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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/26/2025 has been entered.
Response to Arguments
Applicant's arguments filed 12/08/2025 regarding the Deem reference (US 2005/0261672) have been fully considered but they are not persuasive. Applicant argues, “Deem does not teach or suggest electrodes that are ‘implanted on or within the heart of the patient’. Rather, as depicted in Fig. 8 of Deem, the electrodes 126, 127 of Deem are not implanted on or within the heart, but rather the electrodes 126, 127 of Deem are coupled to a catheter 122… A person of ordinary skill in the art would not have understood Deem to teach or suggest electrodes ‘implanted on or within the heart of the patient’ that generate a bipolar pulsed electrical field, that as recited amended claim 1”, see Remarks pg. 8. Examiner respectfully disagrees.
Examiner submits that Deem discloses electrodes which are implanted on or within the heart of the patient via insertion of catheters having electrodes disposed thereon into the heart. For example, Fig. 3 depicts ablation catheters 40, 48 having electrodes 44, 52 disposed thereon respectively, wherein the catheters are implanted within the heart of the patient. More specifically, ablation catheter 40 is implanted within the right artery 24, while catheter 48 is implanted within superior vena cava 36. Deem also discloses generating a bipolar pulsed electrical field between the electrodes to cause reversible electroporation of myocardial cells of the heart (para. 26, 58). As such, the argument that Deem does not disclose such features is not persuasive.
Applicant’s arguments with respect to Klein (US 2003/0191404), see Remarks pg. 9, have been considered but are moot because the new ground of rejection over Asirvatham et al. (US 2018/0360650) does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See rejection below.
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 (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.
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.
Claim(s) 1, 3-4, 6-8, 11, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Deem et al. (US 2005/0261672) (hereinafter Deem) in view of Asirvatham et al. (US 2018/0360650) (hereinafter Asirvatham).
Regarding claims 1 and 3, Deem discloses a method of terminating cardiac arrhythmias, the method comprising: in response to detecting the presence of abnormal activity, generating a bipolar pulsed electrical field between a first electrode positioned on a first portion of a heart of a patient and a second electrode positioned on a second portion of the heart of the patient to cause reversible electroporation of myocardial cells of the heart (para. 26: “methods and apparatus for treating atrial fibrillation and other conduction defects by utilizing an electric field to disrupt tissue at the cellular level via permeabilization of the cell causing reversible electroporation of the cellular membrane”; para. 58: “electroporation may be achieved utilizing a device adapted to activate an electrode set or series of electrodes to produce an electric field. Such a field may be generated using either a bipolar or monopolar electrode configuration. When applied to cells, depending on the duration and strength of the applied pulses, this field operates to increase permeabilization of the cells membrane and either: 1) reversibly open the cells membrane for a short period of time by causing pores to form in the cell lipid bilayer…”; Fig. 3 depicts first electrode 44 at right pulmonary artery 24 and second electrode 52 at superior vena cava 36, with reference to para. 44; Fig. 2 depicts multiple target locations 1 and 2 in the heart for electroporation via first and second electrodes, with reference to para. 43).
Deem does not disclose monitoring, using at least one of the first electrode positioned on the first portion of the heart of the patient or the second electrode positioned on the second portion of the heart of the patient, electrical activity of the heart of the patient to detect a presence of abnormal cardiac activity (claim 1); wherein monitoring the electrical activity of the heart of the patient to determine the presence of abnormal cardiac activity comprises monitoring, using the at least one of the first electrode or the second electrode, the electrical activity of the heart of the patient to detect a heart arrhythmia (claim 3).
Asirvatham, however, teaches treating cardiac electrical disorders (Abstract) wherein a method of treating cardiac arrhythmia of a heart may optionally include one or more of the following features. The cardiac arrhythmia may be an atrial arrhythmia. The tissue surface may be an atrial tissue surface. The cardiac arrhythmia may be a ventricular arrhythmia. The tissue surface may be a ventricle tissue surface… The method may further include detecting (after the applying anti-tachycardia pacing to the heart) that the ventricular arrhythmia still exists, and applying electroporation to the heart (para. 12). Electroporation, using the devices and methods provided herein, may allow painless VF/VT termination, or more organize the rhythm (para. 42). In operation 390, electroporation can be performed/applied to the cooled heart. Such electroporation involves an application of DC energy to the epicardium. The result of the DC energy is a non-thermal cellular treatment that, in some cases, can resolve the arrhythmia (para. 58). Some embodiments of the epicardially placed defibrillator devices include bipolar and/or unipolar recording electrodes. Such recording electrodes can function to detect and diagnose arrhythmia (para. 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Deem to include monitoring, using at least one of the first electrode positioned on the first portion of the heart of the patient or the second electrode positioned on the second portion of the heart of the patient, electrical activity of the heart of the patient to detect a presence of abnormal cardiac activity; wherein monitoring the electrical activity of the heart of the patient to determine the presence of abnormal cardiac activity comprises monitoring, using the at least one of the first electrode or the second electrode, the electrical activity of the heart of the patient to detect a heart arrhythmia. Making this modification would be useful for detecting and treating arrhythmia via electroporation, as taught by Asirvatham.
Regarding claim 4, Deem discloses generating a pulsed electrical field comprises generating a plurality of electrical pulses between the first electrode and the second electrode with a pulse width in the range of 1 nanosecond to 300 microseconds (para. 58, last sentence: “pulse durations ranging from 1 nanosecond to 0.1 seconds may be applied”).
Regarding claim 6, Deem discloses generating a pulsed electrical field between the first electrode positioned on the first portion of the heart of the patient and the second electrode positioned on the second portion of the heart of the patient: porates cell membranes of myocardial cells of the heart (para. 58: “this field operates to increase permeabilization of the cells membrane and either: 1) reversibly open the cells membrane for a short period of time by causing pores to form in the cell lipid bilayer…”)
Although Deem does not explicitly disclose that the pulsed electrical field increases cardiac ion channel conduction within the myocardial cells, the Examiner submits that Applicant is claiming an inherent effect of applying the pulsed electric field to the heart. Seeing that Deem already discloses applying the pulsed bipolar electric field to the heart as claimed (see rejection of claim 1 above), the Examiner submits that Deem’s disclosed electric field application would inherently result in increasing cardiac ion channel conduction within the myocardial cells.
Regarding claim 7, Deem does not explicitly disclose that the pulsed electrical field passes through a critical mass of myocardial tissue of the heart of the patient.
It is first noted that Applicant defines a “critical mass of myocardial tissue” as “large enough to ensure termination of a cardiac arrhythmia” (para. 57 of corresponding publication US 2023/0142793). Given this definition, given that Deem already discloses that the bipolar pulsed electric field treats atrial fibrillation (para. 18; para. 26), and given that Deem discloses a wide variety of cardiac structures which the electric field passes through (Fig. 2), the Examiner submits that Deem’s pulsed electrical field must inherently pass through a critical mass of myocardial tissue in order to treat atrial fibrillation as disclosed.
Regarding claim 8, Deem discloses the first portion of the heart comprises a first portion an epicardial surface of the heart or a first portion of an endocardial surface of the heart; and the second portion of the heart comprises a second portion an epicardial surface of the heart or a second portion of an endocardial surface of the heart (Fig. 2 lists various endocardial structures of the heart which are stimulated via electroporation; Fig. 3 depicts electrodes 44 and 52 within right pulmonary artery 24 and superior vena cava 36, respectively; para. 74 discloses using epicardial probes).
Regarding claim 11, Deem discloses the first portion of the heart comprises a first portion of a myocardium of a ventricle or an atrium of the heart of the patient; and the second portion of the heart comprises a second portion of a myocardium of a ventricle or an atrium of the heart of the patient (Fig. 2 discloses targeting left and right atriums of the heart).
Regarding claims 26-27, Deem does not disclose wherein the at least one of the first electrode or the second electrode is configured to detect a particular location within the heart that the abnormal cardiac activity is occurring, wherein generating the bipolar pulsed electrical field comprises modifying an energy delivered by at least one of the first electrode or the second electrode that is positioned closest to the detected particular location where the abnormal cardiac activity is occurring.
Asirvatham Fig. 3A depicts determining whether arrhythmia is in ventricle or atrium and modifying energy of electrode positioned closest to arrhythmia, see box 320-390 and para. 56-58. It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Deem to include wherein the at least one of the first electrode or the second electrode is configured to detect a particular location within the heart that the abnormal cardiac activity is occurring, wherein generating the bipolar pulsed electrical field comprises modifying an energy delivered by at least one of the first electrode or the second electrode that is positioned closest to the detected particular location where the abnormal cardiac activity is occurring. Making this modification would be useful for determining whether arrhythmia is in the ventricle or atrium and treating the appropriate location, as taught by Asirvatham.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over modified Deem in view of Housley et al. (US 2016/0129246) (hereinafter Housley).
Regarding claim 5, modified Deem does not disclose an electrical potential of the pulsed electrical field ranges from 0.2 microCoulombs to about 30 milliCoulombs.
Housley, however, teaches methods and apparatus for close-field electroporation (Abstract) wherein the taught method allows for significantly lower total charge delivery while maintaining highly efficient transformation of cells, significantly reducing the risk of collateral damage to cells in the region of cells being treated. According to an embodiment the total electric charge delivered during said electroporation is less than 4 Coulombs, more typically less than 0.4 Coulombs, more typically less than 0.1 Coulombs, and more typically less than 0.01 Coulombs (para. 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Deem such that an electrical potential of the pulsed electrical field ranges from 0.2 microCoulombs to about 30 milliCoulombs by adopting the taught ranges of Housley. Making this modification would be useful for allowing for significantly lower total charge delivery while maintaining highly efficient transformation of cells, significantly reducing the risk of collateral damage to cells in the region of cells being treated, as taught by Housley.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over modified Deem in view of Freeman et al. (US 2019/0282822) (hereinafter Freeman).
Regarding claim 12, modified Deem does not disclose monitoring the electrical activity of the heart of the patient following the generation of the bipolar pulsed electrical field; determining a heart arrhythmia is present; and in response to determining a heart arrhythmia is present, generating another bipolar pulsed electrical field.
Freeman, however, teaches an arrhythmia monitoring and treatment device (Abstract) wherein electrical activity of the heart is monitored following the generation of a pulsed therapeutic stimulation (Fig. 16-17, after initiating therapy S1614, calculation of transthoracic impedance at S1702 & detection of normal heart rhythm occurs at S1726), and if a heart arrhythmia is present, generating another pulsed therapeutic stimulation (if no normal heart rhythm at S1726, generate therapy at S1719).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Deem to include monitoring the electrical activity of the heart of the patient following the generation of the bipolar pulsed electrical field; determining a heart arrhythmia is present; and in response to determining a heart arrhythmia is present, generating another bipolar pulsed electrical field. Making this modification would be useful for detecting one or more treatable arrhythmias and delivering one or more therapeutic pulses to the patient in response, as taught by Freeman (Abstract).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over modified Deem in view of Darvish et al. (US 2002/0183682) (hereinafter Darvish).
Regarding claim 15, Deem does not disclose that the first and second electrodes are attached to at least one mesh, and positioning the at least one mesh on the surface of the heart.
Darvish, however, teaches an electrical treatment apparatus (Abstract) wherein the use of mesh electrodes allows the local treatment of many locations in the heart and/or the treatment of large areas of the heart, which is not possible using a standard pacing lead. Also, this can lower the impedance of the electrode (para. 66; Fig. 3D provides illustration of mesh electrode 174).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Deem such that the first and second electrodes are attached to at least one mesh, and positioning the at least one mesh on the surface of the heart. Making this modification would be useful for allowing local treatment of many locations in the heart and/or the treatment of large areas of the heart, which is not possible using a standard pacing lead, as well as lowering the impedance of the electrode, as taught by Darvish.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Knisley et al. (WO 2011/159641) discloses stimulation waveform and system for cardiac resynchronization via electroporation (Front page).
Altmann et al. (US 2021/0162210) discloses using reversible electroporation on cardiac tissue (Abstract).
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/A.A.G./Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796