CTNF 18/868,469 CTNF 101324 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statements (IDS) submitted on 02/14/2025 and 02/19/2025 are being considered by the examiner. Specification 06-31 AIA The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-15, and 17-20 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. Claims 1-15, and 17-20 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019). Step 1 : Claim 1 is drawn to a device. Step 2A – Prong 1: Claim 1 is drawn to an abstract idea, that under its broadest reasonable interpretation, covers mental processes but for the recitation of insignificant extra-solution activity and generic computer components to collecting and processing data. In particular, claim 1 recites the following limitations: A medical device system comprising: processing circuitry configured to: receive a cardiac motion signal sensed over a first signal episode (mental process); receive at least one cardiac electrical signal (mental process); determine that a first P-wave of the at least one cardiac electrical signal occurs in a diastolic period of a first cardiac cycle of the first signal episode (mental process); in response to the first P-wave being in the diastolic period of the first cardiac cycle, determine at least a first feature of the cardiac motion signal sensed during the first cardiac cycle (mental process); and establish at least a first control parameter based on at least the first feature, at least the first control parameter used for controlling delivery of atrial synchronous ventricular pacing (mental process). In re claim 17 , see above (In re claim 1). Substantially, the same reasoning applies. These limitations of claim 1 are drawn to an abstract idea because they are processes that, under their broadest reasonable interpretation, are steps merely comprised of mental processes. Step 2A – Prong Two: Claim 1 recites the following emphasized (indicated in bold) additional elements that are beyond the judicial exception: processing circuitry (generic computer element) configured to The additional elements do not integrate the exception into a practical application of the exception because the elements are directed to insignificant extra-solution activity . The processing circuitry is a generic computer element that carries out abstract steps described in claim 1 (see 2106.05(g) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Further, the judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field. The alleged improvement made by the claimed invention as argued by the application above sets forth the improvement in a conclusory manner and the claim does not include the components or steps of the invention that the improvement described. In re claim 17 , see above (In re claim 1). Substantially, the same reasoning applies. Claim 17 has an additional limitation of “a non-transitory computer readable storage media storing instructions”, subject to the same analysis of the processing circuitry discussed above In re claim 1. Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well understood, routine, conventional activity. The processing circuitry is a computer element that carries out abstract steps described in claim 1. Moreover, implementing an abstract idea on a generic computer, does not add significantly more. Reconsidering the claim limitations individually and as a combination, the claims fail to meet the requirements for eligibility under 35 U.S.C. 101. All uses of the recited abstract idea require the pre-solution data gathering. In re claim 17 , see above (In re claim 1). Substantially, the same reasoning applies. Claim 17 has an additional limitation of “a non-transitory computer readable storage media storing instructions”, subject to the same analysis of the processing circuitry discussed above In re claim 1. Claims 3-15 and 18-20 recite the same abstract idea as their respective parent claims. Furthermore, these claims only contain recitations that further limit the abstract idea. In re claim 2 , see above 35 U.S.C. analysis for claim 1. Claim 2 recites the same abstract idea as its parent claim, claim 1 with the additional limitation “ input the at least one cardiac electric signal to a cardiac signal analyzer ” containing an additional element as indicated in bold. The additional elements do not integrate the exception into a practical application of the exception because the elements are directed to insignificant extra-solution activity . The cardiac signal analyzer is a computer element that carries out abstract steps described in claim 1 (Instant Specification: [0041]: “ a cardiac signal analyzer 51, which may be a processing sub-unit or module of the processing circuitry ”). Moreover, implementing an abstract idea on a generic computer, does not add significantly more. Reconsidering the claim limitations individually and as a combination, the claims fail to meet the requirements for eligibility under 35 U.S.C. 101. In re claim 5 , see above 35 U.S.C. analysis for claim 1. Claim 5 recites the same abstract idea as its parent claim, claim 1 with the additional limitation “ receive the cardiac motion signal and the at least one cardiac electrical signal sensed over a second signal episode during which atrial synchronous ventricular pacing is delivered according to at least the established first control parameter established based on at least the first feature ” containing an additional element as indicated in bold. The additional elements do not integrate the exception into a practical application of the exception because the limitation does not positively recite providing treatment (see 2106.04(d)(2)) and is directed to insignificant extra solution activity. Reconsidering the claim limitations individually and as a combination, the claims fail to meet the requirements for eligibility under 35 U.S.C. 101. Claim 16 recites the same abstract idea as its parent claim, claim 1 with the additional limitation “ a pulse generator configured to deliver the atrial synchronous ventricular pacing; and a control circuit configured to operate according to at least the first control parameter for controlling the pulse generator to deliver the atrial synchronous ventricular pacing ” contains additional elements as indicated in bold that overcome the 35 U.S.C. 101 rejection by providing a practical application. Allowable Subject Matter Claims 1-15, and 17-20 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 101 set forth in this Office action. 12-151-08 AIA 07-43 12-51-08 Claim 16 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. Examiner has not found any references that teach or suggest either alone or in combination the limitations recited in claim 1. The following is an Examiner’s statement of reasons for the indication of the allowable subject matter: The closest prior art is: Sheldon (US 20190321634), Pei (US 20090281587), Sanghera (US 10315036), and Toth (US 20220211328). Sheldon (US 20190321634) discloses an intracardiac pacing system [0024] with a processor that receives cardiac electric signals and cardiac motion signals [0056] and determines if an atrial event, such as P-wave, has sensed [0056; 0085] where the atrial event is detected during an expectation window [0055, 0075] and then delays an AV interval and delivers a ventricular pacing pulse (Fig. 6; [0095]). In addition, Sheldon discloses an atrial mechanical event (A4) event that may occur during an A3 ([0069]: “ a ventricular passive filling event” that “ occurs during ventricular diastole ”) sensing window (starting with an end of a post-ventricular atrial refractory period) or afterwards ([0075]; note: a P-wave could be an example of an A4 event as it is a marker of atrial systole). Sheldon does not disclose: processing circuitry configured to: determine that a first P-wave of the at least one cardiac electrical signal occurs in a diastolic period of a first cardiac cycle of the first signal episode; in response to the first P-wave being in the diastolic period of the first cardiac cycle, determine at least a first feature of the cardiac motion signal sensed during the first cardiac cycle; and establish at least a first control parameter based on at least the first feature, at least the first control parameter used for controlling delivery of atrial synchronous ventricular pacing. While the atrial event is suggested to occur around or after a ventricular diastolic event, the cited reference fails to individually disclose, or suggest when combined, determining if a P-wave occurring during a diastolic period. It would not be obvious to one of ordinary skill in the art before the effective filing date to modify the intracardiac pacing system to detect the P-wave during a diastolic period and to use the P-wave presence as an indicator to control pacing based on a cardiac motion signal. Pei (US 20090281587) discloses a system for an implantable cardiac stimulation device [0087] wherein a microcontroller and microprocessor receive accelerometer signals ([0081]; i.e. cardiac motion signal) and IEGM signals ([0080]; i.e. cardiac electric signals) and when a P-wave is confirmed to occur during an expected PVAB interval [0030-0033], determines pacing parameters based on accelerometer signals [0081] that is used to control automatic mode switching [0033]. Pei does not disclose: processing circuitry configured to: determine that a first P-wave of the at least one cardiac electrical signal occurs in a diastolic period of a first cardiac cycle of the first signal episode; in response to the first P-wave being in the diastolic period of the first cardiac cycle, determine at least a first feature of the cardiac motion signal sensed during the first cardiac cycle; and establish at least a first control parameter based on at least the first feature, at least the first control parameter used for controlling delivery o f atrial synchronous ventricular pacing. However, it would not be obvious to one of ordinary skill in the art before the effective filing date to modify the intracardiac pacing system to detect a first P-wave during a diastolic period and to use the P-wave presence as an indicator to control pacing based on a cardiac motion signal. Sanghera (US 10315036) discloses a cardiac pacing system (abstract) with a processor (Col. 3, ln. 17-20) which receives accelerometer signals (Col. 12, ln. 62-64: “ blood flowing through the blood-filed structures ”, i.e. cardiac motion signals) and ECG signals (Col. 39, ln. 1-10; i.e. cardiac electric signals), determines if a subsequent P-wave occurs during an expectation window (Col. 38, ln. 1-12), controls pacing delivery of atrial synchronous ventricular pacing (Col. 46; ln. 52-55) based pacing characteristics determined by the accelerometer signals (Col. 2, ln. 60-67). Sanghera does not disclose: processing circuitry configured to: determine that a first P-wave of the at least one cardiac electrical signal occurs in a diastolic period of a first cardiac cycle of the first signal episode; in response to the first P-wave being in the diastolic period of the first cardiac cycle, determine at least a first feature of the cardiac motion signal sensed during the first cardiac cycle; and establish at least a first control parameter based on at least the first feature, at least the first control parameter used for controlling delivery of atrial synchronous ventricular pacing. As discussed above, Sanghera discloses searching for a subsequent P-wave as the expectation window is determined after examining prior P waves and atrial templates (Fig. 21; Col. 37, 51-67 to Col. 38, ln. 1-12). This is contrary to the Applicant’s instant invention which requires determining if a first P wave of the cardiac electrical signal occurs during a diastolic period. Toth (US 20220211328) discloses that the completion of a P-wave represents the end of ventricular diastole and the start of ventricular systole [0110]. However, Toth does not disclose searching for the P-wave during diastole. It would not have been obvious to modify Sheldon, Pei, or Sanghera to determine if a first P-wave occurs during diastolic period of a first cardiac cycle of the first signal. No prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically determining that a first P-wave of the at least one cardiac electrical signal occurs in a diastolic period of a first cardiac cycle of the first signal episode; and in response to the first P-wave being in the diastolic period of the first cardiac cycle, determine at least a first feature of the cardiac motion signal sensed during the first cardiac cycle in combination with the recited structural limitations of the claimed invention. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm.. 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, David E Hamaoui can be reached at (571) 270-5625. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /HALLE MARGARET WELCH/Examiner, Art Unit 3796 /DAVID HAMAOUI/SPE, Art Unit 3796 Application/Control Number: 18/868,469 Page 2 Art Unit: 3796 Application/Control Number: 18/868,469 Page 3 Art Unit: 3796 Application/Control Number: 18/868,469 Page 4 Art Unit: 3796 Application/Control Number: 18/868,469 Page 5 Art Unit: 3796 Application/Control Number: 18/868,469 Page 6 Art Unit: 3796 Application/Control Number: 18/868,469 Page 7 Art Unit: 3796 Application/Control Number: 18/868,469 Page 8 Art Unit: 3796 Application/Control Number: 18/868,469 Page 9 Art Unit: 3796 Application/Control Number: 18/868,469 Page 10 Art Unit: 3796 Application/Control Number: 18/868,469 Page 11 Art Unit: 3796
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