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 .
Election/Restrictions
Applicant’s election without traverse of the species depicted by Figures 13-14B, Figure 8, and Figure 7A in the reply filed on 1/20/2026 is acknowledged.
Claim Objections
Claims 24-25 are objected to because of the following informalities:
Claim 24, line 3: “the user” should read –the patient--; and
Claim 25, line 4: “the user” should read –the patient--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-21, 25, and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the patient" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Regarding dependent claims 2-21, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(b).
Regarding claims 2, 9, and 17, the claims recite the language “a patient” in lines 3, 6, and 4, respectively. It is unclear if this is the same patient claimed in claim 1 or a different patient. Clarity is needed. For examination purposes, the “patient” in claims 2, 9, and 17 will be considered the same patient as disclosed in line 12 of claim 1.
Claims 9, 15, 25, and 28 recite the limitation “the plurality of supporting tubes” in lines 2-5, lines 2-3, line 1, and lines 2-5, respectively. There is insufficient antecedent basis for this limitation in the claims.
Regarding claim 28, the claim recites the language “a patient” in line 6. It is unclear if this is the same patient claimed in claim 22 or a different patient. Clarity is needed. For examination purposes, the “patient” in claim 28 will be considered the same patient as disclosed in line 12 of claim 22.
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, 7-10, 12-17, 19, 21-24, and 26-30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Olson et al., US 20250177037, herein referred to as “Olson”.
Regarding claim 1, Olson discloses an apparatus (Figure 1E), comprising: a conduit having a proximal end and a distal end (Figure 1E: catheter shaft 508), the conduit defining a longitudinal axis extending from the proximal end to the distal end ([0052]: “The catheter shaft 508 may also define a catheter shaft longitudinal axis.”); and a contact assembly (Figure 1E: multi-electrode assembly 500) extending from the distal end of the conduit (Figure 1E), the contact assembly including: a monolithic connecting component configured to provide structural support to the contact assembly (Figure 1E: energy delivery region 507), including a tube support section (Figure 1E: struts 502-505) and a lateral support section disposed between the tube support section and a distal tip of the contact assembly (Figure 1E: coupler 514 and outer layer 512); a plurality of tubes disposed on the tube support section of the connecting component (Figure 1E: struts 502-505 and outer layer 512); and a plurality of conductive elements disposed on the plurality of tubes (Figure 1E: electrodes 506) and configured to measure physiological signals associated with the patient ([0051]).
Regarding claim 2, Olson discloses the apparatus of claim 1, further comprising an elongated conductor coupled to the connecting component ([0047]: “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. ”) and configured to deliver electroporation ablation therapy to a patient ([0049] and [0003]), wherein each conductive element from the plurality of conductive elements is electrically isolated from the elongated conductor ([0047] and [0049]).
Regarding claim 3, Olson 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 ([0051]).
Regarding claim 4, Olson discloses the apparatus of claim 1, wherein the conductive elements are ring electrodes (Figure 1E: electrodes 506 are ring electrodes and [0055]), each ring electrode having a nominal length of at least about 0.5 mm to no more than about 1.0 mm ([0025]: “ An exemplary exposed electrode surface area can be about 2.5 mm.sup.2 or less, such as roughly 1 mm.sup.2; however, smaller or larger areas can be exposed as dictated by the nature of the catheter and by the electrode's intended application. For example, an electrode can have a small diameter and surface area, such as 0.8 millimeters in diameter with a total surface area of 0.3 to 0.5 mm.sup.2.”’ wherein the language “at least about” and “no more than about” is broad and thus is interpreted broadly).
Regarding claim 5, Olson 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 ([0025]: “For example, an electrode can have a small diameter and surface area, such as 0.8 millimeters in diameter”).
Regarding claim 7, Olson discloses the apparatus of claim 1, 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]).
Regarding claim 8, Olson discloses the apparatus of claim 1, wherein the lateral support section is structurally weaker than the tube support section such that the connecting component can be flexed concavely or convexly ([0053]).
Regarding claim 9, Olson 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 supporting tubes is oriented along a plane and each supporting tube from the plurality of supporting tubes is disposed parallel to all the other supporting tubes from the plurality of supporting tubes such that the contact assembly can lay flat at a close proximity of or flush to intracardiac tissue of a patient (Figure 1E and [0059]).
Regarding claim 10, Olson discloses the apparatus of claim 9, wherein the connecting component includes an 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. ”).
Regarding claim 12, Olson discloses the apparatus of claim 9, wherein the connecting component includes a conductive material ([0047]: “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. ”).
Regarding claim 13, Olson discloses the apparatus of claim 12, wherein the conductive material is nitinol ([0020]: “In some cases, the electrode support member is constructed entirely, or in part, of nitinol, referred to herein as a nitinol-based electrode support member.”).
Regarding claim 14, Olson 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 1E: vertex is coupler 514, arms are outer layer 512, thus forming a V-shape).
Regarding claim 15, Olson 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 supporting tubes are compressed towards each other such that the contact assembly has an outer diameter substantially similar to an inner diameter of the conduit ([0053]).
Regarding claim 16, Olson discloses the apparatus of claim 8, 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”).
Regarding claim 17, Olson 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 a patient ([0057] and [0049]: “Struts 502-505 include interelectrode regions configured to deliver ablation energy. ”).
Regarding claim 19, Olson discloses the apparatus of claims 2, wherein the elongated conductor is made of nitinol ([0020]: “In some cases, the electrode support member is constructed entirely, or in part, of nitinol, referred to herein as a nitinol-based electrode support member. ”).
Regarding claim 21, Olson discloses the apparatus of claim 1, wherein the distal tip is convex and atraumatic (Figure 1F: coupler 514 is convex and atraumatic), and the plurality of tubes terminate proximal to the lateral support section (Figure 1E: struts 502-505 terminate at outer tubing 512, which is proximal the lateral support section).
Regarding claim 22, Olson discloses an apparatus (Figure 1E), comprising: a conduit having a proximal end and a distal end (Figure 1E: catheter shaft 508), the conduit defining a longitudinal axis extending from the proximal end to the distal end ([0052]: “The catheter shaft 508 may also define a catheter shaft longitudinal axis.”); and a contact assembly (Figure 1E: multi-electrode assembly 500) extending from the distal end of the conduit (Figure 1E), the contact assembly including: a connecting component configured to provide structural support to the contact assembly (Figure 1E: energy delivery region 507), including a tube support section (Figure 1E: struts 502-505) and a lateral support section disposed between the tube support section and a distal tip of the contact assembly (Figure 1E: coupler 514 and outer layer 512); a plurality of tubes disposed on the tube support section of the connecting component (Figure 1E: struts 502-505 and outer layer 512); a plurality of conductive elements disposed on the plurality of tubes (Figure 1E: electrodes 506) and configured to measure physiological signals associated with the patient ([0051]); and an elongated conductor coupled to the connecting component ([0047]: “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. ”) and configured to deliver electroporation ablation therapy to the patient ([0049] and [0003]), wherein each conductive element from the plurality of conductive elements is electrically isolated from the elongated conductor ([0047] and [0049]).
Regarding claim 23, Olson discloses the apparatus of claim 22, wherein the distal tip includes at least one of a lubricant coating or a biocompatible plastic coating ([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. ”).
Regarding claim 24, Olson 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 ([0051]).
Regarding claim 26, Olson discloses the apparatus of claim 22, wherein the conductive elements are ring electrodes (Figure 1E: electrodes 506 are ring electrodes and [0055]), each ring electrode having a nominal length of at least about 0.5 mm to no more than about 1.0 mm ([0025]: “ An exemplary exposed electrode surface area can be about 2.5 mm.sup.2 or less, such as roughly 1 mm.sup.2; however, smaller or larger areas can be exposed as dictated by the nature of the catheter and by the electrode's intended application. For example, an electrode can have a small diameter and surface area, such as 0.8 millimeters in diameter with a total surface area of 0.3 to 0.5 mm.sup.2.”’ wherein the language “at least about” and “no more than about” is broad and thus is interpreted broadly).
Regarding claim 27, Olson discloses the apparatus of claim 22, wherein the lateral support section is structurally weaker than the tube support section such that the connecting component can be flexed concavely or convexly ([0053]).
Regarding claim 28, Olson 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 supporting tubes is oriented along a plane and each supporting tube from the plurality of supporting tubes is disposed parallel to all the other supporting tubes from the plurality of supporting tubes such that the contact assembly can lay flat at a close proximity of or flush to intracardiac tissue of a patient (Figure 1E and [0059]).
Regarding claim 29, Olson discloses the apparatus of claim 22, wherein the elongated conductor is a Nitinol tube disposed about the connecting component ([0020]: “In some cases, the electrode support member is constructed entirely, or in part, of nitinol, referred to herein as a nitinol-based electrode support member. ”).
Regarding claim 30, Olson 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 1E: vertex is coupler 514, arms are outer layer 512, thus forming 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 Olson in view of Gundert et al., US 20230240746, herein referred to as “Gundert”.
Regarding claim 6, Olson 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 ([0028]) 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 Olson 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, Olson discloses the apparatus of claim 3, wherein the elongated conductor has a nominal diameter of at least about 0.2 millimeters and no more than about 1 mm ([0025]: “For example, an electrode can have a small diameter and surface area, such as 0.8 millimeters in diameter”), 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 Olson 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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Olson.
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 Olson in view of Byrd et al., US 20210161582, herein referred to as “Byrd”.
Regarding claim 18, Olson 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 Olson in view of Sobe, US 10390889, herein referred to as “Sobe”.
Regarding claim 25, Olson 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 Olson, the coils of Sobe are part of the plurality of supporting tubes, outer layer 512 of Olson.
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 Olson 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