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 .
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 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.
Response to Amendment
Acknowledgement is made to the amendment received 5/21/2026.
Acknowledgement is made to the amendment of claims 1, 8, and 15.
Acknowledgement is made to the cancellation of claims 2, 5, 7, 9, 12, 14, 16, and 19.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1, 3-4, 6, 8, 10-11, 13, 15, 17-19, and 20 are pending. A complete action on the merits appears below.
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.
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.
Claims 1, 4, 6, 8, 11, 13, 15 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Werneth (US 20070083193 A1) in view of Maskara ’152 (US 20140180152 A1), Koblish (US 20190038349 A1) and Nieremberg (US 20140012151 A1).
Regarding claim 1, Werneth teaches a system ([0046]- [0047]) for visualizing multiple electrogram signals sensed by multiple electrodes of a multi-electrode catheter ([0088]- [0089], comprising:
one or more processors ([0125] teaches the interface unit as performing the function of signal processing); and
a non-transitory computer readable medium storing a plurality of instructions, which when executed, cause the one or more processors ([0110]- [0112]) to:
receive, from multiple electrodes of a multi-electrode catheter in a heart of a patient, respective signals indicative of a level of physical contact of each electrode with cardiac tissue ([0059] teaches information from sensors, such as strain gauge sensors which receive information indicative of the amount of contact between an electrode and tissue of the patient, as being carried from the sensors to the interface unit); and
present to a user, on a display, using a single screen ([0077], [0089] discusses the visual representation of the carrier assembly which displays the sensor information as being provided on a first visual display) of a graphical user interface (GUI):
the electrodes determined to be in contact with cardiac tissue using a first graphical feature ([0117] teaches the catheter as receiving electrical signals recorded from the tissue in contact with mapping elements, these mapping elements being the ablation elements, i.e. electrodes, of the catheter which additionally perform the function of cardiac mapping, and processing these signals to display ECG and other relevant signal information, [0089] teaches the signal information as being that of the electrode icons and the ECG information icons);
one or more real-time electrogram signals from the electrodes determined to be in contact with cardiac tissue plotted using a first line style ([0117] teaches the catheter as receiving electrical signals recorded from the tissue in contact with mapping elements, these mapping elements being the ablation elements, i.e. electrodes, of the catheter which additionally perform the function of cardiac mapping, and processing these signals to display ECG and other relevant signal information, [0089] teaches the signal information as being that of the electrode icons and the ECG information icons); and
performing ablation using one or more of the electrodes depicted using the first graphical feature ([0089] discusses two of the electrodes on the visual display as receiving ablation energy).
While Werneth does teach determining the amount of contact between an electrode and patient tissue ([0059]), Werneth does not specifically teach determining which of the multiple electrodes are in contact with cardiac tissue and which of the electrodes are not in contact with cardiac tissue based at least in part on the respective signals; and the electrodes being determined to be in contact with the cardiac tissue as using a first graphical feature and the electrodes determined not to be in contact with cardiac tissue using a second graphical feature different from the first graphical feature.
Maskara ’152 teaches a catheter system including a mapping catheter including a plurality of electrodes and a processor operatively coupled to the plurality of mapping electrodes and configured to receive the signals sensed by the mapping electrodes and output a contact of the plurality of mapping electrodes with the anatomical structure based on the signal characterization (Abstract).
Maskara ’152 further teaches the system having a display device configured to display a graphical representation of the contact of the electrodes to patient tissue, where the display presents the electrodes making good or poor contact which is based on a threshold signal value, where the electrodes making good contact are displayed with a first color and the electrodes making poor contact are displayed with a second color ([0055]) so as to aid the physician in manipulation of a distal tip of a catheter to the tissue to be ablated ([0003, [0036], [0039]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of a display which presents the different levels of contact between an electrode and tissue using different features, such as different colors, as is taught by Maskara ’152, into the system which displays electrode signals, such as signals based on electrode tissue contact, as is taught by Werneth, to produce the predictable result of aiding the physician in manipulation of a distal tip of a catheter to the tissue to be ablated, as is taught by Maskara ’152, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
While Maskara ’152 does teach the signal which indicates the contact of the electrodes as either having good or poor contact based on a voltage measurement where the good contact and poor contact is determined by a threshold ([0055]). Maskara ’152 does not specifically teach the good contact as being in contact with tissue and the poor contact as being not in contact with tissue.
Koblish teaches displaying a graphical representation of an electrode assembly and a level of contact between the electrode assembly and viable tissue, where the level of contact is determined by a measured voltage ([0005], [0019], [0741]- [0744]).
Koblish further teaches determining the level of contact using a threshold of a measured voltage to determine sufficient contact or inadequate contact, where if the voltage drops below a particular threshold the contact between the catheter and the tissue is determined to be inadequate and therefore the system can determine and indicate that there is “no contact” between the portion of the catheter and tissue ([0742]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the voltage threshold which determines the level of contact between an electrode and tissue as being a threshold which determines that there is contact or that there is no contact, as is taught by Koblish, into the system which shows the level of contact between an electrode and patient tissue as is taught by Maskara ’152, to produce the predictable result of using a known voltage threshold to conclude known determinations, as is taught by Koblish, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Werneth as modified does not teach the electrogram signal from electrodes determined to be in contact with cardiac tissue as being plotted using a first line style; and
one or more real-time electrogram signals from the electrodes determined not to be in contact with cardiac tissue plotted using a second line style different from the first line style.
However, Werneth as currently modified does teach visually distinguishing the signal data information (such as ECG and electrode signal information, as is taught by Werneth in [0077], [0089], [0117]) of each electrode based on the electrode tissue contact of the electrode which receives the signal data (as is taught by the incorporation of Maskara ’152 in [0055]).
Nierenberg teaches a method and system for displaying electrical activity of electrodes attached to a patient (Abstract). The electrical activity being displayed as individually plotted lines (Fig. 1; EEG report 100).
Nierenberg further teaches the first and second graphical features as being plotted with a first line style and a second line style which is distinctive from the first line style in order to allow a physician or technician to easily and visually distinguish between the two data sets ([0063]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of visually distinguishing signal data information, such as ECG signal data information, by providing the ECG signals to be distinguished with separate line styles, as is taught by Nieremberg, into the signal data, such as ECG signal data, which is to be visually distinguished based on electrode tissue contact as is taught by Werneth as currently modified, to produce the predictable result of easily and visually distinguishing between two sets of data, as is taught by Nieremberg, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 4, Werneth as currently modified teaches the system according to claim 1, wherein the plurality of instructions further cause the one or more processors to automatically update the presentation of the electrogram signals from the electrodes in contact with cardiac tissue based on determining a level of physical contact of each electrode with tissue ([0085], [0095], [0102]).
Regarding claim 6, Werneth as currently modified teaches the system according to claim 1, wherein the plurality of instructions further cause the one or more processors to present the multiple electrodes on a graphical illustration of the catheter ([0089]).
Regarding claims 8, 11, and 13, the recited methods are considered inherent in the ordinary use of the device as described by the Werneth as modified in claim 1, 4, and 6.
Regarding claim 15, 18, and 20, the recited computer-readable storage medium is taught by the current rejection of Werneth as modified in claim 1, 4, and 6.
Claims 3, 10, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Werneth (US 20070083193 A1) in view of Maskara ’152 (US 20140180152 A1), Koblish (US 20190038349 A1) and Nieremberg (US 20140012151 A1) further in view of Maskara ’629 (US 2014031629 A1).
Regarding claim 3, Werneth as modified teaches the system according to claim 1.
Maskara ’152 further teaches distinguishing the information from the electrodes which contact tissue from those which do not ([0017], [0035]- [0036]).
However, Werneth as modified fails to teach the system wherein the plurality of instructions further cause the one or more processors to visualize the electrogram signals from the electrodes determined not to be in contact with cardiac tissue by partially blanking the electrogram signals from the electrodes determined not to be in contact with cardiac tissue.
Maskara ’629 teaches a method and system for mapping anatomical structures by sensing activation signals of intrinsic physiological activity with a plurality of electrodes (Abstract). During this sensing of electrical activity, activation signals and ambient electrical activity away from the sensor may both be sensed ([0004]). In order to provide more accurate location information, a manner of filtering the activation signal from the ambient electrical activity, i.e. far-field activations, is provided ([0013]).
Maskara ’629 further teaches this filtering out of the non-active electrode signals from the active electrode signals by blanking the signals that are identified as non-active, specifically referred to as far-field activations ([0047]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teaching of blanking non-active signals, as is taught by Maskara ’629, into the system of Cohen, so as to provide a more accurate tissue therapy to the patient, as is taught by Maskara ’629.
Regarding claim 10, the recited methods are considered inherent in the ordinary use of the device as described by the Werneth as modified in claim 3.
Regarding claim 17, the recited computer-readable storage medium is taught by the current rejection of Werneth as modified in claim 3.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Cohen/Nieremberg reference are moot in view of the new rejections under Werneth/Maskara/Koblish and Nieremberg.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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