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 (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
The information disclosure statement (IDS) submitted on 12/31/2025 was filed after the mailing date of the Non-Final Office Action on 07/21/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Claims 2, 8, and 12 are amended. Claims 2-9, 11-13, and 15-18 are pending herein, with claims 2, 8, and 12 being the only independent claims.
Response to Arguments
Applicant’s arguments, see Remarks, filed 11/19/2025, with respect to the rejection of claims 8-11 under 35 U.S.C. 103 as being unpatentable over Swanson (US Patent No. 6,023,638) have been fully considered and are persuasive. Swanson does not teach the amended claimed limitation “wherein each spline extends from different location along a cardiac catheter”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of de la Rama (US Patent No. 6,029,091).
Applicant’s arguments, see Remarks, filed 11/19/2025, with respect to the rejection of claims 2, 4-7, 12-13, and 15-16 as rejected under 101 as being directed to an abstract idea and mental process without significantly more has been fully considered and are persuasive. The amendments made to these claims overcome the 101 rejection. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Bencini (U.S. Patent Publication US 2009/0299355).
Priority
Currently, the herein application is a continuation (CON) of U.S. Patent No. 12,036,026, filed 02/08/2021, before the issuance of its parent application, U.S. Patent No. 10,912,476 on 02/09/2021. U.S. Patent No. 10,912,476 is a continuation in part (CIP) of U.S. Patent No. 9,706,935, which was filed 12/05/2016, before the issuance of U.S. Patent No. 9,706,935 (07/18/2017). U.S. Patent No. 9,706,935 was filed 03/15/2013. The subject matter of the instant application is seen in the specification and claims of the CON and CIP applications, and therefore, the instant application is being granted an effective filing date of 03/15/2013.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-7, 12-13, 15, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Bencini (U.S. Patent Publication US 2009/0299355).
Regarding claims 2 and 12, Bencini teaches “placing an electrode in proximity to a cardiac ablation” in the abstract, which states “… (c) ablating the body tissue… (d) employing electrodes to determine whether the ablating caused desired electrical changes in the body tissue”, where it is understood that the body tissue could be cardiac tissue (p.[0004], “Another method of ablating tissue of the heart”), and the electrodes would inherently be deployed to the tissue that was ablated in order to determine electrical changes therein. Bencini teaches “stimulating the electrode” in p.[0011], which states “some electrodes can also be used to stimulate body tissue”. Bencini does not explicitly teach “measuring tissue activation time” verbatim, however, describes the process of determining how quickly cells or tissue respond to stimulus (such as biopotential values, electrical characteristics, electrical activity) in p.[0008, 0056, 0057, 0077, 0083] and claim 11. Bencini does not explicitly teach that the measuring of tissue activation timing can be used for conduction blocks, however, does recognize conduction blocks can be measured in p.[0006], and further, that by confirming the status of the tissue, additional treatments can be made based on the data received.
It is the Examiner’s position that while Bencini does not explicitly teach “measuring tissue activation timing using one or more additional electrodes in proximity to the cardiac ablation to determine extent of a conduction block across the cardiac ablation; and performing supplementary ablation based on the extent of the conduction block”, Bencini’s system is capable of performing such a function. Bencini’s invention describes that electrodes can be used to determine the electrical characteristics of the tissue before and after ablation, which would in turn allow for the user to determine if a conduction block had occurred (Abstract, p.[0004, 0006, 0058-0062]). Bencini generically recites that the electrical characteristics and activity of the tissue could be determined, which under broadest reasonable interpretation, would encompass a conduction block, given that a conduction block is a type of electrical characteristic the tissue would display/have. Bencini further describes that additional treatment can occur based on the status of the electrical characteristics of the tissue (p.[0082], Figure 14), once more, generically teaching the limitation “performing supplementary ablation based on the extent of the conduction block”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Bencini’s system to arrive at the claimed invention. As stated in Bencini (p.[0032]), it is known to be advantageous in the art to measure tissue before and after ablation procedures to determine if the desired outcome has been achieved (i.e., if the induced electrical characteristics are in line with the goal of the procedure, including electrical characteristics such as a conduction block), and such a system produces predictable results.
Regarding claim 12 specifically, claim 12 recites the same method as above, additionally including an ablation electrode and recording electrode. It is the Examiner’s position that since the electrodes of Bencini can both record and stimulate, any two arbitrary electrodes could be chosen as a recording and ablation pair and therefore teaches the limitation as described. Bencini further teaches storing and recording the electrical signals in p.[0032, 0058, 0062] and Figures 5A-D. Bencini does not explicitly teach the use of a cardiac tissue representation, but does teach in p.[0033] that the signal processor can be configured to produce a representation of the signals in a user interface. It is the Examiner’s position that a cardiac tissue representation would fall under a type of graphical representation of signals, and moreover, that it would have been readily understood to one of ordinary skill in the art to use a cardiac tissue representation although not explicitly stated. Bencini’s invention is focused on the mapping of electrical characteristics of tissue, and it is known in the art to use cardiac tissue representations for mapping cardiac tissue electrical characteristics. Further, the use of cardiac tissue representations does not provide any novel or nonobvious results that would be outside of the disclosure of Bencini. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a cardiac tissue representation. Bencini already contemplates the use of graphical representation of signals, which a cardiac tissue representation may fall under considering broadest reasonable interpretation.
Regarding claims 3 and 13, the limitations of claim 2 and 12 are taught as described above. Bencini teaches the electrodes being arranged in an array in p.[0053], which states “In some implements, as depicted in Fig. 3, the electrodes 112 are disposed in a regular array” therefore teaching the limitation as described.
Regarding claim 4, the limitations of claim 3 are taught as described above. Bencini teaches the use of electrode pairs in an array in p.[0056], which states “By measuring biopotentials at various pairs of electrodes over time, an electrical "map" can be created to characterize and visually depict electrical activity in tissue that is in contact with the electrodes” therefore teaching the limitation as described.
Regarding claims 5-6 and 15 the limitations of claims 4 and 12 are taught as described above. Bencini does not explicitly state that the electrodes are configured to be orthogonal, or perpendicular, to the cardiac tissue surface, but Bencini’s system is capable of achieving this. Note that an orthogonal close unipolar configuration is interpreted to encompass electrodes that are disposed near one another along a spline or arm that bisects them, and is seen in Bencini. Figure 3 of Bencini shows the electrodes displayed on splines within a balloon, wherein the balloon (and hence, the electrodes) can be manipulated to push against the surface of the cardiac tissue. An orthogonal or 90-degree contact point can be made if the user simply orients the balloon (and therefore, the electrodes) in an appropriate manner to make such a connection. Further, the electrodes of Bencini appear to be oriented on the surface of the balloon, therefore being orthogonal to the balloon and capable of making a 90-degree contact with the surface of the cardiac tissue. This is also demonstrated in Figure 4, which shows that electrodes E3-5 of the outer-spines assume a relatively perpendicular arrangement when compared to the tissue’s surface, therefore teaching the limitation as described.
Regarding claim 7, the limitations of claim 2 are taught as described above. Bencini teaches a first electrode in contact with the tissue surface to record a first signal and second electrode separated from the first electrode by a distance to record a second signal in p.[0057] and Figure 1A, showing a first signal, and p.[0059] and Fig. 2B showing a second signal, therefore teaching the limitation as described.
Regarding claim 17, the limitations of claim 12 are taught as described above. Bencini shows splines extending from a proximal end of the cardiac catheter, such that the Examiner is considering the proximal end as the portion of the device where the electrodes and balloons are. Therefore, in light of this interpretation, the splines are on the proximal end of the cardiac catheter as seen in Figure 3 and therefore teaches the limitation as described.
Regarding claim 18, the limitations of claim 17 are taught as described above. Bencini does not explicitly teach that at least one of the splines comprises the ablation electrodes and at least one other spline comprises the recording electrode pairs, but is the Examiner’s position that this is a mere matter of design choice. The electrodes of Bencini can assume either an ablative or sensory function, as described above, and therefore one of ordinary skill in the art could define one spline for ablation electrodes, and one spline for recording electrodes, without introducing or involving inventive activity. Further, the designation of a spline for either recording or ablation electrodes does not provide any novel or nonobvious results, and therefore is considered taught by Bencini.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Bencini (U.S. Patent Publication US 2009/0299355) in view of Ciaccio (U.S. Patent No. 7,245,962 B2).
Regarding claim 16, the limitations of claim 12 are taught as described above. Bencini does not teach displaying where reentrant circuits are distributed across the cardiac tissue, but Ciaccio does in an analogous cardiac device. Ciaccio teaches this limitation in the abstract, which states “A method and system for identifying and localizing a reentrant circuit isthmus in a heart of a subject during sinus rhythm is provided. The method may include (a) receiving electrogram signals from the heart during sinus rhythm via electrodes, (b) creating a map based on the electrogram signals, (c) determining, based on the map, a location of the reentrant circuit isthmus in the heart, and (d) displaying the location of the reentrant circuit isthmus.” This is further described in Figure 14A-B, 16A-B, and col. 3 lines 55-67, col. 4, lines 1-65 and moreover, Figures 1A-1D. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the display of reentrant circuits of Ciaccio in Bencini. As taught in Ciaccio, it is “of potential benefit for targeting ablation sites to know a priori the characteristics of the isthmus (the reentrant) that are of importance for determining the best lesion length and orientation” (col. 44, lines 37-42).
Claims 8-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Swanson (U.S. Patent No. 6,023,638) in view of de la Rama (US Patent No. 6,029,091).
Regarding claim 8, Swanson teaches in Figure 39, with a plurality of splines (358) extending from a proximal end of the cardiac catheter (356), wherein at least one of the splines comprises an ablation electrode (368) and at least one other spline comprises a recording electrode as described in col. 14, lines 49-69, each electrode on each spine can either record/sense electrical stimulation and deliver electrical treatment (ablation).
While Swanson teaches the use of a multitude of electrodes in Figure 39, Swanson does not explicitly teach that the electrodes are recording pairs. It is the Examiner’s position that this is a mere duplication of parts, and that the electrodes of Swanson, while not being explicitly called pairs, would perform the same function and has no patentable significance unless a new and unexpected result is shown by Applicant. See MPEP 2144.04.
Swanson does not teach the limitation “wherein each spline extends from a different location along a cardiac catheter”, however, de la Rama does in an analogous catheter device. De la Rama teaches in the abstract and Fig. 2 the use of a two-dimensional plane for mapping and ablation electrodes, with electrodes 32 along the splines that branch bilaterally across the shaft 24. Note that the Examiner is interpreting each of the splines to be the entire length across the shaft 24, following that Figure 2 shows 4 splines, each extending from a different location along shaft 24. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use splines that extend from a different location along the cardiac catheter, as taught in de la Rama, in Swanson. As stated in de la Rama, the use of the two-dimensional set of splines allows for “a more accurate and more intimate means for mapping and/or ablation capabilities” (col. 4, lines 22-23).
Regarding claim 9, the limitations of claim 8 are taught as described above. Swanson teaches an array of electrodes in Figure 39 and therefore teaches the limitation as described. De la Rama also teaches an array of electrodes in Figure 2, further teaching the limitation as described.
Regarding claim 11, the limitations of claim 8 are taught as described above. Swanson’s arrangement of the electrodes in Figure 39 are considered to be “orthogonal close unipolar configuration” and are therefore taught as described.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794