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 12/23/2021.
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, see pages 8-10, filed 5/11/2026, with respect to the rejections of claims 1, 14, 22, and 29-30 under 35 U.S.C. 102(a)(2) as being anticipated by Olson have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Narayan, which is now used to rejected claims 1, 14, 22, and 29-30.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 8-10, 12-15, 17, 19, 21-24, and 26-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Narayan et al., US 20230049942, herein referred to as “Narayan”.
Regarding claim 1, Narayan discloses an apparatus (Figures 1 and 14), comprising: a conduit having a proximal end and a distal end (sheath not labeled in Figure 1, same as Figure 4A: sheath 410), the conduit defining a longitudinal axis extending from the proximal end to the distal end (Figure 1 and Figure 14: center axis 1406); and a contact assembly (Figure 14) extending from the distal end of the conduit (not shown in Figure 14, see Figure 1), the contact assembly including: a monolithic connecting component configured to provide structural support to the contact assembly (Figure 14: connectors 1430 and [0222]: “The splines 1420 and connectors 1430 may be monolithically formed.”), including a tube support section (Figure 14: the portion of connectors 1430 that are covered by splines 1420) and a lateral support section disposed between the tube support section and a distal tip of the contact assembly (Figure 14: the portion of connectors 1430 that are uncovered by splines 1420); a plurality of tubes disposed on the tube support section of the connecting component (Figure 14: splines 1420); and a plurality of conductive elements disposed on the plurality of tubes (Figure 14: electrode array 1440) and configured to measure physiological signals associated with a patient ([0067]: “The present invention relates to a novel system for use in a diagnostic and/or treatment device for the management of biological rhythm disorders, comprising a catheter and software for mapping and identification of critical regions (sources) of the biological rhythm disorder for therapy. The novel catheter is capable of both sensing electrical signals in tissue and ablating source regions.”).
Regarding claim 2, Narayan discloses the apparatus of claim 1, further comprising an elongated conductor coupled to the connecting component (not shown in Figure 14, same as conductor wires 360 in Figure 3A) and configured to deliver electroporation ablation therapy to the patient ([0067]: “The present invention relates to a novel system for use in a diagnostic and/or treatment device for the management of biological rhythm disorders, comprising a catheter and software for mapping and identification of critical regions (sources) of the biological rhythm disorder for therapy. The novel catheter is capable of both sensing electrical signals in tissue and ablating source regions.”), wherein each conductive element from the plurality of conductive elements is electrically isolated from the elongated conductor ([0139]: “The splines 420 are flexible and insulative, e.g., formed with Nitinol having an insulative coating composed of polyether block amide (PEBA).”).
Regarding claim 3, Narayan discloses the apparatus of claim 1, wherein the plurality of conductive elements is configured to measure physiological signals from various locations on tissue of a heart of the patient ([0147]: “Each electrode of the electrode array 440 is capable of sensing electrical signals of the heart tissue and for delivering ablation energy to the heart tissue.”; wherein the electrodes of electrode array 1440 have the same capabilities).
Regarding claim 4, Narayan discloses the apparatus of claim 1, wherein the conductive elements are ring electrodes (Figure 14: electrodes of electrode array 1440 are ring electrodes), each ring electrode having a nominal length of at least about 0.5 mm to no more than about 1.0 mm ([0147]: “For example, the size of each electrode in FIG. 4 is on the order of 0.8 mm diameter (it is a cylinder), measured along the center axis 406 and 1 mm along the spline.”; wherein the electrodes of electrode array 1440 are similar and wherein the language “at least about” and “no more than about” is broad and thus is interpreted broadly).
Regarding claim 5, Narayan discloses the apparatus of claim 4, wherein each ring electrode has a nominal outer diameter of at least about 0.6 mm to no more than about 0.85 mm ([0147]: “For example, the size of each electrode in FIG. 4 is on the order of 0.8 mm diameter (it is a cylinder), measured along the center axis 406 and 1 mm along the spline.”; wherein the electrodes of electrode array 1440 are similar and wherein the language “at least about” and “no more than about” is broad and thus is interpreted broadly).
Regarding claim 8, Narayan discloses the apparatus of claim 1, wherein the lateral support section is structurally weaker than the tube support section (Figure 14: not having the material of splines 1420 makes this section structurally weaker) such that the connecting component can be flexed concavely or convexly ([0140]: “The connectors 430 are also flexible and insulative, e.g., formed with Nitinol with an insulative coating.”; wherein the connectors in Figure 14 are made of the same material).
Regarding claim 9, Narayan discloses the apparatus of claim 1, wherein the connecting component is configured to place the contact assembly in an expanded configuration in which the plurality of tubes is oriented along a plane and each tube from the plurality of tubes is disposed parallel to all the other tubes from the plurality of tubes such that the contact assembly can lay flat at a close proximity of or flush to intracardiac tissue of a patient (Figure 14 and [0005]: “The implementation of the connector struts provides for a creative solution for easy expansion and collapse of the catheter from the sheath.”).
Regarding claim 10, Narayan discloses the apparatus of claim 9, wherein the connecting component includes an insulating material ([0140]: “The connectors 430 are also flexible and insulative, e.g., formed with Nitinol with an insulative coating.”; wherein the connectors in Figure 14 are made of the same material).
Regarding claim 12, Narayan discloses the apparatus of claim 9, wherein the connecting component includes a conductive material ([0140]: “The connectors 430 are also flexible and insulative, e.g., formed with Nitinol with an insulative coating.”; wherein the connectors in Figure 14 are made of the same material).
Regarding claim 13, Narayan discloses the apparatus of claim 12, wherein the conductive material is nitinol ([0140]: “The connectors 430 are also flexible and insulative, e.g., formed with Nitinol with an insulative coating.”; wherein the connectors in Figure 14 are made of the same material).
Regarding claim 14, Narayan discloses the apparatus of claim 9, wherein the lateral support section includes a V- shape with arms and a vertex, with the arms extending distally from the vertex (Figure 14: vertex between 1430A and 1430B has arms that extend distally and make a V-shape).
Regarding claim 15, Narayan discloses the apparatus of claim 8, wherein the contact assembly is configured to transition from the expanded configuration to a compressed configuration in which the plurality of tubes are compressed towards each other such that the contact assembly has an outer diameter substantially similar to an inner diameter of the conduit ([0108]: “he catheter 155 is deployed from the shaft 150”).
Regarding claim 17, Narayan discloses the apparatus of claim 2, wherein the elongated conductor is configured to establish a potential with respect to one or more conductive elements from the plurality of conducting elements, the potential capable of delivering energy to cause electroporation of cardiac cells included in tissue of a heart of the patient ([0151]: “”In an ablation configuration, each electrode can be configured to deliver ablation energy to heart tissue. … This also includes very high powers associated with pulsed field ablation (to cause irreversible electroporation).”).
Regarding claim 19, Narayan discloses the apparatus of claims 2, wherein the elongated conductor is made of nitinol ([0140]: “The connectors 430 are also flexible and insulative, e.g., formed with Nitinol with an insulative coating.”; wherein the connectors in Figure 14 are made of the same material).
Regarding claim 21, Narayan discloses the apparatus of claim 1, wherein the distal tip is convex and atraumatic (Figure 14: distal tip is convex and atraumatic), and the plurality of tubes terminate proximal to the lateral support section (Figure 14: splines 1420 terminate proximal to distal section).
Regarding claim 22, Narayan discloses an apparatus (Figures 1 and 14), comprising: a conduit having a proximal end and a distal end (sheath not labeled in Figure 1, same as Figure 4A: sheath 410), the conduit defining a longitudinal axis extending from the proximal end to the distal end (Figure 1 and Figure 14: center axis 1406); and a contact assembly (Figure 14) extending from the distal end of the conduit (not shown in Figure 14, see Figure 1), the contact assembly including: a connecting component configured to provide structural support to the contact assembly (Figure 14: connectors 1430 and [0222]: “The splines 1420 and connectors 1430 may be monolithically formed.”), including a tube support section (Figure 14: the portion of connectors 1430 that are covered by splines 1420) and a lateral support section disposed between the tube support section and a distal tip of the contact assembly (Figure 14: the portion of connectors 1430 that are uncovered by splines 1420); a plurality of tubes disposed on the tube support section of the connecting component (Figure 14: splines 1420); a plurality of conductive elements disposed on the plurality of tubes (Figure 14: electrode array 1440) and configured to measure physiological signals associated with a patient ([0067]: “The present invention relates to a novel system for use in a diagnostic and/or treatment device for the management of biological rhythm disorders, comprising a catheter and software for mapping and identification of critical regions (sources) of the biological rhythm disorder for therapy. The novel catheter is capable of both sensing electrical signals in tissue and ablating source regions.”); and an elongated conductor coupled to the connecting component (not shown in Figure 14, same as conductor wires 360 in Figure 3A) and configured to deliver electroporation ablation therapy to the patient ([0067]: “The present invention relates to a novel system for use in a diagnostic and/or treatment device for the management of biological rhythm disorders, comprising a catheter and software for mapping and identification of critical regions (sources) of the biological rhythm disorder for therapy. The novel catheter is capable of both sensing electrical signals in tissue and ablating source regions.”), wherein each conductive element from the plurality of conductive elements is electrically isolated from the elongated conductor ([0139]: “The splines 420 are flexible and insulative, e.g., formed with Nitinol having an insulative coating composed of polyether block amide (PEBA).”).
Regarding claim 23, Narayan discloses the apparatus of claim 22, wherein the distal tip includes at least one of a lubricant coating or a biocompatible plastic coating ([0140]: “The connectors 430 are also flexible and insulative, e.g., formed with Nitinol with an insulative coating.”; wherein the connectors in Figure 14 are made of the same material and [0139]: “Other example insulative materials that may be used include, but are not limited to, polyimides, polyamide-imides, PTFE, other high performance plastics, etc.”).
Regarding claim 24, Narayan discloses the apparatus of claim 22, wherein the plurality of conductive elements is configured to measure the physiological signals to collectively construct a three-dimensional map of the heart of the patient ([0281]: “Cardiac Images (magnetic resonance imaging, computed tomography), or other indices that may have diagnostic value. More detailed data includes three-dimensional anatomical and structural abnormalities.”).
Regarding claim 26, Narayan discloses the apparatus of claim 22, wherein the conductive elements are ring electrodes (Figure 14: electrodes of electrode array 1440 are ring electrodes), each ring electrode having a nominal length of at least about 0.5 mm to no more than about 1.0 mm ([0147]: “For example, the size of each electrode in FIG. 4 is on the order of 0.8 mm diameter (it is a cylinder), measured along the center axis 406 and 1 mm along the spline.”; wherein the electrodes of electrode array 1440 are similar and wherein the language “at least about” and “no more than about” is broad and thus is interpreted broadly).
Regarding claim 27, Narayan discloses the apparatus of claim 22, wherein the lateral support section is structurally weaker than the tube support section (Figure 14: not having the material of splines 1420 makes this section structurally weaker) such that the connecting component can be flexed concavely or convexly ([0140]: “The connectors 430 are also flexible and insulative, e.g., formed with Nitinol with an insulative coating.”; wherein the connectors in Figure 14 are made of the same material).
Regarding claim 28, Narayan discloses the apparatus of claim 22, wherein the connecting component is configured to place the contact assembly in an expanded configuration in which the plurality of tubes is oriented along a plane and each supporting tube from the plurality of tubes is disposed parallel to all the other tubes from the plurality of tubes such that the contact assembly can lay flat at a close proximity of or flush to intracardiac tissue of the patient (Figure 14 and [0005]: “The implementation of the connector struts provides for a creative solution for easy expansion and collapse of the catheter from the sheath.”).
Regarding claim 29, Narayan discloses the apparatus of claim 22, wherein the elongated conductor is a Nitinol tube disposed about the connecting component ([0140]: “The connectors 430 are also flexible and insulative, e.g., formed with Nitinol with an insulative coating.”; wherein the connectors in Figure 14 are made of the same material)
Regarding claim 30, Narayan discloses the apparatus of claim 22, wherein the lateral support section includes a V-shape with arms and a vertex, with the arms extending distally from the vertex (Figure 14: vertex between 1430A and 1430B has arms that extend distally and make a V-shape).
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 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Narayan in view of Gundert et al., US 20230240746, herein referred to as “Gundert”.
Regarding claim 6, Narayan discloses the apparatus of claim 1, wherein one or more of the conductive elements from the plurality of conductive elements are configured to measure a voltage ([0150]) but does not explicitly disclose an apparatus wherein one or more of the conductive elements from the plurality of conductive elements are configured to measure a voltage with respect to a ground electrode, the ground electrode being spaced from the plurality of conductive elements, the voltage being associated with depolarization of the tissue of the heart during a heartbeat.
However, Gundert teaches an apparatus (Figure 1A) wherein one or more of the conductive elements from the plurality of conductive elements are configured to measure a voltage with respect to a ground electrode ([0071]), the ground electrode being spaced from the plurality of conductive elements (Figure 1A: active electrode 108 and return electrode 140 are spaced apart), the voltage being associated with depolarization of the tissue of the heart during a heartbeat ([0055]-[0056]).
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 apparatus disclosed by Narayan so that one or more of the conductive elements from the plurality of conductive elements are configured to measure a voltage with respect to a ground electrode as taught by Gundert so that the resolution of the measurements can be specifically tailored to and optimized, respectively, for the range of expected HV measurements the range of expected LV measurements (Gundert [0072]).
Regarding claim 20, Narayan discloses the apparatus of claim 2, wherein the elongated conductor has a nominal diameter of at least about 0.2 millimeters and no more than about 1 mm ([0147]: “For example, the size of each electrode in FIG. 4 is on the order of 0.8 mm diameter (it is a cylinder), measured along the center axis 406 and 1 mm along the spline.” wherein the language “at least about” and “no more than about” is broad and thus is interpreted broadly), but does not explicitly disclose an apparatus wherein the elongated conductor has a nominal length of at least 2 mm and no more than about 20 mm.
However, Gundert teaches an apparatus (Figure 1A) wherein the elongated conductor has a nominal length of at least 2 mm and no more than about 20 mm ([0030]: “In this embodiment, the delivery electrode 108 is shown as a “solid tip” electrode having a cylindrical shape with a distal face having a continuous surface. In some embodiments, the cylindrical shape has a diameter across its distal face of approximately 2-3 mm and a length along the shaft 106 of approximately 1 mm, 2 mm, 1-2 mm, 3 mm, 4 mm, 3-4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, etc. ”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Narayan so that the elongated conductor has a nominal length of at least 2 mm and no more than about 20 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Narayan in view of Olson et al., US 20250177037, herein referred to as “Olson”.
Regarding claim 7, Narayan discloses the apparatus of claim 1, but does not explicitly disclose an apparatus wherein the plurality of conductive elements is configured to measure a plurality of voltages to collectively construct a three-dimensional map of electrical propagation through the heart during a heartbeat.
However, Olson teaches an apparatus wherein the plurality of conductive elements is configured to measure a plurality of voltages to collectively construct a three-dimensional map of electrical propagation through the heart during a heartbeat ([0051]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Narayan so that the plurality of conductive elements is configured to measure a plurality of voltages to collectively construct a three-dimensional map of electrical propagation through the heart during a heartbeat as taught by Olson to remove catheter orientation-based signal effects (Olson [0051]).
Regarding claim 16, Narayan discloses the apparatus of claim 8, but does not explicitly disclose an apparatus wherein the outer diameter of the conduit is no more than about 8.5 Fr.
However, Olson teaches an apparatus wherein the outer diameter of the conduit is no more than about 8.5 Fr (Figure 1E: catheter shaft 508 is no more than about 2.83 mm wherein the language “no more than about” is broad and thus is interpreted broadly; [0025]: “For example, an electrode can have a small diameter and surface area, such as 0.8 millimeters in diameter”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus disclosed by Narayan so that the outer diameter of the conduit is no more than about 8.5 Fr as taught by Olson to achieve desired resiliency, flexibility, foldability, conformability, and stiffness characteristics (Olson [0053]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Narayan.
Regarding claim 11, Olson discloses the apparatus of claim 10 including the insulating material ([0047]: “ Suitable material for outer layer 512 includes, without limitation, polyethylene terephthalate (PET), parylene, polyimide (e.g., PI-2771 or HD-4004 available from HD Microsystems), polyether block amide (PEBA) and/or an adhesive (e.g., SU8 epoxy available from MicroChem Corp). Where the electrode support member is made of electrically conductive material, the dielectric can electrically insulate electrodes that are mounted thereon (not shown) from the electrically conductive material. ”). Olson does not explicitly disclose that the insulating material is nylon.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use nylon as the insulating material, 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. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Narayan in view of Byrd et al., US 20210161582, herein referred to as “Byrd”.
Regarding claim 18, Narayan discloses the apparatus of claim 17, but does not explicitly disclose an apparatus wherein the potential is at least about 3,000 volts to no more than about 15,000 volts.
However, Byrd teaches an apparatus (Figure 1) wherein the potential is at least about 3,000 volts to no more than about 15,000 volts ([0053]: “ In some embodiments, electroporation generator 26 outputs or generates a DC pulse having a peak magnitude of between about 500 V and about 3.5 kV, between about 600 V and 2.5 kV, between about 800 V and about 3.5 kV, between about 600 V and about 2.0 kV, between about 800 V and about 2.5 kV, between about 1.0 kV and about 3.5 kV, between about 600 V and about 1.5 kV, between about 800 V and about 2.0 kV, or between about 1.0 kV and about 2.5 kV.”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to set the potential to be at least about 3,000 volts to no more than about 15,000 volts, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Narayan in view of Sobe, US 10390889, herein referred to as “Sobe”.
Regarding claim 25, Narayan discloses the apparatus of claim 22, but does not explicitly disclose an apparatus wherein the plurality of supporting tubes include wound coils, the wound coils configured to interact magnetically with an electromagnetic localization sensor to determine a location of the plurality of supporting tubes with respect to the heart of the user.
However, Sobe teaches an apparatus (Figure 1) wherein the support tube includes wound coils (Figure 1: positioning sensor 32), the wound coils configured to interact magnetically with an electromagnetic localization sensor to determine a location of the plurality of supporting tubes with respect to the heart of the patient (Col. 6, line 60 – Col. 7, line 7). In combination with Narayan, the coils of Sobe are part of the plurality of supporting tubes, splines 1420 of Narayan.
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 apparatus disclosed by Narayan so that the plurality of supporting tubes include wound coils, the wound coils configured to interact magnetically with an electromagnetic localization sensor to determine a location of the plurality of supporting tubes as taught by Sobe to notify the user of the position and orientation of the device (Sobe Col. 1, lines 22-32).
Conclusion
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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