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, 10-14, and 17-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Ben-Ezra(US 20140046407 A1).
Regarding claim 1, Ben-Ezra discloses a medical device, comprising: one or more stimulation leads configured to stimulate at least a person’s vagus nerve to treat, via the stimulation of the person’s vagus nerve, 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]).
Regarding claim 10, Ben-Ezra discloses 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 discloses the medical device of claim 10, comprising the one or more sensors, 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 discloses the medical device of claim 10, comprising the one or more sensors, 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]).
Regarding claim 14, Ben-Ezra discloses the method of claim 13, further comprising: changing the configuration of electrodes from the selected one configuration to another one configuration of the two selectable configurations of electrodes; and providing electric stimulation to the vagus nerve utilizing the other one configuration(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 discloses 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 discloses 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 discloses 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 discloses 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 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) 2-9, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra in view of Pardo(US 20060259077 A1).
Regarding claim 2, Ben-Ezra discloses the medical device of claim 1, but fails to explicitly specify wherein the one or more stimulation leads comprise a first electrode and a second electrode, the first and second electrodes being configured to provide electric stimulation to the person’s vagus nerve and 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 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 Pardo teaches the medical device of claim 2, further comprising a third and 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 discloses the medical device of claim 1, but fails to disclose wherein the one or more stimulation leads comprise: a first stimulation lead comprising a first set of electrodes on the first stimulation lead and configured to stimulate the person’s vagus nerve; and a second stimulation lead comprising a second set of electrodes on the second stimulation lead and configured to stimulate at least one selected from among the person’s 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. 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 Pardo teaches the medical device of claim 5, but Ben-Ezra fails to explicitly specify wherein the second set of electrodes are configured to stimulate the person’s vagus nerve or a branch of the vagus nerve, and 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 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 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 discloses the medical device of claim 1, but fails to explicitly disclose wherein the one or more stimulation leads comprise a stimulation lead comprising a first set of electrodes at a first position along the stimulation lead and a 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 discloses 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 discloses 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.
Conclusion
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
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796