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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/14/2026 has been entered.
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.
Response to Amendment
With the entry of this amendment, claims 2-9, 11-13, and 15-21 are pending, with claims 2, 8, and 12 being the only independent claims. Claims 19-21 are newly presented.
Response to Arguments
Applicant's arguments, see Remarks filed 04/14/2026 pages 5-6, with regard to the rejection of claims 2, 8, and 12 under 35 U.S.C. 103 as unpatentable over Bencini (US 2009/0299355) have been fully considered but they are not persuasive. Applicant argues that Bencini (US 2009/0299355) does not teach that the extent of a conduction block is determined, but the Examiner does not agree. Bencini teaches repeating the ablation if the electrical signals are not correct or desired (p.[0082]), for the purpose of preventing or blocking electrical activity within the heart via destruction of heart tissue. Bencini Figure 5D shows no electrical activity in sections of the heart because it has been blocked by tissue destroyed during ablation, further described in p.[0061], which specifically notes the elimination of electrical pathways causing atrial fibrillation. Therefore, it is the Examiner’s position that Bencini does teach measuring the extent of the conduction block as claimed in the instant application.
Applicant’s arguments, see Remarks filed 04/14/2026 pages 5-8, with respect to the rejection of claims 2, 8, and 12 under 35 U.S.C. 103 as unpatentable over Bencini (US 2009/0299355) have been fully considered and are persuasive. Bencini does not teach “measuring tissue activation time”, and therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Bencini (US 2009/0299355) and Edgerton (US 2011/0125144).
Claim Rejections - 35 USC § 103
Claims 2-7 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bencini (U.S. Patent Publication US 2009/0299355) in view of Edgerton (US 2011/0125144).
Regarding claim 2, 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 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 as described in p.[0082]. Further, Bencini Figure 5D shows no electrical activity because it has been blocked by tissue destroyed using ablation (a type of conduction block), and further in p.[0061] which specifically notes the elimination of electrical pathways causing atrial fibrillation.
Bencini does not explicitly teach “measuring tissue activation time… to determine extent of a conduction block across the cardiac ablation;” 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. However, Edgerton does teach the use of measuring tissue activation timing specifically to determine the extent of a conduction block across the cardiac ablation in an analogous method for treating cardiac tissue. Edgerton teaches in p.[0061-63] and Fig. 17A-B that electrodes are placed to verify activation blocks (conduction blocks), with activation times being measured at several locations to confirm conduction blocks across the linear lesion. Further, Edgerton teaches performing supplementary ablation based on the extend of the conduction block in p.[0011], specifically but not limited to “producing an ablation line on the right pulmonary vein antrum by firing the clamp 2-6 times; obtaining a second right electrogram on multiple sites on both the superior and inferior pulmonary veins with the sensing pen, wherein the absence of transmitted electrical activity from the atrium indicates acute entrance block has been obtained”.
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 system of Bencini in view of Edgerton to arrive at the claimed invention. First, 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]), while Edgerton does so in p.[0011,0061-63], and Figure 17A-B. 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), suggesting “performing supplementary ablation based on the extent of the conduction block” in view of Edgerton’s p.[0011]. 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 3, the limitations of claim 2 is 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, the limitations of claim 4 is 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.
Regarding claim 19, the limitations of claim 2 are taught as described above. Bencini does not explicitly teach the use of radiofrequency ablation in the ablation step, but does recognize that radiofrequency ablation is known in the art for radiofrequency to be used for ablating tissue of the heart in order to create conduction blocks to treat fibrillation (p.[0003]). Edgerton, an analogous ablation device, does teach the use of radiofrequency ablation as a supplemental step for creating a conduction block in p.[0007, 0010, 0011, 0022, 0034, 0050-0051, 0060-0063] and Figures 13-17B. 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 system of Edgerton in Bencini to arrive at the claimed invention. Radiofrequency ablation is known in the art (both Edgerton and Bencini as stated above) for creating conduction blocks to treat atrial fibrillation and such an ablation method produces predictable results.
Claims 12-13, 15, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bencini (U.S. Patent Publication US 2009/0299355) in view of Edgerton (US 2011/0125144) and Porath (US 2004/0039293).
Regarding claim 12, claim 12 recites the same method as claim 1 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. Further, Edgerton teaches the use of pacing and recording electrodes in Figure 16, showing distinct electrode pairs. Bencini nor Edgerton do not explicitly teach “mapping the recorded electrical signals onto a representation of the cardiac tissue using the processing unit; displaying a site for ablation on the cardiac tissue representation; and ablating the cardiac tissue based on the site for ablation displayed on the cardiac tissue”, but Bencini does teach storing and recording the electrical signals in p.[0032, 0058, 0062] and Figures 5A-D, and in p.[0033] that the signal processor can be configured to produce a representation of the signals in a user interface. Further, Edgerton also teaches that the electrical signals can be mapped in Figure 17A-B and p.[0063] but does not teach displaying this site via a processing unit. Porath cures both of these deviancies and teaches the limitation “mapping the recorded electrical signals onto a representation of cardiac tissue using the processing unit (Fig 3B); displaying a site for ablation on the cardiac tissue representation (Fig. 3B, p.[0004]); and ablating the cardiac tissue based on the site for ablation displayed on the cardiac tissue representation (p.[0004, 0020, 0028, 0058, 0060]”.
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 system of Porath/Bencini/Edgerton to arrive at the claimed invention. As stated in Porath p.[0004, 0020], it is known in the art to use generated maps to determine locations of ablation and such a system produce predictable results.
Regarding claim 13, the limitations of claim 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 15 the limitation of claim 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 does achieve 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 21, the limitations of claim 12 are taught as described above. Bencini does not explicitly teach the use of radiofrequency ablation in the ablation step, but does recognize that radiofrequency ablation is known in the art for radiofrequency to be used for ablating tissue of the heart in order to create conduction blocks to treat fibrillation (p.[0003]). Edgerton, an analogous ablation device, does teach the use of radiofrequency ablation as a supplemental step for creating a conduction block in p.[0007, 0010, 0011, 0022, 0034, 0050-0051, 0060-0063] and Figures 13-17B. 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 system of Edgerton in Bencini to arrive at the claimed invention. Radiofrequency ablation is known in the art (both Edgerton and Bencini as stated above) for creating conduction blocks to treat atrial fibrillation and such an ablation method produces predictable results.
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 Edgerton (US 2011/0125144) Porath (US 2004/0039293), and Ciaccio (U.S. Patent No. 7,245,962 B2).
Regarding claim 16, the limitations of claim 12 are taught as described above. Bencini/Edgerton/Porath 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/Edgerton. 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, 11, and 20 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, instead that the electrodes can be recording or sensing electrodes. Any of the electrode A to H could be paired together for recording (col. 29, lines 57-58, “electrode elements can also be used to sense electrical elements events in the heart”).
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.
Regarding claim 20, the limitations of claim 8 are taught as described above. Swanson does not explicitly state that “the cardiac catheter is an intracardiac catheter”, however, Swanson does teach that the cardiac catheter is used for endocardial electrical events (Fig. 1, col. 7, lines 16-21), mapping the endocardium (col. 3, lines 39-26, Fig. 1, col. 7, lines 16-21), and shows in Figures 1, 9, 11, the cardiac catheter being placed internally to the structure of the heart. For the record, the Examiner is interpreting an intracardiac catheter to be a catheter that can maneuver to and treat the internal structures of the heart. Therefore, it is the Examiner’s position that because the cardiac catheter of Swanson is used internal to the heart (both within the heart itself and within the internal tissues, such as the endocardium), that the cardiac catheter of Swanson is an intracardiac catheter although not explicitly being titled as one. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to recognize Swanson as an intracardiac catheter, despite not being explicitly called one, as Swanson does treat the internal cardiac space and falls under the broadest reasonable interpretation of an intracardiac catheter and therefore teaches the limitation as described.
Conclusion
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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