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 .
DETAILED ACTION
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,857,789. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are directed to essentially the same features as claims 1-20 of U.S. Patent No. 11,857,789, except for the limitation of therapy delivery in a manner that follows an actively emulated passive discharge profile.
One of ordinary skill in the art would have found it obvious to eliminate the actively emulated passive discharge profile feature, because it is obvious to eliminate a step or element and its function, See MPEP 2144.04.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,946,199. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are directed to an obvious broadening of claims 1-20 of U.S. Patent No. 10,946,199 and elimination of the feature of therapy delivery in a manner that follows an actively emulated passive discharge profile.
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.
Claims 1, 2, 9-12 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra et al (US 2019/0001139).
Regarding claim 1, Mishra discloses a system, comprising:
a plurality of electrodes positioned within a patient, the plurality of electrodes
including an active electrode, the active electrode configured to be a cathode
electrode located proximate to tissue of interest that is associated with a target
region;
an anode electrode, see paragraph [0263]. Mishra teaches lead 265 comprises between 2 and 64 electrodes and the electrodes have an anode/cathode configuration, see paragraph [0162].;
an antenna 240;
a control circuit 550 is configured to control delivery of a therapy during a therapy delivery interval, the therapy to be delivered between the anode electrode and the active electrode, the system developing a residual charge between the anode electrode and the active electrode over the therapy delivery interval, see paragraphs [0248] and [0249];
a regulator circuit comprising controller 250 is connected to the cathode electrode, the regulator circuit configured to control at least one of voltage or current at the cathode electrodes, see paragraph [0249].
Mishra teaches the controller 250 has a clamping circuit configured to allow fast charging and/or discharging of the energy storage assembly 270, functional element 260 drivers (e.g. electrode drivers) of controller 250, and/or other components of implantable device 200, see paragraph [0252].
During a discharge operation, the control circuit 550 is configured to manage the regulator circuit comprising controller 250 to control at least one of a discharge voltage or current over the discharge operation to discharge the residual charge after therapy delivery in a manner that follows a predetermined profile.
Mishra teaches the stimulation signal produced by an implantable device 200 can be created independent from a power signal received from an external device 500, so that any electromagnetic interference in the wireless link does not affect generation and delivery of the stimulation signal, see paragraph [0293].
One of ordinary skill in the art would have found it obvious to configure the regulator circuit comprising controller 250 to regulate at least one of the discharge voltage or current through the active electrode based on an electromagnetic interference (EMI) feedback signal, to maintain the predetermined profile over the discharge operation while in a presence of an EMI event during the discharge operation because it is desirable to limit patient discomfort due to EMI. Motivation to regulate the discharge voltage or current through the active electrode based on an electromagnetic interference feedback signal is provided by the Mishra teaching that probability distributions are shifted during use (e.g. to greater or lower values or other change in distribution), such as a distribution shifted based on patient feedback received in a patient diagnostic procedure in which patient discomfort (e.g. paresthesia) or therapeutic efficacy (e.g. pain relief) are assessed, see paragraph [0409].
Regarding claim 2, Mishra discloses the antenna 240 is configured to receive power from one or more external devices 500, see paragraph [0375]. Antenna 240 is an EMI antenna configured to generate the EMI feedback signal indicative of a voltage interference induced at least in part by an electromagnetic field surrounding the system.
Regarding claim 9, Mishra discloses the control circuit 550 is configured to deliver a neurostimulation (NS) therapy as the therapy, see paragraphs [0171], [0176] and [0205].
Regarding claim 10, Mishra discloses the regulator circuit comprising controller 250 is configured to modulate the current flow over the discharge operation, based on the EMI feedback signal, in order to follow the predetermined profile to compensate for voltage fluctuation caused by the EMI event, see paragraph [0386].
Regarding claim 11, Mishra discloses a method, comprising:
providing a plurality of electrodes to be located proximate to tissue of interest that is associated with a target region, the plurality of electrodes including an active electrode configured to be a cathode electrode, see paragraph [0263]. Mishra teaches lead 265 comprises between 2 and 64 electrodes and the electrodes have an anode/cathode configuration, see paragraph [0162].
Mishra discloses delivering a therapy during a therapy delivery interval between an anode electrode and the active electrode, the system developing a residual charge between the anode electrode and the active electrode over the therapy delivery interval, see paragraph [0289] and FIG 1A.
One of ordinary skill in the art would have found it obvious during a discharge operation in a presence of an EMI event to:
control at least one of a discharge voltage or current over the discharge operation to discharge the residual charge after therapy delivery in a manner that follows a predetermined profile, see paragraph [0393];
obtain an electromagnetic interference (EMI) feedback signal from an antenna 240 while in the presence of the EMI event; and
regulate the at least one of a discharge voltage or current at the anode and cathode electrodes 260 based on the EMI feedback signal to maintain the predetermined profile over the discharge operation while in the presence of the EMI event. One of ordinary skill in the art would have found it obvious to configure the regulator circuit comprising controller 250 to regulate at least one of the discharge voltage or current through the active electrode based on an electromagnetic interference (EMI) feedback signal, to maintain the predetermined profile over the discharge operation while in a presence of an EMI event during the discharge operation because it is desirable to limit patient discomfort due to EMI. Motivation to regulate the discharge voltage or current through the active electrode based on an electromagnetic interference feedback signal is provided by the Mishra teaching that probability distributions are shifted during use (e.g. to greater or lower values or other change in distribution), such as a distribution shifted based on patient feedback received in a patient diagnostic procedure in which patient discomfort (e.g. paresthesia) or therapeutic efficacy (e.g. pain relief) are assessed, see paragraph [0409].
Regarding claim 12, Mishra discloses the EMI feedback signal is indicative of a voltage interference induced at least in part by an electromagnetic field surrounding the system, see paragraph [0409].
Regarding claim 18, Mishra discloses implanting an implantable pulse generator 200 that houses a control circuit 550 and current regulator (CR) circuit 250 that deliver a neurostimulation (NS) therapy as the therapy, see paragraphs [0171], [0176] and [0205].
Regarding claim 19, one of ordinary skill in the art would have found it obvious to deliver the NS therapy repeatedly over successive therapy delivery intervals because the device 200 delivers therapy for successive periods during which EMI occurs, and where the therapy intervals are separated by corresponding successive discharge operations while in the presence of the EMI event.
Regarding claim 20, Mishra discloses the regulator circuit comprising controller 250 is configured to modulate the current flow over the discharge operation, based on the EMI feedback signal, in order to follow the predetermined profile to compensate for voltage fluctuation caused by the EMI event, see paragraph [0386].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pivonka et al (US 2018/0256906) disclose a related therapy device having an implantable system and an external device where therapy is delivered via electrodes to a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Manuel whose telephone number is (571) 272-4952.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached on (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George Manuel/
Primary Examiner
Art Unit: 3792
1/15/2026