DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 10 May 2024 and 16 January 2025 has been considered by the Examiner.
Claim Rejections - 35 USC § 102
3. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claims 1-2, 7-8, 10-11, and 16-17 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Amos et al. (US 2021/0393187 A1).
Regarding claims 1 and 10, Amos teaches a system (system 100 [0028]) and a method ([abstract]), comprising:
an interface configured to send signals to a multi-electrode catheter placed in a ventricle of a heart of a patient and receive cardiac signals acquired in response to the sent signals (the multiple-electrode catheter 105 is placed in a ventricle of the patient’s heart to acquire input intracardiac signals (e.g., ventricle measurements) [0028, 0040, 0059, 0140, 0145]. Specifically, the computing device 161 comprises interface circuits 161 for transmitting and receiving signals to and from the catheter 105 [0051]. For example, the interface circuits 162 of the computing device 161 may receive the input intracardiac signals ([0051-0052]); and
a processor (the computing device 161 includes a processor [0050]), which is configured to:
apply pacing to the ventricle from multiple electrode locations over a circumference of an area of the catheter (the multiple-electrode catheter 105 is configured to apply stimulation or pacing to the ventricle [0037, 0041-0042, 0066-0067]);
receive cardiac signals acquired in response to the pacing (the processor of the computing device 161 comprises the interface circuits 161 for transmitting and receiving signals to and from the catheter [0051]. Specifically, the processor of the computing device 161 is configured to measure electrophysiologic data in response to the pacing [0050-0051, 0066-0067]);
apply a correlation algorithm to the received signals to calculate a plurality of correlations among the received signals (the autoencoder is an algorithm or trained model that is configured to calculate data points from the received input intracardiac signals [0023, 0025, 0027, 0035]. Specifically, the autoencoder uses the data points to generate 3D maps of cardiac regions of the heart [0036-0037, 0043-0044]. The Examiner respectfully submits that the autoencoder is utilized by the processor of the computing device 161 [0050]);
based on the calculated correlations, check if the area includes an arrhythmogenic location identified with a predefined sufficient spatial resolution (the autoencoder can generate 3D maps (e.g., spatial resolution) which can be used to identify arrhythmogenic location [0038-0041, 0043]);
if the resolution is insufficient, define a sub-area to pace (if the resolution is insufficient, the preliminary 3D map may be combined with data taken at additional points to generate a more comprehensive or sufficient 3D map of the heart’s electrical activity [0038, 0045]. In order to generate additional data points, the catheter 104 is inserted into the heart to provide stimulation (e.g., electrical pulses or energy) to a cardiac region of concern [0041-0043, 0045, 0066]. In response to the stimulation, the autoencoder is configured to receive the electrophysiological signals (e.g., electrical potential measurements) which is used to gather the additional data points for generating a more sufficient 3D map [0038, 0041-0042, 0045, 0066]);
apply subsequent pacing to the ventricle from multiple electrode locations over a circumference of the sub-area (the multiple-electrode catheter 105 is configured to apply stimulation or pacing to the ventricle [0037, 0041-0042, 0066-0067]);
receive subsequent cardiac signals in response to the subsequent pacing (the processor 161 of the computing device 161 comprises the interface circuits 161 for transmitting and receiving signals to and from the catheter [0051]. Specifically, the processor of the computing device 161 is configured to measure electrophysiologic data in response to the pacing [0050-0051, 0066-0067]);
calculate subsequent correlations among the subsequent received signals (the autoencoder is an algorithm or trained model that is configured to calculate data points from the received input intracardiac signals [0023, 0025, 0027, 0035]. Specifically, the autoencoder uses the data points to generate 3D maps of cardiac regions of the heart [0036-0037, 0043-0045]);
based on the subsequent correlations, ascertain whether the arrhythmogenic location is found in the sub-area (the autoencoder can generate 3D maps (e.g., spatial resolution) which can be used to identify arrhythmogenic location [0038-0041, 0043]);
and if an arrhythmogenic location is found with the sufficient spatial resolution, indicate the identified arrhythmogenic location to a user (the autoencoder can generate 3D maps (e.g., spatial resolution) which can be used to indicate an arrhythmogenic location to the user [0038-0041, 0043]).
Regarding claims 2 and 11, Amos teaches wherein the processor is configured to check the area with sufficient spatial resolution by checking an area enclosed by a set of adjacent catheter electrodes (the electrodes of the catheter 105 are configured detect electrophysiological signals which are used by the autoencoder to generate a sufficient or comprehensive 3D cardiac map (e.g., spatial resolution) [0025, 0043-0045, 0062]. For example, the 3D cardiac map will be constructed based on positioning of the series of electrodes which may contact or enclose an endocardial surface of the left or right ventricle [0040, 0061, 0064, 0066]. The Examiner respectfully submits that the autoencoder is utilized by the processor of the computing device 161 [0050]).
Regarding claims 7 and 16, Amos teaches wherein the processor is configured to apply a correlation algorithm to the received signals to calculate a plurality of correlations among the received signals by correlating the signals with reference signals (the autoencoder is configured to utilize the combination of electrical signals that are detected by the electrodes and the reference electrodes to generate data points for a 3D map of the heart [0035-0036, 0038, 0050, 0064]. Specifically, the autoencoder is configured to distinguish between signals that are used for selecting target areas and the signals that are artifacts [0035-0036]. As stated previously in claim 1, the autoencoder is a trained model or algorithm that is utilized by the processor of the computing device 161 [0027, 0050]).
Regarding claims 8 and 17, Amos teaches wherein the processor is configured to apply a correlation algorithm to the received signals to calculate a plurality of correlations among the received signals by correlating between the signals (the autoencoder is configured to utilize the combination of electrical signals that are detected by the electrodes and the reference electrodes to generate data points for a 3D map of the heart [0035-0036, 0038, 0050, 0064]. Specifically, the autoencoder is configured to distinguish between signals that are used for selecting target areas and the signals that are artifacts [0035-0036]. As stated previously in claim 1, the autoencoder is a trained model or algorithm that is utilized by the processor of the computing device 161 [0027, 0050]).
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
6. Claims 3-6, 9, 12-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Amos et al. in view of Bort et al. (US 2022/0344025 A1)
Regarding claims 3 and 12, Amos suggests the system according to claim 1 and the method according to claim 10. Amos does not explicitly teach wherein, in response to failing to find an arrhythmogenic location, the processor is further configured to, based on the calculated correlations, calculate, and indicate a direction to move the catheter.
The prior art by Bort is analogous to Amos, as they both teach a catheter having sensing and/or mapping capabilities ([0092]).
Bort teaches wherein, in response to failing to find an arrhythmogenic location, the processor is further configured to, based on the calculated correlations, calculate, and indicate a direction to move the catheter (if neither the body surface nor catheter signals are of sufficient quality, the past records and calculation data from a database may be used to provide a probabilistic directionality [0092, 0195, 0197-0198]. Specifically, the processor of the computing system is configured to execute an algorithm to provide directional guidance to the catheter [0197-0198]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time application was effectively filed to modify Amos’ processor to indicate a direction to move the catheter when failing to find an arrhythmogenic location, as taught by Bort. The advantage of such modification will the processor to use past records and calculation data from a database to provide probabilistic directionality to the catheter (see paragraphs [0092, 0195, 0197-0198] by Bort).
Regarding claims 4 and 13, Bort teaches wherein the interface is configured to receive cardiac signals acquired in response to the sent signals by receiving ECG signals from body surface ECG electrodes ([0097, 0119, 0161-0162]).
Regarding claims 5 and 14, Bort teaches wherein the multi-electrode catheter comprises a flat rectangular shape distal end assembly (figure 9C illustrates the multipole device 904 (e.g., high-resolution multipolar spade catheter) having a flat rectangular shape distal end [0198, FIG. 9C]).
Regarding claims 6 and 15, Bort teaches wherein the multi-electrode catheter comprises a multi-arm distal end assembly (figure 9C illustrates the multipolar basket catheter 908 having multiple arms or branches at the distal end [0198, FIG. 9C]).
Regarding claims 9 and 18, Bort teaches wherein the signals acquired in response to the pacing are ECG signals acquired using body surface electrodes ([0110, 0161-0163]).
Statement on Communication via Internet
7. Communications via Internet email are at the discretion of the applicant. All Internet communications between USPTO employees and applicants must be made using USPTO tools.
Without a written authorization by applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. A paper copy of such correspondence and response will be placed in the appropriate patent application. Except for correspondence that only sets up an interview time, all correspondence between the Office and the applicant including applicant's representative must be placed in the appropriate patent application. If an email contains any information beyond scheduling an interview such as an interview agenda or authorization, it must be placed in the application.
For those applications where applicant wishes to communicate with the examiner via Internet communications, e.g., email or video conferencing tools, the following is a sample authorization form which may be used by applicant:
"Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file."
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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 on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.B.S./Examiner, Art Unit 3792
/ANKIT D TEJANI/Primary Examiner, Art Unit 3796