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
1. Applicant’s election without traverse of Group I and species of bile acids as biomarkers in the reply filed on April 13, 2026 is acknowledged.
2. Claims 49, 50, 53-56, 59, 62, 65, 68, 71, 73, 75 and 78 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 April 13, 2026.
3. Claims 1-8, 10, 16-18, 20, 44 and 79-87 are under examination.
Claim Objections
4. Claim 1 is objected to because of the following informalities:
The claim recites “ACE” and “ARB” without first providing the full name of the terms. It is suggested that the terms be spelled out at their first use and in all independent claims so that it is clearly understood what they stand for. Appropriate correction is suggested.
5. Claim 1 is further objected to because of the following informalities: the claim capitalizes “diuretic,” which appears a typo unless the term is intended to define a proper name. Appropriate correction is required.
6. Claim 2 is objected to because of the following informalities: the claim recites limitation “a healthy” instead of “a healthy subject,” perhaps a typo as a result of editing. Appropriate correction is required.
7. Claim 79 is objected to because of the following informalities: The claim has a period in the middle of the text.
MPEP 608.01(m), Form of Claims, states,
Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).
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.
8. Claims 3-8, 10, 17, 18 and 20 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.
9. Claims 3-8 recite the limitations directed to determining the stage in progression to heart failure, predicting heart failure and determining a risk of developing heart failure while being dependent from claim 1, which is limited to one outcome of indication that “the pediatric subject has heart failure.” Thus, there is insufficient antecedent basis for these limitations in the claims.
10. Claim 10 is vague and ambiguous for failing to specifically point out what ratio is intended to be calculated, such as what concentration levels are divided by what values.
11. Claim 17 recites the limitation "four to ten validated low molecular weight metabolic biomarkers" in claim 1. There is insufficient antecedent basis for this limitation in the claim because claim 1 is limited to only four markers, see “selected from the group consisting of.”
12. Claim 18 is vague and indefinite in reciting limitation “further comprising” followed by recitation of products. It is not clear and cannot be determined from the claim or the specification as filed how these products relate to the method of claim 1.
13. Claim 20 is indefinite wherein it recites functional language. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” In the instant case, the claim recites the pediatric subject as undergoing a treatment but then defines the treatment —based on the concentration level— by functional language. While a functional limitation can provide a patentable distinction (limit the claim scope) by imposing limits on the function of a structure, material or action, in the instant case it is unclear what material/structural or manipulative differences are encompassed by recitation of the results obtained within the diagnostic step(s) of the method.
Conclusion
14. Claims 3-8, 10, 17, 18 and 20 are rejected. Claims 1, 2 and 79 are objected to. Claims 16, 44 and 80-87 are objected to as being dependent upon an objected base claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
June 9, 2026
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