I. ACKNOWLEDGEMENTS
This Office Action addresses U.S. Application No. 18/747552 (“’552 Application” or “instant application”). Based upon a review of the instant application, the actual filing date of the instant application is June 19, 2024.
II. STATUS OF CLAIMS
Claims 1-20 were filed with the application
a. Claim 1-20 (“Pending Claims”).
b. Claim 1-20 are examined (“Examined Claims”)
II. PRIORITY AND CONTINUING DATA
The ‘552 application claims no priority. Because the earliest possible effective filing date is after March 16, 2013, the first to file provision of the AIA , apply to this proceeding.
IV. REJECTIONS UNDER 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 1-20 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more (See MPEP 2106.04(a)).
Claim 1 recites the limitations:
1. A method to locate Electro-Physiological (EP) landmark within a heart in real-time during an electro-physiological mapping of a patient's heart utilizing a catheter, the method comprising:
(a) tracking locations within the heart via which a distal end of said catheter is traversed during said electro-physiological mapping;
(b) recording reference location of at least a first spatial reference landmark in the heart;
(c) determining a region of interest (ROI) for locating said sought EP landmark based on a pre-defined distance range relative to the at least first spatial reference landmark;
(d) as long as at least one electrode at the distal end is within the ROI:
obtaining data indicative of an IEGM measured by the at least one electrode in synchronization with data indicative of an ECG signal;
identifying reference timing based on the ECG signal;
identifying a portion of the IEGM signal being within a predetermined time window relative to the referenced timing; and
determining whether a predetermined characterizing signal feature of the sought EP landmark is manifested in the portion of the IEGM;
upon determining that said characterizing signal feature is manifested within the time window, identifying a location of the at least one electrode as a location of the sought EP landmark; and
(e) marking said location of the sought EP landmark on a map of the heart rendered on a display.
The first step in the 101 analysis, step 1 in MPEP 2106, is whether the claimed invention is in one of the 4 statutory classes of invention. Here, the claim is drawn to a method of identifying fidgeting, which is one of the 4 statutory classes of invention. Hence, step 1 is satisfied.
The next step in the analysis, step 2A prong one, is whether the claim is directed to judicial exception, i.e. a law of nature, a natural phenomenon, or an abstract idea. Steps i – v define a process that can be performed mentally, given the data an input. Mental processes are recognized as judicial exceptions that recite an abstract idea. See MPEP 2164
In Step 2A, prong two of the analysis, the claim is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application.
The claim has several additional elements. Steps a-c amount to pre-solution activity, i.e. data gathering, which do not integrate the claim into a practical application. Step e amounts to post solution activity, which does not integrate the exception into a practical application. Therefore, the additional elements and steps do not integrate the claim into a practical application. Further, to the extent that structure is recite, it is recited at a high level of generality. As such, the answer to step 2A, prong 2, is no.
The final step of the analysis, step 2B, where the claim is evaluated to determine whether the recited additional elements amount to significantly more than the judicial exception. Here, the additional steps and structure are simply well-understood, routine, and conventional processing steps and structure. Hence, the step does not recite an inventive concept.
As such, claim 1 is directed to an abstract idea and is not patent eligible.
As to claims 2-15 the claims do not add anything that changes the analysis and hence, are also drawn to an abstract idea.
Claims 16-20 are directed to an abstract idea for the same reasons claims 1-15, noting that the processor and structure are recited at a high level of generality.
V. REJECTIONS UNDER 35 USC 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected in that there is no antecedent basis for the sought EP landmark in line 8.
Claim 1 is further rejected in that no electrodes have been recited prior to line 11. Applicant should add a step of providing a catheter with electrodes at the distal end.
Claims 2, 11, and 15 are also rejected in that there is no antecedent basis for the sought EP landmark.
Claims 7-10 are rejected in that there is no antecedent basis for the additional sought EP landmark.
Claim 16 is rejected in that there is no antecedent basis for the sought landmark.
Claim 18 is rejected in that the claim recites whereby for locating …. Whereby means thus, i.e. all of the following features necessarily flow from the previously recited structure. Here, that is not the case. It seems that Applicant should recite wherein rather than whereby.
Claims 18 and 19 are rejected in that the term sought landmark has no antecedent basis.
Claim 19 is also rejected in that it depends upon itself.
Claims 3-6, 12-14, and 17 are rejected as being dependent upon a rejected base claim.
VI. ALLOWABLE SUBJECT MATTER
Claims 1-20 would be allowable if the rejections under 35 USC 101 and 112 were overcome.
Claims 1-20 define over the art of record in that none of the art determines a region of interest for locating an electrophysical landmark in the heart based on a known distance from a spatial reference landmark, then while an electrode of a catheter is in the region of interest, determining whether a predetermined characterizing signal feature of a sought EP landmark occurs in a window following a reference timing of an ECG signal, and marking the location where the feature occurs on a map of the heart.
VII. PRIOR ART
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ravuna et al 2021/0369174 shows an alternate method of locating the HIS bundle.
VIII. CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT L NASSER whose telephone number is (571)272-4731. The examiner can normally be reached M-F 8-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Kosowski can be reached at (571) 272-3744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT L NASSER/ Primary Examiner, Art Unit 3992