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 .
Response to Amendment
The Amendment filed on 4/20/2026 has been entered. Claims 1, 2, 4, 5 and 7-20 remain pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “a potential aggravation risk or a potential high aggravation risk or a potential high aggravation risk” which appears to recite “a potential high aggravation risk” twice. 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, 2, 4 and 15-20 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.
Claim 1 recites quantifying a concentration of a liver-type fatty acid binding protein then determining the aggravation risk and then treating the subject by a number of different methods. However, the claim does not clearly link the aggravation risk to the treating step. It appears that the claim determines the aggravation risk and then treats the patient either way. The claim is therefore unclear if the treating step is performed if a potential aggravation risk or potential high aggravation risk is not determined. Claims 2, 4, and 15-19 are rejected by virtue of their dependence on a rejected base claim.
Claim 1 recites “wherein the subject is a subject unrelated to renal damage,” however this recitation is unclear. It is unclear if this recitation is trying to say that the subject does not have renal damage or if it is trying to say it doesn’t matter if the subject has renal damage. Claims 2, 4, and 15-19 are rejected by virtue of their dependence on a rejected base claim.
Claim 20 recites quantifying a concentration of a liver-type fatty acid binding protein then determining the aggravation risk and then treating the subject by a number of different methods. However, the claim does not clearly link the aggravation risk to the treating step. It appears that the claim determines the aggravation risk and then treats the patient either way. The claim is therefore unclear if the treating step is performed if no aggravation risk or a low potential aggravation risk is not determined.
Claim 20 recites “lower than or equal to one cut-off value in the range of less than 35 ng/ml and 30 ng/ml or more.” This recitation is unclear as the range appears to be open ended with the high side saying less than 35 ng/ml and the low side is reciting 30 ng/ml or more. The examiner suggests to instead recite “in the range of 30 ng/ml to 35 ng/ml.”
Claim 20 recites “wherein the subject is a subject unrelated to renal damage,” however this recitation is unclear. It is unclear if this recitation is trying to say that the subject does not have renal damage or if it is trying to say it doesn’t matter if the subject has renal damage.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 4/14/2026 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection under 112(b) is made.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
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