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
Response to Amendment
1. Claims 1, 16, 19, 20, 23, 24, 28, 49, 50, 52 and 74-78 have been amended and claims 79 and 80 added as requested in the amendment filed on February 23, 2026. Following the amendment, claims 1, 2, 9, 16, 19, 20, 23-25, 28, 49, 50, 52 and 74-80 are pending in the instant application.
2. Claims 28, 74-78 and new claim 80 (dependent from the original withdrawn claim 28) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 16, 2025.
3. Claims 1, 2, 9, 16, 19, 20, 23-25, 49, 50, 52 and 79 are under examination in the instant office action. Applicant is reminded of the election of species, sTNFR1, made in the reply filed on September 16, 2025. When allowable subject matter is indicated, other recited species will be examined on the merit.
4. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
5. Applicant’s arguments filed on February 23, 2026 have been fully considered but found to be not persuasive for reasons set forth below. New grounds of rejection necessitated by Applicant’s amendment are set forth below as well.
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.
6. Claims 1, 2, 9, 16, 19, 20, 23-25, 49, 50, 52, as amended, and new claim 79 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.
7. Claim 1, as currently presented, is indefinite for reasons that follow. In section I), the claim recites “determining a patient’s outcome risk selected from risk of […] requiring hospitalization or safe to discharge,” wherein “safe to discharge” is in conflict with the treatment recited within the claim’s preamble.
Next, in section I) c., comparing the level of biomarkers and inputting the resulting measurement data does not allow for clear understanding how these steps lead to triaging the patient. Amending the claim to recite specific levels of sTNFR1, the elected biomarker, that are associated with steps of intubation, mechanical ventilation etc., would overcome this ground of rejection.
8. Claims 2, 9, 16, 19, 20, 23-25, 49, 50, 52 and 79 are indefinite for being dependent from indefinite claim(s).
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.
9. Claims 1, 2, 9, 16, 19, 20, 23-25, 49, 50 and 52, as amended, and new claim 79 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more, see reasons of record in section 12 of Paper mailed on October 23, 2025.
At pp. 11-13 of the Response, Applicant traverses the rejection on premises that the claims have been amended to recite positive treatment steps, as suggested within the previous office action, thus overcoming the rejection. Applicant’s argument has been fully considered but found to be not persuasive for reasons that follow.
Independent claim 1, as currently amended, encompasses a method for triaging a patient, wherein the triaging is achieved by determining a patient’s outcome risk selected from risk of requiring intubation, requiring mechanical ventilation, requiring hospitalization or safe to discharge by measuring differential expression of sTNFR1 (the elected species) and proceeding with intubation, mechanical ventilation, hospitalization or discharging the patient. As fully explained earlier, admission to a hospital or discharging the patient from the hospital are not meaningful active steps of treatment protocol. Because the claimed method encompasses judicial exception, which is reciting a naturally occurring correlation between the levels of sTNFR1 and pathology of respiratory illness, then the claims do not satisfy the requirement of 101, patentability and therefore stand rejected.
Conclusion
10. No claim is allowed.
11. 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 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
April 14, 2026
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