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 Species A, Claims 2-6 & 11 in the reply filed on April 28th, 2026 is acknowledged. Claims 7-10 & 12-21 are withdrawn from consideration. Claim 7 comprises subject matter directed to unelected Species C, (Figs. 9-10); claims 8-10 are therefore withdrawn since they depend from a withdrawn claim.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2, line 10: “the plurality of electrodes configured” should read --the plurality of electrodes are configured--.
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 2-6 & 11 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.
Regarding claim 2, the claim recites “each aperture” in line 9 and it is unclear if these are the same apertures as the plurality of apertures recited in line 2 or are different apertures. For examination purposes, these are the same apertures and the limitation will be interpreted as “each aperture of the plurality of apertures”.
Regarding claim 2, the claim recites “a ventricle” in line 17 and it is unclear if this is the same ventricle or a different ventricle from line 15. For examination purposes, these are the same ventricles and the limitation will be interpreted as “the ventricle”.
Claims 2-6 & 11 are also rejected by virtue of their dependency on claim 2.
Regarding claim 6, the claim recites “Purkinje fibers” and it is unclear if these are the same Purkinje features as the “Purkinje tissue” recited in claim 2, from which claim 6 depends or are a different Purkinje tissue/fiber. For examination purposes, these are the same Purkinje tissue and the limitation will be interpreted as “the Purkinje tissue”.
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.
Claims 2-6 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Rioux et al. (U.S. Pub. No. 20090099560, cited in IDS), herein referred to as "Rioux" in view of Harlev et al. (U.S. Pub. No. 20200205890, cited in IDS) and further in view of Radl et al. (U.S. Pub. No. 20190105057, cited in IDS), herein referred to as "Radl".
Regarding claim 2, Rioux discloses an electroporation catheter (Abstract: A tissue treatment system … one or more electrodes that deliver RF energy to the target tissue; wherein an electrode capable of RF delivery is also capable of electroporation), comprising:
a single catheter shaft (shaft 18) having a distal-most portion (distal end 22) defining a plurality of apertures (perfusion ports 38) arranged linearly along the single catheter shaft (see Figs. 3 & 4; [0032]: The probe 12 further comprises a plurality of perfusion ports 38 carried by the distal end 22 of the shaft 18; [0041]: FIGS. 3 and 4 illustrate a single set of aligned perfusion ports 38);
a balloon (expandable occlusive body 40) coupled to the single catheter shaft ([0033] The probe 12 further comprises one or more expandable occlusive bodies 40 carried by the distal end 22 of the shaft 18), the balloon having a length extending along a proximal-to-distal direction of the single catheter shaft and an outer profile size that extends transverse to the length, wherein the outer profile size is greater than the length (see Figs. 3 & 4 where the expandable occlusive body is shown as being a disk shape where the circumference/outer profile size is greater than the length extending along a proximal to distal direction of the catheter shaft);
a plurality of electrodes (electrodes 32) coupled to the distal-most portion of the single catheter shaft that extends distally of the balloon (see Figs. 3 & 4; [0031]: The probe 12 further comprises one or more electrodes 32 carried by the distal end 22 of the shaft 18), the plurality of electrodes distributed among the plurality of apertures such that each aperture is positioned between two adjacent electrodes of the plurality of the electrodes ([0039]: The perfusion ports 38 are located near the electrode(s) 32, and in particular, at least one port 38 is located between the windings of the electrode 32(1) or electrodes 32(2), 32(3), as shown in FIGS. 3 and 4; see alternating patterning in Figs. 3-4), wherein the plurality of electrodes configured to selectively electroporate a Purkinje tissue while causing minimal damage to a healthy heart tissue (wherein absent a clear structural recitation of an electrode feature used exclusively for selectively electroporating a Purkinje tissue while causing minimal damage to a healthy heart tissue, all electrodes for ablation are seen as being capable of selectively electroporating a Purkinje tissue while causing minimal damage to a healthy heart tissue);
wherein the balloon is shaped to occlude and extend into a mitral valve or a tricuspid valve of a heart associated with a ventricle of the heart, such that when the balloon is inflated, the inflated balloon fills a portion of the ventricle ([0043]: The balloon 40(1) is radially expandable about the distal end 22 of the probe shaft 18, having a diameter when fully expanded that is consistent with or slightly greater than the inner diameter of the vessel in which the balloon 40(1) is introduced, e.g., about one to three centimeters; wherein a balloon with a diameter of 1-3 cm is capable of occluding a mitral or tricuspid valve and when inflated, the balloon fills a portion of the ventricle alongside occluding the mitral valve), and
wherein the pluralities of apertures and electrodes are disposed distally of the balloon ([0044]: referring to FIG. 3, the electrode 32(1) and the perfusion ports 38 are located on one side of the balloon 40(1), preferably a distal side of the balloon 40(1)), such that the pluralities of apertures and electrodes are configured to be positioned within the ventricle when the balloon occludes the mitral or tricuspid valves ([0044]: the electrode 32(1) and the perfusion ports 38 are located on one side of the balloon 40(1), preferably a distal side of the balloon 40(1), so that the expanded balloon 40(1) occludes the target vessel on the proximal side of the electrode 32(1) and the perfusion ports 38. Thus, mobile bodily fluids approaching the target vessel region from the proximal side of the balloon 40(1) are prevented from entering the target vessel region; where if this device was to be used for mitral/tricuspid valve occlusion, the electrodes and apertures distal to the balloon would be within the ventricle when the balloon is occluding the mitral or tricuspid valve).
But Rioux fails to disclose one or more sensors configured to monitor an ablation signal, an impedance of the distal-most portion of the single catheter shaft, and an aortic blood pressure waveform; and
a feedback circuit operatively coupled to the one or more sensors, the feedback circuit configured to modulate blood flow in and/or out of a ventricle and/or an aorta.
However, Harlev discloses one or more sensors configured to monitor an ablation signal ([0155]: sensing electrode 146 (on balloon 122 which is on the distal end portion of the catheter) can be passive and sense a voltage difference between its conductive components 150, 152 The resistance or impedance can be used to detect good contact between tissue and the conductive surface near the sensing electrode 146, an undesired blood coating on the sensing electrode 146, and a poor current flow to the return electrodes 118) and an impedance of the distal-most portion of the single catheter shaft ([0155]: sensing electrode 146 (on balloon 122 which is on the distal end portion of the catheter) can be passive and sense a voltage difference between its conductive components 150, 152. The voltage difference between the conductive components 150, 152 and the current applied between the conductive outer surface and the return electrode 118 can be used to determine an impedance. [0158]: impedance is an indicator of lesion formation, such monitoring can accurately determine when the application of ablation energy can be terminated); and
a feedback circuit operatively coupled to the one or more sensors, the feedback circuit configured to modulate blood flow in and/or out of a ventricle and/or an aorta ([0162]: a titration of power and flow in order to maximize lesion size and avoid endocardial sparing. In the first phase, lasting approximately 30 seconds, high (e.g., 15-30 mL/min) flow could be used with a lower power setting (e.g., 40 W). This phase helps heat the immediate endocardial tissue, reducing its impedance, thus allowing deeper penetration of power in the second phase. Once heating and impedance drop is accomplished, a second phase, lasting approximately 30 seconds, with the same flow and higher power (e.g., 300 W) can be applied; where automatic adjustment of irrigation fluid flow based off of tissue impedance is seen as a feedback circuit coupled to the one or more sensors and the catheter is capable of the increase/decrease in fluid flow is modulating blood flow in and/or out of a ventricle and/or an aorta if placed in a ventricle). Therefore, it would have been obvious to one of ordinary skill before the effective filing date to modify the catheter of Rioux to include the one or more sensors and feedback circuit of Harlev for the purpose of utilizing the sensors to detect good contact between tissue and the conductive surface near the sensing electrode and for using the impedance measurements to accurately determine when the application of ablation energy can be terminated and the feedback circuit reducing the effects of endocardial sparing, which is undesirable when applying a permanent ablation lesion (Harlev: [0155], [0158], [0162]).
But Rioux in view of Harlev fail to disclose one or more sensors configured to monitor an aortic blood pressure waveform.
However, Radl discloses one or more sensors configured to monitor an aortic blood pressure waveform ([0079]: monitoring the pressure in the aorta above the balloon by means of the pressure sensor 48.). Therefore, it would have been obvious to one of ordinary skill before the effective filing date to modify the sensor of Rioux in view of Harlev to include the blood pressure monitoring of Radl for the purpose of monitoring the pressure in the aorta above the balloon because some blood will be enabled to flow past the balloon to perfuse tissues of the lower extremities (Radl: [0079]).
Regarding claim 3, Rioux discloses wherein the plurality of apertures allows for injection of a fluid through a lumen defined by the single catheter shaft ([0032]: The perfusion ports 38 are coupled to the fluid inlet port 30 via a fluid lumen 42 (shown in FIG. 2) extending through the probe shaft 18).
Regarding claim 4, Rioux discloses wherein the balloon is proximal to the pluralities of electrodes and apertures ([0044]: the electrode 32(1) and the perfusion ports 38 are located on one side of the balloon 40(1), preferably a distal side of the balloon 40(1)).
Regarding claim 5, Rioux fails to disclose wherein the portion of the ventricle filled by the inflated balloon is 25% to 75% of the ventricle.
However, Harlev discloses wherein the portion of the ventricle filled by the inflated balloon is 25% to 75% of the ventricle ([0118]: the catheter 104 described herein facilitates deeper lesion formation and can also be effective for performing ventricular ablations; [0105]: the body 132 of the balloon 122 has a diameter of 2.0 mm to 25 mm (e.g., 5 mm, 10 mm, and 12 mm); wherein this diameter is seen as being capable of filling a ventricle by 25%-75%). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electroporation catheter of Rioux to fill 25% to 75% of the ventricle, as taught by Harlev, for the purpose of facilitating deeper lesion formation (Harlev: [0188]).
Regarding claim 6, Rioux fails to disclose a sensing electrode, wherein the sensing electrode is configured to sense signals from Purkinje fibers.
However, Harlev discloses a sensing electrode, wherein the sensing electrode is configured to sense signals from Purkinje fibers ([0133]: The electrical activity of the heart as sensed by the sensing electrodes 146; [0024]: catheter is placed into the vasculature of the patient depending on whether the left ventricle or right ventricle of the heart is to be treated; where the Purkinje fibers are located within the walls of the ventricles and if the sensors are sensing electrical activity of the heart when placed within the ventricles, they are sensing signals from Purkinje fibers).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date to modify the catheter of Rioux to include the sensing electrode of Harlev for the purpose of the electrical signals sensed by the sensing electrodes can be evaluated to analyze an arrhythmia, to determine where to deliver the ablation energy as a therapy for the arrhythmia, and to determine whether a lesion has formed in the cardiac tissue as a result of the application of the ablation energy (Harlev: [0133]).
Regarding claim 11, Rioux discloses wherein each aperture of the plurality of apertures is positioned between each pair of adjacent electrodes of the plurality of electrodes ([0039]: The perfusion ports 38 are located near the electrode(s) 32, and in particular, at least one port 38 is located between the windings of the electrode 32(1) or electrodes 32(2), 32(3), as shown in FIGS. 3 and 4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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