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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 12-25 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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 12-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moffitt et al. (Patent No.: US 8,180,445 B1); hereinafter referred to as “Moffitt”, in view of Lozano (Pub. No.: US 2008/0275526 A1).
Regarding claim 12, Moffitt discloses a system (e.g. see figure 2 element 10) for stimulating nerves, comprising: a pulse generator (e.g. see element 14) configured to generate biphasic waveforms including a positive anodal pulse followed by a negative cathodal pulse (e.g. see column 12 lines 24-43, figures 9 and 10); electrodes (e.g. see figure 5 elements E1-E16) connected to the pulse generator by wires, wherein the electrodes are configured to be connected to a nerve conduction pathway (e.g. see abstract); and a programmable computing unit (e.g. see figure 2 elements 16, 18, 20, column 5 line 63 through column 6 line 3, figure 5 element 52) connected to the pulse generator, wherein the programmable computing unit includes circuitry and program instructions stored therein that, when executed by one or more processors, cause the one or more processors to signal the pulse generator to generate the waveforms (e.g. see figure 2 elements 16, 18, 20, column 5 line 63 through column 6 line 3, figure 5 element 52), wherein the waveforms include the positive anodal pulse followed immediately by the negative cathodal pulse (e.g. see figures 8, 9, and 10).
Moffitt discloses generating the waveforms disclosed by the applicant (see the rejection for claims 12-23) but is silent as to the waveforms are generated by the pulse generator to lower a membrane potential of a nerve in the nerve conduction pathway below a resting membrane potential of the nerve to effectuate a therapeutic benefit. Lozano teaches it is known to use such a modification as set forth in [0100]-[0101], figure 5C elements t3 and t4 (Note: In figure 5c, the resting membrane potential is -XmV and the “lower” membrane potential is -YmV. The waveform at t3 moves -YmV closer to the threshold and thus “lowers” the membrane potential required ([0100]-[0101]). Note that the graph is on the negative Y-axis, so the terms lower and raise are opposite) to enhance or induce neuroplasticity in the nerve cells (e.g. see [0100]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to lower the membrane potential below the resting membrane potential as taught by Lozano in the system of Moffitt, since said modification would provide the predictable results of enhancing or inducing neuroplasticity in the nerve cells (see [0100]).
Regarding claim 13, Moffitt discloses the program instructions, when executed by the one or more processors, cause the one or more processors to signal the pulse generator to: apply the positive anodal pulse for a pulse length of t milliseconds; and apply the negative cathodal pulse for a pulse length of k milliseconds, wherein t is greater than k, t is equal to k, or t is less than k (e.g. see figures 6-12).
Regarding claim 14, Moffitt discloses the program instructions, when executed by the one or more processors, cause the one or more processors to signal the pulse generator to: apply a square wave voltage of positive amplitude Vi to an anodal electrode operably coupled to the pulse generator; and apply a square wave voltage of negative amplitude V2 to an cathodal electrode operably coupled to the pulse generator, wherein Vi is less than or equal to V2 (e.g. see figures 6-12).
Regarding claim 15, Moffitt discloses a sensing circuit operably connected to the electrodes, the electrodes being configured for implantation in a brain, and further wherein: the sensing circuit is configured to sense electrical signals in the brain which indicate an onset of an epileptic seizure; and the program instructions, when executed by the one or more processors, cause the one or more processors to apply the biphasic anodal and the cathodal pulses when the sensing circuit detects the onset of the epileptic seizure (e.g. see figure 2 element 10, column 5 lines 47-63. Note: The prior art is capable of and/or configured to meet these functional limitations of a system/device claim).
Regarding claim 16, Moffitt discloses the electrodes are configured to be implanted in a left-side vagus nerve of a patient, and further wherein the program instructions, when executed by the one or more processors, cause the one or more processors to apply the biphasic waveforms to the electrodes to stimulate distal brain structures (e.g. see figure 2 element 10, column 5 lines 47-63. Note: The prior art is capable of and/or configured to meet these functional limitations of a system/device claim).
Regarding claim 17, Moffitt discloses the electrodes are configured to be attached to a scalp of a patient, and further wherein the program instructions, when executed by the one or more processors, cause the one or more processors to apply the biphasic waveforms to the electrodes to stimulate distal brain structures (e.g. see figure 2 element 10, column 5 lines 47-63. Note: The prior art is capable of and/or configured to meet these functional limitations of a system/device claim).
Regarding claim 18, Moffitt discloses the electrodes are configured to be operably coupled to a conduction pathway of a hormone secreting organ, and further wherein the program instructions, when executed by the one or more processors, cause the one or more processors to apply the biphasic waveforms to the electrodes to stimulate hormone secreting cells of the hormone secreting organ (e.g. see figure 2 element 10, column 5 lines 47-63. Note: The prior art is capable of and/or configured to meet these functional limitations of a system/device claim).
Regarding claim 19, Moffitt discloses the electrodes are configured to be operably coupled to a conduction pathway of a pancreas of a patient, and further wherein the program instructions, when executed by the one or more processors, cause the one or more processors to apply the biphasic waveforms to the electrodes to stimulate release of insulin from the pancreas (e.g. see figure 2 element 10, column 5 lines 47-63. Note: The prior art is capable of and/or configured to meet these functional limitations of a system/device claim).
Regarding claim 20, Moffitt discloses the electrodes are configured to be operably coupled to a conduction pathway of a living cell, and further wherein the program instructions, when executed by the one or more processors, cause the one or more processors to apply the biphasic waveforms to the electrodes to change the cell membrane permeability of the living cell (e.g. see figure 2 element 10, column 5 lines 47-63. Note: The prior art is capable of and/or configured to meet these functional limitations of a system/device claim).
Regarding claim 21, Moffitt discloses the electrodes are configured to be attached to a conduction pathway of distal brain structures of a patient, and further wherein the program instructions, when executed by the one or more processors, cause the one or more processors to apply the biphasic waveforms to the electrodes to stimulate distal brain structures to improve mitochondrial function in glutan ataxia (e.g. see figure 2 element 10, column 5 lines 47-63. Note: The prior art is capable of and/or configured to meet these functional limitations of a system/device claim).
Regarding claim 22, Moffitt discloses the electrodes are configured to be attached to a conduction pathway of distal brain structures of a patient, and further wherein the program instructions, when executed by the one or more processors, cause the one or more processors to apply the biphasic waveforms to the electrodes to stimulate distal brain structures to improve mitochondrial function in spinocerebellar ataxia (e.g. see figure 2 element 10, column 5 lines 47-63. Note: The prior art is capable of and/or configured to meet these functional limitations of a system/device claim).
Regarding claim 23, Moffitt discloses the electrodes are configured to be attached to a tenth cranial nerve of a patient, and further wherein the program instructions, when executed by the one or more processors, cause the one or more processors to apply the biphasic waveforms to the electrodes to stimulate distal brain structures of the patient (e.g. see figure 2 element 10, column 5 lines 47-63. Note: The prior art is capable of and/or configured to meet these functional limitations of a system/device claim).
Regarding claim 24, Moffitt discloses the negative cathodal pulse is an inverse negative symmetric cathodal pulse (e.g. see figure 8 element E1).
Regarding claim 25, Moffitt discloses generating the waveforms disclosed by the applicant (see the rejection for claims 12-24) but is silent as to the waveforms are generated by the pulse generator lower a membrane potential of a nerve in the nerve conduction pathway below a resting membrane potential of the nerve to effectuate interruption of an epileptic seizure. Lozano teaches it is known to use such a modification as set forth in [0100]-[0101], figure 5C elements t3 and t4 (Note: In figure 5c, the resting membrane potential is -XmV and the “lower” membrane potential is -YmV. The waveform at t3 moves -YmV closer to the threshold and thus “lowers” the membrane potential required ([0100]-[0101]. Note that the graph is on the negative Y-axis, so the terms lower and raise are opposite. Also, the limitation “to effectuate interruption of an epileptic seizure” is met by the prior art as the same treatment will elicit the same patient response) to enhance or induce neuroplasticity in the nerve cells (e.g. see [0100]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to lower the membrane potential below the resting membrane potential as taught by Lozano in the system of Moffitt, since said modification would provide the predictable results of enhancing or inducing neuroplasticity in the nerve cells (see [0100]).
Conclusion
The following prior art is being made of record as they also disclose biphasic stimulation with the positive anodic phase preceding the negative cathodic phase: Lee et al. (Pub. No.: US 2009/0024189 A1) (e.g. see figure 11) and Herb et al. (Pub. No.: US 2017/0056643 A1) (e.g. see figures 2, 4, 6). Also, [0072] of Maschino et al. (Pub. No.: US 2007/0027492 A1) teaches lowering and raising the resting membrane potential.
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.
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/P.C.E/ Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792