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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,786,722 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,786,722 has been found to anticipate each and every element of the present invention, for instance both provide a neuromodulation apparatus for a medical treatment comprising: a plurality of active electrodes electrically isolated from each other and arranged in at least one electrodes array, wherein each active electrode comprises an electrically conductive element configured to be applied to a skin of a patient; at least one reference electrode configured to be applied to the skin of the patient; an electrical pulse generator electrically connected to each active electrode of the plurality of active electrodes and configured to selectively transmit electrical pulses for the neuromodulation medical treatment to each of the plurality of active electrodes; a control unit coupled to the electrical pulse generator and adapted to measure a resistance and/or a current-voltage characteristic between each active electrode of the plurality of active electrodes and the at least one reference electrode, wherein the control unit is adapted to evaluate active electrodes arranged in the same electrode array based on the measured resistance and/or current voltage characteristic, wherein from the evaluated active electrodes the control unit is adapted to select for a reception of the electrical pulses generated by the electrical pulse generator to one or more active electrodes.
As set forth above, the present invention is not viewed to be patentably distinct from US 11,786,722.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,226,624 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 12,226,624 B2 has been found to anticipate each and every element of the present invention, for instance both provide a neuromodulation apparatus for a medical treatment comprising: a plurality of active electrodes electrically isolated from each other and arranged in at least one electrodes array, wherein each active electrode comprises an electrically conductive element configured to be applied to a skin of a patient; at least one reference electrode configured to be applied to the skin of the patient; an electrical pulse generator electrically connected to each active electrode of the plurality of active electrodes and configured to selectively transmit electrical pulses for the neuromodulation medical treatment to each of the plurality of active electrodes; a control unit coupled to the electrical pulse generator and adapted to measure a resistance and/or a current-voltage characteristic between each active electrode of the plurality of active electrodes and the at least one reference electrode, wherein the control unit is adapted to evaluate active electrodes arranged in the same electrode array based on the measured resistance and/or current voltage characteristic, wherein from the evaluated active electrodes the control unit is adapted to select for a reception of the electrical pulses generated by the electrical pulse generator to one or more active electrodes.
As set forth above, the present invention is not viewed to be patentably distinct from US 12,226,624 B2.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by King (US 8,108,049 B2).
As to claim 1, King discloses a neuromodulation apparatus comprising: a plurality of active electrodes (depicted as 40 in Figure 3; col. 8, lines 17-29) electrically isolated from each other and arranged in at least one electrodes array (Figure 3; col. 8, lines 17-29), wherein each active electrode comprises an electrically conductive element configured to be applied to or under a skin of a patient (via the lead; Figure 3; col. 8, lines 17-45); at least one reference electrode configured to be applied to or under the skin of the patient (col. 9, lines 42-47); an electrical pulse generator (signal generation circuitry; depicted as 42 in Figure 3; col. 8, lines 30-64) electrically connected to each active electrode of the plurality of active electrodes and configured to selectively transmit electric pulses for the neuromodulation medical treatment to each of the plurality of active electrodes (col. 8, lines 30-64); a control unit (processor, depicted as 44 in Figure 3) coupled to the electrical pulse generator (signal generation circuitry) and adapted to measure a resistance and/or a current-voltage characteristic between each active electrode of the plurality of active electrodes and the at least one reference electrode (impedance measure; depicted as 52 in Figure 3, for example; col. 8, line 65 - col. 10, line 17), wherein from the evaluated active electrodes the control unit is configured to select one or more active electrodes with the lowest measured values of resistance and/or one or more active electrodes with current voltage characteristics showing the lowest voltage drop for the same value of passing current to receive the electrical pulses generated by the electrical pulse generator (col. 8, line 65 - col. 10, line 17; also see Figure 5).
As to claim 2, King discloses the control unit is adapted to control a shape of the electrical pulses generated by the electrical pulse generator (since King discloses controlling or adjusting the parameters of electrical stimulation (amplitude, etc.), King controls the “shape of the electrical pulses” generated) based on the measured value of resistance and/or the measured current voltage characteristic of the selected one or more active electrodes (col. 8, lines 30-67, col. 9, lines 1-67 and col. 10, lines 1-32; also Figures 4-5; Furthermore, since King discloses controlling or adjusting the parameters of electrical stimulation (amplitude, etc.), King controls the “shape of the electrical pulses” generated).
As to claim 3, King discloses the control unit is configured to repeatably measure the resistance and/or the current-voltage characteristic between each active electrode of the plurality of active electrodes and the at least one reference electrode (Figures 4-5; cols. 9-10, lines 3-67 and 1-32), wherein the control unit is further configured to update the selection of which of an active electrode or active electrodes of the plurality of active electrodes are to receive the electrical pulses for the neuromodulation medical treatment generated by the pulse generator (Figures 4-5; cols. 9- 10, lines 3-67 and 1-32, respectively).
As to claim 4, King discloses at least one detector (sensor, depicted as 54 in Figures 3) configured to detect a response of the patient to at least one electrical pulse generated by the electrical pulse generator, wherein the detector is further adapted to provide feedback on the detected response to the control unit (Figures 4-5; e.g., col. 10, lines 33-65).
As to claim 5, King discloses the at least one detector (sensor, depicted as 54 in Figure 3) is at least one motion detector configured to detect a movement of the patient and adapted to provide feedback on the movement to the control unit, wherein the movement of the patient body is in response to the at least one pulse of the pulse generator (Figures 4-5; col. 10, lines 33-65).
As to claim 6, King discloses the at least one motion detector includes at least one of an accelerometer (col. 10, lines 51-65).
As to claims 7-8, King discloses at least one electromyography based (EMG) detector is configured to detect a change in an electrical activity produced by muscles of the patient in response to the at least one electrical pulse generated by the electrical pulse generator (col. 10, lines 33-42).
As to claim 9, King discloses the control unit is adapted to receive a patient's response detected by the detector (sensor, depicted as 54 in Figure 3) in response to the at least one electrical pulse generated by the electrical pulse generator conveyed by the one or more selected active electrodes and the control unit is adapted to control the shape of the electrical pulses generated by the electrical pulse generator based on the measured value of resistance and/or the current- voltage characteristic and the detected response by the at least one detector (Figures 4-5; col. 10, lines 33-65; also see Abstract).
As to claim 10, King discloses the control unit is further configured to determine current density of electrical pulses for flowing through each of selected active electrodes and based on the result selectively employ active electrodes neighboring to the each of the selected active electrodes within the same electrodes array to also receive electrical pulses for the neuromodulation medical treatment for the neuromodulation medical treatment generated by the pulse generator (cols. 8-9, lines 65- 67 and 1-65, respectively).
As to claim 11, King discloses the control unit is configured to control a slope of rising edge of the electric pulses and/or a magnitude of the electric pulses for the neuromodulation medical treatment (since King discloses controlling or adjusting the parameters of electrical stimulation (amplitude, etc.), King controls the “shape of the electrical pulses” generated; Figures 4-5; col. 5, lines 51-66).
As to claims 12-13, King discloses a probe (i.e., leads 16) having a contact surface which bears the electrode array, the contact surface comprising a bump which has at least part of the active electrodes of the electrode array (col. 8, lines 17-29) wherein the electrode array extends on the contact surface around the bump (col. 8, lines 17-29).
As to claim 14, King discloses the contact surface has in first direction a general concave shape from which the bumps protrudes, wherein the contact surface has in second direction that is perpendicular to the first direction a general convex shape (col. 8, lines 17-29).
As to claim 15, King discloses a neuromodulation apparatus comprising: a plurality of active electrodes (depicted as 40 in Figure 3; col. 8, lines 17-29) electrically isolated from each other and arranged in at least one electrodes array (Figure 3; col. 8, lines 17-29), wherein each active electrode comprises an electrically conductive element configured to be applied to or under a skin of a patient (via the lead; see Figure 3; col. 8, lines 17-45); at least one reference electrode configured to be applied to or under the skin of the patient (col. 9, lines 42-47); a pulse generator (signal generation circuitry; depicted as 42 in Figure 3; col. 8, lines 30-64) electrically connected to each active electrode of the plurality of active electrodes and configured to selectively transmit electric pulses for the neuromodulation medical treatment to each of the plurality of active electrodes (col. 8, lines 30-64); a control unit (processor, depicted as 44 in Figure 3) coupled to the electrical pulse generator (signal generation circuitry) and adapted to measure a resistance and/or a current-voltage characteristic between each active electrode of the plurality of active electrodes and the at least one reference electrode (impedance measure; depicted as 52 in Figure 3, for example; col. 8, line 65 - col. 10, line 17), wherein from the evaluated active electrodes the control unit is adapted to select for a reception of the electrical pulses generated by the electrical pulse generator a one or more active electrodes with the lowest measured values of resistance and/or a one or more active electrodes with current voltage characteristics showing the lowest voltage drop for the same value of passing current (col. 8, line 65 - col. 10, line 17; also see Figure 5).
As to claim 16, King discloses controlling by the control unit a shape of the electrical pulses generated by the electrical pulse generator (since King discloses controlling or adjusting the parameters of electrical stimulation (amplitude, etc.), King controls the “shape of the electrical pulses” generated) based on the measured value of resistance and/or the measured current voltage characteristic of the selected one or more active electrodes (col. 8, lines 30-67, col. 9, lines 1-67 and col. 10, lines 1-32; also see Figures 4-5, for example; Furthermore, since King discloses controlling or adjusting the parameters of electrical stimulation (amplitude, etc.), King controls the “shape of the electrical pulses” generated).
As to claim 17, King discloses the target nerve is at least one of sciatic, pudendal, peroneal, cavernous, sacral plexus, vagus or a tibial nerve (col. 5, lines 37-50).
As to claim 18, King discloses repeatably measuring the resistance and/or the current- voltage characteristic between each of active electrodes arranged within each of the at least one electrodes array and each of the at least one reference electrode and updating the measured values with the new measurements for each of the at least one electrode array (Figures 4-5).
As to claim 19, King discloses detecting a response of the patient's body to the at least one electrical pulse generated by the pulse generator and providing feedback on the detected response to the control unit (Figures 4-5; col. 10, lines 33-65).
As to claim 20, King discloses receiving by a control unit a patient's response detected by the detector (sensor, depicted as 54 in Figure 3) in response to the at least one electrical pulse generated by the electrical pulse generator and controlling the shape of the electrical pulses based on the measured value of resistance and/or current-voltage characteristic and the detected response by the at least one detector (Figures 4-5; col. 10, lines 33-65; also see Abstract).
As to claim 21, King discloses determining current density of electrical pulses flowing through each of selected active electrodes and based on the result selectively employing active electrodes neighboring to the each of the selected active electrodes within the same electrodes array to also receive electrical pulses for the neuromodulation medical treatment generated by the pulse generator (cols. 8-9, lines 65-67 and 1-65, respectively).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 7am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached on (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3792
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