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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on May 08, 2026 has been entered.
Status of Claims / Response to Amendment
This office action is in response to an amendment filed on May 08, 2026.
Claims 1-2, 4-9, 11, 13, 15-16 and 18-24 were previously pending. Applicant amended claims 1, 6, 21 and 23; cancelled claims 4-5, 8, 11-15, 18-19 and 24.
Claims 1-2, 6-7, 9, 16 and 20-23 are currently pending and under consideration.
Applicant's submission of the amendment to specification obviated the previously presented objection.
All of the previously presented rejections have been withdrawn as either being addressed or obviated by the amendment of the claims, which introduces a new combination of elements that were not previously considered in the prior rejection.
Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
This office action contains new grounds for rejection necessitated by amendment.
Priority -- Updated
For the instant claims 1-2, 6-7, 9, 16 and 20-23 in this U.S. Application, the applicant claims priority of Foreign Application FRANCE 1906830 (certified English translation submitted on 10/27/2025), which has a filling date on 06/24/2019.
Claim Objections
Claims 1 and 23 are objected to because of the following informalities:
In Claim 1, line 3: "(a) of determining in a skin sample of the subject" should read "(a)
In Claim 23, line 3: "B)" should read "(d)" for consistency with base claim 1.
Claim Interpretation -- Updated
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
For the purpose of applying prior art, claim 1 has been amended to recite "cosmetic diagnosis," which is a term not defined in the application's disclosure with any features that distinguishes the term "cosmetic diagnosis" with any diagnosis method in the art.
Therefore, under BRI, the "cosmetic diagnosis" method is interpreted to encompass any prior art diagnosis method of pollution-related early ageing of the skin that disclose all the claimed steps.
For the purpose of applying prior art, claim 1 has been amended to recite "pollution-related early ageing of the skin."
The specification defines the term "pollution" as follows:
"By «pollution», it is meant herein chronic exposure to particulate matter, in particular to polycyclic aromatic hydrocarbons (PAHs)." (specification, page 6, lines 11-12).
Accordingly, under BRI and in light of the specification, "pollution-related early ageing of the skin" is interpreted as early ageing of the skin that relates to chronic exposure to particulate matter, wherein the term "early ageing of the skin" is defined in claim 1 as comprising "the presence of lines and/or wrinkles, large macules, lentigo simplex and/or red patches"
For the purpose of applying prior art, claim 1 recites "determining in a skin sample of the subject the relative abundance of a first marker of fungi comprising a nucleic acid encoding an ITS 1 (< Internal Transcribed Spacer 1n) region of sequence at least 90 % identical to sequence SEQ ID NO: 1."
Under BRI, this step is interpreted to require determining the relative abundance of a marker, of fungi that comprise a nucleic acid sequence at least 90% identical to SEQ ID NO: 1. Thus, this determining step is interpreted to not require detecting the specific sequence itself, only detecting any maker of any fungi meeting this description. This interpretation aligns with the specification, which does not explicitly describe any method step of specifically detecting SEQ ID NO: 1.
Thus, any step in the prior art detecting relative abundance of a marker of fungi comprising a sequence at least 90 % identical to sequence SEQ ID NO: 1 would meet this limitation.
For the purpose of applying prior art, claim 1 recites "an ITS 1(< Internal Transcribed Spacer 1 >) region of sequence at least 90 % identical to sequence SEQ ID NO: 1," it is interpreted that the "sequence at least 90 % identical to sequence SEQ ID NO: 1" is the sequence that comprise the ITS1 region, SEQ ID NO: 1 is a sequence representative of the ITS1 of fungi of the genus Candida. This interpretation is made in view of Applicant's remarks filed on October 27, 2025, at page 8 (detailed discussion is in Final Rejection - 11/21/2025, p. 6-7).
Claim Rejections - 35 USC § 101 -- New
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 1-2, 6-7, 9, 16 and 20-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Independent claim 1 has been amended to recite:
A method for cosmetic diagnosis of pollution-related early ageing of the skin in a subject, comprising the following steps:
(a) of determining in a skin sample of the subject the relative abundance of a first marker of fungi comprising a nucleic acid encoding an ITS 1 (< Internal Transcribed Spacer 1n) region of sequence at least 90 % identical to sequence SEQ ID NO: 1, and optionally at least one optional marker selected from the group consisting of fungi comprising a nucleic acid encoding an ITS 1 of sequence at least 90 % identical to sequence SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9 or SEQ ID NO: 10,
wherein the early ageing includes the presence of lines and/or wrinkles, large macules, lentigo simplex and/or red patches;
b) comparing the relative abundance of the first marker and optionally the optional marker measured at step (a) with a reference value determined by the mean value of the level of the marker in a predetermined population; and
c) on the basis of the comparison at step (b), determining whether the skin of the subject shows early ageing.
Claim 1 is drawn to a method for diagnosis of early ageing of the skin in a subject, comprising the steps to determine abundance of fungal marker in a sample, for diagnosis of early skin aging.
Following the analysis below the claims are not patent eligible under 35 U.S.C. 101.
Step 1 - Whether the Claim is to a Statutory Category: YES. The claims are drawn to a method, therefore to one of the of statutory categories.
Step 2A Prong 1 - Whether the Claim Recite an Abstract idea, Law of Nature, or Natural Phenomenon: Yes. The claim recites a judicial exception, namely a law of nature of natural phenomenon. Specifically, the claim recites the natural correlation between fungi (as measured using marker such as ITS1) and a skin condition (e.g. skin aging) in individuals exposed to environmental pollution.
As stated in MPEP 2106.04(b)(I), laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
According to the specification, the inventors observed that:
"skin samples from individuals presenting with early ageing of the skin and exposed to chronic pollution (based on the detection of high levels of pollutants in hair samples thereof) have significantly different levels of some fungi compared with individuals not showing said early ageing and not exposed to such pollution." (Specification, Page 1).
Therefore, the judicial exception is the natural correlation of fungi (with presence indicated by their marker) and an early aging skin condition in subjects exposed to chronic pollution. Pollution is a naturally occurring environmental condition, including biological particles (pollen, fungal spores) and pollution formed from incomplete combustion of organic materials, such as forest fires and volcanoes. See Morakinyo1, p. 2, lines 9-12.
In conclusion, the claims recite laws of nature and natural phenomena.
Step 2A Prong 2 - Whether the Claim Recite Additional Elements that Integrate the Judicial Exception into a Practical Application: No. The claim as a whole do not integrates the exception into a practical application of that exception.
The additional element in the claim do not transform the claimed natural phenomena to something that are markedly different than their naturally occurring counterparts in their natural state, nor does it integrate the recited judicial exception into a practical application of the exception.
Claim 1 involves a natural correlation (amount of fungi on skin and early aging phenotype in subjects exposed to chronic pollution), a comparison to a reference value, and an abstract "determining" step in (c) that appears to encompass merely stating the presence of the correlation. The "determining... a relative abundance" and "comparing" to a reference steps appear to encompass any/all methods of observing the presence of the correlation at a high level of generality and is data gathering necessary to perform the "determining...early aging" step for diagnosis.
Therefore, the comparing and determining steps in the claim, recited at high-level of generality, merely observe natural laws and constitute abstract ideas.
The diagnosis aspect in the preamble has also been considered but does not integrate the judicial exception into a practical application nor render the claim patent-eligible. The courts have repeatedly held that diagnostic claims based on naturally occurring correlations, without additional elements that impose meaningful limits on the judicial exception, are ineligible under 35 U.S.C. 101. See Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 927 F.3d 1333, 1352 (Fed. Cir. 2019) (en banc) (Moore, J., dissenting) (expressing that the current interpretation of Section 101 eliminated diagnostic testing as patentable subject matter). Diagnostic testing claims fail because the step across the claims involves the mental step of reading the results and comparing them to a known relationship, or otherwise observing a natural law. See id. at 1336 (Lourie, J., concurring) (acknowledging that the only consistent interpretation of Supreme Court decisions resolving issues of patentable subject matter requires invalidating patents for diagnostic tests that merely observe natural laws); Roche Molecular Sys., Inc. v. CEPHEID, 905 F.3d 1363, 1372 (Fed. Cir. 2018) (explaining that observation of the relationship between the sample and known phenomena does not involve an inventive concept).
Claim 23 further recites a treatment step: "treating the skin of the subject diagnosed as showing early ageing of the skin with a cosmetic composition allowing reducing and/or slowing early ageing of the skin."
The treating step fails to transform the claimed method into patent-eligible subject matter because it does not recite a treatment that is sufficiently particular.
MPEP 2106.04(d)(2) states the following regarding consideration for particular treatment in Step 2A Prong Two:
"In order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. "
"The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s)."
Here, claim 23 broadly recites treating with any composition suitable for treating the skin condition identified through the judicial exception, without specifically identifying any treatment that goes beyond merely applying the exception in a generic manner. Such cosmetic composition broadly encompasses a large range of anti-pollution cosmetic formulations that are well-know and conventional in the field, such as products that contain antioxidants, pH balancing products, moisturizing products, and products that balance the natural oil levels of the skin2.
Thus, this treatment step does not integrate the observed natural correlation and the mental determination step of claim 1 into a practical application. However, if claim 1 were amended to recite a particular treatment step requiring a specific composition comprising probiotics (specification, page 9, lines 20-21), which are known in the art to provide beneficial anti-aging effects on skin through pH balancing and antioxidant production3, such an amendment could potentially overcome the presently set forth rejection under 35 U.S.C. 101.
Step 2B- Whether a Claim Amounts to Significantly More: No. In this instant case, the claims, when considered as a whole, do not recite any inventive concept with additional elements that amount to significantly more than the judicial exception.
The claims do not appear to add markedly different characteristics that significantly modify or use the naturally occurring correlation in a manner that is not naturally occurring.
The dependent claims have been considered but they do not recite additional elements that amount to significantly more than the judicial exception, as they represent mere general linkage of the judicial exception to the additional elements in the claims (MPEP § 2106.05(h)).
Claim 6 recites, at a high level of generality, determining the marker level through PCR amplification and sequencing; but this merely represents well-understood, routine, conventional activity in the life science arts, as recognized by the courts. See University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014).
As discussed above, the treating step in claim 23 does not amount to significantly more, because the broadly recited compositions suitable for treating skin aging, specifically pollution-related skin aging, were well-known, routine, and commercially available.
In conclusion, the claims are not patent eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103 -- New
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.
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 1-2, 6-7, 9, 16 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Leung (Leung et al. (2016). Skin fungal community and its correlation with bacterial community of urban Chinese individuals. Microbiome, 4, Article 46. doi.org/10.1186/s40168-016-0192-z), in view of
Flament (Flament et al. A severe chronic outdoor urban pollution alters some facial aging signs in Chinese women. A tale of two cities. Int J Cosmet Sci. 2018 Oct;40(5):467-481. doi: 10.1111/ics.12487. Epub 2018 Oct 8. PMID: 30112861) ;
Morakinyo (Morakinyo et al., Hunter RP. Health Outcomes of Exposure to Biological and Chemical Components of Inhalable and Respirable Particulate Matter. Int J Environ Res Public Health. 2016 Jun 14;13(6):592. doi: 10.3390/ijerph13060592. PMID: 27314370; PMCID: PMC4924049.); and
Fröhlich-Nowoisky (Fröhlich-Nowoisky et al., High diversity of fungi in air particulate matter. Proc Natl Acad Sci U S A. 2009 Aug 4;106(31):12814-9. doi: 10.1073/pnas.0811003106. Epub 2009 Jul 17. PMID: 19617562; PMCID: PMC2722276)
A) The claimed method relies on the correlation among pollution, early skin aging, and the abundance of skin fungi.
Leung teaches a method for analyzing skin fungal community using PCR and sequencing (entire document, see Fig. 1, methods for example).
Regarding claim 1, Leung teaches a method comprising:
determining in a skin sample of the subject the relative abundance of a first marker of fungi comprising a nucleic acid encoding an ITS 1 (< Internal Transcribed Spacer 1n) region of sequence at least 90 % identical to sequence SEQ ID NO: 1 ( Figure 1, relative abundance of Candida, according to specification, page 9, a fungi comprising SEQ ID NO: 1 is any fungi in the genus Candida),
and comparing the relative abundance of the first marker measured at step (a) with a reference value determined by the mean value of the level of the marker in a predetermined population (page 5, right-hand col, para 1, individual relative abundance for each fungal genera is compared with population average, which is a mean value of fungal abundance level in a predetermined population ;see also page 6, right-hand col, para 2, lines 2-5, mean BCDs (Bray-Curtis distance measures fungal relative abundance) is compared between individuals of two households).
While Leung teaches methods for analyzing skin fungal community and does not explicitly teach determining pollution-related early aging of skin based on fungal abundance. This feature would have been obvious in view of the knowledge in the prior art. Specifically, both fungi and the early aging of skin condition are known to positively correlate with air pollution.
Flament teaches that a highly polluted environment accelerates the skin aging process, leading to early aging of skin when compared to a moderately polluted area (abstract, p. 477), wherein the early ageing includes the presence of lines and/or wrinkles (Figure. 2, the age 30-34 group in high pollution area shows more signs of wrinkles than the same age group in low pollution area).
Morakinyo teaches that fungi make up a substantial fraction of air pollution (page 3, Particulate Matter-Associated Bioaerosols, “Fungi accounted for up to ~10% of organic carbon, and ~5% of PM10 at urban and suburban locations and abundant in a coarser particulate fraction”).
Fröhlich-Nowoisky specifically reports that Candida fungi, as recited in the claim, are found in air pollution (p. 12816, right-hand col, para3, lines 13-16).
Thus, the prior art teaches that pollution is associated with early-aging of skin, and that air pollution includes fungi, including the claimed genus Candida. In view of these teachings, a person of ordinary skill in the art would have expected high skin fungal abundance on the skin surface of an individual having pollution-related skin conditions, because greater exposure to air pollution also entails greater exposure to fungi present in the pollution. In other words, the abundance of pollution-related fungi on the skin surface would have served as a marker of the degree of the skin's exposure to pollution and the likelihood of the individual having pollution-related skin conditions.
Accordingly, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Leung’s methods for analyzing skin fungal community in determining pollution-related early aging of skin based on fungal abundance. This proposed combination uses Leung’s known skin fungal analysis method for its known purpose of determining skin fungal abundance, applied to a skin early aging condition known to be caused or accelerated by pollution exposure and fungi known to be present in pollution.
A skilled artisan, motivated by the commonly shared objective in promoting skin health - aim at protecting and/or maintaining the normal/healthy status of the human skin, as suggested by Flament (p. 480, right-hand col, lines 10-13), would have found it obvious to utilize this modified approach for the determination of pollution-related aging condition based on relative abundance of skin fungi, so that appropriate step could be taken to mitigate or prevent pollution-related negative impacts on the skin.
The person of ordinary skill would have had a reasonable expectation of success because Leung already teaches methods suitable for determining relative fungal abundance in skin samples, and Flament, Morakinyo, and Fröhlich-Nowoisky provide reason to associate pollution-related skin aging with exposure to pollution-associated fungi.
B) Regarding claim 2, Leung teaches genus Candida (Figure 1).
Regarding claim 6, Leung teaches PCR amplification of the ITS1 region, followed by sequencing the amplicons (page 3, left-hand col, para 2 “PCR, sequence library preparation, and sequencing”).
Regarding claims 7, 16 and 20, Leung teaches before analyzing, taking a skin sample by rubbing the surface of the skin of the subject(page 2, right hand col, lines 33-35).
Regarding claim 9, Leung teaches the subject's age is between 25 and 45 (Additional file 5: Figure S1, age group 21-50).
Regarding claim 21, Leung teaches method further comprises determining the relative abundance of at least one marker selected from the group consisting of fungi comprising a nucleic acid encoding an ITS 1 region of sequence at least 90 % identical to sequence SEQ ID NO: 3 (Fig. 1, Aspergillus sp. is a fungi comprising SEQ ID NO: 3 according to Application's specification: page 4: "Sequence SEQ ID NO: 3 is a sequence representative of the ITS1 of fungi of genus Emericella"; page 5 "By « fungi of genus Emericella », it is meant herein teleomorphs of fungi of genus Aspergillus.").
Regarding claim 22, Leung teaches fungi of genus Emericella (Fig. 1, Aspergillus sp. is a fungi of genus Emericella according to Application's specification: page 5 "By « fungi of genus Emericella », it is meant herein teleomorphs of fungi of genus Aspergillus.").
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Leung, in view of Flament, Morakinyo, and Fröhlich-Nowoisky, as applied to claim 1 above and further in view of Milani (Milani et al., Skin protective effects of an antipollution, antioxidant serum containing Deschampsia antartica extract, ferulic acid and vitamin C: a controlled single-blind, prospective trial in women living in urbanized, high air pollution area. Clin Cosmet Investig Dermatol. 2019 May 29;12:393-399. doi: 10.2147/CCID.S204905. PMID: 31213870; PMCID: PMC6549792).
Regarding claim 23, Flament suggests treating the skin of the subject diagnosed as showing early ageing of the skin with a cosmetic composition allowing reducing and/or slowing early ageing of the skin (p. 480, right-hand col, para 1). Such a treatment is known in the art.
Milani teaches an antipollution, antioxidant serum that counteract the skin oxidative stress in women living in high pollution urban area, thereby reducing pollution-related skin aging such as dark spots and wrinkles (Abstract).
Accordingly, a skilled artisan would have found it prima facie obvious to apply the antipollution, antioxidant serum, disclosed in Milani, to treat the pollution-related early aging condition as taught in the combined teachings of Leung, Flament, Morakinyo, and Fröhlich-Nowoisky.
This combination would have been obvious as it represents the KSR principle of predictable use of prior art elements (i.e., an antipollution serum for the skin) according to a known method (i.e., method of determining and treating pollution-related skin condition) to yield predictable results. (See MPEP §2143).
Prior Art
Below are relevant prior art not used in rejection but pertinent to the claims or disclosure.
Francesc (Francesc et al, Fungi growing on aromatic hydrocarbons: biotechnology's unexpected encounter with biohazard?, FEMS Microbiology Reviews, Volume 30, Issue 1, January 2006, Pages 109–130, doi.org/10.1111/j.1574-6976.2005.00007.x) teaches hydrocarbon-polluted environments show an increased abundance of fungi, because a large number of fungi strains can assimilate volatile aromatic hydrocarbons as a source of carbon and energy.
Conclusion
Claims 1 and 23 are objected; claims 1-2, 6-7, 9, 16 and 20-23 are rejected. No claims are allowed.
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/TIAN NMN YU/Examiner , Art Unit 1681
1 Morakinyo (Morakinyo et al., Hunter RP. Health Outcomes of Exposure to Biological and Chemical Components of Inhalable and Respirable Particulate Matter. Int J Environ Res Public Health. 2016 Jun 14;13(6):592. doi: 10.3390/ijerph13060592. PMID: 27314370; PMCID: PMC4924049.);
p. 2, lines 9-12: "Though it may be apt to cluster PM as particulates, their sources, spread and effects may be highly varied [9]. These particles can originate from natural sources, such as biological particles (pollen, fungal spores, etc.), fine soil particles, fine marine salts, wildfire smoke particles and volcanic ash, among other things."
2 See Formula Botanica (How to Make Anti-Pollution Skincare; Archived April 21, 2016 on WaybackMachine).
See Brisman (Anti-Pollution Skin Care: How 3 Products Can Help Defend Your Skin, Skincare.com ; March 29, 2017);
See Martin (How to Protect Your Skin Against Air Pollution - The New York Times; June 29, 2016)
3 See Kober MM, Bowe WP. The effect of probiotics on immune regulation, acne, and photoaging. Int J Womens Dermatol. 2015 Apr 6;1(2):85-89. doi: 10.1016/j.ijwd.2015.02.001. PMID: 28491964; PMCID: PMC5418745. (p.87, right-hand col, para 2-3)
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