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 .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 21 October 2025 is acknowledged.
Claims 4-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 21 October 2025.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1-3 are objected to because of the following informalities:
Claim 1 recites, in part, “comparing said expression to determined standard”; this should recite “comparing said expression to a determined standard”.
Appropriate correction is required.
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 1-3 are 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 calls recites that “an increase in the expression as compared to said determined standard indicates propensity”; only one expression is observed, such that it is not possible for this single expression to exhibit any sort of “increase”. It is unclear if the intent is to observe the expression over time to determine changes in the expression such as an increase, or if the intent is for the comparison to indicate propensity if the expression is elevated/higher than a value of the determined standard. Clarification is required.
Further, claim 1 calls for observing the expression of the biomarker “on a skin area” but later uses that expression to determine “the propensity of an individual to develop atopic dermatitis” – is the skin area a skin area of the individual or some other skin area? How does the skin area relate to the recited individual? Clarification 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 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) using the result of a comparison to determine the propensity to develop a disease, which falls into the grouping of mental processes.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a process, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 16 recites a method comprising observing an expression of a biomarker on a skin area, comparing the expression to a standard derived from observations of expression of the biomarker in the absence of atopic dermatitis, and based on the comparison determining the propensity to develop atopic dermatitis
The dependent claims appear to be encompassed by the abstract idea of the independent claims since they merely specify the location of observation.
The claim elements may be summarized as the idea of obtaining data to report biometric information; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the observation and evaluation of the expression of the biomarker
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because any additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The invention as claimed does not include any elements additional to the judicial exception itself, which appears to be an entirely mental process and as presented is fully disembodied. As there are no additional elements, they do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition, implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, as indicated above
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
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.
Claim(s) s 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fukagawa (WO2021/221138; citations below are to the corresponding US publication US 2023/0235399).
Regarding claim 1, Fukagawa discloses a method of predicting a propensity of an individual to develop atopic dermatitis, comprising:
a) observing the expression of a biomarker selected from hBD1, IL1RA, IL36g and S 100A8/9 or a combination thereof (see Table C-1-6, Table C-1-11, Table C-4-1, Table C-4-5, Table C-7-1, Table C-11-1, Table C-11-2, Table C-12-1) on a skin area (paragraph [0142]);
b) comparing said expression to determined standard, wherein said determined standard is ascertained by measuring a level of said biomarker in a subject or pool of subjects who have demonstrated an absence of atopic dermatitis (paragraph [0121], [0123], [0126]); and
c) determining the propensity of an individual to develop atopic dermatitis, wherein an increase in the expression as compared to said determined standard indicates propensity of said individual to develop atopic dermatitis (paragraph [0119], [0123], [0124], [0126], [0129]).
Regarding claim 2, Fukagawa further discloses that the individual is selected from the group consisting of infants and young children (paragraph [0062]).
The Examiner notes that the disclosure of the instant invention defines “young” children as having an age of approximately twelve months of life to approximately 3 years, or approximately 5 years, or approximately 7 years of life, see paragraph [0064] as filed.
Regarding claim 3, Fukagawa further discloses that the skin is selected from face skin and body skin (paragraph [0142]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2012/0034226 to Yoshida, US 2020/0223508 to Leung
Rinnov MR, Halling A-S, Gerner T, et al. Skin biomarkers predict development of atopic dermatitis in infancy. Allergy. 2023; 78: 791-802. doi: 10.1111/all.15518
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/KAREN E TOTH/Examiner, Art Unit 3791