Prosecution Insights
Last updated: May 29, 2026
Application No. 16/312,346

Blood Test for Screening Out Amyloid and Alzheimers Disease Presence

Non-Final OA §101§112
Filed
Dec 21, 2018
Priority
Jun 22, 2016 — provisional 62/353,360 +1 more
Examiner
CHERNYSHEV, OLGA N
Art Unit
1675
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
University Of North Texas Health Science Center AT Fort Worth
OA Round
13 (Non-Final)
54%
Grant Probability
Moderate
13-14
OA Rounds
0m
Est. Remaining
89%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allowance Rate
516 granted / 946 resolved
-5.5% vs TC avg
Strong +34% interview lift
Without
With
+34.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
26 currently pending
Career history
987
Total Applications
across all art units

Statute-Specific Performance

§101
15.2%
-24.8% vs TC avg
§103
10.9%
-29.1% vs TC avg
§102
12.4%
-27.6% vs TC avg
§112
35.6%
-4.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 946 resolved cases

Office Action

§101 §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 Continued Examination Under 37 CFR 1.114 1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 06, 2026 has been entered. Response to Amendment 2. Claims 17 and 39 have been amended as requested in the amendment filed on April 06, 2026. Following the amendment, claims 17, 23-25 and 39 are pending in the instant application. 3. Claims 17, 23-25 and 39 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or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn. 5. Applicant’s arguments filed on April 05, 2026 have been fully considered but they are not deemed to be persuasive for the reasons 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 17, 23-25 and 39 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 17 and 39, as currently presented, are vague and indefinite for reciting limitation “screening a subject […] for positron emission tomography (PET) amyloid imaging.” The metes and bounds of the limitation cannot be ascertained from the claims or the specification as filed. Applicant is advised to rewrite the claims to better express claimed subject matter. 8. Claim 23 recites the limitation "the subject determined as having cerebral Aβ" in claim 17. There is insufficient antecedent basis for this limitation in the claim. 9. Similarly, claim 24 recites the limitation "the subject determined as not having cerebral Aβ" in claim 17. There is insufficient antecedent basis for this limitation in the claim. 10. Claim 25 is indefinite for being dependent from indefinite claim. 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. 11. Claims 17, 23-25 and 39 stand 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 for reasons of record in section 10 of Paper mailed on November 14, 2022, section 8 of Paper mailed on May 30, 2023, section 9 of Paper mailed on January 22, 2024, section 5 of Paper mailed on July 16, 2024, section 8 of Paper mailed on February 27, 2025 and in section 8 of Paper mailed on November 05, 2025. See also section 26 of Paper mailed on October 19, 2020, section 18 of Paper mailed on March 09, 2021, section 14 of Paper mailed on November 16, 2021, section 8 of Paper mailed on April 01, 2022, section 9 of Paper mailed on November 14, 2024 and in section 9 of Paper mailed on June 04, 2025. At p. 6 of the Response, Applicant traverses the rejection by presenting the same line of arguments that were presented earlier, fully considered and fully answered by the Examiner. The full text of the rejection will not be reiterated here, the Examiner maintains the same position. Briefly, claims 17, 23-25 and 39 are directed to a judicial exception because the claims set forth the law of nature—a correlation between the levels of expression of IL-5, IL-6, IL-7, TNF-a, and CRP in the blood or serum of the subject and pathological accumulation of cerebral amyloid (Aβ). As fully explained earlier, observation of the natural phenomenon, currently in claims, is not patentable under 35 U.S.C. 101 because it is limited to a process governed by nature, which exists independently of any action by Applicant, or Applicant’s discovery, knowledge or disclosure. For reasons of record in office actions of record enumerated earlier and reasons above, the rejection is maintained. Conclusion 12. No claim is allowed. 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 April 29, 2026
Read full office action

Prosecution Timeline

Show 32 earlier events
May 27, 2025
Request for Continued Examination
May 29, 2025
Response after Non-Final Action
Jun 04, 2025
Non-Final Rejection mailed — §101, §112
Oct 03, 2025
Response Filed
Nov 05, 2025
Final Rejection mailed — §101, §112
Apr 06, 2026
Request for Continued Examination
Apr 07, 2026
Response after Non-Final Action
May 06, 2026
Non-Final Rejection mailed — §101, §112 (current)

Precedent Cases

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

13-14
Expected OA Rounds
54%
Grant Probability
89%
With Interview (+34.2%)
2y 11m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 946 resolved cases by this examiner. Grant probability derived from career allowance rate.

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