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 .
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 1-21 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) the mentally performable step of monitoring the signal waveform to detect a change in a negative component of a unipolar electrogram signal.
This judicial exception is not integrated into a practical application because there are no improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a), because the catheter and display function in their usual capacity of collecting and indicating information; there is no application or use of a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition, but only monitoring and display – see Vanda Memo; there is no application of the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b), but only generic catheter, processor and display elements; there is no transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c), but only data collection, data monitoring and data displaying; and there is no application or use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the particular technological environment of electrogram signals, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the act of receiving a unipolar electrogram from a catheter is considered insignificant data gathering that would be required in any method of processing electrogram data. The processor is generic and functions in its usual capacity. A processor would be necessary in any computer implemented system. The act of displaying the collected data on a digital display using an attribute is also insignificant because such a display would be required in order to perform the abstract idea and signal changes in the unipolar electrogram. Signaling the change represents insignificant data outputting. Again, any method would require such signaling in order to provide a human perceivable output.
The individual additional elements and their combination is also WURC in the art. The applicant discloses that the one or more processors may include well-known machines such as CPUs and GPUs (pars. 0093 and 0094). Generic catheters, displays/monitors, memories and various interface devices may be employed as is standard in the art of cardiac monitoring (pars. 0023, 0095+). The combination of such structure forms the basic building blocks of any cardiac monitoring system.
Regarding claims 2-4, the act of displaying determined information such as by using a second attribute (e.g., including colors) or an annotation, is insignificant and only nominally related to the invention as a means to differentiate changes in the waveform. Using different colors or annotating the waveforms to distinguish abnormalities from normal rhythms is also WURC in the electrogram monitoring art. Related comments apply to patentably indistinct apparatus claims 13-15.
Regarding the use of a counter in claim 5, such an element would be required in any method/system performing the recited abstract idea of determining whether the unipolar electrogram has a negative component, updating the count when a negative component is not detected, and comparing the count to at the at least threshold number of consecutive cycles. The counter is merely the tool upon which the mentally performable aspect of counting is performed. The same comments apply to related apparatus claim 16.
Claims 6, 7, 9, 17 and 18 contain no new additional elements.
Regarding claim 8, redisplaying, or refreshing, a display to account for changing conditions represents insignificant extra-solution activity that would be required in any system attempting to display real-time data. Such an action is also WURC in the art.
Regarding claim 10, the display of clean electrogram signals using different filtering settings represents insignificant extra-solution activity involving routine signal processing to eliminate noise and other spurious signals that may negatively affect interpretation of the waveform, and allows highlighting of various frequencies of importance. Filtering of signals at different settings to highlight various aspects of the waveform and/or eliminate noise to create a clean signal is WURC in the signal processing arts.
Regarding claim 11, the display of an indication of change at a location of a digital representation of the patient’s heart is considered insignificant extra-solution activity as the limitation amounts to necessary data outputting as it would be required in any electro-anatomical mapping system in order to apprise the physician performing the ablation of the progress of the ablation procedure, as well as ensuring that the appropriate regions are targeted. The display of such indications using a digital representation of the patient’s heart is also WURC in the art of cardiac electrical signal monitoring, ablation therapy and mapping.
Regarding claim 12, note the comments made above. The additional element of the memory is insignificant as such an element would be required in any computer implemented invention. The use of memory is also WURC in the art (see also pars. 0096-0099).
Regarding claim 21, note the comments made above for patentably indistinct claims 1 and 12.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1, 2, 4-9, 12, 13 and 15-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (Pub. No. 2021/0093375).
Regarding claim 1, Chu discloses a method for therapeutic signaling, the method comprising: receiving, by at least one processor (par. 0088), a unipolar electrogram signal from a catheter (pars. 0018, 0056); displaying, on at least one digital display, a signal waveform based on the unipolar electrogram signal using a first attribute (percentage of similarity with a signal profile; par. 0070; Figs. 5a-5d), wherein the signal waveform represents one or more cycles from a patient's heart; monitoring, by the at least one processor, the signal waveform to detect a change in a negative component of the unipolar electrogram signal (Fig. 9: “All negative portions disappeared?”; par. 0081); and signaling the change on the at least one digital display when the change is detected (pars. 0023, 0050, 0052, 0065).
While Chu does not explicitly state that the change is signaled on the display when the change is detected in at least a threshold number of consecutive cycles, such a feature would have been considered a matter of obvious design by those of ordinary skill in the art. Chu discloses that a predetermined limited time may be used -- the added time ensuring proper ablation and limiting the possibility of reversible damage, with the time being limited to prevent excessive ablation (pars. 0011, 0022, 0080). Whether one wishes to set a predetermined time or limit the time to a predetermined number of consecutive cycles would have been a matter of obvious design since both techniques allow for control of the requisite short delay. Further supporting this position, the applicant discloses that the threshold period may represent a predetermined delay period that can be set to any desired value by the physician (par. 0073).
Regarding claims 2 and 13, the examiner considers the real time display of different percentages of similarity or dissimilarity (see Figs. 5a-5d) to represent different attributes in the same way the applicant considers different colors to represent different attributes, where, for example, a different color indicates the presence or absence of a negative component in the same manner that a percentage under or over the set percentage threshold might indicate the presence or absence of a negative component.
Regarding claims 4 and 15, the change in the signal waveform is displayed (via display 150) to the physician in the form of a percentage annotation (see Figs. 5a-5d; pars. 0012, 0023, 0078-0080).
Regarding claims 5 and 16, note the comments made above regarding the obviousness of using a threshold number of consecutive cycles in the process. Chu discloses comparison to a baseline in order to determine whether the unipolar electrogram has negative components (see pars. 0009, 0058; Figs. 5a-5d, 8 and 9). The requirement that there be at least three consecutive cycles without a negative component has the same effect as Chu’s requirement that the percentage indicating complete ablation be present for a delay period of time considered sufficient to ensure success. As argued above, whether one uses consecutive cycles or predetermined delay times is a matter of obvious design. Again, the applicant discloses that a predetermined delay time may be used as well.
Regarding claims 6 and 17, the baseline of Chu is dynamically determined based on one or more cycles received by the catheter (see Fig. 8, pars. 0058-0060).
Regarding claims 7 and 18, note the comments made above in the rejection of limitations pertaining to the use of a threshold number of consecutive cycles. Given that Chu discloses that the delay may be variable and range by way of example from 1-10 seconds (par. 0011), and given that three cycles of the electrogram waveform would for all intensive purposes fall within this range, the use of a three cycle threshold would have been considered a matter of obvious design based on the prerogatives of the physician and the patient under treatment.
Regarding claims 8 and 19, real-time operation and display of information concerning the degree of the waveform similarity and the waveform comparison result would necessarily involve redisplay/refresh (see par. 0053) using the first attribute in order to indicate the presence of any negative component as they occur.
Regarding claims 9 and 20, see pars. 0011, 0022 and 0080.
Regarding apparatus claim 12, note the comments made for the patentably indistinct limitations of claim 1. Regarding the use of memory, see par. 0042.
Regarding patentably indistinct claim 21, note the comments made above in the rejection of claims 1 and 12.
Claim(s) 2, 3, 11, 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. as applied to claims 1, 2, 4-9, 12, 13 and 15-21 above, and further in view of Donaldson (Pub. No. 2007/0049827).
While the examiner considers the Chu reference to broadly disclose the limitations of claim 2 and 13 as discussed above, out of an abundance of caution, these claims are additionally rejected in view of Donaldson who teaches that feedback of ablation efficiency may be indicated by color attributes, where, as in present claim 3, different colors may be used to indicate the various efficiencies or inefficiencies (par. 0018).
Regarding claim 11, Chu does not discuss indication of change at a location of a digital representation of the patient’s heart, wherein the indication indicates that a therapy at the location is successfully completed. Donaldson, however, discloses a related method wherein it is taught that colors indicating ablation effectiveness can be displayed over an ultrasound image of the heart or overlayed onto a map created by a 3-D mapping system (pars. 0005, 0008, 0018). Such a feature allows the physician to clearly see the progress of the ablation therapy and ensures that all appropriate areas for ablation have been addressed. To utilize such a feature in the method of Chu would have therefore been considered a matter of obvious design by those of ordinary skill in the art.
The rejection of claims 13 and 14 parallel the rejection of claims 2 and 3.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. as applied to claims 1, 2, 4-9, 12, 13 and 15-21 above, and further in view of Schmidt et al. (Pub. No. 2023/0255684).
Regarding claim 10, filtering of signal waveforms to provide clean signals in the medical arts is well-known and an absolute necessity in order to prevent spurious signals and/or noise from negatively affecting operation. Chu discloses that filtering may be used to process the electrogram signals (par. 0055). The waveforms displayed in real-time reflect the filtering/change in each cycle. Chu does not explicitly discuss the use of different filtering settings.
Schmidt discloses a related method and system for ablation lesion evaluation wherein it is taught that frequency analysis of various different frequency bands in the iEGM signals may be useful (pars. 0045-0047, 0052, 0070, 0072, etc.) with an indication of the electrical properties of the bioelectrical signals, e.g., an iEGM being indicated (Figs. 4, 5; par. 0062) as would be old and well-known in the art, with the particular information displayed being a matter of obvious design based on physician preference, experience and need.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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, David E. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
September 6, 2025