Prosecution Insights
Last updated: October 02, 2026
Application No. 18/500,637

ATRIAL FIBRILLATION DETECTION USING HEART SOUND MORPHOLOGY

Non-Final OA §101
Filed
Nov 02, 2023
Priority
Nov 02, 2022 — provisional 63/421,834
Examiner
DOWNEY, JOHN R
Art Unit
3792
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Cardinal Health Inc.
OA Round
2 (Non-Final)
60%
Grant Probability
Moderate
2-3
OA Rounds
5m
Est. Remaining
83%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allowance Rate
322 granted / 539 resolved
-10.3% vs TC avg
Strong +24% interview lift
Without
With
+23.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
35 currently pending
Career history
584
Total Applications
across all art units

Statute-Specific Performance

§101
7.1%
-32.9% vs TC avg
§103
47.5%
+7.5% vs TC avg
§102
15.0%
-25.0% vs TC avg
§112
22.7%
-17.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 539 resolved cases

Office Action

§101
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 Arguments Applicant’s remarks concerning the §101 rejections have been fully considered but are mostly not persuasive, except for the remark related to new claim 21. Applicant argues that the claimed invention results in various technological improvements such as improved sensitivity of atrial fibrillation detection, reduction of false positives, and the like. The Examiner respectfully disagrees. These alleged improvements appear to be due entirely to the mental steps themselves. As noted in MPEP § 2106.05(a), “It is important to note, the judicial exception alone cannot provide the improvement.” Thus, alleged improvements that result solely from the mental steps themselves cannot be considered a “technological” improvement. Here, if a person were to manually carry out the functions of the assessment circuit and atrial fibrillation detection circuit, they would presumably arrive at the very same “improvements” compared to carrying out those steps on generic processing circuitry, such as reducing false positives. As such, to the degree that an improvement is claimed, it is not an inherently technological one. Applicant’s further remarks concerning the alleged improvements in Para. [0047] (which it appears should have been Para. [0048]) are not persuasive because they are vague (e.g. they allege vague improvements generally without any specific basis for comparison, e.g. when stating “reducing storage” – reduced compared to what?), and also because those alleged improvements are not claimed nor are they tied to any of the specific limitations currently claimed. Applicant’s remark about transitioning the device from a low-power mode to a high-power mode in connection with new claim 21 is persuasive. The Examiner agrees that such a step as positively claimed amounts to a fundamental change in how the underlying technology operates, and thus is sufficient to be categorized as a technological improvement in combination with the other elements of claim 1 (from which new claim 21 depends). As such, claim 21 is indicated as containing allowable subject matter if it were amended to be in independent form. 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. Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more. Step 1: All of claims 1-20 are directed either to a method/process or to a system/machine. Step 2A, Prong One: The claims recite a mental process including steps such as the steps carried out by the assessment circuit (“to determine … and to determine …”) and the atrial fibrillation circuit (“to detect …”) in claim 1 (see corresponding steps in claim 12, which are the steps of “determining … determining … and detecting …”) which could be performed by the human mind and/or by a human with a physical aid such as pen and paper. Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process using generic processing technology and add insignificant extra-solution activity. Specifically: the steps of “receiving” the data using a signal receiver circuit, and/or using sensors to sense the data, is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process. Furthermore, merely carrying out mental steps using generic computing technology such as “an assessment circuit” and the like is well established to not amount to an integration into a practical application under the § 101 analysis. See, e.g., MPEP §§ 2106.04(a)(2)(III)(C) and 2106.04(d)(I) and 2106.05(f). Additionally, merely carrying out the mental process in the context of an implantable device (as in claims 3 or 14) is considered to be merely linking the use of the mental process to a particular technological environment. See MPEP § 2106.05(e). Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims are generic processing/computing components and generic data receiving and sensing components. The Examiner takes official notice that these are basic, generic components which are well-understood, routine and conventional in the medical diagnostic arts, and the claims here merely use them for their well-understood, routine and conventional functions. As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis. Dependent claims 2-11 and 13-20 otherwise merely expand on the mental steps themselves and/or expand on the insignificant pre-solution activity of mere data gathering, and thus follow the same analysis above. Allowable Subject Matter Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET. 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, NIKETA PATEL can be reached at (571)-272-4156. 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. /JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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Prosecution Timeline

Nov 02, 2023
Application Filed
Jan 15, 2026
Request for Continued Examination
Feb 17, 2026
Response after Non-Final Action
Mar 02, 2026
Non-Final Rejection mailed — §101
Jun 01, 2026
Response Filed
Aug 11, 2026
Non-Final Rejection mailed — §101 (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

2-3
Expected OA Rounds
60%
Grant Probability
83%
With Interview (+23.7%)
3y 4m (~5m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 539 resolved cases by this examiner. Grant probability derived from career allowance rate.

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