DETAILED ACTION
The Examiner acknowledges the amendments received 25 March 2026. Claims 1-9 and 20 are withdrawn; claims 10-19 are pending.
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 arguments, see “Remarks”, filed 25 March 2026, with respect to the rejection(s) of claim(s) 10-19 under 35 USC 112 and 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the amendments to the claims.
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 10-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 10-19 are directed to a system (machine) to find local activation times of intracardiac electrogram (IEGM) signals.
Step 2A, Prong One
Regarding claim 10, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper. See MPEP § 2106.04(a)(2)(Ill). The limitation(s) of “receive, from each of a plurality of electrophysiological laboratory sub-systems training data comprising first IEGM signals and corresponding local activation time annotations of the first IEGM signals manually annotated by respective annotation personnel, wherein the training data comprises IEGM signals and corresponding local activation time annotations manually annotated by different annotation personnel at different electrophysiological laboratory sub-systems;” and “receive a second IEGM signal” is/are a process that, as drafted, covers performance of the limitation by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard interpretation. For example, these limitations are nothing more than annotation personnel (in par. 0041 of the Published Application, these are explicitly disclosed as physicians or other medical professionals, i.e., humans) reading IEGM data from a sheet or screen, and marking them manually, as plainly stated in the claim.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. In particular, claim 1 also recites “a remote server including processing circuitry”, “train an artificial neural network using the training data to find local activation times of IEGM signals responsively to the first IEGM signals and the corresponding local activation time annotations”, and “apply the trained artificial neural network to the received second IEGM signal to provide an indication of a local activation time of the received second IEGM signal”. The “remote server” and “processing circuitry” are recited at a high-level of generality and amount to nothing more than parts of a generic computer. The additional limitation of “artificial neural network” generally could be applied to a piece of software rather than a physical structure. “Artificial neural network” here is recited at a high level of generality and is nothing more than a deep learning neural network that is well known as suggested by par. 0076 of the Published Application (“the artificial neural network may comprise any suitable ANN. The artificial neural network 68 may comprise software executed by the processing circuitry 60 (FIG. 4) and/or hardware modules”). Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of remote server, processing circuitry and artificial neural network are generic computer structures, which does not amount to an inventive concept.
Regarding dependent claims 11-19, the limitations of claim 10 further defines the limitations already indicated as being directed to the abstract idea.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 10-19 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 10 requires “annotation personnel” throughout the claim. As previously noted, these personnel explicitly refer to humans in the Specification of the instant application.
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 DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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