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 .
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 5, 6, 8, 10-15, 17, 18, 20 and 22-25 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Ideker(US 6470211 B1).
Regarding claim 1, Ideker discloses A method of reducing arrhythmic electrical states in a biological tissue(The present invention relates to methods and apparatus for treating cardiac arrhythmia, and particularly relates to an implantable apparatus that can treat both atrial and ventricular arrythmia with the implantation of two transvenous leads(Field of the Invention, paragraph 1), comprising:
sequentially applying electric charge pulses with an energy of 0.01-5 Joules around the biological tissue(The system includes a first and second pair of atrial defibrillation electrodes operatively associated with the control circuit and power supply, with the first pair of atrial defibrillation electrodes configured for delivering an atrial defibrillation pulse along a first current pathway and the second pair of atrial defibrillation electrodes configured for delivering a second defibrillation pulse along a second current pathway that is different from the first current pathway, and wherein the control circuit is configured for delivering an atrial defibrillation shock comprising in sequence the first and second atrial defibrillation pulses(Summary of the Invention, paragraph 3). The energy of the first atrial defibrillation pulse is preferably not greater than 8 joules, more preferably not greater than 6 joules, still more preferably not greater than 4 joules, and most preferably not greater than 2 joules. The energy of the second atrial defibrillation pulse is typically not greater than the energy of the first defibrillation pulse (although such a result is possible where a dual capacitor design is employed), and is preferably not greater than 8 joules, more preferably not greater than 6 joules, still more preferably not greater than 4 joules, and most preferably not greater than 2 joules(Detailed Description of the Invention, paragraph 37))
Regarding claim 2, Ideker discloses the method of claim 1, wherein each electric charge pulse stimulates a distinct portion of the biological tissue(In one embodiment of the invention, the first pair of atrial defibrillation electrodes comprises a defibrillation electrode positioned in the right atrium or superior vena cava of the heart, and a defibrillation electrode positioned in the distal coronary sinus or great cardiac vein of the heart. The electrodes themselves may be configured for positioning in the indicated location(Detailed Description of the Invention, paragraph 31)).
Regarding claim 4, Ideker discloses the method of claim 1, wherein sequentially applying electric charge pulses comprises: applying a first electric charge across a first pair of electrodes; and after applying the first electric charge across the first pair of electrodes, applying a second electric charge across a second pair of electrodes(In overview, an implantable system for the defibrillation of the atria of a patient's heart comprises (a) a first pair of atrial defibrillation electrodes configured for delivering a first atrial defibrillation pulse along a first current pathway in the heart; (b) a pulse generator operatively associated with the first pair of atrial defibrillation electrodes for delivering the first atrial defibrillation pulse; (c) a second pair of atrial defibrillation electrodes configured for delivering a second atrial defibrillation pulse along a second current pathway in the heart, with the second current pathway different from the first current pathway; and (d) a pulse generator operatively associated with the second pair of atrial defibrillation electrodes for sequentially delivering the second atrial defibrillation pulse after the first defibrillation pulse(Detailed Description of the Invention, paragraph 30)).
Regarding claim 5, Ideker discloses the method of claim 1, wherein sequentially applying the electric charge pulses results in a rotating electric field across the biological tissue(With the system including a plurality of primary electrodes configured for delivering a ventricular defibrillation pulse along a predetermined current pathway in a first portion of the heart, the current pathway defining a weak field area in a second portion of the heart, and with the defibrillation electrodes further including at least one auxiliary electrode configured for delivering an auxiliary pulse to the weak field area, with at least one auxiliary electrode configured for positioning through the coronary sinus and in a vein on the surface of the left ventricle of the heart; a power supply; and a control circuit operatively associated with the power supply and the electrodes, and wherein the control circuit is configured for delivering an atrial defibrillation shock comprising in sequence the first and second atrial defibrillation pulses(Summary of the Invention, Paragraph 4). Regarding the rotating field limitation, it comes after the phrase “results in” which makes it an intended use recitation and it is not required in prior art disclosure.
Regarding claim 6, Ideker discloses the method of claim 1, wherein sequentially applying the electric charge pulses results in a three-dimensional rotating electric field across the biological tissue(With the system including a plurality of primary electrodes configured for delivering a ventricular defibrillation pulse along a predetermined current pathway in a first portion of the heart, the current pathway defining a weak field area in a second portion of the heart, and with the defibrillation electrodes further including at least one auxiliary electrode configured for delivering an auxiliary pulse to the weak field area, with at least one auxiliary electrode configured for positioning through the coronary sinus and in a vein on the surface of the left ventricle of the heart; a power supply; and a control circuit operatively associated with the power supply and the electrodes, and wherein the control circuit is configured for delivering an atrial defibrillation shock comprising in sequence the first and second atrial defibrillation pulses(Summary of the Invention, Paragraph 4). Regarding the rotating field limitation, it comes after the phrase “results in” which makes it an intended use recitation and it is not required in prior art disclosure. Further it is inherent that the generated electric field would be three dimensional because all generated fields are 3 dimensional vector fields.
Regarding claim 8, Ideker discloses the method of claim 1, wherein each electric charge pulse has a duration of 1-50ms(The auxiliary pulse may be from 0.5 or 1 to 5 or 10 milliseconds in duration, with a 2 millisecond pulse currently preferred(Detailed Description of the Invention, paragraph 40)).
Regarding claim 10, Ideker discloses the method of claim 1, wherein the biological tissue is a human heart(A first aspect of the present invention is an implantable system for the defibrillation or cardioversion of the atria and the ventricles of a patient's heart(Summary of the Invention, paragraph 2)).
Regarding claim 11, Ideker discloses the method of claim 10, wherein the human heart is in a state of tachycardia or fibrillation(The present invention may be used to treat all forms of cardiac tachyarrhythmias, including atrial and ventricular fibrillation, with defibrillation (including cardioversion) shocks or pulses. The treatment of polymorphic ventricular tachycardia, monomorphic ventricular tachycardia, ventricular fibrillation, and atrial fibrillation are particularly preferred(detailed Description of the Invention, paragraph 1)).
Regarding claim 12, Ideker discloses the method of claim 11, wherein the human heart is in a state of atrial tachycardia or fibrillation(The present invention may be used to treat all forms of cardiac tachyarrhythmias, including atrial and ventricular fibrillation, with defibrillation (including cardioversion) shocks or pulses. The treatment of polymorphic ventricular tachycardia, monomorphic ventricular tachycardia, ventricular fibrillation, and atrial fibrillation are particularly preferred(detailed Description of the Invention, paragraph 1)).
Regarding claim 13, Ideker discloses the method of claim 11, wherein the human heart is in a state of ventricular tachycardia or fibrillation(The present invention may be used to treat all forms of cardiac tachyarrhythmias, including atrial and ventricular fibrillation, with defibrillation (including cardioversion) shocks or pulses. The treatment of polymorphic ventricular tachycardia, monomorphic ventricular tachycardia, ventricular fibrillation, and atrial fibrillation are particularly preferred(detailed Description of the Invention, paragraph 1)).
Regarding claim 14, Ideker discloses a system for reducing arrhythmic electrical states in a biological excitable tissue(The present invention relates to methods and apparatus for treating cardiac arrhythmia, and particularly relates to an implantable apparatus that can treat both atrial and ventricular arrythmia with the implantation of two transvenous leads(Field of the Invention, paragraph 1), comprising:
electrode pairs configured to be placed around the biological excitable tissue(The system includes a first and second pair of atrial defibrillation electrodes operatively associated with the control circuit and power supply, with the first pair of atrial defibrillation electrodes configured for delivering an atrial defibrillation pulse along a first current pathway and the second pair of atrial defibrillation electrodes configured for delivering a second defibrillation pulse along a second current pathway that is different from the first current pathway, and wherein the control circuit is configured for delivering an atrial defibrillation shock comprising in sequence the first and second atrial defibrillation pulses(Summary of the Invention, paragraph 3); and a controller configured to sequentially apply electric charge pulses with an energy of 0.01-5 Joules to the electrode pairs(The energy of the first atrial defibrillation pulse is preferably not greater than 8 joules, more preferably not greater than 6 joules, still more preferably not greater than 4 joules, and most preferably not greater than 2 joules. The energy of the second atrial defibrillation pulse is typically not greater than the energy of the first defibrillation pulse (although such a result is possible where a dual capacitor design is employed), and is preferably not greater than 8 joules, more preferably not greater than 6 joules, still more preferably not greater than 4 joules, and most preferably not greater than 2 joules.(Detailed Description of the Invention, paragraph 37)).
Regarding claim 15, Ideker discloses the system of claim 14, wherein the controller is further configured to apply each electric charge pulse to the electrode pairs to stimulate a distinct portion of the biological excitable tissue(In one embodiment of the invention, the first pair of atrial defibrillation electrodes comprises a defibrillation electrode positioned in the right atrium or superior vena cava of the heart, and a defibrillation electrode positioned in the distal coronary sinus or great cardiac vein of the heart. The electrodes themselves may be configured for positioning in the indicated location(Detailed Description of the Invention, paragraph 31)).
Regarding claim 17, Ideker discloses the system of claim 15, wherein the controller is further configured to: apply a first electric charge across a first pair of electrodes; and after applying the first electric charge across the first pair of electrodes, apply a second electric charge across a second pair of electrodes(In overview, an implantable system for the defibrillation of the atria of a patient's heart comprises (a) a first pair of atrial defibrillation electrodes configured for delivering a first atrial defibrillation pulse along a first current pathway in the heart; (b) a pulse generator operatively associated with the first pair of atrial defibrillation electrodes for delivering the first atrial defibrillation pulse; (c) a second pair of atrial defibrillation electrodes configured for delivering a second atrial defibrillation pulse along a second current pathway in the heart, with the second current pathway different from the first current pathway; and (d) a pulse generator operatively associated with the second pair of atrial defibrillation electrodes for sequentially delivering the second atrial defibrillation pulse after the first defibrillation pulse(Detailed Description of the Invention, paragraph 30)).
Regarding claim 18, Ideker discloses the system of claim 14, wherein the controller is further configured to sequentially apply the electric charge pulses to the electrodes to cause a rotating electric field across the biological excitable tissue(With the system including a plurality of primary electrodes configured for delivering a ventricular defibrillation pulse along a predetermined current pathway in a first portion of the heart, the current pathway defining a weak field area in a second portion of the heart, and with the defibrillation electrodes further including at least one auxiliary electrode configured for delivering an auxiliary pulse to the weak field area, with at least one auxiliary electrode configured for positioning through the coronary sinus and in a vein on the surface of the left ventricle of the heart; a power supply; and a control circuit operatively associated with the power supply and the electrodes, and wherein the control circuit is configured for delivering an atrial defibrillation shock comprising in sequence the first and second atrial defibrillation pulses(Summary of the Invention, Paragraph 4). Regarding the rotating field limitation, it comes after the phrase “to cause” which makes it an intended use recitation and it is not required in prior art disclosure.
Regarding claim 20, Ideker discloses the system of claim 18, wherein each electric charge pulse has a duration of 1-50ms(The auxiliary pulse may be from 0.5 or 1 to 5 or 10 milliseconds in duration, with a 2 millisecond pulse currently preferred(Detailed Description of the Invention, paragraph 40)).
Regarding claim 22, Ideker discloses the system of claim 14, wherein the biological tissue is a human heart(A first aspect of the present invention is an implantable system for the defibrillation or cardioversion of the atria and the ventricles of a patient's heart(Summary of the Invention, paragraph 2)).
Regarding claim 23, Ideker discloses the system of claim 22, wherein the human heart is in a state of tachycardia or fibrillation(The present invention may be used to treat all forms of cardiac tachyarrhythmias, including atrial and ventricular fibrillation, with defibrillation (including cardioversion) shocks or pulses. The treatment of polymorphic ventricular tachycardia, monomorphic ventricular tachycardia, ventricular fibrillation, and atrial fibrillation are particularly preferred(detailed Description of the Invention, paragraph 1)).
Regarding claim 24, Ideker discloses the system of claim 23, wherein the human heart is in a state of atrial tachycardia or fibrillation(The present invention may be used to treat all forms of cardiac tachyarrhythmias, including atrial and ventricular fibrillation, with defibrillation (including cardioversion) shocks or pulses. The treatment of polymorphic ventricular tachycardia, monomorphic ventricular tachycardia, ventricular fibrillation, and atrial fibrillation are particularly preferred(detailed Description of the Invention, paragraph 1)).
Regarding claim 25, Ideker discloses the system of claim 23, wherein the human heart is in a state of ventricular tachycardia fibrillation(The present invention may be used to treat all forms of cardiac tachyarrhythmias, including atrial and ventricular fibrillation, with defibrillation (including cardioversion) shocks or pulses. The treatment of polymorphic ventricular tachycardia, monomorphic ventricular tachycardia, ventricular fibrillation, and atrial fibrillation are particularly preferred(detailed Description of the Invention, paragraph 1)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The “Low-energy Atrial Cardioversion Therapy with Controllable Pulse-shaped Waveforms” of Wessels is pertinent prior art for the disclosed application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796 /TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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