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 § 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.
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, 10-14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable by Ben-Ezra(US 20140046407 A1) (cited previously) in view of Verzal(WO 2022246320 A1).
Regarding claim 1, Ben-Ezra discloses a medical device, comprising: one or more stimulation leads comprising: a first set of electrodes configured to provide electrical stimulation to a vagus nerve of a person, and the one or more stimulation leads configured to treat, via the stimulation of the person’s vagus nerve and the second body portion of the person, both obesity and one or more medical conditions comorbid with the obesity; and a controller coupled to the one or more stimulation leads and configured to control and drive the stimulation provided by the one or more stimulation leads(The present invention relates generally to electrical stimulation of and/or sensing signals of tissue, and specifically to methods and devices for regulating the stimulation of nerves or other tissue, including the vagus nerve, and/or sensing of electrical cardiac signals[0012]. In an embodiment, the control unit is adapted to configure the stimulating current to treat one or more of the following conditions of the subject: heart failure, atrial fibrillation, angina, cardiac arrest, arrhythmia, myocardial infarction, hypertension, endocarditis, myocarditis, asthma, an allergy, a neoplastic disorder, rheumatoid arthritis, septic shock, hepatitis, hypertension, diabetes mellitus, an autoimmune disease, a gastric ulcer, a neurological disorder, pain, a migraine headache, peripheral neuropathy, an addiction, a psychiatric disorder, obesity, an eating disorder, impotence, a skin disease, an infectious disease, a vascular disease, a kidney disorder, and a urinary tract disorder[0506]. electrode assembly 20 optionally further comprises a lead assembly 36, which comprises one or more electrical leads, as is known in the art. The leads are coupled to all or a portion of electrode contact surfaces 22. Lead assembly 36 couples electrode assembly 20 to an implanted or external control unit 38, which comprises appropriate circuitry for driving current between two or more of electrode contact surfaces 22, as is known in the art[1261]). Ben-Ezra fails to disclose “a second set of electrodes configured to provide electrical stimulation to a second body portion of the person, the second body portion being at least one selected from among a heart, a baroreceptor, a renal nerve, a splenic nerve, a carotid sinus nerve, parenchyma tissue, a pancreas, a pancreatic nerve, a spinal cord, a hypoglossal nerve, an ansa cervicalis, a pharyngeal nerve, a cranial nerve, a nerve innervating a liver, and a phrenic nerve”.
However, Verzal teaches “At least some of the example arrangements in FIGS. 14A-14R depict multiple stimulation elements on a single, first side of patient’s body (e.g. right side), such as shown in at least FIG. 14B in which both of a first stimulation element for stimulating a hypoglossal nerve and a second stimulation element for stimulating an ansa cervicalis-related nerve are implanted on a same side (e.g. right side or left side) of the patient’s body. However, consistent with at least FIG. 3A, in some examples one of the respective stimulation elements (e.g. for the hypoglossal nerve) may be located on one side of the patient’s body while another stimulation element (e.g. for the ansa cervicalis-related nerve) may be implanted on an opposite, second side of the patients’ body[00206]”.
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It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation techniques of Ben-Exza with the electrode sets of the multiple target stimulation therapy of Verzal. Doing so would allow for multiple nerves to be stimulated in the system in order to optimize treatment.
Regarding claim 10, Ben-Ezra in view of Verzal teaches the medical device of claim 1, further comprising: one or more sensors communicatively coupled to the controller and configured to measure one or more biomarkers and/or one or more biophysical properties; and/or a communication device communicatively coupled to the controller and configured to receive information from an external device(Vagal stimulation system 118 further comprises an implanted or external control unit 120, which typically communicates with electrode device 140 over a set of leads 142[1331]. Alternatively, or additionally, control unit 120 receives signals from one or more physiological sensors 126, such as blood pressure sensors or a copeptin sensor. Sensors 126 are typically implanted in the patient, for example in a left ventricle 32 of heart 30.[1333]).
Regarding claim 11, Ben-Ezra in view of Verzal teaches the medical device of claim 10, wherein the one or more sensors are configured to be implanted in the person(Alternatively or additionally, control unit 120 receives signals from one or more physiological sensors 126, such as blood pressure sensors or a copeptin sensor. Sensors 126 are typically implanted in the patient, for example in a left ventricle 32 of heart 30[1333]).
Regarding claim 12, Ben-Ezra in view of Verzal teaches the medical device of claim 10, wherein the one or more sensors are configured to be operated externally from the person(Vagal stimulation system 118 further comprises an implanted or external control unit 120, which typically communicates with electrode device 140 over a set of leads 142[1331]. Alternatively, or additionally, control unit 120 receives signals from one or more physiological sensors 126, such as blood pressure sensors or a copeptin sensor. Sensors 126 are typically implanted in the patient, for example in a left ventricle 32 of heart 30[1333]).
Regarding claim 13, Ben-Ezra discloses a method of treating obesity in a person, the method comprising: selecting one configuration of electrodes in a medical device from among at least the following two selectable configurations of electrodes: a first configuration of electrodes wherein a cathode electrode is more proximal to a head of the person than an anode electrode is to the person’s head, and a second configuration of electrodes wherein a cathode electrode is more distal to the person’s head than an anode electrode is to the person’s head; and providing electric stimulation to a vagus nerve of the person utilizing the selected one configuration of electrodes(The present invention relates generally to electrical stimulation of and/or sensing signals of tissue, and specifically to methods and devices for regulating the stimulation of nerves or other tissue, including the vagus nerve, and/or sensing of electrical cardiac signals[0012]. In an embodiment, the control unit is adapted to configure the stimulating current to treat one or more of the following conditions of the subject: heart failure, atrial fibrillation, angina, cardiac arrest, arrhythmia, myocardial infarction, hypertension, endocarditis, myocarditis, asthma, an allergy, a neoplastic disorder, rheumatoid arthritis, septic shock, hepatitis, hypertension, diabetes mellitus, an autoimmune disease, a gastric ulcer, a neurological disorder, pain, a migraine headache, peripheral neuropathy, an addiction, a psychiatric disorder, obesity, an eating disorder, impotence, a skin disease, an infectious disease, a vascular disease, a kidney disorder, and a urinary tract disorder[0506]. Electrode assembly 20 optionally further comprises a lead assembly 36, which comprises one or more electrical leads, as is known in the art. The leads are coupled to all or a portion of electrode contact surfaces 22. Lead assembly 36 couples electrode assembly 20 to an implanted or external control unit 38, which comprises appropriate circuitry for driving current between two or more of electrode contact surfaces 22, as is known in the art[1261]. As mentioned above, in this particular configuration, two of segments 100 include electrode contact surfaces 22, in one or more of the recesses defined by the segment. The following tables set forth two exemplary distributions of the electrode contact surfaces in the segments. The tables also indicate, by way of example, which of the surfaces are configured by control unit 38 (FIG. 1A) to function as a cathode, and which as an anode[1303][Fig. 11]). Ben-Ezra fails to disclose “switching the configuration of electrodes from the selected one configuration to the other configuration of the two selectable configurations of electrodes”.
However, Verzal teaches the “In some examples, adjusting the stimulation parameter may comprise switching nerve targets for implementing the stimulation therapy and/or
210 adding (or removing) a nerve target from among multiple nerve targets for implementing the stimulation therapy. In some examples, such switching, adding, or removing may be implemented via at least some aspects of the example arrangements described in association with at least FIGS. 39-40A[00755]. Moreover, in some examples, the stimulation pattern of one of the example stimulation protocols (as described in FIGS. 33A-37D) for a given nerve (e.g. HGN) may be switched and applied to another nerve (e.g. ACN), or vice versa[00461]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation techniques of Ben-Exza with the switching between configurations of the multiple target stimulation therapy of Verzal. Doing so would allow for multiple nerves to be stimulated in the system in order to optimize treatment.
Regarding claim 14, Ben-Ezra in view of Verzal teaches the method of claim 13, further comprising: providing electric stimulation to the vagus nerve utilizing the other one configuration of the two selectable configurations of electrodes(Electrode device 140 comprises a central cathode 146 for applying a negative current ("cathodic current") in order to stimulate vagus nerve 136, as described below. Electrode device 140 additionally comprises a set of one or more anodes 144 (144a, 144b, herein: "efferent anode set 144"), placed between cathode 146 and the edge of electrode device 140 closer to heart 30 (the "efferent edge"). Efferent anode set 144 applies a positive current ("efferent anodal current") to vagus nerve 136, for blocking action potential conduction in vagus nerve 136 induced by the cathodic current, as described below[1334]).
Regarding claim 17, Ben-Ezra in view of Verzal teaches the method of claim 14, wherein the changing of the configuration of electrodes is in response to a change in one or more biomarkers and/or a change in one or more biophysical properties(For some applications, control unit 120 is adapted to receive feedback from one or more of the electrodes in electrode device 140, and to regulate the signals applied to the electrode device responsive thereto[1332]. Typically, parasympathetic stimulation of the vagus nerve is applied responsive to one or more sensed physiological parameters or other parameters, such as heart rate, electrocardiogram (ECG), blood pressure, indicators of cardiac contractility, cardiac output, norepinephrine concentration, baroreflex sensitivity, or motion of the patient[0491]).
Regarding claim 18, Ben-Ezra in view of Verzal teaches the method of claim 13, wherein the method further comprises treating one or more medical conditions comorbid with obesity by providing stimulation to at least one selected from among the vagus nerve, a branch of the vagus nerve, a heart, a baroreceptor, a renal nerve, a splenic nerve, a carotid sinus nerve, parenchyma tissue, a pancreas, a pancreatic nerve, a spinal cord, a hypoglossal nerve, an ansa cervicalis, a pharyngeal nerve, a cranial nerve, a nerve innervating a liver, and a phrenic nerve(In an embodiment, the nerve includes a vagus nerve of the subject, the electrode device is adapted to be coupled to the vagus nerve, and the control unit is adapted to configure the stimulating current to change a level of an inflammatory marker selected from the list consisting of: tumor necrosis factor alpha, interleukin 6, activin A, transforming growth factor, interferon, interleukin 1 beta, interleukin 18, interleukin 12, and C-reactive protein, sufficiently to treat obesity of the subject[0556]).
Regarding claim 19, Ben-Ezra in view of Verzal teaches the method of claim 18, wherein the one or more medical conditions comprise at least one selected from among epilepsy, sleep apnea, obstructive sleep apnea, central sleep apnea, diabetes, hypertension, heart failure, depression, gastroesophageal reflux disease, hypercholesterolemia, pelvic floor disorders, chronic inflammation, auto-immune diseases, and asthma(Stimulation of the vagus nerve has been proposed as a method for treating various heart conditions, including heart failure and atrial fibrillation[0016]).
Regarding claim 20, Ben-Ezra in view of Verzal teaches the method of claim 18, wherein the treating the one or more medical conditions comprises stimulating a portion of the vagus nerve, or a branch of the vagus nerve, different from a portion of the vagus nerve that the electric stimulation is provided to for treating obesity(The present invention relates generally to electrical stimulation of and/or sensing signals of tissue, and specifically to methods and devices for regulating the stimulation of nerves or other tissue, including the vagus nerve, and/or sensing of electrical cardiac signals[0012]. In an embodiment, the control unit is adapted to configure the stimulating current to treat one or more of the following conditions of the subject: heart failure, atrial fibrillation, angina, cardiac arrest, arrhythmia, myocardial infarction, hypertension, endocarditis, myocarditis, asthma, an allergy, a neoplastic disorder, rheumatoid arthritis, septic shock, hepatitis, hypertension, diabetes mellitus, an autoimmune disease, a gastric ulcer, a neurological disorder, pain, a migraine headache, peripheral neuropathy, an addiction, a psychiatric disorder, obesity, an eating disorder, impotence, a skin disease, an infectious disease, a vascular disease, a kidney disorder, and a urinary tract disorder[0506]. electrode assembly 20 optionally further comprises a lead assembly 36, which comprises one or more electrical leads, as is known in the art. The leads are coupled to all or a portion of electrode contact surfaces 22. Lead assembly 36 couples electrode assembly 20 to an implanted or external control unit 38, which comprises appropriate circuitry for driving current between two or more of electrode contact surfaces 22, as is known in the art[1261]).
Claim(s) 2-9, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra in view of Verzal and further in view of Pardo(US 20060259077 A1).
Regarding claim 2, Ben-Ezra in view of Verzal teaches the medical device of claim 1, but fails to explicitly specify wherein the first set of electrodes comprises a first electrode and a second electrode, the first and second electrodes being configured to be positionable so that the first electrode is more proximal to a head of the person than the second electrode is to the person’s head.
However, Pardo teaches “Alternatively, or additionally, EEG sense electrodes 36 may be implanted in spaced apart relation through the skull, and connected to leads 37 implanted and extending along the scalp and temple and then along the same path and in the same manner as described above for the eye movement electrode leads[0060]. . The electrode assembly is surgically implanted on the vagus nerve 27 in the patient's neck. The two electrodes 25-1 and 25-2 are wrapped about the vagus nerve[0058],[Fig. 2],[Fig. 3]”.
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It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation of Ben-Ezra with the vagal nerve stimulation of Pardo. Doing so would specify electrode placement with along the vagal nerve in order to maximize patient stimulation.
Regarding claim 3, Ben-Ezra in view of Verzal and Pardo teaches the medical device of claim 2, wherein the first and second electrodes are configured to be controllably changeable between at least a first configuration, in which the first electrode is a cathode and the second electrode is an anode, and a second configuration, in which the first electrode is an anode and the second electrode is a cathode(Ben-Ezra - Electrode device 140 comprises a central cathode 146 for applying a negative current ("cathodic current") in order to stimulate vagus nerve 136, as described below. Electrode device 140 additionally comprises a set of one or more anodes 144 (144a, 144b, herein: "efferent anode set 144"), placed between cathode 146 and the edge of electrode device 140 closer to heart 30 (the "efferent edge"). Efferent anode set 144 applies a positive current ("efferent anodal current") to vagus nerve 136, for blocking action potential conduction in vagus nerve 136 induced by the cathodic current, as described below[1334]).
Regarding claim 4, Ben-Ezra in view of Verzal and Pardo teaches the medical device of claim 2, wherein the first set of electrodes comprises a third electrode and a fourth electrode, the third and fourth electrodes being configured to provide electric stimulation to the person’s vagus nerve and to be positionable so that the third electrode is more proximal to the person’s head than the fourth electrode is, wherein the first electrode and the fourth electrodes are cathodes, and the second and third electrodes are anodes, and wherein the first and second electrodes are configured with the third and fourth electrodes so that the first and second electrodes can be controlled and driven independently from the third and fourth electrodes(Ben-Ezra - FIG. 13 is a simplified perspective illustration of a multipolar point electrode device 240 applied to vagus nerve 136, in accordance with an embodiment of the present invention. In this embodiment, anodes 244a and 244b and a cathode 246 typically comprise point electrodes (typically 2 to 100), fixed inside an insulating cuff 248 and arranged around vagus nerve 136 so as to selectively stimulate nerve fibers according to their positions inside the nerve[1343]). However, Ben-Ezra fails to explicitly disclose the positioning of the electrodes.
However, Pardo discloses Fig. 2, which shows multiple electrode positioning along the patient.
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It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation of Ben-Ezra with the vagal nerve stimulation of Pardo. Doing so would specify electrode placement with along the vagal nerve in order to maximize patient stimulation.
Regarding claim 5, Ben-Ezra in view of Verzal teaches the medical device of claim 1, but fails to disclose wherein the one or more stimulation leads comprise: a first stimulation lead comprising the first set of electrodes on the first stimulation lead; and a second stimulation lead comprising the second set of electrodes on the second stimulation lead. However, Pardo discloses Fig. 2, with electrodes, 38, 33, and 25 and leads 22, 37, and 34.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation of Ben-Ezra with the vagal nerve stimulation of Pardo. Doing so would specify electrode placement along the vagal nerve in order to maximize patient stimulation.
Regarding claim 6, Ben-Ezra in view of Verzal and Pardo teaches the medical device of claim 5, but Ben-Ezra fails to explicitly specify wherein, the first and second stimulation leads are shaped and sized so that the second set of electrodes are positionable farther from the controller than the first set of electrodes are positionable from the controller. However, Pardo discloses Fig. 2, with electrodes, 38, 33, and 25, leads 22, 37, and 34, and generator/controller 10.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation of Ben-Ezra with the vagal nerve stimulation of Pardo. Doing so would specify electrode placement along the vagal nerve in order to maximize patient stimulation.
Regarding claim 7, Ben-Ezra in view of Verzal and Pardo teaches the medical device of claim 5, but Ben-Ezra fails to specify wherein the first and second stimulation leads are separately coupled to the controller. However, Pardo teaches “This method further comprises operably connecting a proximal electrical connector of the electrical lead to the signal generator, either before or after implanting the signal generator or the lead, and operably coupling a distal nerve electrode of the electrical lead to the trunk of the left vagus nerve in the neck of the patient[0034][Fig. 2 - Leads 22 and 34 separately connected to generator 10]”.
Regarding claim 8, Ben-Ezra in view of Verzal and Pardo teaches the medical device of claim 5, Ben-Ezra fails to specify wherein the first and second stimulation leads are bifurcated from a common lead and are coupled to the controller via the common lead. However, Pardo teaches “A stimulating nerve electrode set 25 (FIG. 3) is conductively connected to the distal end of insulated electrically conductive lead assembly 22, which is attached at its proximal end to connector 20[0058]. Lead(s) 22 is secured, while retaining the ability to flex with movement of the chest and neck, by a suture connection 30 to nearby tissue[0058]”.
Regarding claim 9, Ben-Ezra in view of Verzal teaches the medical device of claim 1, but fails to explicitly disclose wherein the one or more stimulation leads comprise a stimulation lead comprising the first set of electrodes at a first position along the stimulation lead and the second set of electrodes at a second position along the stimulation lead and separated from the first position. Pardo discloses Fig. 2, with electrodes, 38, 33, and 25, leads 22, 37, and 34, and generator/controller 10.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation of Ben-Ezra with the vagal nerve stimulation of Pardo. Doing so would specify electrode placement with along the vagal nerve in order to maximize patient stimulation.
Regarding claim 15, Ben-Ezra in view of Verzal teaches the method of claim 14, but fails to specify wherein the changing of the configuration of electrodes is in response to a rate of weight loss of the person being below a set threshold rate. However, Pardo teaches “The device parameters may be varied to provide the optimal nerve stimulation for each individual patient. In one embodiment, patients typically received 0.75 mA and pulse width of either 250 microsecond (.mu.s) or 500 microsecond (.mu.s) (Example 1). The method of the invention comprises providing chronic pre-programmed vagal stimulation to a patient in the neck either unilaterally or bilaterally. Desirably, the patient is treated for a six to twelve month period or longer. The amount of weight loss obtained using the method of the invention will vary between patients, with the heaviest patients showing the greatest weight loss. There is no known limit to the period of treatment that can be safely and effectively applied to an obese patient, while those with normal weight will maintain their weight if treated according to the present invention methods[0062]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation of Ben-Ezra with the vagal nerve stimulation of Pardo. Doing so would specify measuring the patients weight loss throughout stimulation to try and reach a target weight.
Regarding claim 16, Ben-Ezra in view of Verzal teaches the method of claim 14, but fails to specify wherein the changing of the configuration of electrodes is in response to a rate of weight loss of the person being above a set threshold rate. However, Pardo teaches “The device parameters may be varied to provide the optimal nerve stimulation for each individual patient. In one embodiment, patients typically received 0.75 mA and pulse width of either 250 microsecond (.mu.s) or 500 microsecond (.mu.s) (Example 1). The method of the invention comprises providing chronic pre-programmed vagal stimulation to a patient in the neck either unilaterally or bilaterally. Desirably, the patient is treated for a six to twelve month period or longer. The amount of weight loss obtained using the method of the invention will vary between patients, with the heaviest patients showing the greatest weight loss. There is no known limit to the period of treatment that can be safely and effectively applied to an obese patient, while those with normal weight will maintain their weight if treated according to the present invention methods[0062]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the nerve stimulation of Ben-Ezra with the vagal nerve stimulation of Pardo. Doing so would specify measuring the patients weight loss throughout stimulation to try and reach a target weight.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant argues that prior art fails to disclose amended claims limitations “comprising: a first set of electrodes configured to provide electrical stimulation to a vagus nerve of a person, and a second set of electrodes configured to provide electrical stimulation to a second body portion of the person”. However, new art Verzal teaches “ In some examples, the particular arrangement (e.g. number, shape, spacing, orientation, etc.) of electrodes on stimulation portion 6310A may be different from the particular arrangement of electrodes on stimulation portion 6313A[00198]. In some examples, the stimulation location of a non-hypoglossal nerve target may comprise, in addition to or instead of, the ansa cervicalis-related nerve, at least one of: glossopharyngeal nerve; a superior laryngeal nerve; a superior cervical ganglion; and a chemoreceptor (e.g. in close proximity to the carotid body)[00788]. With further reference to the example arrangement 501 in FIG. 3A, in some examples just one stimulation element is implanted at a left side of the head-and- neck portion 520 to stimulate a first type of nerve (e.g. hypoglossal, ansa cervicalis-related, or other) and just one stimulation element is implanted at right side of the head-and-neck portion 520 to stimulate a different second type of nerve (e.g. hypoglossal, ansa cervicalis-related, other). For instance, in some examples just stimulation element 510A is implanted to stimulate a right hypoglossal nerve 505R and just stimulation element 513B is implanted to stimulate a left ansa cervicalis-related nerve 515L, or vice versa[0088].” Verzal teaches two different sets of electrodes that stimulate two different types of nerves. Applicant further argues prior art fails to disclose amendment “switching the configuration of electrodes from the selected one configuration to the other configuration of the two selectable configurations of electrodes”. However new art Verzal teaches “Moreover, in some examples, the stimulation pattern of one of the example stimulation protocols (as described in FIGS. 33A-37D) for a given nerve (e.g. HGN) may be switched and applied to another nerve (e.g. ACN), or vice versa[00461 14R may be implemented so that both the left and right hypoglossal nerves and both the left and right ansa cervical is-related nerves have their own stimulation element (e.g. 4 different locations) such that stimulation may be applied in any desired combination from among a right side hypoglossal nerve, a left side hypoglossal nerve, a right side ansa cervicalis-related nerve, and a left side ansa cervicalis-related nerve. With these examples in mind, FIG. 36A provides one example stimulation protocol 5510 when a stimulation element is implanted at each of the 4 different locations (e.g. FIG. 3A, other). However, of course, the fact that each of the 4 different locations may have an implanted stimulation element does not necessitate that stimulation occurs at any one of the given locations at least because at least some of the various example stimulation protocols, methods, etc. throughout the various examples of the present disclosure may comprise selective stimulation among multiple implanted stimulation elements in order to achieve various goals in treating sleep disordered breathing[00206]”. Verzal teaches selectively stimulating specific areas where electrode configurations are and switching between areas of stimulation based on patient needs. Verzal can be naturally combined with Ben-Ezra and Pardo to disclose all the claimed limitations. Therefore the 103 rejections for all claims stand.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571)272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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