Prosecution Insights
Last updated: April 19, 2026
Application No. 18/593,210

SYSTEMS, DEVICES, AND METHODS FOR NON-INVASIVE IMAGE-BASED PLAQUE ANALYSIS AND RISK DETERMINATION

Final Rejection §112
Filed
Mar 01, 2024
Examiner
MEHL, PATRICK M
Art Unit
3798
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Cleerly Inc.
OA Round
2 (Final)
48%
Grant Probability
Moderate
3-4
OA Rounds
3y 10m
To Grant
72%
With Interview

Examiner Intelligence

Grants 48% of resolved cases
48%
Career Allow Rate
178 granted / 375 resolved
-22.5% vs TC avg
Strong +25% interview lift
Without
With
+24.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
10 currently pending
Career history
385
Total Applications
across all art units

Statute-Specific Performance

§101
13.4%
-26.6% vs TC avg
§103
52.5%
+12.5% vs TC avg
§102
4.6%
-35.4% vs TC avg
§112
26.0%
-14.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 375 resolved cases

Office Action

§112
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 . Status of Claims Claims 1-2, 5-18, 21-24 are currently under examination. Claims 3, 4, 19 and 20 are cancelled. Information Disclosure Statement The information disclosure statement (IDS) document(s) submitted on 12/31/2025, is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner. Priority This application is a CON of US application 18/508,098, filed 11/13/2023, which is a CIP of US application 18/179,921, filed 03/07/2023. Applicant' s claim for the benefit of priority under 35 U.S.C. 119(e) for this application to provisional application 63/477,985, filed 12/30/2022, 63/478,076, filed 12/30/2022, 63/477,961, filed 12/30/2022, 63/478,084, filed 12/30/2022, 63/477,656, filed 12/29/2022, 63/477,638, filed 12/29/2022, 63/477,640, filed 12/29/2022, 63/476,251, filed 12/20/2022, 63/476,245, filed 12/20/2022, 63/476,255, filed 12/20/2022, 63/386,376, filed 12/07/2022, 63/386,297, filed 12/06/2022, 63/385,472, filed 11/30/2022, 63/385,179, filed 11/28/2022, 63/383,904, filed 11/15/2022, 63/383,632, filed 11/14/2022. After review of the provisional applications, the examiner notes that the earliest disclosure of “aortic diseases” and “pulmonary embolism” as claimed is disclosed in provisional application 63/386,376 filed 12/07/2022. The priority date is therefore given at 12/07/2022. Withdrawn Objections/Rejections The claim rejections under 35 USC 101 are withdrawn in view of applicant’s arguments and/or amendments and in view of the new guidance for subject matter eligibility (2019 Revised Patent Subject Matter Eligibility Guidance 01/07/2019) since the amendment also provided practicality of the subject matter for improving the plaque identification and diagnosis imaging technology. The rejections of claims 1-20 under 35 U.S.C. 112(a) and (b) are withdrawn in view of applicant’s arguments and/or amendments as clarifying the claims. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-2, 5-18, 21-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims depending directly or indirectly from claims 1 and 17 are rejected due to their dependency from claims 1 and 17. Regarding independent claim 1 and claim 17, claims 1 and 17 recite “ wherein the machine learning algorithm is configured to convert the generated one or more low-resolution plaque parameters and the generated one or more low-resolution vascular parameters to one or more high-resolution plaque parameters and one or more high-resolution vascular parameters respectively to improve image quality of the low-resolution medical image”. Nowhere within the original disclosure is found the conversion of plaque and vascular parameters from low resolution images into high resolution plaque and vascular parameters to improve the quality of the low resolution images. Reciting conversion of low resolution images into high resolution image based on those plaque and vascular parameters does not provide any detailed description on how the improvement of the quality of the images is performed. Therefore the claim contains subject matter not described in sufficient details to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. 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, 5-18, 21-24 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. Claims depending directly or indirectly from claim 1 are rejected due to their dependency from claim 1. Regarding independent claim 1, claim 1 recites Claims depending directly or indirectly from claims 1 and 17 are rejected due to their dependency from claims 1 and 17. Regarding independent claim 1 and claim 17, claims 1 and 17 recite “ wherein the machine learning algorithm is configured to convert the generated one or more low-resolution plaque parameters and the generated one or more low-resolution vascular parameters to one or more high-resolution plaque parameters and one or more high-resolution vascular parameters respectively to improve image quality of the low-resolution medical image”. Nowhere within the original disclosure is found the conversion of plaque and vascular parameters from low resolution images into high resolution plaque and vascular parameters to improve the quality of the low resolution images. Therefore it is unclear what limiting effect is intended with these recitations since no description is provided to differentiate what is low resolution plaque or vascular parameters and what is high resolution plaque and vascular parameters. Clarification is requested for the conversion and the definition of these parameters with amendments. Regarding independent claim 1 and claim 17, claims 1 and 17 recite also “low-resolution plaque parameters”, “low-resolution vascular parameters”, also “high-resolution plaque parameters”, “high-resolution vascular parameters” while reciting also describing “the one or more plaque parameters” and “the one or more vascular parameters”. Therefore it is unclear what are these “the one or more plaque parameters” and therefore there is insufficient antecedent basis for this limitation in the claim. Allowable Subject Matter Claims 1-2, 5-18, 21-24 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. No prior art was found to teach the conversion of low resolution plaque and vascular parameters via a machine learning into high resolution plaque and vascular parameters to improve the quality of low resolution images. 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 PATRICK M MEHL whose telephone number is (571)272-0572. The examiner can normally be reached Monday-Friday 9AM-6PM. 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, KEITH M RAYMOND can be reached at (571) 270-1790. 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. /PATRICK M MEHL/ Examiner, Art Unit 3798 /KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798
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Prosecution Timeline

Mar 01, 2024
Application Filed
Sep 24, 2025
Non-Final Rejection — §112
Dec 30, 2025
Response Filed
Jan 21, 2026
Final Rejection — §112 (current)

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

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Prosecution Projections

3-4
Expected OA Rounds
48%
Grant Probability
72%
With Interview (+24.8%)
3y 10m
Median Time to Grant
Moderate
PTA Risk
Based on 375 resolved cases by this examiner. Grant probability derived from career allow rate.

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