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 .
Status of Claims
The amendments and remarks filed on 02MAR2026 have been entered and considered.
Claims 1-8, 11-15, & 17-19 are currently pending.
Claims 17 has been amended.
claims 1-16 have been canceled.
Claims 20-22 have been added.
No new matter has been added.
Claims 17-22 are under examination.
Response to Arguments
Applicant's arguments filed 02MAR2026 regarding the rejections under 35 USC 102(a)(1) have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Page 6 of the Remarks):
In other words, claim 17 expressly recites that in a first stimulus phase, the current injection current source is connected between the first supply rail and stimulus electrode such that it passes a first current from the first supply rail to the stimulus electrode, and that the at least one return electrode is connected to a second supply rail such that the first current flows from the return electrode to the second supply rail. Claim 17 further expressly recites that in a second stimulus phase, the current extraction current source is connected between the stimulus electrode and the second supply rail such that it passes a second current from the stimulus electrode to the second supply rail, and that the at least one return electrode is connected to the first supply rail such that the second current flows from the first supply rail to the return. Rather, Weiss appears to disclose connecting two active current sources to the electrodes during each of the stimulus phases. For example, Weiss at paragraph [0022] discloses, "During the stimulation phase, electrode El acts as the anode or source for the current pulse, while electrode E2 acts of the cathode or sink for the current pulse. Thus, sourced current of the desired amplitude is issued from the PDAC 72p to E1 while sunk current of that same amplitude is drawn into the NDAC 72n from E2.". Thus, during the stimulation phase in Weiss, two current sources are active, both electrodes are connected to a current source, and neither electrode is connected to a supply rail. The same is true in the active recovery phase: "The stimulation phase is eventually followed by the active recovery phase during which E1 acts as the cathode (sunk current is drawn into the NDAC 72n from E1) and E2 as the anode (source current is issued from PDAC 72p to E2), such that current flows through the tissue R in the opposite direction." Id. 1 [0022] (emphasis added). Thus, it is clear that in both the "stimulation phase" and the "active recovery phase," Weiss teaches that two current sources are active, both electrodes are connected to a current source, and neither electrode is connected to a supply rail. Accordingly, Weiss here fails to teach or suggest the features "the current injection current source is connected between a first supply rail and the stimulus electrode" and "the at least one return electrode is connected to a second supply rail" in the first stimulus phase; and "the current extraction current source is connected between the stimulus electrode and the second supply rail" and "the at least one return electrode is connected to the first supply rail" in the second stimulus phase as recited in amended claim 17.
However, the Examiner disagrees because such as seen in Figure 3A the NDAC/PDAC units which are described in ¶022 are shown to have the supply rails (VH/GND) (i.e Compliance voltage to power the circuit and ground) which both need to be used for the operation of the circuitry. The examiner maintains that the reference teaches the claim limitations.
Applicant states (see Pages 6-7 of the Remarks):
In response to Applicant's previous arguments, the Office Action at page 5 asserted that Weiss teaches the connections recited in former claim 17, and asserted, "These parts as described are connected in a circuit to operate as a whole. The claim limitations do not provide further details on the configuration of the circuitry as argued, which states more than a circuit containing the relevant parts which are coupled together, since the amendments instead describe a general path of current as it flows through a circuit." However, Applicant submits that claim 17 as amended now recites more than "a general path of current as it flows through a circuit." Accordingly, Applicant submits that claim 17 as amended positively recites circuit configurations and operations that are not disclosed by Weiss.
The Examiner notes the attempted amendment to disclose more than “a general path of current as it flows through a circuit”, but the amended language does not change either the scope or interpretation provided previously.
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 17-22 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Weiss et al. (US Publication Number 20180071513; Previously Cited).
Regarding claim 17, Weiss discloses an implantable neurostimulator comprising (Weiss Abstract “Improved stimulation circuitry for controlling the stimulation delivered by an implantable stimulator is disclosed. The stimulation circuitry includes memory circuitry that stores pulse programs that define pulse shapes, steering programs that define electrode configurations, and aggregate programs that link a selected pulse program with a selected steering program.”; ¶0034):an implantable electrode array comprising at least one stimulus electrode and at least one return electrode, each electrode configured to deliver electrical stimuli to neural tissue (Weiss ¶0004 “The IPG 10 is coupled to electrodes 16 via one or more electrode leads 18, such that the electrodes 16 form an electrode array 20. The electrodes 16 are carried on a flexible body 22, which also houses the individual signal wires 24 coupled to each electrode. In the illustrated embodiment, there are eight electrodes (Ex) on two leads 18 for a total of sixteen electrodes 16, although the number of leads and electrodes is application specific and therefore can vary. The leads 18 couple to the IPG 10 using lead connectors 26,”; ¶0017; ); an implantable control module configured to produce the electrical stimuli delivered by the at least one stimulus electrode and at least one return electrode (Weiss ¶0025 “The microcontroller 50 in turn typically receives information about the structure of the pulses wirelessly from an external device, such as an external controller through which the patient or clinician could select the various pulse parameters (amplitude, pulse width, frequency), the electrodes, and whether they are to act as anodes or cathodes.”; ¶0063; ¶0069; ¶0121-¶0124), the control module comprising at least one current injection current source (Weiss ¶0018- ¶0022, Supply rails denoted as (VH, GND).) and at least one current extraction current source (Weiss ¶0018-¶0022 current extraction source denoted as NDAC 72n) wherein in a first stimulus phase the current injection current source is connected between a first supply rail and the stimulus electrode such that the current injection current source passes a first current from the first supply rail to the stimulus electrode (Weiss ¶0117 “Rows of the switches 178 in the switch matrix 190 are connected to nodes 191 in each of the electrodes' output paths. In the example shown, there are 25 branch transistors 184, and 33 electrode nodes (E1′ through E32′ and Ec′), and thus switch matrix 190 comprises 25 times 33 switches and control signals <Cn1> to control each. Of course, differing numbers of branch transistors and electrode nodes could also be used.”); the at least one return electrode is connected to a second supply rail such that the first current flows from the return electrode to the second supply rail (Weiss Figure 3A showing how the electrodes are in connected in the circuit to the supply rails and switching matrix. Further described in ¶0020 “one or more DACs (or one or more current sources within a DAC) may be distributed to a selected electrode by a switch matrix (not shown), in which case optional control signals <Psel> and <Nsel> would be used to control the switch matrix and establish the connection between the selected electrode and the PDAC 72p or NDAC 72n”) ; in a second stimulus phase, the current extraction current source is connected between the stimulus electrode and the second supply rail such that the current extraction current source pass a second current from the stimulus electrode to the second supply rail (Weiss Figure 5B showing the multiple components, extraction source NDAC, injection source PDAC, and switch matrix 190 which is not shown but described in ¶0117 “Rows of the switches 178 in the switch matrix 190 are connected to nodes 191 in each of the electrodes' output paths. In the example shown, there are 25 branch transistors 184, and 33 electrode nodes (E1′ through E32′ and Ec′), and thus switch matrix 190 comprises 25 times 33 switches and control signals <Cn1> to control each. Of course, differing numbers of branch transistors and electrode nodes could also be used.”;) the at least one return electrode is connected to the first supply rail such that the second current flows from the first supply rail to the return electrode. (Weiss Figures 3A & 3B; ¶0018- ¶0022, stimulus electrode (E1), return electrode (E2), first phase (stimulation phase), second phase (active recovery phase), current injection source (PDAC 72p), current extraction source (NDAC 72n), rails (VH, GND).).
Regarding claim 18, Claim 17 is anticipated by Weiss. Weiss further discloses wherein the second supply rail is a ground rail (Weiss ¶0018- ¶0022, Supply rails denoted as (VH, GND).).
Regarding claim 19, Claim 17 is anticipated by Weiss. Weiss further discloses wherein the first supply rail is a voltage supply rail (Weiss ¶0018- ¶0022, Supply rails denoted as (VH, GND).).
Regarding claim 20, Weiss discloses a method of operating an implantable neurostimulator to deliver neural stimuli (Weiss Abstract “Improved stimulation circuitry for controlling the stimulation delivered by an implantable stimulator is disclosed. The stimulation circuitry includes memory circuitry that stores pulse programs that define pulse shapes, steering programs that define electrode configurations, and aggregate programs that link a selected pulse program with a selected steering program.”; ¶0034), the implantable neurostimulator comprising: an implantable electrode array comprising at least one stimulus electrode and at least one return electrode, each electrode configured to deliver electrical stimuli to neural tissue(Weiss ¶0004 “The IPG 10 is coupled to electrodes 16 via one or more electrode leads 18, such that the electrodes 16 form an electrode array 20. The electrodes 16 are carried on a flexible body 22, which also houses the individual signal wires 24 coupled to each electrode. In the illustrated embodiment, there are eight electrodes (Ex) on two leads 18 for a total of sixteen electrodes 16, although the number of leads and electrodes is application specific and therefore can vary. The leads 18 couple to the IPG 10 using lead connectors 26,”; ¶0017; ); a first supply rail and a second supply rail (Weiss ¶0018- ¶0022, Supply rails denoted as (VH, GND).); and a current injection current source and a current extraction current source (Weiss ¶0018-¶0022 current extraction source denoted as NDAC 72n) configured to produce the electrical stimuli delivered by the at least one stimulus electrode and at least one return electrode (Weiss ¶0025 “The microcontroller 50 in turn typically receives information about the structure of the pulses wirelessly from an external device, such as an external controller through which the patient or clinician could select the various pulse parameters (amplitude, pulse width, frequency), the electrodes, and whether they are to act as anodes or cathodes.”; ¶0063; ¶0069; ¶0121-¶0124), the method comprising: connecting, in a first stimulus phase, the current injection current source between the first supply rail and the stimulus electrode such that the current injection current source passes a first current from the first supply rail to the stimulus electrode (Weiss ¶0117 “Rows of the switches 178 in the switch matrix 190 are connected to nodes 191 in each of the electrodes' output paths. In the example shown, there are 25 branch transistors 184, and 33 electrode nodes (E1′ through E32′ and Ec′), and thus switch matrix 190 comprises 25 times 33 switches and control signals <Cn1> to control each. Of course, differing numbers of branch transistors and electrode nodes could also be used.”),connecting the at least one return electrode to the second supply rail during the first stimulus phase such that the first current flows from the return electrode to the second supply rail (Weiss Figure 3A showing how the electrodes are in connected in the circuit to the supply rails and switching matrix. Further described in ¶0020 “one or more DACs (or one or more current sources within a DAC) may be distributed to a selected electrode by a switch matrix (not shown), in which case optional control signals <Psel> and <Nsel> would be used to control the switch matrix and establish the connection between the selected electrode and the PDAC 72p or NDAC 72n”); connecting, in a second stimulus phase, the current extraction current source between the stimulus electrode and the second supply rail such that the current extraction current source passes a second current from the stimulus electrode to the second supply rail (Weiss Figure 5B showing the multiple components, extraction source NDAC, injection source PDAC, and switch matrix 190 which is not shown but described in ¶0117 “Rows of the switches 178 in the switch matrix 190 are connected to nodes 191 in each of the electrodes' output paths. In the example shown, there are 25 branch transistors 184, and 33 electrode nodes (E1′ through E32′ and Ec′), and thus switch matrix 190 comprises 25 times 33 switches and control signals <Cn1> to control each. Of course, differing numbers of branch transistors and electrode nodes could also be used.”;); and connecting the at least one return electrode to the first supply rail during the second stimulus phase such that the second current flows from the first supply rail to the return electrode. (Weiss Figures 3A & 3B; ¶0018- ¶0022, stimulus electrode (E1), return electrode (E2), first phase (stimulation phase), second phase (active recovery phase), current injection source (PDAC 72p), current extraction source (NDAC 72n), rails (VH, GND).).
Regarding claim 21, Claim 20 is anticipated by Weiss. Weiss further discloses wherein the second supply rail is a ground rail. (Weiss ¶0018- ¶0022, Supply rails denoted as (VH, GND).).
Regarding claim 22, Claim 20 is anticipated by Weiss. Weiss further discloses wherein the first supply rail is a voltage supply rail. (Weiss ¶0018- ¶0022, Supply rails denoted as (VH, GND).)
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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