skin-4799792 and “Everything You Need to Know About Fermented Skincare Products.” DesignDash. 21 February 2024. https://designdash.com/wellness/self-care/everything-you-need-to-know-about-fermented-skincare-products/.
As claims 1-5 recited a judicial exception that is not integrated into a practical application and recite no elements that amount to significantly more the judicial exception, the claims are dram to ineligible subject matter under 35 U.S.C. 101.
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.
Claims 1-5 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 “peptides (palmitoyl tripeptide-5 and/or acetyl tetrapeptide-11).” The terms “(palmitoyl tripeptide-5 and/or acetyl tetrapeptide-11)” in the parenthesis render
Claim 2 recites “said actives” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites “one plant-based stem cell extract” in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the claim to recite “…claim 1, further comprising at least one plant-based stem cell extract in concentrations…” In addition, the recitation of 0.1 to 0.5% is without unit and/or base amount. It is not clear if the percentage is based on the total weight, amount or volume of the composition or based on part of the composition.
Claim 5 recites “the peptide” in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 from which claim 5 depends on recite “peptides” in the plural, and claim 5 recites a peptide, and thus it is not clear to which peptide from the plurality of the peptides the term is referring.
Claim 5 recites “in combination with ceramide-cholesterol systems” in line 2. The phrase renders the claim indefinite because it is unclear how the peptide is in combination with a ceramide-cholesterol system. See MPEP § 2173.05(d).
Claim 5 recites “ceramide-cholesterol systems” in line 2. There is insufficient antecedent basis for this limitation in the claim because there is no previous recitation that the composition has these properties.
In addition, claim 5’s recitation of 0.1 to 0.5% is without unit and/or base amount. It is not clear if the percentage is based on the total weight, amount or volume of the composition or based on part of the composition.
Claim 3 depends on claim 1 and does not clarify the issue of claim 1 and thus is rejected.
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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) / (a)(2) as being anticipated by Petit et al. (US10758490; published 1 September 2020; filed on 3/21/2013 or earlier).
Regarding claim 1, Petit et al. (henceforth referred to as Petit) teaches a delivery system for a cosmetic active ingredients composition (para. 01). Petit teaches the composition comprising a whitening or skin depigmenting agent selected group a group containing niacinamide (para. 53). Petit teaches the composition further comprising a hydrophilic active ingredient selected from a group including acetyl tetrapeptide-11 (Claim 18). Petit discloses the composition comprising ceramides and/or squalene and/or ectoine as the humectant or substance that retains moisture within the composition (para. 38). Petit teaches the composition comprising cell extracts such as Pseudoalteromonas ferment extract (reads on fermented extract)(para. 35).
For the purpose of the below rejection, the recitation “formulated for use as a three-product skincare set consisting of a toner, emulsion, and cream” is interpreted as intended use of the composition and do not provide additional patentable weight to the claimed cosmetic composition.
Regarding claim 2, the instant claim 2 recites the process from which the composition is made, by adding the actives in separate thermal phases to ensure bioactivity and product stability. The reference teaches a composition, with all the ingredients and is structurally the same as the end product of the instant claimed product-by-process limitation.
Regarding claim 3, Petit teaches the composition in the form of an emulsion and cream (para. 73).
Regarding claim 4, Petit teaches suitable cell extracts for the composition include hydrolyzed soy protein (para. 35). Petit exemplifies hydrolyzed soy protein, with lauryldimonium hydroxypropyl, in an amount of 0.2% within the composition (p. 18, col. 32).
Regarding claim 5, Petit teaches the composition wherein the at least one hydrophilic active ingredients includes a peptide selected from a group containing acetyl tetrapeptide-11 (claim 18). Petit further teaches the hydrophilic active ingredient present in the composition in amounts ranging from 0.00001% in weight and 50% in weight.
With regards to the claim limitation “in combination with ceramide-cholesterol systems for barrier restoration”, Petit teaches that the humectant or substance that retains moisture may be a mixture of ceramides and cholesterol (para. 38). The instant specification does not clearly define the meaning of “in combination with”, so the phrase is interpreted to mean in the same composition. Therefore, the claim limitation of instant claim 5 is satisfied.
Conclusion
Claims 1-5 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA A MACMILLAN whose telephone number is (571)272-0692. The examiner can normally be reached Mon-Fri 9:00-5:00.
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/Olivia Anne MacMillan/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
