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 amendment and explanation are sufficient to overcome the previous specification objections and prior art rejection.
Applicant's arguments filed 12/2/2025 have been fully considered but they are not persuasive. Regarding the 101 rejection, the Applicant argues the claims are not directed to an abstract idea, but to an implantable medical device that includes sensor arrangement and processing circuitry. The Applicant then identifies the steps performed by the processing circuitry and argues these are unconventional and non-routine processing steps to being about a technical improvement in an implantable medical device. Therefore, the claims are directed to a specific device which performs specific operation functions that concretely result in a technological improvement in the way in which an implantable medical device operates. The examiner respectfully disagrees as the steps of 1. Monitor the cardiac sense signal to detect a first atrial event candidate in a cardiac cycle based on comparison with a sense threshold; 2. Determine a modified sense threshold upon detection of the first atrial event candidate; 3. Monitor the cardiac sense signal to detect in an atrial-ventricular delay period starting at the detection of the first atrial event candidate a second atrial event candidate based on a comparison of the cardiac sense signal with the modified sense threshold; and 4. Identify the first atrial event candidate as a valid atrial event if no second atrial event candidate is detected within the atrial-ventricular delay period, is a mental process and therefore an abstract idea. The IMD comprising a body with sensor arrangement and processing circuitry are additional elements, but do not integrate the abstract idea into a practical application or recite significantly more than the abstract idea itself. MPEP 216.05(I) discloses the "‘novelty’ of any steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter. Therefore, the argument regarding the unconventional and non-routine processing steps is not persuasive. A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
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 1-3, and 5-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a mental process of detecting a first atrial event candidate in a cardiac cycle by comparing the signal to a threshold, modifying the sense threshold and then comparing the cardiac cycle to the modified threshold to monitor for a second atrial event candidate. This judicial exception is not integrated into a practical application because the additional elements of a IMD comprising a body and sensor arrangement on the body are part of pre-solution activity of data gathering and the processing circuitry is part of a generic computing structure. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because using an IMD comprising a body with a sensor to gather cardiac sense signal is well-known, routine and conventional Dahl et al (US Publication 2002/0111663) in Paragraph [0051] discloses an IMD with sensing circuit to sense cardiac signals and in communication with processing circuit 114. Li (US Publication 2005/0261744) discloses in Figure 2 an IMD with the ability to sense and in communication with a controller. Kracker (US Publication 2009/0326356) discloses in Figure 4 an IMD with EGM sensing module and in communication with a processor. While these references also disclose processing circuitry there is nothing in the disclosure to suggest this is implementing the abstract idea on a non-generic computer.
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 William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796