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 .
Response to Amendment
Acknowledgment is made to the amendment received 12/4/2025.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC § 112(b) rejections set forth in the previous office action.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claim 1 was rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gnanashanmugam. Now, based on amendments to the claim language, claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Gnanashanmugam in view of Toth. The amendment appears based on previously claimed claims 2, 3, and 4. However, with subtle differences including the fact that claim 3 and 4 previously were dependent off of claim 2 only and that the functional guide core was previously fixed in a way to the rear end of the pulse ablation part.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Gnanashanmugam et al., US 20150216592, herein referred to as “Gnanashanmugam” in view of Toth et al., US 20180303414, herein referred to as “Toth”.
Regarding claim 1, Gnanashanmugam discloses a pulse ablation catheter for treating pulmonary arterial hypertension (Figure 1A), comprising an ablation catheter part (Figures 23A-B and Figure 1A: flexible body 12) and an energy platform (Figure 1A: treatment controller 24 and [0078]: “the treatment member is an energy delivery device for delivering energy 20 to the nerve(s), and controller 24 is an energy source for providing energy to the treatment member.”), wherein the ablation catheter part comprises a movable outer sheath tube (Figures 23A: sheath 150), an ablation catheter (Figure 23A: catheter 252), a functional guide core ([0176]: “In such a configuration, catheter 252 may, for example, comprise inner and outer shafts that are moveable relative to one another.”; wherein the inner shaft is equivalent to a functional guide core), a pulse ablation part (Figure 23A: expandable basket 254) and an operating part (Figure 1A: actuator 22 and [0081]), the movable outer sheath tube moves axially outside the ablation catheter ([0175]: “the basket may be collapsed for delivery within sheath 150, and may self-expand into contact with the wall of the artery upon removal from the sheath. ”), and the operating part at a rear end of the ablation catheter part is capable of controlling a position and a shape of the pulse ablation part of the ablation catheter part (Figure 23A: proximal and distal connections 255a and 255b and Figure 1A: actuator 22 and [0176]), the pulse ablation part fits the ablation catheter or arches to form a hollow spherical shape (Figure 23A: expandable basket 254 and [0175]-[0176]), and the pulse ablation part is connected with the energy platform for pulse ablation (Figures 23A-B: electrodes 256 and [0174] and [0114]); wherein the ablation catheter is movably connected with the movable outer sheath tube ([0175]: “In such a configuration, the basket may be collapsed for delivery within sheath 150, and may self-expand into contact with the wall of the artery upon removal from the sheath. Proximal and/or distal connection 255a and 255b optionally may be configured to translate along the shaft of catheter 252 for a specified or unspecified distance in order to facilitate expansion and collapse of the basket.”), a rear end of the movable outer sheath tube is the operating part (Figures 1A: actuator 22), the functional guide core is arranged in the ablation catheter ([0176]: “In such a configuration, catheter 252 may, for example, comprise inner and outer shafts that are moveable relative to one another.”; wherein the inner shaft is equivalent to a functional guide core), a front end of the pulse ablation part is a movable end ([0175]: “Proximal and/or distal connection 255a and 255b optionally may be configured to translate along the shaft of catheter 252 for a specified or unspecified distance in order to facilitate expansion and collapse of the basket.”), and the operating part is capable of controlling the pulse ablation part to slide axially along the functional guide core in a center of the ablation catheter ([0175]: “Proximal and/or distal connection 255a and 255b optionally may be configured to translate along the shaft of catheter 252 for a specified or unspecified distance in order to facilitate expansion and collapse of the basket.” And Figure 1A: actuator 22 and [0081] and [0176]), and a middle of the pulse ablation part is provided with a plurality of strip-shaped arches (Figures 23A-B: struts 253), and the strip-shaped arches are capable of arching in a circumferential direction ([0175]).; a front end of the pulse ablation part is fixed with a functional guide core ([0176]: “Distal connection 255b of basket 254 may be coupled to the inner shaft and proximal connection 255a of the basket may be coupled to the outer shaft. ”); and pulse electrode sheets are provided on each of the strip-shaped arches at intervals (Figures 23B: struts 253 have electrodes 256 at intervals), the pulse electrode sheets are powered by the energy platform connected with a rear end of the functional guide core ([0180]), and a tail end of the pulse ablation part is integrated with the ablation catheter ([0176]: “Distal connection 255b of basket 254 may be coupled to the inner shaft and proximal connection 255a of the basket may be coupled to the outer shaft. ”). Gnanashanmugam does not explicitly disclose an ablation catheter wherein the functional guide core is a hollow inner core for an internal guide wire to pass through.
However, Toth teaches an ablation catheter (Figures 11d-f) wherein the functional guide core (Figures 11d-f: guide ring 1162) is a hollow inner core for an internal guide wire to pass through (Figures 11d-f: guidewire 1160 and [0334]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter of Gnanashanmugam so that the functional guide core is a hollow inner core for an internal guide wire to pass through as taught by Toth to provide a path over which a second surgical tool may be delivered to the target tissue (Toth [0018]).
Regarding claim 5, Gnanashanmugam in view of Toth discloses the pulse ablation catheter for treating the pulmonary arterial hypertension according to claim 1, with Gnanashanmugam disclosing a catheter wherein the energy platform is connected with the ablation catheter, and the energy platform comprises a host (Figure 1A: controller 24) and an adjusting end ([0078]). Toth further discloses an ablation catheter wherein the energy platform comprises a host (Figure 14b: central console 1425), a display end (Figure 14b: console display 1430), and an adjusting end ([0356]: “communication between the catheter 1427 and control console 1425 is wireless and digital” and [0351]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter of Gnanashanmugam so that it includes a display end as taught by Toth to display the mapped physiologic information for a user, construct an anatomical model therefrom, direct a surgical robot to perform a treatment therefrom, compare the map with a previously determined map (e.g., as a means for monitoring the outcome of a procedure, tracking a therapy, etc.), combinations thereof, or the like (Toth [0345]).
Regarding claim 6, Gnanashanmugam in view of Toth discloses the pulse ablation catheter for treating the pulmonary arterial hypertension according to claim 1, and Toth further discloses an ablation catheter wherein the functional guide core is configured for monitoring pulmonary arterial pressure ([0051]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ablation catheter of Gnanashanmugam so that the functional guide core is configured for monitoring pulmonary arterial pressure as taught by Toth to assess a change in a body response to the stimulus (Toth [0379]).
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.
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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