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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/18/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 1/20/2026 and 2/18/2026.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive. Regarding claims 1, 14, and 19, applicant argues that Shen in view of Sliwa and Sheth does not disclose the claim language “a navigator sensor lumen extending from the proximal opening and terminating in a closed end forming a blind hole, the navigator sensor lumen sized and configured to receive a magnetic tracking sensor to enable magnetic localization of the ablation catheter”. However, Figure 4 of Sheth depicts cable 133 in a lumen 113. As described in paragraph [0059] of Sheth, this cable is for an EM position sensor, which is not shown in the figures. However, Figures 2 and 5A of Sheth do not depict any passages to the exterior of the device except for apertures 127 and 129 and do not depict an elements on the exterior of the device except for plates 137 and 138. Thus, based on Figure 4 and paragraph [0059], at some point in the distal portion 104 of the device, the cable 133 ends in an EM position sensor in a blind hole, similar to how thermocouple wires 151/153 are positioned in blind hole 124. Therefore, the previous rejections stand and claim 1 remains rejected under 35 U.S.C. 103 as being unpatentable over Shen in view of Sliwa and Sheth and claims 14 and 19 remain rejected under 35 U.S.C. 103 as being unpatentable over Shen in view of Sheth.
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.
Claims 1-13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al., CN 112914721, herein referred to as “Shen”, in view of Sliwa et al., US 20210267671, herein referred to as “Sliwa”, further in view of Sheth, US 20190357848, herein referred to as “Sheth”.
Regarding claim 1, Shen discloses a cardiac ablation catheter (Figure 1) comprising: a handle (Figure 1: handle assembly 102); an elongated shaft (Figure 1: tube body 8) having a proximal end (Figure 1: portion of tube body 8 near bending pushing piece 10) and a distal end (Figures 1-2a: catheter head end 100), the proximal end extending distally from the handle (Figure 1 and Page 11, 3rd full paragraph: “the handle assembly 102 connected with the proximal end of the tube body 8”); and a distal assembly (Figures 1-2A: catheter head end 100) having a proximal end and a distal end (Figure 2A), the proximal end secured to the distal end of the shaft (Figure 2B), the distal assembly comprising: a tip electrode at the distal end of the distal assembly (Figures 2D and 3A: first head electrode 1-A); a first ring electrode located proximal of and spaced apart from the tip electrode (Figure 2B and 3A: first ring electrode 5), the first ring electrode having a distal leading end and a proximal trailing end (Figure 2A); and an insulator preform (Figures 2B and 3A: first insulator 3-1 and second insulator 3-2) comprising a proximal portion having a forward portion defining a first diameter (Figures 2B and 3A: second insulator 3-2), and a distal portion extending distally from the proximal portion (Figures 2B and 3A: first insulator 3-1), the distal portion having a distal face and a distal portion length (Figure 2B: first insulator 3-1 has a distal face and a distal portion length), wherein the tip electrode extends distally from the distal face of the insulator preform (Figure 2B: first head electrode 1-A extends distally from the distal face of insulator 3-1), and the first ring electrode is disposed over the proximal portion such that the distal leading end of the first ring electrode abuts the radial shoulder of the insulator preform (Figure 3A: first ring electrode 5 abuts the radial shoulder of the insulator preform at second insulator 3-2), and wherein the distal portion length defines a longitudinal spacing between the tip electrode and the first ring electrode distal leading end (Figure 2B: the length of first insulator 3-1 defines a longitudinal spacing between first head electrode 1-A and first ring electrode 5 which is proximal second insulator 3-2). Shen does not explicitly disclose an insulator preform comprising a proximal portion having a forward portion defining a first diameter, and a distal portion extending distally from the proximal portion, the distal portion having a distal face and a second diameter greater than the first diameter so as to define a radial shoulder, the proximal portion including a proximal opening and a navigation sensor lumen extending from the proximal opening and terminating in a closed end forming a blind hole, the navigation sensor lumen sized and configured to receive a magnetic tracking sensor to enable magnetic localization of the ablation catheter.
However, Sliwa teaches a cardiac ablation catheter (Figure 3) comprising an insulator preform (Figure 7: The electrically-insulative substrate 505,507) comprising a proximal portion having a forward portion defining a first diameter (Figure 7: electrically-insulative substrate 507), and a distal portion extending distally from the proximal portion (Figure 7: electrically-insulative substrate 505), the distal portion having a distal face and a second diameter greater than the first diameter so as to define a radial shoulder (Figure 7: electrically-insulative substrate 505 has a distal face and a diameter greater than the diameter of electrically-insulative substrate 507 to define a radial shoulder).
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 cardiac ablation catheter of Shen so that the insulator preform comprises a distal portion having a second diameter greater than the diameter of the proximal portion so as to define a radial shoulder as taught by Sliwa so that the proximal portion of the insulating material can be sized and configured to fit within a catheter body to couple the distal assembly to the catheter body (Sliwa [0062]).
Further, Sheth teaches a cardiac ablation catheter (Figures 1-2) comprising an insulator preform (Figure 5A: plug 107) comprising a proximal portion (Figure 5A: plug 107 has a proximal portion) including a proximal opening and a navigation sensor lumen (Figure 4: third lumen 113) extending from the proximal opening and terminating in a closed end forming a blind hole ([0059]: “ a cable 133 for an EM position sensor (not shown) housed in the distal section 104, ” and Figure 4: cable 133 and Figure 5A: since the EM position sensor is not depicted, it must be located either in a similar position as thermocouple wire pair 151/153 or it can be located more proximal; either way, it must terminate in a closed end forming a blind hole because it does not stick out of the device at shell 106 or tubing 144), the navigation sensor lumen sized and configured to receive a magnetic tracking sensor to enable magnetic localization of the ablation catheter (Figure 4: cable 133 for an EM position sensor and ([0055]).
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 cardiac ablation catheter of Shen so that the insulator preform comprises a proximal portion including a proximal opening and navigation sensor lumen extending from the proximal opening and terminating in a closed end forming a blind hole as taught by Sheth to ensure separation between the sensor and the irrigation fluid (Sheth [0061]).
Regarding claim 2, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 1, and Shen further discloses a cardiac ablation catheter wherein the tip electrode (Figure 2B: first head electrode 1-A) includes a tip electrode shoulder that abuts the distal face of the insulator preform (Figure 2B: first head electrode 1-A includes a shoulder that abuts the distal face of first insulator 3-1).
Regarding claim 3, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 2, and Shen further discloses a cardiac ablation catheter wherein the distal portion of the insulator preform includes a distal opening in the distal face (Figures 2B, 2D, and 3A: first insulator 3-1 includes a distal opening in the distal face).
Regarding claim 4, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 3, and Shen further discloses a cardiac ablation catheter wherein the tip electrode includes an active portion having an active portion diameter (Figure 3A: diameter of first head electrode 1-A near second insulator 3-2), and a tip electrode shank having a tip electrode shank diameter that is smaller than the active portion diameter (Figure 3A; the diameter of first head electrode 1-A near the distal end of the device is a smaller diameter), and wherein the tip electrode shank is received within the distal opening in the distal face of the insulator preform (Figure 3A: the width of first insulator 3-1 decreases slightly near the distal end of the device, this is the distal opening in the distal face and the tip electrode shank is received by it).
Regarding claim 5, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 4, and Shen further discloses a cardiac ablation catheter wherein the distal assembly further comprises a second ring electrode (Figure 3A: second ring electrode 6) located proximally of and longitudinally spaced from the first ring electrode (Figure 3A: second ring electrode 6 is proximal to and longitudinally spaced from first ring electrode 5).
Regarding claim 6, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 5, and Shen further discloses a cardiac ablation catheter wherein the distal assembly further comprises an insulating material disposed at least proximally of the first ring electrode (Figure 2B: elastic pipe body 16 and tube body 8 are proximal first ring electrode 5 and Page 9, 2nd full paragraph).
Regarding claim 7, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 6, and Shen further discloses a cardiac ablation catheter wherein the insulating material is disposed between the first ring electrode and the second ring electrode (Figure 2B: elastic pipe body 16 and tube body 8 are exposed between first ring electrode 5 and second ring electrode 6 and Page 9, 2nd full paragraph).
Regarding claim 8, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 6, and Sliwa further discloses a cardiac ablation catheter wherein the insulator preform includes first and second longitudinal channels extending through the proximal portion to the insulator preform distal portion (Figure 7: first via or wire channel 515 and third via or wire channel 519 extend through base 507 to electrically-insulative substrate 505).
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 cardiac ablation catheter of Shen so that the insulator preform includes first and second longitudinal channels extending through the proximal portion to the insulator preform distal portion as taught by Sliwa to secure each electrode in a desired position in relation to the rest of the electrodes (Sliwa [0068]).
Regarding claim 9, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 8, and Sliwa further discloses a cardiac ablation catheter wherein the insulating material extends through the first and second longitudinal channels (Figure 7: first spot non-conductive portion 527 and third spot non-conductive 529) and about the tip electrode shank so as to secure the tip electrode to the insulator preform ([0068]: “The first spot non-conductive portion 527 can be used to secure the first spot electrode 521 in a desired position in relation to the rest of the electrodes on the tip electrode 501. Similarly, the third spot non-conductive portion 529 can be used to secure the third spot electrode 523 in a desired position in relation to the rest of the electrodes on the tip electrode 501. ”).
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 cardiac ablation catheter of Shen so that the insulating material extends through the first and second longitudinal channels and about the tip electrode shank so as to secure the tip electrode to the insulator preform as taught by Sliwa to secure each electrode in a desired position in relation to the rest of the electrodes (Sliwa [0068]).
Regarding claim 10, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 8, and Shen further discloses a cardiac ablation catheter wherein the tip electrode shank includes a plurality of radial projections that abut an inner surface of the insulator preform distal portion (Figure 2D: portion of first head electrode 1-A that has a larger diameter includes two radial projections that abut an inner surface of first insulator 3-1), and wherein the insulating material encapsulates the radial projections to secure the tip electrode to the insulator preform (Page 12, 4th and 5th full paragraphs).
Regarding claim 11, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 7, and Shen further discloses a cardiac ablation catheter wherein the tip electrode shank includes a plurality of radial apertures extending inward (Figure 2D: portion of first head electrode 1-A that has a larger diameter includes two radial projections that extend inward), and wherein the insulating material extends through the radial apertures to secure the insulator preform to the distal assembly (Page 12, 4th and 5th full paragraphs). .
Regarding claim 12, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 11, and Sliwa further discloses a cardiac ablation catheter wherein the lumen is a navigator sensor lumen (Figure 7: second via or wire channel 517 and [0039]).
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 cardiac ablation catheter of Shen so that the lumen is a navigator sensor lumen as taught by Sliwa so that the device can perform motion compensation, including compensation for respiration-induced patient body movement (Sliwa [0036]).
Regarding claim 13, Shen in view of Sliwa and Sheth discloses the cardiac ablation catheter of claim 12, and Sliwa further discloses a cardiac ablation catheter wherein the insulator preform proximal portion (Figure 2b: second insulation 3-2) has a planar portion defining a space to accommodate attachment of an electrical conductor to the first ring electrode (Figure 2b: lead 15 and lead passage 1-F and Figure 2A: first ring electrode 5).
Claims 14-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shen in view of Sheth.
Regarding claim 14, Shen discloses an ablation electrode assembly (Figures 2A-B) for a pulsed field ablation catheter (Page 6, last paragraph, Page 7, first paragraph), the ablation electrode assembly comprising: an insulator preform (Figures 2B and 3A: first insulator 3-1 , second insulator 3-2, and elastic pipe body 16) comprising a proximal portion having a forward portion defining a first diameter (Figures 2B and 3A: elastic pipe body 16), and a distal portion extending distally from the proximal portion (Figures 2B and 3A: first insulator 3-1), the distal portion having a distal face and a second diameter greater than the first diameter (Figure 2B: first insulator 3-1 has a distal face and a diameter greater than the diameter of elastic pipe body 16) so as to define a radial shoulder (Figure 2B: second insulator 3-2), and a distal portion length (Figure 2B: first insulator 3-1 has a distal portion length); a tip electrode extending distally from the distal face of the insulator preform (Figures 2D and 3A: first head electrode 1-A); and a ring electrode disposed over the proximal portion of the insulator preform (Figures 2A-B: first ring electrode 5 is disposed over elastic pipe body 16 ) such that a distal leading end of the ring electrode abuts the radial shoulder of the insulator preform (Figures 2A-B: first ring electrode 5 abuts second insulator 3-2), and wherein the distal portion length of the insulator preform defines a longitudinal spacing between the tip electrode and the first ring electrode distal leading end (Figure 2B: the length of first insulator 3-1 and second insulator 3-2 defines a longitudinal spacing between first head electrode 1-A and first ring electrode 5 which is proximal second insulator 3-2). Shen does not explicitly disclose an ablation electrode assembly comprising an insulator preform comprising a proximal portion including a proximal opening and a navigation sensor lumen extending from the proximal opening and terminating in a closed end forming a blind hole, the navigation sensor lumen sized and configured to receive a magnetic tracking sensor.
Further, Sheth teaches an ablation electrode assembly (Figures 1-2) comprising an insulator preform (Figure 5A: plug 107) comprising a proximal portion (Figure 5A: plug 107 has a proximal portion) including a proximal opening and a navigation sensor lumen (Figure 4: third lumen 113) extending from the proximal opening and terminating in a closed end forming a blind hole ([0059]: “ a cable 133 for an EM position sensor (not shown) housed in the distal section 104, ” and Figure 4: cable 133 and Figure 5A: since the EM position sensor is not depicted, it must be located either in a similar position as thermocouple wire pair 151/153 or it can be located more proximal; either way, it must terminate in a closed end forming a blind hole because it does not stick out of the device at shell 106 or tubing 144), the navigation sensor lumen sized and configured to receive a magnetic tracking sensor (Figure 4: cable 133 for an EM position sensor and ([0055]).
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 electrode assembly of Shen so that the insulator preform comprises a proximal portion including a proximal opening and a navigation sensor lumen extending from the proximal opening and terminating in a closed end forming a blind hole as taught by Sheth to ensure separation between the sensor and the irrigation fluid (Sheth [0061]).
Regarding claim 15, Shen in view of Sheth discloses the ablation electrode assembly of claim 14, and Shen further discloses an ablation electrode assembly wherein the tip electrode (Figure 2B: first head electrode 1-A) includes a tip electrode shoulder that abuts the distal face of the insulator preform (Figure 2B: first head electrode 1-A includes a shoulder that abuts the distal face of first insulator 3-1).
Regarding claim 16, Shen in view of Sheth discloses the ablation electrode assembly of claim 15, and Shen further discloses an ablation electrode assembly wherein the distal portion of the insulator preform includes a distal opening in the distal face (Figures 2B, 2D, and 3A: first insulator 3-1 includes a distal opening in the distal face).
Regarding claim 17, Shen in view of Sheth discloses the ablation electrode assembly of claim 16, and Shen further discloses an ablation electrode assembly wherein the tip electrode includes an active portion having an active portion diameter (Figure 3A: diameter of first head electrode 1-A near second insulator 3-2), and a tip electrode shank having a tip electrode shank diameter that is smaller than the active portion diameter (Figure 3A; the diameter of first head electrode 1-A near the distal end of the device is a smaller diameter), and wherein the tip electrode shank is received within the distal opening in the distal face of the insulator preform (Figure 3A: the width of first insulator 3-1 decreases slightly near the distal end of the device, this is the distal opening in the distal face and the tip electrode shank is received by it).
Regarding claim 19, Shen discloses a method of making an ablation electrode assembly of a cardiac ablation catheter (Figures 2A-B and Page 12), the method comprising: providing an insulator preform (Figures 2B and 3A: first insulator 3-1 , second insulator 3-2, and elastic pipe body 16) comprising a proximal portion having a forward portion defining a first diameter (Figures 2B and 3A: elastic pipe body 16), and a distal portion extending distally from the proximal portion (Figures 2B and 3A: first insulator 3-1), the distal portion having a distal face having a distal opening (Figures 2B, 2D, and 3A: first insulator 3-1 includes a distal opening in the distal face), a second diameter greater than the first diameter (Figure 2B: first insulator 3-1 has a diameter greater than the diameter of elastic pipe body 16)so as to define a radial shoulder (Figure 2B: second insulator 3-2), and a distal portion length (Figure 2B: first insulator 3-1 has a distal portion length); securing a tip electrode to the distal portion of the insulator preform so that the tip electrode extends distally from the distal face of the insulator preform (Figures 2D and 3A: first head electrode 1-A); and securing a ring electrode over the proximal portion of the insulator preform (Figures 2A-B: first ring electrode 5 is disposed over elastic pipe body 16) such that a distal leading end of the ring electrode abuts the radial shoulder of the insulator preform (Figures 2A-B: first ring electrode 5 abuts second insulator 3-2), wherein the distal portion length of the insulator preform defines a longitudinal spacing between the tip electrode and the first ring electrode distal leading end (Figure 2B: the length of first insulator 3-1 and second insulator 3-2 defines a longitudinal spacing between first head electrode 1-A and first ring electrode 5 which is proximal second insulator 3-2). Shen does not explicitly disclose a method comprising providing an insulator preform comprising a proximal portion including a proximal opening and a lumen extending from the proximal opening and terminating in a closed end forming a blind hole, the lumen sized and configured to receive a magnetic tracking sensor.
However, Sheth teaches a method (Figure 5A) comprising an insulator preform (Figure 5A: plug 107) comprising a proximal portion (Figure 5A: plug 107 has a proximal portion) including a proximal opening and a lumen extending from the proximal opening and terminating in a closed end forming a blind hole a blind hole ([0059]: “ a cable 133 for an EM position sensor (not shown) housed in the distal section 104, ” and Figure 4: cable 133 and Figure 5A: since the EM position sensor is not depicted, it must be located either in a similar position as thermocouple wire pair 151/153 or it can be located more proximal; either way, it must terminate in a closed end forming a blind hole because it does not stick out of the device at shell 106 or tubing 144), the lumen sized and configured to receive a magnetic tracking sensor (Figure 4: cable 133 for an EM position sensor and ([0055]).
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 method of Shen so that the insulator preform comprises a proximal portion including a proximal opening and a lumen extending from the proximal opening and terminating in a closed end forming a blind hole, the lumen sized and configured to receive a magnetic tracking sensor as taught by Sheth to ensure separation between the sensor and the irrigation fluid (Sheth [0061]).
Regarding claim 20, Shen in view of Sheth discloses the method of claim 19, and Shen further discloses a method wherein the tip electrode includes an active portion having an active portion diameter (Figure 3A: diameter of first head electrode 1-A near second insulator 3-2), and a tip electrode shank having a tip electrode shank diameter that is smaller than the active portion diameter (Figure 3A; the diameter of first head electrode 1-A near the distal end of the device is a smaller diameter), and wherein securing the tip electrode to the insulator preform includes inserting the tip electrode shank within the distal opening in the distal face of the insulator preform (Figure 3A: the width of first insulator 3-1 decreases slightly near the distal end of the device, this is the distal opening in the distal face and the tip electrode shank is received by it).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Shen in view of Sheth, further in view of Sliwa.
Regarding claim 18, Shen in view of Sheth discloses the ablation electrode assembly of claim 14, but does not explicitly disclose an ablation electrode assembly wherein the insulator preform includes first and second longitudinal channels extending through the proximal portion to the insulator preform distal portion, and wherein an insulating material extends through the first and second longitudinal channels and about the tip electrode shank so as to secure the tip electrode to the insulator preform.
However, Sliwa teaches an ablation electrode assembly (Figure 7) wherein the insulator preform includes first and second longitudinal channels extending through the proximal portion to the insulator preform distal portion (Figure 7: first via or wire channel 515 and third via or wire channel 519 extend through base 507 to electrically-insulative substrate 505), and wherein the insulating material extends through the first and second longitudinal channels (Figure 7: first spot non-conductive portion 527 and third spot non-conductive 529) and about the tip electrode shank so as to secure the tip electrode to the insulator preform ([0068]: “The first spot non-conductive portion 527 can be used to secure the first spot electrode 521 in a desired position in relation to the rest of the electrodes on the tip electrode 501. Similarly, the third spot non-conductive portion 529 can be used to secure the third spot electrode 523 in a desired position in relation to the rest of the electrodes on the tip electrode 501. ”).
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 electrode assembly of Shen so that the insulator preform includes first and second longitudinal channels extending through the proximal portion to the insulator preform distal portion, and the insulating material extends through the first and second longitudinal channels and about the tip electrode shank so as to secure the tip electrode to the insulator preform as taught by Sliwa to secure each electrode in a desired position in relation to the rest of the electrodes (Sliwa [0068]).
Conclusion
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/N.W.R./Examiner, Art Unit 3794 /SEAN W COLLINS/Primary Examiner, Art Unit 3794
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