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.
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.
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(s) 1, 5-6, 8, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sallee et al., (US 20170049349; hereinafter Sallee) in view of Townley, (US 20200405383) and Basu, (US 20170164858).
Regarding claim 1, Sallee (Figures 1-3) discloses a catheter (10), comprising: a shaft (14) for insertion into an organ of a patient; an expandable distal-end assembly (16), which is coupled to the shaft (14) and comprises multiple splines (30), wherein at least one of the multiple splines (30) comprises a flexible substrate (34), which is configured to conform to tissue of the organ; and at least one sensing electrode (36), which is configured: (a) to be coupled to the flexible substrate (34), and (b) when placed in contact with tissue of the organ, to produce an electrical signal indicative of an electrocardiogram (ECG) signal sensed in the tissue, the at least one sensing electrode (36) comprising: (i) a gold substrate (42), which is formed on the flexible substrate (34) and is configured to conduct the electrical signal, (ii) a first polymer layer (48), which comprises a first outer surface (shown in annotated Figure 3 below) configured to be placed in contact with the tissue of the organ, is formed over a first section of the gold substrate (42) and is configured to electrically isolate between the tissue and the gold substrate (42), the first outer surface (shown in annotated Figure 3 below) facing away from the gold substrate (42), and the first polymer laver (48) comprising one or more opening surfaces (vertical surfaces of the first outer surface shown on both sides of the second outer surface in annotated Figure 3 below) extending from the first outer surface to the gold substrate (42) to define an opening (holding second layer 46), and (iii) a second layer (46) disposed within the opening (shown in annotated Figure 3 below as the opening surrounding the area corresponding the second outer surface and second layer 46), which comprises a second outer surface (shown in annotated Figure 3 below) configured to be placed in contact with the tissue of the organ ([0053]: the outer surface of layer 46 must make contact with the target tissue in order to sense the cardiac signals within the heart), is formed over a second section of the gold substrate (42), different from the first section (48), and is configured to conduct the electrical signal between the tissue and the gold substrate (42), the second outer surface (of layer 46) being flush with or protruding relative to the first outer surface (of layer 48), ([0049], [0052]-[0055], [0057]: as shown in annotated Figure 3 below, the second outer surface of layer 46 is flush with/protruding relative to the second outer surface of layer 48).
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Annotated Figure 3 from the Sallee reference
Sallee fails to disclose that the second conductive layer is a polymer layer. However, Townley (Figure 6) teaches an electrosurgical catheter in which the conductive electrode layer is a polymer/PEDOT layer ([0071]). Furthermore, Townley teaches that iridium oxide and PEDOT may be substituted for each other as the conductive layer for the electrode (Townley; [0071]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sallee to include a polymer conductive layer, as taught by Townley, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Sallee/Townley fails to teach the first outer surface of the first polymer layer extending along a first axis and the second outer surface of the second polymer layer extending along the first axis, wherein the second outer surface is flush with or protruding relative to the first outer surface in a direction of the first axis. However, Basu (Figures 1-3) teaches a catheter (10) comprising at least one electrode (20) which may be configured as a sensing electrode ([0034]). The first outer surface of a first insulating layer (24) of the electrode extends along a first longitudinal axis and the second outer surface of a second conductive layer (20) extends along the first longitudinal axis, wherein the second outer surface (of element 20) is flush with or protruding relative to the first outer surface (of element 24) in a direction of the first longitudinal axis ([0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sallee/Townley to include the first outer surface of the first polymer layer extending along a first axis and the second outer surface of the second polymer layer extending along the first axis, wherein the second outer surface is flush with or protruding relative to the first outer surface in a direction of the first axis, as taught by Basu because the modification would facilitate tissue engagement with the conductive layer (Basu; [0034]).
Regarding claim 5, Sallee (Figures 1-3) further discloses wherein the first section (corresponding to the first polymer layer 48) and the second section (corresponding to the second layer 46) have a common interface and do not overlap one another ([0049], [0052]-[0055], [0057]).
Regarding claim 6, Sallee (Figures 1-3) further discloses wherein at least one of the multiple splines (30) comprises one or more of the at least one sensing electrode (36) that are coupled to the flexible substrate (34) at selected positions along a longitudinal axis of the at least one of the multiple splines ([0049], [0052]-[0055], [0057]).
Regarding claim 8, Sallee/Townley/Basu further teaches wherein the second polymer layer (second layer 46 of Sallee with polymer/PEDOT material taught by Townley) includes a circular shape (as shown in Figure 3 of Sallee), and wherein the first polymer layer (first polymer layer 48 of Sallee) is shaped for surrounding the circular shape of the second polymer layer (as shown in Figure 3 of Sallee).
Regarding claim 21, Sallee (Figures 1-3) discloses a catheter (10), comprising: a shaft (14) for insertion into an organ of a patient; an expandable distal-end assembly (16), which is coupled to the shaft (14) and comprises multiple splines (30), wherein at least one of the multiple splines (30) comprises a flexible substrate (34), which is configured to conform to tissue of the organ; and at least one sensing electrode (36), which is configured: (a) to be coupled to the flexible substrate (34), and (b) when placed in contact with tissue of the organ, to produce an electrical signal indicative of an electrocardiogram (ECG) signal sensed in the tissue of the organ, the at least one sensing electrode (36) comprising: (i) a gold substrate (42), which is formed on the flexible substrate (34) and is configured to conduct the electrical signal, (ii) a first polymer layer (48), which comprises a first outer surface (shown in annotated Figure 3 below) configured to be placed in contact with the tissue of the organ, is formed over a first section of the gold substrate (42) and is configured to electrically isolate between the tissue of the organ and the gold substrate (42), the first outer surface (shown in annotated Figure 3 below) facing away from the gold substrate (42), the first outer surface (shown in annotated Figure 3 above) comprising (i) a first section (first vertical portion of the first outer surface directly adjacent to a first right side of the second outer surface in annotated Figure 3 above) disposed on a first (right) side of the second outer surface (shown in annotated Figure 3 above) and (ii) a second section (second vertical portion of the first outer surface directly adjacent to a second left side of the second outer surface in annotated Figure 3 above) disposed on a second (left) side of the second outer surface (shown in annotated Figure 3 above), and the first polymer laver (48) comprising one or more opening surfaces (vertical surfaces of the first outer surface shown on both sides of the second outer surface in annotated Figure 3 below) extending from the first outer surface to the gold substrate (42) to define an opening (holding second layer 46), and (iii) a second layer (46) disposed within the opening (shown in annotated Figure 3 below as the opening surrounding the area corresponding the second outer surface and second layer 46), which comprises a second outer surface (shown in annotated Figure 3 below) configured to be placed in contact with the tissue of the organ ([0053]: the outer surface of layer 46 must make contact with the target tissue in order to sense the cardiac signals within the heart), is formed over a second section of the gold substrate (42), different from the first section (48), and is configured to conduct the electrical signal between the tissue of the organ and the gold substrate (42), ([0049], [0052]-[0055], [0057]).
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Annotated Figure 3 from the Sallee reference
Sallee fails to disclose that the second conductive layer is a polymer layer. However, Townley (Figure 6) teaches an electrosurgical catheter in which the conductive electrode layer is a polymer/PEDOT layer ([0071]). Furthermore, Townley teaches that iridium oxide and PEDOT may be substituted for each other as the conductive layer for the electrode (Townley; [0071]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sallee to include a polymer conductive layer, as taught by Townley, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Sallee/Townley fails to teach the first section of the first outer surface of the first polymer layer and the second section of the second outer surface of the second polymer layer being coplanar such that the second outer surface is flush with or protruding relative to the first outer surface in a direction of the first axis. However, Basu (Figures 1-3) teaches a catheter (10) comprising at least one electrode (20) which may be configured as a sensing electrode ([0034]). The first outer surface of a first insulating layer (24) of the electrode extends along a first longitudinal axis and the second outer surface of a second conductive layer (20) extends along the first longitudinal axis, wherein the second outer surface (of element 20) is flush with or protruding relative to the first outer surface (of element 24) in a direction of the first longitudinal axis ([0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sallee/Townley to include the first section of the first outer surface of the first polymer layer and the second section of the second outer surface of the second polymer layer being coplanar such that the second outer surface is flush with or protruding relative to the first outer surface in a direction of the first axis, as taught by Basu because the modification would facilitate tissue engagement with the conductive layer (Basu; [0034]).
Regarding claim 22, Sallee/Townley/Basu further teaches wherein the second outer surface protrudes relative to the first outer surface (as explained in the rejection of claim 1 above, the modified device includes the second outer surface being flush with or protruding relative to the first outer surface in a direction of the first axis; Basu, [0034]).
Regarding claim 23, Sallee/Townley/Basu further teaches wherein the second outer surface is flush with the first outer surface so as to form a continuous plane with the first outer surface (as explained in the rejection of claim 1 above, the modified device includes the second outer surface being flush with or protruding relative to the first outer surface in a direction of the first axis to form a continuous plane with the first outer surface; Basu, [0034]).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sallee/Townley/Basu as applied to claim 1 above, and further in view of Viswanathan et al, (US 20190231421; hereinafter Viswanathan).
Regarding claims 3-4, Sallee/Townley/Basu further teaches wherein the organ comprises a heart (Sallee; [0053]), but fails to teach one or more ablation electrodes, which are coupled to the flexible substrate of at least one of the multiple splines, wherein the one or more ablation electrodes are positioned on the at least one of the multiple splines at first positions, and the at least one sensing electrode is positioned on the at least one of the multiple splines at a second position, different from the first positions; and wherein when placed in contact with the tissue, at least one of the one or more ablation electrodes is configured to apply to the tissue one or more ablation signals for producing a lesion in the tissue. However, Viswanathan (Figure 33A) an electrosurgical catheter configured for combined ECG sensing and ablation comprising electrodes (3332) which may be configured for ECG sensing and electrodes (3334) which may be configured for ablation coupled to the flexible substrate of at least one spline (3330), wherein the ablation electrodes (3334) are positioned on the spline (3330) at first positions, and the sensing electrode (3332) is positioned on the spline (3330) at a second position, different from the first positions; and wherein when placed in contact with the tissue, at least one of the ablation electrodes (3334) is configured to apply to the tissue one or more ablation signals for producing a lesion in the tissue ([0249]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sallee/Townley/Basu to include one or more ablation electrodes, as taught by Viswanathan, because the modification would provide both ECG and ablation capabilities in one device (Viswanathan; [0013], [0249]) for efficient treatment.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sallee/Townley/Basu as applied to claim 1 above, and further in view of Chou et al., (US 20150366508; hereinafter Chou).
Regarding claim 9, Sallee/Townley/Basu further teaches wherein the second polymer layer comprises poly(3, 4-ethylenedioxythiophene) (PEDOT), or poly(3, 4 ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), (Townley; [0071]: PEDOT), but fails to teach wherein the first polymer layer comprises polyethylene terephthalate (PET) or polyether block amide (PEBA). However, Chou (Figures 1-2B) teaches an electrosurgical catheter in which the polymer layer (230) surrounding a conductive layer comprises PEBA ([0093], [0102]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sallee/Townley/Basu such that the first polymer layer comprises PEBA, as taught by Chou, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Regarding claim 10, Sallee/Townley/Basu teaches the catheter according to claim 1, but fails to teach wherein the flexible substrate comprises an alloy of nickel-titanium, and wherein at least the at least one sensing electrode is coupled to the alloy of nickel-titanium. However, Chou (Figures 1-2b) teaches an electrosurgical catheter in which the flexible substrate comprises an alloy of nickel-titanium ([0076]-[0077], [0145]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sallee/Townley/Basu such that the flexible substrate comprises an alloy of nickel-titanium, as taught by Chou, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07. Furthermore, since the at least one sensing electrode is coupled to the flexible substrate in the base Sallee device, the at least one sensing electrode would be coupled to the alloy of nickel-titanium in the modified device.
Response to Arguments
Applicant’s arguments filed 10/02/2025, with regard to the newly amended limitations of claims 1 and 21, have been fully considered and are persuasive. Therefore, the rejection(s) has/have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art reference Basu, which teaches a catheter comprising at least one electrode including a first outer surface of a first insulating layer of the electrode extending along a first longitudinal axis and a second outer surface of a second conductive layer extending along the first longitudinal axis, wherein the second outer surface is flush with or protruding relative to the first outer surface in a direction of the first longitudinal axis. In combination with Sallee/Townley, the modified device teaches the invention as recited at least in the currently amended set of claims.
Conclusion
THIS ACTION IS MADE FINAL. 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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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794