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 April 20, 2026 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.
Claim Objections
Claims 8 and 11 are objected to because of redundant/convoluted claim language:
Claim 8, lines 10-15, can be changed to “f) applying the candidate cosmetic compound to the the at least one protein selected from extended synaptotagmin-3 (ESYT3) and Ubiquinin-carboxyl terminal hydrolase 7 (USP7), thereby hydrating the skin sample.
Claim 11, lines 6-21, can be changed to “: c) determiningfor ESYT3 and/or USP7the ESYT3 and/or USP7 protein(s) in a control population based on a skin classification
d) determining a moisture content of said skin sample as: dryer than that of the control population when the expression level of said at least one protein measured at step b) is higher than said reference value; or more moisturized than that of the control population when the expression level of said at least one protein measured at step b) is lower than said reference value; and e) treating the skin of said subject based on the moisture content determined at step d) as having a moisture content dryer than that of the control population with a cosmetic compound that decreases expression level of ESYT3 and/or USP7 , thereby hydrating the skin of a subject in need thereof.
Appropriate correction is required.
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 claim 7, and generally reference a cosmetic compound is ‘designated as efficient’ hydrating the skin. 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. The newly added active steps in claim 8 of ‘applying the candidate cosmetic compound to decrease expression level of the at least one protein’ and claim 11 of ‘treating the skin…with a cosmetic compound that decreases expression level of at the at least one protein’, are merely generic applications applying the judicial exception that are common and routine in the art as evidenced by Zhuang et al. (US2019/0369119 A1, cited in PTO-892 mailed 02/02/2024). 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 April 20, 2026 have been fully considered but they are not persuasive.
In response, the amended claims remain rejected under 35 U.S.C. §101 because the claimed method is still drawn to an abstract idea that is a mere appreciation of a natural correlation, which does not integrate the mental 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. For claim 7, Applicant argues the method now recites the skin as being modified from its natural state by the cosmetic treatment, thus does not recite the abstract idea of a natural correlation between the expression levels of biomarkers and skin moisture. However, merely measuring biomarkers after generically treating skin to ascertain differences in the natural correlation of biomarkers in hydrated and dry skin that is a conventional routine, and well-understood practice in the art does not amount to significantly more than the judicial exception.
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 subject matter eligibility 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 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). Applicant argues the Vanda case recites administering the iloperidone, which is the same amended method step of ‘applying’ the candidate cosmetic compound to the skin to decrease the expression level of the protein (claim 8) and ‘treating’ the subject’s skin based on moisture content correlating the natural expression levels of the proteins in different skin classifications, which integrates into a practical application. However, the Examiner points out that Vanda recites administering a particular medicament (iloperidone) in a specific amount of 12 mg/day to the patient with the CYPD2D6 poor metabolizer genotype. The instant claims are directed to a cosmetic treatment in any amount applied in any timeframe to decrease one or both of the two recited proteins based on the natural correlation of the biomarkers in different skin conditions, which has a nominal relationship to the exception. 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). The treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s). MPEP §2106.04(d)(2)a.-b.
One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to affect 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 rejection under 35 U.S.C. 101 is maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
Prosecution Insights