DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(c) he has abandoned the invention.
(d) the invention was first patented or caused to be patented, or was the subject of an inventor’s certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor’s certificate filed more than twelve months before the filing of the application in the United States.
Claims 2-6, 8, 15-19, and 21 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Tehrani et al. (US 20060247729 A1, "Tehrani").
Regarding claim 2, Tehrani teaches a stimulation system (Fig. 1A and 2; stimulator 20) comprising: a signal generator (para. [0068]: " The electrode assemblies 21, 22, 31, 32, 41, 42 described herein are coupled to outputs of a pulse generator and are configured to deliver electrically stimulating signals to tissue associated with the implanted electrode assemblies.") to produce stimulation signals (para. [0068]: "…configured to deliver electrically stimulating signals…"); a plurality of leads (Fig. 1A; para. [0069]: " The electrode assemblies 21, 22 are coupled via leads 23, 24 to control unit 100.") to receive stimulation signals from the signal generator (para. [0068]: "The electrode assemblies 21, 22, 31, 32, 41, 42 described herein are coupled to outputs of a pulse generator and are configured to deliver electrically stimulating signals to tissue associated with the implanted electrode assemblies."; the pulse generator delivers signals to the electrodes via the leads 23, 24); a first set of electrodes (Fig. 1A; electrodes 21a-d), wherein each electrode of the first set of electrodes is configured to receive stimulation signals from at least one of the plurality of leads for stimulation of a phrenic nerve (para. [0069]: "The electrode assemblies 21, 22 (31, 32, 41, 42) may sense as well as pace or electrically stimulate at the diaphragm muscle or at the phrenic nerve."; The electrodes both sense and stimulate); a second set of electrodes (Fig. 1A; electrodes 22a-d), wherein each electrode of the second set of electrodes is configured to receive stimulation signals from at least one of the plurality of leads for stimulation of the phrenic nerve (para. [0069]: "The electrode assemblies 21, 22 (31, 32, 41, 42) may sense as well as pace or electrically stimulate at the diaphragm muscle or at the phrenic nerve."; The electrodes both sense and stimulate); and a processor (Fig. 1; control unit 100; Fig. 2; Processor 105) configured to: apply a first stimulation to the phrenic nerve from the first set of electrodes (para. [0074]: "Electrodes may also be selected to form bipolar pairs or multipolar groups to optimize stimulation response. Alternatively, electrodes may be in a monopolar configuration. Testing the response may be done by selecting at least one electrode from the electrodes in an assembly or any other combination of electrodes to form at least one closed loop system, by selecting sequence of firing of electrode groups and by selecting stimulation parameters."; A first stimulation (test stimulation) is applied to either 21a-d or 22a-d); apply a second stimulation to the phrenic nerve from the second set of electrodes (para. [0074]: "[0074] Electrodes may be selected from the plurality of electrodes 21a-d and 22a-d once implanted, to optimize the stimulation response. Electrodes may also be selected to form bipolar pairs or multipolar groups to optimize stimulation response. Alternatively, electrodes may be in a monopolar configuration. Testing the response may be done by selecting at least one electrode from the electrodes in an assembly or any other combination of electrodes to form at least one closed loop system, by selecting sequence of firing of electrode groups and by selecting stimulation parameters."; The group of electrodes not selected in the first group of electrodes could be selected in the next combination of electrodes to provide a second stimulation); select the first set of electrodes (Fig. 1A; 21a-d) or the second set of electrodes (Fig. 1A; 22a-d) for use in treatment based on which of the first set of electrodes and the second set of electrodes provided greater stimulation during the steps of applying the first stimulation and applying the second stimulation (para. [0074]: " Electrodes may be selected from the plurality of electrodes 21a-d and 22a-d once implanted, to optimize the stimulation response. Electrodes may also be selected to form bipolar pairs or multipolar groups to optimize stimulation response. Alternatively, electrodes may be in a monopolar configuration. Testing the response may be done by selecting at least one electrode from the electrodes in an assembly or any other combination of electrodes to form at least one closed loop system, by selecting sequence of firing of electrode groups and by selecting stimulation parameters. The electrodes may be selected by an algorithm programmed into the processor that determines the best location and sequence for stimulation and/or sensing nerve and/or EMG signals, e.g., by testing the response of the electrodes by sensing respiratory effort or flow in response to stimulation pulses. Alternatively, the selection process may occur using an external programmer that telemetrically communicates with the processor and instructs the processor to cause stimulation pulses to be delivered and the responses to be measured. From the measured responses, the external programmer may determine the optimal electrode configuration, by selecting the electrodes to have an optimal response to delivery of stimulation." The processor would select the group with the optimal response, which would be the one with greater stimulation); and activate a diaphragm of a subject by applying further electrical stimulation from the selected electrode set of the first set of electrodes and the second set of electrodes. (para. [0068]: " The electrode assemblies 21, 22 are implanted in the diaphragm muscle so that one or more of electrodes 21a-d and of electrodes 22a-d are approximately adjacent to one or more junctions of the phrenic nerves 15, 16, respectively, with the diaphragm 18 muscle. Alternatively, or additionally, electrodes or electrode assemblies may be implanted on the diaphragm from the thoracic side, at a location along the phrenic nerve in the thoracic region, neck region or other location adjacent a phrenic nerve (e.g. transvenously) where stimulating the phrenic nerve affects breathing and/or diaphragm movement of the subject. In addition, leads may be subcutaneously placed to stimulate at least a portion of the diaphragm or phrenic nerve. The electrode assemblies 21, 22, 31, 32, 41, 42 described herein are coupled to outputs of a pulse generator and are configured to deliver electrically stimulating signals to tissue associated with the implanted electrode assemblies.").
Regarding claim 3, Tehrani teaches the system of claim 2 (see above), wherein the first set of electrodes, the second set of electrodes, or both, are configured to be positioned in a neck when the first stimulation is applied to the phrenic nerve. (para. [0068]: "Alternatively or additionally, electrodes or electrode assemblies may be implanted on the diaphragm from the thoracic side, at a location along the phrenic nerve in the thoracic region, neck region or other location adjacent a phrenic nerve (e.g. transvenously) where stimulating the phrenic nerve affects breathing and/or diaphragm movement of the subject.").
Regarding claim 4, Tehrani teaches the system of claim 2 (see above), wherein the processor is configured to apply the further electrical stimulation while the subject is receiving mechanical ventilation. (para. [0072]: " The control unit 100 may determine when to stimulate the diaphragm and/or hypoglossal nerve, as well as specific stimulation parameters, e.g., based on sensed information. The control unit 100 may determine when to stimulate the chest wall or abdominal muscles, as well as specific stimulation parameters, e.g., based on sensed information."; para. [0101]: "Stimulating during intrinsic inspiration may also be used to normalize breathing in an obstructive sleep apnea patient and to increase ventilatory stability associated with airway obstructions."). The claim recites the intended use for the stimulation during mechanical ventilation, and does not limit the structure of the device. Further, para. [0072] states that the controller can determine when to deliver stimulation. Absent evidence of the contrary, the control unit (100) of Tehrani would be able to deliver stimulation while a subject is receiving mechanical ventilation. Further, Tehrani states using the device for increased ventilatory stability, which implies that a subject with mechanical ventilation could benefit from the device).
Regarding claim 5, Tehrani teaches the system of claim 2 (see above), wherein the selected electrode set includes more than two electrodes. (Fig. 1A; electrodes 21a-d or 22a-d could all be selected and include more than 2 electrodes).
Regarding claim 6, Tehrani teaches the system of claim 2 (see above), wherein the selected electrode set includes a bipolar electrode pair. (para. [0074]: " Electrodes may also be selected to form bipolar pairs.").
Regarding claim 8, Tehrani teaches the system of claim 2 (see above), wherein the first set of electrodes comprises a first electrode and the second set of electrodes comprises the first electrode. (Fig. 1A; electrodes 21a-d and 22a-d; The limitation is entirely a matter of groupings. As disclosed in para. [0074], the control unit 100 can group and select electrodes for stimulation based on optimal parameters; The control unit could stimulate a first set and a second set that could include the same electrode in both sets.).
Regarding claim 15, Tehrani teaches a stimulation system (Fig. 1A and 2; stimulator 20) comprising: a signal generator (para. [0068]: " The electrode assemblies 21, 22, 31, 32, 41, 42 described herein are coupled to outputs of a pulse generator and are configured to deliver electrically stimulating signals to tissue associated with the implanted electrode assemblies.") to produce stimulation signals (para. [0068]: "…configured to deliver electrically stimulating signals…"); a plurality of leads (Fig. 1A; para. [0069]: " The electrode assemblies 21, 22 are coupled via leads 23, 24 to control unit 100.") to receive stimulation signals from the signal generator (para. [0068]: "The electrode assemblies 21, 22, 31, 32, 41, 42 described herein are coupled to outputs of a pulse generator and are configured to deliver electrically stimulating signals to tissue associated with the implanted electrode assemblies."; the pulse generator delivers signals to the electrodes via the leads 23, 24); first electrodes (Fig. 1A; 21a-d) on the lead structure (structure shown in Fig. 1A in which the electrodes are disposed) configured to receive stimulation signals from at least one of the plurality of leads (leads 23, as well as the leads conducting signals from the sensor 57, 59, 51, 56, etc. to the control 100) for stimulation of a left phrenic nerve (Fig. 1A; para. [0076]: “Electrodes 21' and 22' are microstimulating electrodes positioned on or adjacent the phrenic nerve branches 15, 16 respectively.” Branch 16 would be the left phrenic nerve); second electrodes (Fig. 1A; electrodes 22a-d) on the lead structure(structure shown in Fig. 1A in which the electrodes are disposed) configured to receive stimulation signals from at least one of the plurality of leads (leads 23, as well as the leads conducting signals from the sensor 57, 59, 51, 56, etc. to the control 100) for stimulation of a right phrenic nerve (Fig. 1A; para. [0076]: “Electrodes 21' and 22' are microstimulating electrodes positioned on or adjacent the phrenic nerve branches 15, 16 respectively.” Branch 15 would be the left phrenic nerve);; and a processor (Fig. 1; control unit 100; Fig. 2; Processor 105) configured to: select a first set of electrodes (Fig. 1A; electrodes 21a-d) from the first electrodes on the lead structure (see Fig. 1A in rejection of claim 7, where the lead structure is circled), the first set of electrodes including electrodes best positioned, relative to other first electrodes, to stimulate the left phrenic nerve (Fig. 1A; para. [0076]: “Electrodes 21' and 22' are microstimulating electrodes positioned on or adjacent the phrenic nerve branches 15, 16 respectively.” Branch 16 would be the left phrenic nerve); and select a second set of electrodes (electrodes 22a-d) from the second electrodes on the lead structure, the second set of electrodes including electrodes best positioned, relative to other second electrodes, to stimulate the right phrenic nerve. (para. [0074]: " Electrodes may be selected from the plurality of electrodes 21a-d and 22a-d once implanted, to optimize the stimulation response. Electrodes may also be selected to form bipolar pairs or multipolar groups to optimize stimulation response. Alternatively, electrodes may be in a monopolar configuration. Testing the response may be done by selecting at least one electrode from the electrodes in an assembly or any other combination of electrodes to form at least one closed loop system, by selecting sequence of firing of electrode groups and by selecting stimulation parameters. The electrodes may be selected by an algorithm programmed into the processor that determines the best location and sequence for stimulation and/or sensing nerve and/or EMG signals, e.g., by testing the response of the electrodes by sensing respiratory effort or flow in response to stimulation pulses. Alternatively, the selection process may occur using an external programmer that telemetrically communicates with the processor and instructs the processor to cause stimulation pulses to be delivered and the responses to be measured. From the measured responses, the external programmer may determine the optimal electrode configuration, by selecting the electrodes to have an optimal response to delivery of stimulation." The processor would select the group with the optimal response, which would be the one with greater stimulation. The processor would be able to optimize the electrodes and determine which have the best position based on the greatest response during the test stimulation.). Additionally, the examiner notes that the stimulation of a “right phrenic nerve” and a “left phrenic nerve” is a matter of electrode placement, and does not distinguish the structure of claim 15 from that of Tehrani. Further, Tehrani teaches the structural limitations of claim 15, and therefore, absent evidence in the contrary, would be able to stimulate the right and left phrenic nerves.
Regarding claim 16, Tehrani teaches the system of claim 1 (see above), further comprising a breathing sensor (para. [0069]: "The stimulator 20 further comprises one or more sensors configured to sense one or more physiologic parameters. For example, one or more sensors such as an accelerometer or movement sensor may sense information regarding movement pattern of the diaphragm muscles, intercostal muscles, and rib movement and thus determine overall respiratory activity and patterns. An electrode or electrodes may be used to sense the EMG of the diaphragm to determine respiration parameters. A flow sensor may be implanted in or near the trachea to sense tracheal air flow. A flow sensor 56 may be implanted in or near the mouth.") configured to sense breathing of the patient, wherein the signal generator adjusts stimulation signals based on the sensed breathing. (para. [0071]: "Electrode(s) 51 is (are) coupled through lead(s) 52 to electronics in control unit 100. Control unit 100 is also configured to receive information from one or more sensors, including, for example upper airway pressure sensor 56 or intrapleural pressure sensor 57."; para. [0072]: "The control unit 100 is also configured to receive information corresponding to other physiological parameters as sensed by other sensors. The control unit 100 delivers stimulation to the nerves 15, 16 or diaphragm as desired in accordance with the invention. The control unit 100 also delivers stimulation to the hypoglossal nerve 19. The control unit 100 may determine when to stimulate the diaphragm and/or hypoglossal nerve, as well as specific stimulation parameters, e.g., based on sensed information. The control unit 100 may determine when to stimulate the chest wall or abdominal muscles, as well as specific stimulation parameters, e.g., based on sensed information."; The sensed information regarding breathing is input into the control unit and determines stimulation parameters based on the sensed information.).
Regarding claim 17, Tehrani teaches the system of claim 16 (see above), wherein the breathing sensor (Fig. 1A; intrapleural pressure sensor 57) is configured to detect an onset of breathing. (para. [0087]: "Intrapleural pressure may be used by setting threshold levels used to determine different phases of a respiration cycle. For example, the negative peak 175a of intrapleural pressure correlates generally with the start of the exhalation cycle. This point 175a or other information derived from the sensed signal (FIG. 16E) may be used to trigger stimulation in accordance with one or more stimulation protocols of the embodiments of the invention described herein; Additionally, para. [0089] describes sensing different phases of the respiratory cycle, meaning the onset of breathing would be detected.).
Regarding claim 18, Tehrani teaches the system of claim 15 (see above), wherein the processor is configured to generate a control signal based on a measurement signal meeting a determined condition, the measurement signal being indicative of a motion of the subject. (para. [0073]: " Additional sensors may comprise movement detectors 25, 26, in this example, strain gauges or piezo-electric sensors included with the electrode assemblies 21, 22 respectively and electrically connected through leads 23, 24 to the control unit 100. The movement detectors 25, 26 detect movement of the diaphragm 18 and thus the respiration parameters. The movement detectors 25, 26 sense mechanical movement and deliver a corresponding electrical signal to the control unit 100 where the information is processed by the processor 105. The movement information correlates to airflow and may accordingly be used to determine related respiration parameters.").
Regarding claim 19, Tehrani teaches the system of claim 18 (see above), wherein the system further comprises an accelerometer and the measurement signal is transmitted from the accelerometer to the processor. (para. [0082]: " A second RAM memory 120 (event memory) is provided to store sensed data sensed, e.g., by the electrodes of one or more electrode assemblies 21, 22 (EMG or nerve activity), position sensor 121, diaphragm movement sensors or strain gauges 25, 26, or the accelerometer 122 or other sensors such as a flow or tidal volume correlated sensors (e.g. using movement sensors or impedance plethysmography with a sensor positioned at one or more locations in the body such as on the control unit 100. These signals may be processed and used by the control unit 100 as programmed to determine if and when to stimulate or provide other feedback to the patient or clinician.").
Regarding claim 21, the system of claim 15 (see above), wherein the processor is configured to determine a breathing rate based on a respiratory motion caused by stimulation of the phrenic nerve. (para. [0164]: " For example, stimulating breathing during intrinsic inspiration may be useful in any treatment involving control of breathing. Stimulating during intrinsic inspiration may be used as a technique to gradually begin to control or manipulate breathing parameters such as breathing rate, inspiration duration and tidal volume. Simulation during intrinsic breathing may be used with a number of breathing control protocols to initiate control of breathing, e.g., to gradually take over or to entrain breathing and to gradually control or manipulate breathing parameters."; para. [0131]: "Also, rate may be increased gradually until no intrinsic breaths occur between the paced breaths. When control of respiratory rate is achieved (and possibly entrainment), if a slowing of the breathing rate is desired, the pacing rate can be decreased gradually as shown schematically…"; Para. [0131] and Fig. 14A/B demonstrate that the stimulation is adjusted based on intrinsic breaths, which means the breathing rate must have been determined and processed to control stimulation parameters.; para. [0073]: "The movement detectors 25, 26 detect movement of the diaphragm 18 and thus the respiration parameters."; para. [0082]: "A second RAM memory 120 (event memory) is provided to store sensed data sensed, e.g., by the electrodes of one or more electrode assemblies 21, 22 (EMG or nerve activity), position sensor 121, diaphragm movement sensors or strain gauges 25, 26, or the accelerometer 122 or other sensors such as a flow or tidal volume correlated sensors (e.g. using movement sensors or impedance plethysmography with a sensor positioned at one or more locations in the body such as on the control unit 100." Para. [0073] and [0082] demonstrate that the movement sensor senses the correlation between motion and breathing and is used to determine stimulation parameters.).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tehrani et al. (US 20060247729 A1, "Tehrani") in view of Scheiner et al. (US 6584362 B1, "Scheiner").
Regarding claim 7, Tehrani teaches the system of claim 2 (see 102 rejection above). Tehrani further teaches wherein the first set of electrodes and the second set of electrodes are supported on at least one lead structure (Fig. 1A; The electrodes 21a-d and 22a-d are disposed on a structure (see the circled structures in Fig. 1A) comprising the plurality of leads (para. [0071: "The leads 23, 24 comprise a plurality of electrical connectors and corresponding lead wires, each coupled individually to one of the electrodes 21a-d, 22a-d."; A plurality of leads coupled to the electrodes corresponds to the number of electrodes). However, Tehrani does not expressly teach wherein the lead structure is configured to be positioned such that the first set of electrodes and the second set of electrodes are within at least one blood vessel of the subject.
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Scheiner, in the same field of endeavor of implantable leads, discloses leads for pacing and sensing within the coronary veins of the heart. Scheiner discloses wherein a lead structure (lead 100) is configured to be positioned such that the first set of electrodes and the second set of electrodes (para. (7)"…the electrodes 122 are evenly spaced at about 120 degrees apart, which increases the opportunity for the electrodes 122 to make contact with the myocardial wall 128. In a further option, pairs of electrodes 122 are evenly spaced about 120 degrees apart along the lead body 120."; This electrodes can be grouped into pairs, and each pair can be a first or second (or third, or fourth, etc.) set of electrodes.) are within at least one blood vessel (Abstract: "The lead is constructed and arranged so that when it is implanted, the electrodes are housed in the coronary vasculature and urged into intimate contact a vessel wall.") of the subject.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tehrani to further include a lead configuration for insertion in the blood vessel of a subject, as disclosed by Scheiner. One of ordinary skill in the art would have recognized that configuring leads for insertion into a blood vessel would effectively allow a stimulation lead to sense and pace the heart (see Scheiner, para. (9)). This would have been an obvious improvement to the device of Tehrani, as it would improve versatility in the types of treatments the lead would be able to treat. As disclosed by Schreiner, there is a need for an endocardial lead, and configuring the lead of Tehrani for insertion in a blood vessel would meet this need. Therefore, it would have been obvious to combine the system of Tehrani with the lead configured for a blood vessel, as disclosed by Scheiner.
Claims 9-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tehrani et al. (US 20060247729 A1, "Tehrani") in view of King (US 20060253182 A1).
Regarding claim 9, Tehrani teaches a signal generator (para. [0068]: " The electrode assemblies 21, 22, 31, 32, 41, 42 described herein are coupled to outputs of a pulse generator and are configured to deliver electrically stimulating signals to tissue associated with the implanted electrode assemblies.") to produce stimulation signals (para. [0068]: "…configured to deliver electrically stimulating signals…"); a plurality of leads (Fig. 1A; para. [0069]: " The electrode assemblies 21, 22 are coupled via leads 23, 24 to control unit 100.") to receive stimulation signals from the signal generator (para. [0068]: "The electrode assemblies 21, 22, 31, 32, 41, 42 described herein are coupled to outputs of a pulse generator and are configured to deliver electrically stimulating signals to tissue associated with the implanted electrode assemblies."; the pulse generator delivers signals to the electrodes via the leads 23, 24); a first set of electrodes (Fig. 1A; electrodes 21a-d), wherein each electrode of the first set of electrodes is configured to receive stimulation signals from at least one of the plurality of leads for stimulation of a phrenic nerve (para. [0069]: "The electrode assemblies 21, 22 (31, 32, 41, 42) may sense as well as pace or electrically stimulate at the diaphragm muscle or at the phrenic nerve."; The electrodes both sense and stimulate); a second set of electrodes (Fig. 1A; electrodes 22a-d), wherein each electrode of the second set of electrodes is configured to receive stimulation signals from at least one of the plurality of leads for stimulation of the phrenic nerve (para. [0069]: "The electrode assemblies 21, 22 (31, 32, 41, 42) may sense as well as pace or electrically stimulate at the diaphragm muscle or at the phrenic nerve."; The electrodes both sense and stimulate); a breathing sensor configured to sense breathing of the subject (para. [0069]: "The stimulator 20 further comprises one or more sensors configured to sense one or more physiologic parameters. For example, one or more sensors such as an accelerometer or movement sensor may sense information regarding movement pattern of the diaphragm muscles, intercostal muscles, and rib movement and thus determine overall respiratory activity and patterns. An electrode or electrodes may be used to sense the EMG of the diaphragm to determine respiration parameters. A flow sensor may be implanted in or near the trachea to sense tracheal air flow. A flow sensor 56 may be implanted in or near the mouth."); and a processor (Fig. 1; control unit 100; Fig. 2; Processor 105) configured to: apply a first stimulation from the first set of electrodes to the phrenic nerve (para. [0074]: "Electrodes may also be selected to form bipolar pairs or multipolar groups to optimize stimulation response. Alternatively, electrodes may be in a monopolar configuration. Testing the response may be done by selecting at least one electrode from the electrodes in an assembly or any other combination of electrodes to form at least one closed loop system, by selecting sequence of firing of electrode groups and by selecting stimulation parameters."; A first stimulation (test stimulation) is applied to either 21a-d or 22a-d); apply a second stimulation from the second set of electrodes to the phrenic nerve (para. [0074]: "[0074] Electrodes may be selected from the plurality of electrodes 21a-d and 22a-d once implanted, to optimize the stimulation response. Electrodes may also be selected to form bipolar pairs or multipolar groups to optimize stimulation response. Alternatively, electrodes may be in a monopolar configuration. Testing the response may be done by selecting at least one electrode from the electrodes in an assembly or any other combination of electrodes to form at least one closed loop system, by selecting sequence of firing of electrode groups and by selecting stimulation parameters."; The group of electrodes not selected in the first group of electrodes could be selected in the next combination of electrodes to provide a second stimulation), select the first set of electrodes or the second set of electrodes for use in treatment based on which of the first set of electrodes and the second set of electrodes provided greater stimulation during the steps of applying the first stimulation and applying the second stimulation (para. [0074]: " Electrodes may be selected from the plurality of electrodes 21a-d and 22a-d once implanted, to optimize the stimulation response. Electrodes may also be selected to form bipolar pairs or multipolar groups to optimize stimulation response. Alternatively, electrodes may be in a monopolar configuration. Testing the response may be done by selecting at least one electrode from the electrodes in an assembly or any other combination of electrodes to form at least one closed loop system, by selecting sequence of firing of electrode groups and by selecting stimulation parameters. The electrodes may be selected by an algorithm programmed into the processor that determines the best location and sequence for stimulation and/or sensing nerve and/or EMG signals, e.g., by testing the response of the electrodes by sensing respiratory effort or flow in response to stimulation pulses. Alternatively, the selection process may occur using an external programmer that telemetrically communicates with the processor and instructs the processor to cause stimulation pulses to be delivered and the responses to be measured. From the measured responses, the external programmer may determine the optimal electrode configuration, by selecting the electrodes to have an optimal response to delivery of stimulation." The processor would select the group with the optimal response, which would be the one with greater stimulation); and activate a diaphragm of a subject by applying further electrical stimulation from the selected electrode set of the first set of electrodes and the second set of electrodes. (para. [0068]: " The electrode assemblies 21, 22 are implanted in the diaphragm muscle so that one or more of electrodes 21a-d and of electrodes 22a-d are approximately adjacent to one or more junctions of the phrenic nerves 15, 16, respectively, with the diaphragm 18 muscle. Alternatively, or additionally, electrodes or electrode assemblies may be implanted on the diaphragm from the thoracic side, at a location along the phrenic nerve in the thoracic region, neck region or other location adjacent a phrenic nerve (e.g. transvenously) where stimulating the phrenic nerve affects breathing and/or diaphragm movement of the subject. In addition, leads may be subcutaneously placed to stimulate at least a portion of the diaphragm or phrenic nerve. The electrode assemblies 21, 22, 31, 32, 41, 42 described herein are coupled to outputs of a pulse generator and are configured to deliver electrically stimulating signals to tissue associated with the implanted electrode assemblies."); and in response to input from the breathing sensor (para. [0069]: "The stimulator 20 further comprises one or more sensors configured to sense one or more physiologic parameters. For example one or more sensors such as an accelerometer or movement sensor may sense information regarding movement pattern of the diaphragm muscles, intercostal muscles, and rib movement and thus determine overall respiratory activity and patterns. An electrode or electrodes may be used to sense the EMG of the diaphragm to determine respiration parameters. A flow sensor may be implanted in or near the trachea to sense tracheal air flow. A flow sensor 56 may be implanted in or near the mouth."), adjust the further electrical stimulation from the selected set of electrodes of the first set of electrodes and the second set of electrodes (para. [0071]: "Electrode(s) 51 is (are) coupled through lead(s) 52 to electronics in control unit 100. Control unit 100 is also configured to receive information from one or more sensors, including, for example upper airway pressure sensor 56 or intrapleural pressure sensor 57."; para. [0072]: "The control unit 100 is also configured to receive information corresponding to other physiological parameters as sensed by other sensors. The control unit 100 delivers stimulation to the nerves 15, 16 or diaphragm as desired in accordance with the invention. The control unit 100 also delivers stimulation to the hypoglossal nerve 19. The control unit 100 may determine when to stimulate the diaphragm and/or hypoglossal nerve, as well as specific stimulation parameters, e.g., based on sensed information. The control unit 100 may determine when to stimulate the chest wall or abdominal muscles, as well as specific stimulation parameters, e.g., based on sensed information."; para. [0073]: "The movement detectors 25, 26 detect movement of the diaphragm 18 and thus the respiration parameters. The movement detectors 25, 26 sense mechanical movement and deliver a corresponding electrical signal to the control unit 100 where the information is processed by the processor 105. The movement information correlates to airflow and may accordingly be used to determine related respiration parameters."; The sensed information regarding breathing is input into the control unit and determines stimulation parameters based on the sensed information.). However, Tehrani does not expressly teach wherein the signal generator includes a positive output and a negative output; or wherein the first set of electrodes includes a first electrode connected to the negative output of the signal generator, and a second electrode connected to the positive output of the signal generator.
King, in the same field of endeavor of neurostimulation, discloses an implantable lead applying tripolar electric stimulation. King discloses wherein the signal generator includes a positive output and a negative output (para. [0090]: " Any system of electrodes that delivers electrical pulses to the body typically include at least one cathode (negative, source of electrons) and at least one anode (positive, source of cations) to have a complete circuit of finite resistance in which currents may flow. When there are only two active electrodes, one is a cathode and one is an anode."); and, wherein the first set of electrodes includes a first electrode (para. [0090]; the cathode electrode) connected to the negative output of the signal generator (para. [0090]: " least one cathode (negative, source of electrons)"; the negative source of electrons is what makes it a negative output), and a second electrode (para. [0090]; the anode electrode) connected to the positive output (para. [0090]: "least one anode (positive, source of cations)"; the positive source of cations is what makes it a positive output) of the signal generator (para. [0036]: "The implantable pulse generator 22 is capable of generating multiple independent pulses occurring either simultaneously or one pulse shifting in time with respect to the other, and having independently varying amplitudes and pulse widths.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tehrani to further include a positive and negative output, where a first electrode is connected to the positive output and a second electrode is connected to the negative output, as disclosed by King. One of ordinary skill in the art would have recognized that configuring different electrodes to be anodes and cathodes would allow for electric field steering (see abstract of King). Including this would allow the device of Tehrani to steer the electric field to produce optimal stimulation and improve efficacy of stimulation treatment. Therefore, it would have been an obvious improvement to combine the device of King with the system and leads of Tehrani.
Regarding claim 10, Tehrani, in combination with King, discloses the system of claim 9 (see above). However, Tehrani does not expressly disclose wherein the second set of electrodes includes the second electrode and a third electrode connected to the negative output of the stimulator.
King discloses wherein a second set of electrodes includes the second electrode and a third electrode connected to the negative output of the stimulator. (para. [0097]: "FIG. 33 illustrates a non-skewed stimulation configuration in which two opposite side electrodes are anodes and the aligned center electrode, and the two center electrodes that are in the next or adjacent longitudinal position on opposite sides of the aligned center electrode, are used as cathodes.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tehrani to further include a positive and negative output, where a first electrode is connected to the positive output and a second electrode is connected to the negative output, as disclosed by King. It would have been further obvious to modify the configuration to further include multiple electrodes for connected to the negative output. One of ordinary skill in the art would have recognized that configuring different electrodes to be anodes and cathodes would allow for electric field steering (see abstract of King). One of ordinary skill would have also recognized that different configurations would include varying the number of anode and cathode electrodes. It would have been obvious to modify this number until an optimal electric field was reached. Including this configuration would allow the device of Tehrani to steer the electric field to produce optimal stimulation and improve efficacy of stimulation treatment. Therefore, it would have been an obvious improvement to combine the device of King with the system and leads of Tehrani.
Regarding claim 11, Tehrani, in combination with King, discloses the system of claim 9 (see above). Tehrani further discloses wherein the first set of electrodes and the second set of electrodes are supported on at least one lead structure (Fig. 1A; The electrodes 21a-d and 22a-d are disposed on a structure (see the circled structures in Fig. 1A in the rejection of claim 7 above)) comprising the plurality of leads (para. [0071: "The leads 23, 24 comprise a plurality of electrical connectors and corresponding lead wires, each coupled individually to one of the electrodes 21a-d, 22a-d."; A plurality of leads coupled to the electrodes corresponds to the number of electrodes).
Regarding claim 12, Tehrani, in combination with King, discloses the system of claim 11 (see above). Tehrani further discloses wherein the at least one lead structure is configured for percutaneous insertion into the subject. (para. [0068]: "FIGS. 1A and 2 illustrate a stimulator 20 comprising electrode assemblies 21, 22, each comprising a plurality of electrodes 21a-d and 22a-d respectively. The electrode assemblies 21, 22 are implanted in the diaphragm muscle so that one or more of electrodes 21a-d and of electrodes 22a-d are approximately adjacent to one or more junctions of the phrenic nerves 15, 16, respectively, with the diaphragm 18 muscle. Alternatively, or additionally, electrodes or electrode assemblies may be implanted on the diaphragm from the thoracic side, at a location along the phrenic nerve in the thoracic region, neck region or other location adjacent a phrenic nerve (e.g. transvenously) where stimulating the phrenic nerve affects breathing and/or diaphragm movement of the subject."; Fig. 1A shows implantation on the diaphragm, which is percutaneous).).
Regarding claim 13, Tehrani, in combination with King, discloses the system of claim 11 (see above). Tehrani further discloses wherein the at least one lead structure is configured to be inserted in a neck of the subject. (para. [0068]: "Alternatively or additionally, electrodes or electrode assemblies may be implanted on the diaphragm from the thoracic side, at a location along the phrenic nerve in the thoracic region, neck region or other location adjacent a phrenic nerve.").
Regarding claim 14, Tehrani, in combination with King, discloses the system of claim 9 (see above). However, Tehrani does not expressly disclose wherein the selected set of electrodes includes a tripolar set of electrodes.
King discloses wherein the selected set of electrodes includes a tripolar set of electrodes (Abstract: "The neurostimulation lead is are adapted to provide an electrode array defining, for example, a plurality of electrode sets that may be used to provide tripolar stimulation and/or electric field steering."; para. [0099]: " Side electrodes R0 and L1 are active along with center electrode C3 providing in one example a linear diagonal tripolar array transverse but at an angle to the spinal cord.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tehrani to further include a tripolar set of electrodes, as disclosed by King. One of ordinary skill in the art would have recognized that including a tripolar electrode configuration would allow for electric field steering (see abstract of King). Including this configuration would allow the device of Tehrani to steer the electric field to produce optimal stimulation and improve efficacy of stimulation treatment. Therefore, it would have been an obvious improvement to combine the device of King with the system and leads of Tehrani.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tehrani et al. (US 20060247729 A1, "Tehrani") in view of Jackson et al. (US 20040215235 A1, "Jackson").
Regarding claim 20, Tehrani teaches the system of claim 15 (see 102 rejection above). Tehrani further discloses a plurality of leads (Fig. 1A; leads 23, 24, and the lead wires connected to 56, 51, and other sensors). However, Tehrani does not expressly teach a lead structure comprising a flexible insulating sheet, wherein the first electrodes and second electrodes are supported on the flexible insulating sheet.
Jackson, in the same field of stimulation devices, discloses an electrode array with an insulative, backing. Jackson discloses a flexible insulating sheet (para. [0019]: "the array of electrodes or other electrode structure are arranged on a surface of a dimensionally stable support such as a non-distensible, electrode backing. The backing may comprise a thin, rectangular sheet of polymer materials such as polyimide, polyester or other flexible thermoplastic or thermosetting polymer film, polymer covered materials, or other nonconductive materials. The backing may also comprise an electrically insulating polymer, with an electro-conductive material, such as copper, deposited onto a surface."), wherein the first electrodes and second electrodes are supported on the flexible insulating sheet (para. [0019]: "The electrode pattern may be aligned in an axial or traverse direction across the backing, formed in a linear or non-linear parallel array or series of bipolar pairs, or other suitable pattern." The electrodes are disposed on the backing. The pairs are grouped into what could be considered first and second pairs of electrodes.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode of Tehrani to include the flexible, insulative sheet for supporting electrodes, as disclosed by Jackson. One of ordinary skill in the art would have recognized that flexible and insulative support for the electrodes would provide the materials necessary for successful deployment for delivery of the device into the target site. One of ordinary skill in the art would recognize that arranging the electrodes on the support would provide stability for the electrodes during deployment through the tissue, as disclosed by Jackson. Therefore, it would have been obvious for one of ordinary skill in the art to combine the flexible, insulative sheet for supporting electrodes and leads with the device of Tehrani.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Casavant (US 20040088015 A1, "Casavant"), which teaches stimulation of left and right phrenic nerves and an intravascular lead that carries electrodes. This is pertinent to claims 15, as well as claim 7.
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/O.L.M./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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