Office Action Predictor
Application No. 17/601,235

DIAGNOSTIC FOR CHILDHOOD RISK OF AUTISM SPECTRUM DISORDER

Final Rejection §112
Filed
Oct 04, 2021
Examiner
CHERNYSHEV, OLGA N
Art Unit
1675
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Rensselaer Polytechnic Institute
OA Round
4 (Final)
54%
Grant Probability
Moderate
5-6
OA Rounds
3y 2m
To Grant
82%
With Interview

Examiner Intelligence

54%
Career Allow Rate
512 granted / 942 resolved
Without
With
+27.8%
Interview Lift
avg trend
3y 2m
Avg Prosecution
44 pending
986
Total Applications
career history

Statute-Specific Performance

§101
14.8%
-25.2% vs TC avg
§103
8.6%
-31.4% vs TC avg
§102
12.6%
-27.4% vs TC avg
§112
45.6%
+5.6% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§112
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, 21 and 69 have been amended, and claims 73 and 74 added as requested in the amendment filed on February 16, 2026. Following the amendment, claims 1, 2, 16, 18, 21, 25, 29, 33, 44, 47-55, 66, 69 and 71-74 are pending in the instant application. 2. Claims 25, 29, 33 and 47-55 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 10, 2025. 3. Claims 1, 2, 16, 18, 21, 44, 66, 69 and 71-74 are under examination in the instant office action. 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or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn. 5. New grounds of rejection necessitated by Applicant’s amendment are set forth below. 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, 16, 18, 21, 44, 66, 69, 71 and 72, as amended, and new claims 73 and 74 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. Claims 1 and 69, as presented, are vague and indefinite for reasons that follow. The claims are directed to methods that specifically require “measuring a level of each of at least two metabolites in combination wherein the at least two metabolites in combination are selected from the group consisting of 4-Hydroxy-3-methylbenzoic acid and Tryptamine; 4-Hydroxy-3-methylbenzoic acid and 4-Hydroxytryptophan.” Thus, it is not obvious whether the claims recite two combinations, each of two metabolites, or, for instance, a combination of Tryptamine and 4-Hydroxytryptophan is part of the claimed subject matter. Applicant is advised that amending the claims to recite “and” between the two combinations would satisfy the language “selected from the group consisting of” and obviate the rejection. 8. Claims 2, 16, 18, 21, 44, 66 and 71-74 are indefinite for being dependent from indefinite claims. Conclusion 9. No claim is allowed. 10. 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. 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, 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. 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. /OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675 March 8, 2026
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Prosecution Timeline

Oct 04, 2021
Application Filed
Apr 07, 2025
Non-Final Rejection — §112
Jul 10, 2025
Response Filed
Jul 10, 2025
Response after Non-Final Action
Jul 25, 2025
Response Filed
Aug 27, 2025
Final Rejection — §112
Nov 12, 2025
Request for Continued Examination
Nov 13, 2025
Response after Non-Final Action
Jan 13, 2026
Non-Final Rejection — §112
Feb 16, 2026
Response Filed
Mar 08, 2026
Final Rejection — §112
Apr 01, 2026
Response after Non-Final Action

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Prosecution Projections

5-6
Expected OA Rounds
54%
Grant Probability
82%
With Interview (+27.8%)
3y 2m
Median Time to Grant
High
PTA Risk
Based on 942 resolved cases by this examiner