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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 8, 2025 has been entered.
Election/Restrictions
Claims 8-12 & 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 11, 2024.
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 1-4, 13-16 & 21-22, specifically independent claims 1 & 15, are directed to an abstract idea without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 1 is directed to a system, which is a product, i.e. a statutory category of invention.
Claim 15 is directed to a non-transitory computer-readable media executed by a processor, which is a statutory category of invention.
Step 2A, Prong 1:
Claims 1 & 15 recites the method steps of (i.e. processor coupled to the memory/as executed by a processor)
“…establish a communications link between the EP monitoring system and the IMD,”
“…receive the IMD electrical data at the EP monitoring system…”
“…reconstruct electrical signals for locations on the surface of interest based on the EP electrical data and the geometry data…”
“…compute a map of electrical signals for locations on the surface of interest…”
“…combining the reconstructed electrical signals representing the global assessment…”
“…store the map in the memory or provide the map as output…”
These limitations, under their broadest interpretation, fall within the mental processes (i.e. establishing, receiving, reconstructing, computing, storing, etc.) and the mathematical concepts (i.e. computing a map, etc.). It would be practical, but for the recitation “a processor coupled to,” to perform the steps in a human’s mind, or with a pen and paper, to provide the above method steps.
Step 2A, Prong 2:
The claims as a whole fails to integrate the abstract idea into a practical application. Claims 1 & 15 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application.
“…an IMD comprising an IMD electrode and IMD circuitry…” which is directed to data gathering, see MPEP 2106.05(f).
“…a processor configured to…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…for visualization on a display…” which is directed to data output, see MPEP 2106.05(g).
Therefore, the claims fail to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claims 1 & 15 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The claims are silent to providing any treatment at all to a patient.
Step 2B:
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
real-time discrete data obtained from a medical device/data previously collected from a medical device (i.e. body surface/unipolar electrodes) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
Therefore, the claims fail to recite significantly more than the abstract idea and claims 9-28 are rejected under 35 U.S.C 101.
The limitations of the dependent claims 2-4, 13-14, 16 & 21-22 further defines steps of analyzing/synchronizing the IMD and EP electrical data, adapting the instructions and programming of the IMD, communicating with IMD, computing the map, etc. which further limit claim limitations already indicated above as being directed to an abstract idea. Therefore, the above claims are directed to patient-ineligible subject matter.
Allowable Subject Matter
Claims 5-7 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art, Bokan et al., fails to disclose, suggest the claimed invention since the reference is silent in regards to reconstructed EP signals representing effects of each of the pacing signals on cardiac tissue, and wherein the EP signals for regions of the cardiac surface of interest not directly stimulated by the pacing signals are reconstructed using the impedance correction matrix and compute a map of electrical signals adapted for locations on the surface of interest based on the reconstructed EP signals, in combination with the other claimed elements (e.g., see ‘Arguments’).
Response to Arguments
The examiner thanks Attorney Pitzer for conducting the previous interview on September 8, 2025 to discuss the issue(s) of the pending application above. The examiner notes the newly submitted 101 rejections and indicated allowable subject matter mentioned above and invites the applicant to discuss the issue(s) with another interview if needed. Please see the above action.
Applicant’s arguments, filed September 8, 2025, with respect to the non-statutory double patenting rejections and the 112(a) rejections have been fully considered and are persuasive and have been withdrawn.
The examiner notes that there are no prior art rejections against the pending claims, 1-4, 13-16 & 21-22. However, the pending claims are still rejected in view of the above 35 U.S.C. §101, i.e. the pending claims are directed to an abstract idea without significantly more. Please see the above office action and make the appropriate corrections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David 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.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796