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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/10/2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 11/10/2025. As directed by the amendment: Claims 1-3 and 8-15 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-20 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 8-9, filed 11/10/2025, under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues on page 8 that “the claims improve the functioning of cardiac mapping systems. As explained in the specification, "in at least some known commercial cardiac mapping systems, a user defines a roving catheter and a reference catheter… The instant claims, on the other hand, recite methods and systems for computing LATs without the use of an RAI. For instance, claim 1 recites "identifying, using the cardiac mapping system, a corresponding roving cardiac activation of the detected roving cardiac activations that is closest in time to the most recent reference cardiac activation, the corresponding roving cardiac activation identified independent of any roving activation interval (RAI)[.]" The identified roving cardiac activation is used to compute the LAT.” Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application.
Applicant’s arguments, see pages 9-12, filed 11/10/2025, with respect to the rejection(s) the claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Amendments to the claims obviate the rejection of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gaeta (US 20190328258) (Hereinafter Gaeta) in view of Honicker (US 20190365262) (Hereinafter Honicker).
Claim Rejections - 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are 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.
Regarding claims 1, 8, and 15, although the instant specification may have support for not using an RAI for identifying a corresponding roving cardiac activation closest in time to the most recent reference cardiac activation, the RAI being an interval based on cardiac activity in the reference catheter, the instant specification still requires the use of an interval [observation window] for identifying the corresponding roving cardiac activation ([0055]-[0058]). The claim language is confusing because an observation window is still used for identifying a corresponding roving cardiac activation closest in time to the most recent reference cardiac activation, which is not the RAI, but the RAI is also an interval of time, similar to that of an observation window, for identifying a corresponding roving cardiac activation closest in time to the most recent reference cardiac activation. In other words, the RAI and observation window are both just a time frame, which is confusing as the claim does not require the use of time frames for identifying a corresponding roving cardiac activation closest in time to the most recent reference cardiac activation.
Regarding claims 1, 8, and 15, it is unclear how the trigger time is set independent from sensed cardiac activity because there is a reasonable expectation, based on repeated experimentation of obtained cardiac activity, that a trigger time of an event is to occur during an asynchronous time period of 100-1000 ms ([0054]). Knowing that cardiac depolarization, or any other trigger time, were to occur during this asynchronous interval, indirectly uses cardiac activity, for identifying the trigger time due to trial and error, and therefore, cannot be “independent from sensed cardiac activity”.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claims 1, 8, and 15 recites a step computing, using the computing system, a LAT as a time difference between the most recent reference cardiac activation and the corresponding roving cardiac activation, which is a mental process. This judicial exception is not integrated into a practical application because the generically recited computer elements (ie. a computing system), determining values, and computing LAT do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and computing LAT, which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d).
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 8 and 15 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 1 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1, 8 and 15, the following step is an abstract idea:
“computing, using the computing system, a LAT as a time difference between the most recent reference cardiac activation and the corresponding roving cardiac activation”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could determine a time difference between cardiac activation of the two electrograms of different catheters based on a user defined activation interval for one of the electrograms.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 1, 8, and 15, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a memory”, “a computing system”, and “a processor” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “reference and roving catheter” and “electrodes” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “electrogram”, “cardiac activations”, “trigger signal”, “roving activation interval”, “LAT” and “LAT map” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a memory”, “a computing system”, and “a processor” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “reference and roving catheter” and “electrodes” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “electrogram”, “cardiac activations”, “trigger signal”, “roving activation interval”, “LAT” and “LAT map” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
The additional elements of claims 1, 8 and 15, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, memory, processor, and computing system, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The “multi-electrode catheter” is claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure in the diagnostic art since Koyrakh et al. (US 20150057507) teaches multi-electrode catheters [generic data gathering structure] for obtaining EP signals ([0030]-[0033]).
Dependent claims 2-7, 9-14 and 16-20 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1 and 10. The dependent claim limitations are directed to data processing/extra-solution activity (claims 2-7, 9-14, and 16-20), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-20 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Interpretation
Regarding claims 1, 8, and 15, the phrase “the corresponding roving cardiac activation identified independent of any roving activation interval (RAI)” is interpreted to mean that the roving cardiac activation is not based on RAI, which RAI is related to sensed cardiac activity, but any nearby activation of an electrode. Furthermore, the trigger time is an interval of time for detecting an activation.
Claim Rejections - 35 USC § 103
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, 6, 8-9, 11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaeta (US 20190328258) (Hereinafter Gaeta) in view of Honicker (US 20190365262) (Hereinafter Honicker).
Regarding claim 1 and 8, Gaeta teaches A method/cardiac mapping system of generating a local activation time (LAT) map (Abstract “Systems and methods for quantifying cardiac electrophysiologic signals.” And Fig. 6A shows LAT mapping.), said method comprising:
receiving, at a cardiac mapping system, at least one reference electrogram ([0034] “where (as shown in FIG. 4) a, b, and c are the vectors connecting the three vertices (i.e. electrodes) of the triangle and where t.sub.a and t.sub.b are the differences in activation times at the location of the electrodes along edge a and b respectively.” Claim 13 “a controller configured to receive a unipolar electrogram signal from each of a plurality of electrodes, each electrode of the plurality of electrodes positioned at a different location of a heart, calculate a bipolar electrogram signal, the bipolar electrogram signal based on a difference between a unipolar electrogram signal for a first electrode of the plurality of electrodes and a unipolar electrogram signal for a second electrode of the plurality of electrodes”);
receiving, at the cardiac mapping system, at least one … electrogram ([0034] “where (as shown in FIG. 4) a, b, and c are the vectors connecting the three vertices (i.e. electrodes) of the triangle and where t.sub.a and t.sub.b are the differences in activation times at the location of the electrodes along edge a and b respectively.” Claim 13 “a controller configured to receive a unipolar electrogram signal from each of a plurality of electrodes, each electrode of the plurality of electrodes positioned at a different location of a heart, calculate a bipolar electrogram signal, the bipolar electrogram signal based on a difference between a unipolar electrogram signal for a first electrode of the plurality of electrodes and a unipolar electrogram signal for a second electrode of the plurality of electrodes”);
detecting, using the cardiac mapping system, reference cardiac activations in the at least one reference electrogram (Abstract “The LAT difference is indicative of an amount of time between a local activation of a propagating wavefront at the location of the first electrode and a local activation of the propagating wavefront at the location of the second electrode.”);
detecting, using the cardiac mapping system, roving cardiac activations in the at least one roving electrogram (Abstract “The LAT difference is indicative of an amount of time between a local activation of a propagating wavefront at the location of the first electrode and a local activation of the propagating wavefront at the location of the second electrode.”);
identifying, using the cardiac mapping system, …, a most recent reference cardiac activation … ([0033] “determining an absolute local activation time value for each electrode or pairs of electrodes while, in other implementations, the system determines a time delay indicative of a difference in the activation time between two specific electrodes as discussed in further detail below.”);
identifying, using the cardiac mapping system, a corresponding roving cardiac activation … that is closest in time to the most recent reference cardiac activation ([0033] “determining an absolute local activation time value for each electrode or pairs of electrodes while, in other implementations, the system determines a time delay indicative of a difference in the activation time between two specific electrodes as discussed in further detail below.”), the corresponding roving cardiac activation identified independent of any roving activation interval (RAI) (Examiner notes the corresponding roving cardiac activation is dependent on the most recent reference cardiac activation, which is not an RAI. In the instant case, Fig. 9A shows the 5 cardiograms, without a trigger signal or an RAI, with cardiac activations that are closest in time to one another.);
computing, using the cardiac mapping system, a LAT as a time difference between the most recent reference cardiac activation and the corresponding roving cardiac activation (Claim 13 “determine a local activation time difference between a location of the first electrode and a location of the second electrode based at least in part on a voltage amplitude of the bipolar electrogram signal, wherein the local activation time difference is an amount of time between a local activation of a propagating wavefront at the location of the first electrode and a local activation time of the propagating wavefront at the location of the second electrode.”);
and generating and displaying, using the cardiac mapping system, a LAT map based on the computed LAT (Fig. 6A shows LAT mapping. [0033] “determining an absolute local activation time value for each electrode or pairs of electrodes while, in other implementations, the system determines a time delay indicative of a difference in the activation time between two specific electrodes as discussed in further detail below.”).
However, Gaeta does not teach a roving cardiogram from an electrode found on a roving catheter and a reference electrogram from a reference catheter, both of which are communicatively coupled to the computer system. Honicker, in the same field of endeavor, teaches using electrodes on catheters for cardiac activation (Abstract), similar to the device of Gaeta, and further teaches receiving, at a cardiac mapping system, at least one reference electrogram from at least one reference catheter communicatively coupled to the computer system, the at least one reference electrogram recorded by at least one electrode on the at least one reference catheter ([0031] “FIG. 1, in some embodiments, an optional fixed reference electrode 31 (e.g., attached to a wall of the heart 10) is shown on a second catheter 29. For calibration purposes, this electrode 31 may be stationary (e.g., attached to or near the wall of the heart) or disposed in a fixed spatial relationship with the roving electrodes (e.g., electrodes 17), and thus may be referred to as a “navigational reference” or “local reference.” The fixed reference electrode 31 may be used in addition or alternatively to the surface reference electrode 21 described above.” See Fig. 1 where the reference and roving catheter are connected to the computer system.);
receiving, at the cardiac mapping system, at least one roving electrogram from at least one roving catheter communicatively coupled to the computer system, the at least one roving electrogram recorded by at least one electrode on the at least one roving catheter ([0044] “to define a reference signal from a roving electrode (e.g., 17, 52, 54, 56) on catheter 13 and to determine LATs relative to the reference signal” [0055] “FIG. 4B shows the corresponding electrograms 404a, 404b, 404c, and 404d measured by a roving catheter (e.g., catheter 13) at points a-d.”);
identifying, using the cardiac mapping system, at a trigger time … a most recent reference cardiac activation of the detected reference cardiac activations ([0017] “a hypothetical 220 ms cardiac activation wavefront [trigger time/interval].” Fig. 4 (404a));
identifying, using the cardiac mapping system, a corresponding roving cardiac activation of the detected roving cardiac activations that is closest in time to the most recent reference cardiac activation (See Fig. 4B with 2 different activation times between 404a (reference cardiac signal) and 404c-d. ([0057]-[0059])), the corresponding roving cardiac activation identified independent of any roving activation interval (RAI) (Examiner notes the corresponding roving cardiac activation is dependent on the most recent reference cardiac activation, based on the trigger signal. In the instant case, Fig. 4B shows the cardiograms with cardiac activations that are closest in time to one another. [0057]-[0060]) to consistently detect an area of interest in a stable way ([0042]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta, with roving cardiogram from an electrode found on a roving catheter and a reference electrogram from a reference catheter, both of which are communicatively coupled to the computer system of Honicker, because such a modification would allow to consistently detect an area of interest in a stable way.
However, Gaeta in view of Honicker do not teach the trigger signal being independent from cardiac activity. Nevertheless, it is known in the art that a cycle length between cycles can vary in 220 ms, in which an activation may occur in that timeframe/interval [trigger signal] (Honicker [0047],[0051], and Fig. 4), thereby obvious to optimize a timeframe, by a user’s choice, to pick the interval. It would have been obvious to one having ordinary skill in the art at the time the invention was made to trigger signal being independent from cardiac activity, for the purpose of allowing a user to select the activation (Honicker [0047]), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 2 and 9, claims 1 and 8 are obvious over Gaeta and Honicker. However, Gaeta does not teach a identifying the most recent reference cardiac activation comprises identifying the most recent reference cardiac activation that occurs at least a predetermined period of time before the current end of the at least one reference electrogram. Honicker, in the same field of endeavor, teaches using electrodes on catheters for cardiac activation (Abstract), similar to the device of Gaeta, and further teaches wherein identifying the most recent reference cardiac activation comprises identifying the most recent reference cardiac activation that occurs at least a predetermined period of time before the current end of the at least one reference electrogram (See Fig. 4B with 2 different activation times between 404a (reference cardiac signal) and 404c-d. ([0057]-[0059]). [005] “The interval between deflections of like type, however, is still about 220 ms.”) to consistently detect an area of interest in a stable way ([0042]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta, with identifying the most recent reference cardiac activation comprises identifying the most recent reference cardiac activation that occurs at least a predetermined period of time before the current end of the at least one reference electrogram of Honicker, because such a modification would allow to consistently detect an area of interest in a stable way.
Regarding claims 4 and 11, Gaeta teaches wherein detecting reference and roving cardiac activations comprises detecting reference and roving cardiac activations based on neighboring electrograms ([0032] “relative activation times might be determined by comparing electrogram data from different electrodes or pairs of electrodes in each individual “triangle” combination [neighboring electrograms].”).
Regarding claims 6 and 13, claims 1 and 8 are obvious over Gaeta and Honicker. However, Gaeta does not teach the trigger time occurs repeatedly at an asynchronous interval. Honicker, in the same field of endeavor, teaches using electrodes on catheters for cardiac activation (Abstract), similar to the device of Gaeta, and further teaches wherein the trigger time occurs repeatedly at an asynchronous interval (See Fig. 4B with 2 different activation times between 404a (reference cardiac signal) and 404c-d. ([0057]-[0059]). [005] “The interval between deflections of like type, however, is still about 220 ms.”) to consistently detect an area of interest in a stable way ([0042]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta, with the trigger time occurs repeatedly at an asynchronous interval of Honicker, because such a modification would allow to consistently detect an area of interest in a stable way.
Claim(s) 3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaeta (US 20190328258) (Hereinafter Gaeta) in view of Honicker (US 20190365262) (Hereinafter Honicker), and Brodnick et al. (US 20140288451) (Hereinafter Brodnick).
Regarding claims 3 and 10, claims 1 and 8 are obvious over Gaeta, Han, and Honicker. However, Gaeta does not teach comparing LAT to CL and flagging LAT for an invalid LAT when LAT is greater than CL. Brodnick, in the same field of endeavor, teaches determining LAT from activation time and mapping the channels (Abstract), and further teaches further comprising:
comparing, using the cardiac mapping system, the computed LAT to a cardiac cycle length ([0087] “A local activation time map is related to a particular rhythm so that if there is too great a change in cycle length [comparing computed LAT to CL], the EP doctor may choose to start a new map, or in fact may determine that mapping is no longer appropriate at such time.”); and
flagging, using the cardiac mapping system, the computed LAT as an invalid LAT when the computed LAT is greater than the cardiac cycle length ([0087] “A local activation time map is related to a particular rhythm so that if there is too great a change in cycle length, the EP doctor may choose to start a new map, or in fact may determine that mapping is no longer appropriate at such time. A value for the percentage change which triggers an alert [flag] in method step 20 may be that the current reference-channel cycle length (determined in method step 16) is found to differ from the starting cycle length by more than 10%.”) to warn the EP doctor ([0087]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta, with comparing LAT to CL and flagging LAT for an invalid LAT when LAT is greater than CL of Brodnick, because such a modification would allow to warn the EP doctor.
Claim(s) 5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaeta (US 20190328258) (Hereinafter Gaeta) in view of Honicker (US 20190365262) (Hereinafter Honicker), and Han et al. (US 20190350477) (Hereinafter Han2).
Regarding claims 5 and 12, claims 1 and 8 are obvious over Gaeta, Han, and Honicker. However, Gaeta does not teach a cardiac activations based on consistent CL and CV. Han2, in the same field of endeavor, teaches detecting cardiac activations via electrodes for detection time points (Abstract), and further teaches wherein detecting reference and roving cardiac activations comprises detecting reference and roving cardiac activations based on consistent cycle length and conduction velocity ([0008] “a regular cycle length is computed from a group of FDTPs having the most consistent, i.e., regular, deflections or cardiac activations within a given observation window (OW). Similarly, for example, a conduction velocity (CV) is computed from a group of FDTPs having similar CV.” Examiner also notes that [0042] discloses that Han2 teaches the instant limitation.) to provide accurate detection of cardiac activation times based on consistent deflection characteristics ([0008]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta, with cardiac activations based on consistent CL and CV of Han2, because such a modification would allow to provide accurate detection of cardiac activation times based on consistent deflection characteristics.
Claim(s) 7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaeta (US 20190328258) (Hereinafter Gaeta) in view of Honicker (US 20190365262) (Hereinafter Honicker), and Brodnick et al. (US 8768440) (Hereinafter Brodnick2).
Regarding claims 7 and 14, claims 1 and 8 are obvious over Gaeta and Honicker. However, Gaeta does not teach the observation window having a predefined segment length including a first and second interval of time before and after the trigger signal. Brodnick2, in the same field of endeavor, teaches determining LAT from activation time and mapping the channels (Abstract), and further teaches wherein detecting reference and roving cardiac activations comprises detecting reference and roving cardiac activations within an observation window having a predefined segment length, the observation window including a first interval of time before the trigger time and a second interval of time after the trigger time (Col. 7 lines 45-53 “determining the ventricular-channel activations includes the steps of subdividing the first preset time window [observation window] into three equal-length periods of time, determining the signal maximum in each of the three periods of time, setting the threshold to a fixed threshold-percentage of the minimum of the three signal maxima, and identifying ventricular-channel activation times at threshold-crossing times at which a threshold-crossing is preceded by at least a fixed below-threshold period.” See Fig. 4A and 4B where activation/trigger within the one of the 3 intervals of time 76, seen in preset time window 75. Examiner notes that when the trigger signal/activation occurs in the middle interval of time at 2.25 seconds of Fig. 4B, the second interval of time after the trigger signal is the following interval of time within the observation window.) to identify activation times within the period of time (Col. 7 lines 45-53). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta, with observation window having a predefined segment length including a first and second interval of time before and after the trigger signal of Brodnick2, because such a modification would allow to identify activation times within the period of time.
Claim(s) 15-16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaeta (US 20190328258) (Hereinafter Gaeta) in view of Gaeta (citations from US 20200352465)(Hereinafter Gaeta2), and Honicker (US 20190365262) (Hereinafter Honicker).
Regarding claim 15, Gaeta teaches A method/computing system of generating a local activation time (LAT) map (Abstract “Systems and methods for quantifying cardiac electrophysiologic signals.” And Fig. 6A shows LAT mapping.), said method comprising:
receiving, at a computing system, at least one reference electrogram ([0034] “where (as shown in FIG. 4) a, b, and c are the vectors connecting the three vertices (i.e. electrodes) of the triangle and where t.sub.a and t.sub.b are the differences in activation times at the location of the electrodes along edge a and b respectively.” Claim 13 “a controller configured to receive a unipolar electrogram signal from each of a plurality of electrodes, each electrode of the plurality of electrodes positioned at a different location of a heart, calculate a bipolar electrogram signal, the bipolar electrogram signal based on a difference between a unipolar electrogram signal for a first electrode of the plurality of electrodes and a unipolar electrogram signal for a second electrode of the plurality of electrodes”);
receiving, at the computing system, at least one … electrogram ([0034] “where (as shown in FIG. 4) a, b, and c are the vectors connecting the three vertices (i.e. electrodes) of the triangle and where t.sub.a and t.sub.b are the differences in activation times at the location of the electrodes along edge a and b respectively.” Claim 13 “a controller configured to receive a unipolar electrogram signal from each of a plurality of electrodes, each electrode of the plurality of electrodes positioned at a different location of a heart, calculate a bipolar electrogram signal, the bipolar electrogram signal based on a difference between a unipolar electrogram signal for a first electrode of the plurality of electrodes and a unipolar electrogram signal for a second electrode of the plurality of electrodes”);
detecting, using the computing system, reference cardiac activations in the at least one reference electrogram (Abstract “The LAT difference is indicative of an amount of time between a local activation of a propagating wavefront at the location of the first electrode and a local activation of the propagating wavefront at the location of the second electrode.”);
detecting, using the computing system, roving cardiac activations in the at least one roving electrogram (Abstract “The LAT difference is indicative of an amount of time between a local activation of a propagating wavefront at the location of the first electrode and a local activation of the propagating wavefront at the location of the second electrode.”);
identifying, using the computing system, …, a most recent reference cardiac activation … ([0033] “determining an absolute local activation time value for each electrode or pairs of electrodes while, in other implementations, the system determines a time delay indicative of a difference in the activation time between two specific electrodes as discussed in further detail below.”);
identifying, using the computing system, a corresponding roving cardiac activation … that is closest in time to the most recent reference cardiac activation ([0033] “determining an absolute local activation time value for each electrode or pairs of electrodes while, in other implementations, the system determines a time delay indicative of a difference in the activation time between two specific electrodes as discussed in further detail below.”), the corresponding roving cardiac activation identified independent of any roving activation interval (RAI) (Examiner notes the corresponding roving cardiac activation is dependent on the most recent reference cardiac activation, based on the trigger signal. In the instant case, Fig. 9A shows the 5 cardiograms, without a rigger signal o an RAI, with cardiac activations that are closest in time to one another.);
computing, using the computing system, a LAT as a time difference between the most recent reference cardiac activation and the corresponding roving cardiac activation (Claim 13 “determine a local activation time difference between a location of the first electrode and a location of the second electrode based at least in part on a voltage amplitude of the bipolar electrogram signal, wherein the local activation time difference is an amount of time between a local activation of a propagating wavefront at the location of the first electrode and a local activation time of the propagating wavefront at the location of the second electrode.”);
and generating and displaying, using the computing system, a LAT map based on the computed LAT (Fig. 6A shows LAT mapping. [0033] “determining an absolute local activation time value for each electrode or pairs of electrodes while, in other implementations, the system determines a time delay indicative of a difference in the activation time between two specific electrodes as discussed in further detail below.”).
However, Gaeta in view of Han does not teach two separate catheters with their own electrodes for comparing cardiograms for LAT. Gaeta2, in the same field of endeavor, teaches dynamically selecting electrodes for recording electrograms (Abstact), and further teaches two separate catheters with their own electrodes for comparing cardiograms for LAT ([0006] “the optimal electrode pairs (for example, two electrodes on a multielectrode catheter and/or electrodes on two different catheters) are dynamically assigned for use together in bipolar EGM calculations” [0012] “FIG. 1 for selecting an electrode pair for bipolar electrogram recording based on local activation time.”) to avoid unrelated and noisy signals ([0030]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta, with two separate catheters with their own electrodes for comparing cardiograms for LAT of Gaeta2, because such a modification would allow to avoid unrelated and noisy signals.
However, Gaeta does not teach a roving cardiogram from an electrode found on a roving catheter and a reference electrogram from a reference catheter, both of which are communicatively coupled to the computer system. Honicker, in the same field of endeavor, teaches using electrodes on catheters for cardiac activation (Abstract), similar to the device of Gaeta, and further teaches receiving, at a cardiac mapping system, at least one reference electrogram from at least one reference catheter communicatively coupled to the computer system, the at least one reference electrogram recorded by at least one electrode on the at least one reference catheter ([0031] “FIG. 1, in some embodiments, an optional fixed reference electrode 31 (e.g., attached to a wall of the heart 10) is shown on a second catheter 29. For calibration purposes, this electrode 31 may be stationary (e.g., attached to or near the wall of the heart) or disposed in a fixed spatial relationship with the roving electrodes (e.g., electrodes 17), and thus may be referred to as a “navigational reference” or “local reference.” The fixed reference electrode 31 may be used in addition or alternatively to the surface reference electrode 21 described above.” See Fig. 1 where the reference and roving catheter are connected to the computer system.);
receiving, at the cardiac mapping system, at least one roving electrogram from at least one roving catheter communicatively coupled to the computer system, the at least one roving electrogram recorded by at least one electrode on the at least one roving catheter ([0044] “to define a reference signal from a roving electrode (e.g., 17, 52, 54, 56) on catheter 13 and to determine LATs relative to the reference signal” [0055] “FIG. 4B shows the corresponding electrograms 404a, 404b, 404c, and 404d measured by a roving catheter (e.g., catheter 13) at points a-d.”);
identifying, using the cardiac mapping system, at a trigger time … a most recent reference cardiac activation of the detected reference cardiac activations ([0017] “a hypothetical 220 ms cardiac activation wavefront [trigger time/interval].” Fig. 4 (404a));
identifying, using the cardiac mapping system, a corresponding roving cardiac activation of the detected roving cardiac activations that is closest in time to the most recent reference cardiac activation (See Fig. 4B with 2 different activation times between 404a (reference cardiac signal) and 404c-d. ([0057]-[0059])), the corresponding roving cardiac activation identified independent of any roving activation interval (RAI) (Examiner notes the corresponding roving cardiac activation is dependent on the most recent reference cardiac activation, based on the trigger signal. In the instant case, Fig. 4B shows the cardiograms with cardiac activations that are closest in time to one another. [0057]-[0060]) to consistently detect an area of interest in a stable way ([0042]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta, with roving cardiogram from an electrode found on a roving catheter and a reference electrogram from a reference catheter, both of which are communicatively coupled to the computer system of Honicker, because such a modification would allow to consistently detect an area of interest in a stable way.
However, Gaeta in view of Honicker do not teach the trigger signal being independent from cardiac activity. Nevertheless, it is known in the art that a cycle length between cycles can vary in 220 ms, in which an activation may occur in that timeframe/interval [trigger signal] (Honicker [0047],[0051], and Fig. 4), thereby obvious to optimize a timeframe, by a user’s choice, to pick the interval. It would have been obvious to one having ordinary skill in the art at the time the invention was made to trigger signal being independent from cardiac activity, for the purpose of allowing a user to select the activation (Honicker [0047]), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 16, claims 1 and 8 are obvious over Gaeta, Gaeta2, and Honicker. However, Gaeta does not teach a identifying the most recent reference cardiac activation comprises identifying the most recent reference cardiac activation that occurs at least a predetermined period of time before the current end of the at least one reference electrogram. Honicker, in the same field of endeavor, teaches using electrodes on catheters for cardiac activation (Abstract), similar to the device of Gaeta, and further teaches wherein identifying the most recent reference cardiac activation comprises identifying the most recent reference cardiac activation that occurs at least a predetermined period of time before the current end of the at least one reference electrogram (See Fig. 4B with 2 different activation times between 404a (reference cardiac signal) and 404c-d. ([0057]-[0059]). [005] “The interval between deflections of like type, however, is still about 220 ms.”) to consistently detect an area of interest in a stable way ([0042]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta in view of Gaeta2, with identifying the most recent reference cardiac activation comprises identifying the most recent reference cardiac activation that occurs at least a predetermined period of time before the current end of the at least one reference electrogram of Honicker, because such a modification would allow to consistently detect an area of interest in a stable way.
Regarding claim 18, Gaeta teaches wherein detecting reference and roving cardiac activations comprises detecting reference and roving cardiac activations based on neighboring electrograms ([0032] “relative activation times might be determined by comparing electrogram data from different electrodes or pairs of electrodes in each individual “triangle” combination [neighboring electrograms].”).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaeta (US 20190328258) (Hereinafter Gaeta) in view of Gaeta (citations from US 20200352465)(Hereinafter Gaeta2), Honicker (US 20190365262) (Hereinafter Honicker), and Brodnick et al. (US 20140288451) (Hereinafter Brodnick).
Regarding claim 17, claim 15 are obvious over Gaeta, Gaeta2, and Honicker. However, Gaeta does not teach comparing LAT to CL and flagging LAT for an invalid LAT when LAT is greater than CL. Brodnick, in the same field of endeavor, teaches determining LAT from activation time and mapping the channels (Abstract), and further teaches further comprising:
comparing, using the computing system, the computed LAT to a cardiac cycle length ([0087] “A local activation time map is related to a particular rhythm so that if there is too great a change in cycle length [comparing computed LAT to CL], the EP doctor may choose to start a new map, or in fact may determine that mapping is no longer appropriate at such time.”); and
flagging, using the computing system, the computed LAT as an invalid LAT when the computed LAT is greater than the cardiac cycle length ([0087] “A local activation time map is related to a particular rhythm so that if there is too great a change in cycle length, the EP doctor may choose to start a new map, or in fact may determine that mapping is no longer appropriate at such time. A value for the percentage change which triggers an alert [flag] in method step 20 may be that the current reference-channel cycle length (determined in method step 16) is found to differ from the starting cycle length by more than 10%.”) to warn the EP doctor ([0087]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta, with comparing LAT to CL and flagging LAT for an invalid LAT when LAT is greater than CL of Brodnick, because such a modification would allow to warn the EP doctor.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaeta (US 20190328258) (Hereinafter Gaeta) in view of Gaeta (citations from US 20200352465)(Hereinafter Gaeta2), Honicker (US 20190365262) (Hereinafter Honicker), and Han et al. (US 20190350477) (Hereinafter Han2).
Regarding claim 19, claim 15 is obvious over Gaeta, Gaeta2, and Honicker. However, Gaeta does not teach a cardiac activations based on consistent CL and CV. Han2, in the same field of endeavor, teaches detecting cardiac activations via electrodes for detection time points (Abstract), and further teaches wherein detecting reference and roving cardiac activations comprises detecting reference and roving cardiac activations based on consistent cycle length and conduction velocity ([0008] “a regular cycle length is computed from a group of FDTPs having the most consistent, i.e., regular, deflections or cardiac activations within a given observation window (OW). Similarly, for example, a conduction velocity (CV) is computed from a group of FDTPs having similar CV.” Examiner also notes that [0042] discloses that Han2 teaches the instant limitation.) to provide accurate detection of cardiac activation times based on consistent deflection characteristics ([0008]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta, with cardiac activations based on consistent CL and CV of Han2, because such a modification would allow to provide accurate detection of cardiac activation times based on consistent deflection characteristics.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaeta (US 20190328258) (Hereinafter Gaeta) in view of Gaeta (citations from US 20200352465)(Hereinafter Gaeta2), Honicker (US 20190365262) (Hereinafter Honicker), and Brodnick et al. (US 8768440) (Hereinafter Brodnick2).
Regarding claim 20, claim 15 are obvious over Gaeta, Gaeta2, and Honicker. However, Gaeta does not teach the observation window having a predefined segment length including a first and second interval of time before and after the trigger signal. Brodnick2, in the same field of endeavor, teaches determining LAT from activation time and mapping the channels (Abstract), and further teaches wherein detecting reference and roving cardiac activations comprises detecting reference and roving cardiac activations within an observation window having a predefined segment length, the observation window including a first interval of time before the trigger time and a second interval of time after the trigger time (Col. 7 lines 45-53 “determining the ventricular-channel activations includes the steps of subdividing the first preset time window [observation window] into three equal-length periods of time, determining the signal maximum in each of the three periods of time, setting the threshold to a fixed threshold-percentage of the minimum of the three signal maxima, and identifying ventricular-channel activation times at threshold-crossing times at which a threshold-crossing is preceded by at least a fixed below-threshold period.” See Fig. 4A and 4B where activation/trigger within the one of the 3 intervals of time 76, seen in preset time window 75. Examiner notes that when the trigger signal/activation occurs in the middle interval of time at 2.25 seconds of Fig. 4B, the second interval of time after the trigger signal is the following interval of time within the observation window.) to identify activation times within the period of time (Col. 7 lines 45-53). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the invention of Gaeta, with observation window having a predefined segment length including a first and second interval of time before and after the trigger signal of Brodnick2, because such a modification would allow to identify activation times within the period of time.
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796