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
This application has a foreign priority application EP22305568.2, filed April 15, 2022. Applicant’s amendment filed August 19, 2025 is acknowledged. Claims 1-6 and 12-13 are canceled, and claims 7-8 and 11 are amended.
Currently claims 7-11 and 14-16 are pending and under examination.
The previous 112(a) rejection in the Final office action mailed May 19, 2025 is withdrawn due to Applicant’s amendment to the claims filed August 19, 2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 19, 2025 has been entered.
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 7-11 and 14-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea or mental process without significantly more.
The Supreme Court has required analysis based on a 3-part test for subject
matter eligibility.
- Step 1: Is the claim to a process, machine, manufacture, or composition of
matter?
- Step 2A (The Judicial Exceptions): Prong 1: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
-Step 2A (The Judicial Exceptions): Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
- Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
Claims 7-11 and 14-16 recite a process of measuring protein biomarkers and correlating the level of the biomarker proteins with moisture content of skin, and administering a cosmetic treatment for hydrating skin. Claims 7, 11, and 14-16 recite a method for hydrating the skin based on this correlation. Claim 8 recites a method for screening the effectiveness of candidate cosmetic compounds based on this correlation. Thus the claims are drawn to a process which is a statutory category of invention (Step 1: Yes).
Claims 7-11 and 14-16 recite a judicial exception in the form of an abstract idea. The abstract idea is the natural correlation between the expression levels of the biomarkers and skin moisture (Step 2A, Prong 1: Yes).
Claims 7-11 and 14-16 are drawn to the appreciation of the correlation between the biomarkers and skin moisture. For example, claims 7 and 8 merely require a mental process of comparing expression levels of the biomarkers and determining if a cosmetic treatment is effective and then designating or selecting the effective cosmetic treatment. Claims 11 and 14-16 merely require a generic mental determination of the observed protein levels’ correlation with skin classification, wherein a reference value of each protein is measured based on the skin classification as very dry, dry, moisturized, or well-moisturized, and hydrating accordingly. The mental appreciation of observing the natural correlation between biomarkers and skin moisture and then hydrating accordingly is not particular, and instead are merely instructions to “apply” the exception in a generic way. Further, the mental appreciation of comparing expression levels to select/designate a compound as effective are also merely instructions to “apply” the exception in a generic way. The claims do not identify specifically a method of how the skin is hydrated in claims 7 and 11, and generally reference a cosmetic compound is ‘selected for’ hydrating the skin in claims 7 and 8. Furthermore, the scope of claim 7 of ‘designating a cosmetic treatment as efficient for hydrating the skin’ is based on observing the expression levels before and after treatment, does not include an active step of in the method, but are mere mental assessments of the effectiveness of the cosmetic treatment based on the natural correlations. As such, the claims are not integrated into a practical application because the mere appreciation of this natural correlation does not integrate the mental analysis step into a practical application, nor does generally hydrating the skin with a generic cosmetic compound amount to applying the exception into a practical application (Step 2A, Prong 2: No).
Claims 7-11 and 14-16 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims only recite routine data gathering, mental steps of looking at that data and coming to a determination by comparing and/or designating. Beyond routine data gathering and generally hydrating skin by administering a generic cosmetic compound, the only step is the appreciation of the natural correlation between biomarker expression in the skin and skin condition. As evidenced by Bulbiankova et al. (Antioxidants 2023, 12, 444, pgs. 1-26, previously cited in PTO-892 mailed 11/20/2024), the review article states it has been well understood, routine, and conventional to measure protein biomarkers for correlating skin properties/conditions, such as enhanced expression of P16INK4a , the secretion of inflammatory cytokines, and the loss of lamin B1, which are biomarkers of skin senescence (pg. 14, para 3). The crux of the claimed method is the appreciation of the natural correlation between protein biomarkers and skin moisture using a mental determination of the observed expression levels obtained by well understood, routine, and conventional data gathering techniques.
As discussed above, routine data gathering of biomarker expression has been a well-understood, conventional activity already engaged in by the scientific community and does not add significantly more to the judicial exception, nor does it amount to an inventive concept (Prong 2B: No) (See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)).
Therefore, claims 7-11 and 14-16 are not patent eligible subject matter.
Response to Arguments
Applicant's arguments filed August 19, 2025 have been fully considered but they are not persuasive.
The Applicant argues in Remarks (pg. 8-10) the designation of the efficiency of cosmetic treatment based on the expression level of at least one of ESYT3 and USP7 before and after treatment was not well understood, routine, and conventional. The Applicant argues the newly amended claims are patent eligible because claims 7 and 8 are directed to a method of cosmetic treatment or screening candidate cosmetic compounds, by measuring ESYT3 and USP7 protein levels before and after administering said cosmetic treatment, then designating the cosmetic treatment as efficient based on the changes of said protein levels. Claim 11 is directed to a method for hydrating the skin sample based on a reference value for each protein level in a control population having various skin classifications, determining the moisture content of an individual based on that reference value, and hydrating the skin with a cosmetic compound that decreases the expression level of said proteins. Applicant also argues the Bulbiankova review article can not qualify as prior art based on the effective filing date of the claimed invention, and reviews a correlation between protein expression levels and skin aging, not hydration. The Applicant cites Vanda Pharmaceuticals Inc. vs West-Ward Pharmaceuticals as explicitly stating a method of treatment claims that apply to a natural relationship should be considered in determining the invention’s patent eligibility.
In response, the Examiner maintains the amendments do not overcome the previous 101 rejection. The reason being is the overall method is still drawn to an abstract idea that is a mere appreciation of a natural correlation, which does not integrate the mental analysis step into a practical application, nor does generally hydrating the skin with a generic cosmetic compound amount to applying the exception into a practical application. Furthermore, the new amendment does not add any additional elements that amount to significantly more.
In response to applicant’s argument that it was not well understood or routine to measure these particular biomarkers for skin moisture, the fact that these particular protein biomarkers were not identified in the prior art related to skin hydration, is not a factor in the 101 analysis, and is based on the method steps of what is well-understood and routine in the art, which Bulbiankova discloses measuring various protein biomarkers in relation to skin condition as a common practice in the art.
In response to the cited Vanda Pharmaceuticals case, although the method steps in Vanda recite a natural relationship, the overall method integrates that relationship into a practical application, unlike the instant claims. In Mayo, the claims require a treating doctor to administer iloperidone." Id. at 1135 (emphasis added). As a result, the Federal Circuit held the claims in Vanda patent eligible under the first step of the Alice/Mayo framework (Step 2A in the USPTO' s subject matter eligibility guidance), because the claims "are directed to a method of using iloperidone to treat schizophrenia," rather than being "directed to" a judicial exception. According to MPEP §2106.04(d)(2), One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. 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. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.
The claimed method only recites a generic application of a cosmetic treatment, not a particular treatment, and designating it as efficient based on expression level, which is still ultimately drawn to the natural correlation, not integrated into a practical application as the method in Vanda. Thus, the 101 rejection is still maintained.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657