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 .
Election/Restrictions
Applicant’s election without traverse of the IMD product of Group I in the reply filed on 6/18/26 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected EMF mitigating method and diagnostic circuitry product drawn to Groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/18/26.
Specification
The disclosure is objected to because of the following informalities: 1) the first paragraph of the specification should be updated for any issued patent numbers, 2) the same corrections applied in response to the Request for Certificate of Correction of 12/6/24 of parent case 16/931,030 should also be applied in this case.
Appropriate correction is required.
Claim Objections
Claims 1-9 are objected to because of the following informalities: 1) In Claim 1, the “a power supply module;” should be on a separate line from the preamble that ends with “comprising:”. Appropriate correction is required.
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)(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 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2020/0346005 by Boor et al.
The applied reference has a common assignee, and joint inventor(s) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding Claim 1, Boor discloses an implantable medical device (e.g. ¶ 32: IPG), comprising:
a power supply module (e.g. ¶ 9: floating power supply; Fig. 3: power supply 312);
a processing unit (e.g. ¶ 37: CPU);
an implantable lead system including at least one lead having a plurality of electrodes adapted to stimulate a patient’s tissue responsive to instructions generated by the processing unit in association with a pulse generator module, the plurality of electrodes including at least one inactive electrode and at least one active electrode (e.g. ¶ 32, Fig. 3: IPG for SCS having lead 330 with electrodes 332/333/334/335; ¶¶ 28-29: some electrodes are active and some are inactive; ¶ 47: the CPU controls the IPG);
a charge pump voltage source operative to supply a common-mode voltage reference with respect to one or more circuitry portions of the pulse generator module configured to energize one or more electrodes [e.g. Fig. 5 and Fig. 8: common-mode 540 as part of both feedback and stimulation; ¶ 11: “the floating power supply may include a charge pump and a switch network. The switch network may be configured to connect the charge pump to the power supply when charging the charge pump”, ¶ 33: “The unused electrode can operate as the EMI antenna to sense and mitigate interference voltages induced by EMI. Additionally, or alternatively, the EMI antenna may be constructed as a “dummy” wire provided within the lead or routed with insulation substantially alongside the outside of the NS lead and arranged to extend alongside other stimulation wires in the NS lead. The dummy wire may not electrically conduct to human tissue, and thus may not be considered to be an “electrode.” Based on the voltage sensed at the EMI antenna, a control circuit can adjust up/down a common mode voltage applied to the patient tissue at the IPG Can/Case, such that interference voltages induced by EMI do not degrade stimulation therapy. In accordance herewith, neural stimulation therapy may be applied continuously and with a desired control for DBS and SCS patients during MRI scans and/or while in the presence of other types of EMI”; also see ¶ 65,74-75,77-78]; and
diagnostic circuitry configured to generate one or more control signals for adjusting the common-mode voltage reference provided by the charge pump voltage source depending on a difference between the common-mode voltage reference and an interference voltage sensed at a Kelvin connection node associated with the implantable lead system [e.g. ¶ 33: “An EMI antenna can be utilized to sense and mitigate interference voltages induced by EMI. By way of example, the EMI antenna may include one or more Kelvin connect electrodes or unused electrodes in a NS Lead that are not being used to deliver stimulation therapy to the patient” and “Based on the voltage sensed at the EMI antenna, a control circuit can adjust up/down a common mode voltage applied to the patient tissue at the IPG Can/Case, such that interference voltages induced by EMI do not degrade stimulation therapy.”;¶ 57: “the EMI antenna may include one or more Kelvin connect electrodes or unused electrodes (e.g., any one or more of the electrodes 332-335) that are not being used to deliver stimulation therapy to the patient”; ¶ 75: “The voltage source 539 adds the common mode voltage to the Case of the IPG, in order to raise the entire electrode network to the common mode voltage, which in turn offsets induced voltages introduced by EMI interference. Raising the electrode network to the common mode voltage prevents the EMI interference from interfering, through the Case electrode, with a performance of the circuitry 500 while operating in the presence of EMI events.”; ¶ 78: “assume during an EMI event that the V.sub.com common mode voltage reference 539 is maintained between +/−10 V. When no EMI interference is present, the voltages at V.sub.com and at the floating ground node 517 may be biased to approximately 0 V. When EMI interference is experienced in a conventional NS system, the EMI interference adds voltage interferences at the electrodes E1 and E2 that cause their voltages to fluctuate upward and downward (e.g., in a sinusoidal manner). The voltage interferences at electrodes E1 and E2 would also cause the voltage at the floating ground node 517 to similarly fluctuate upward and downward by an amount substantially corresponding to the voltage interference”].
a method of mitigating electromagnetic interference (EMI) in an implantable medical device (IMD) having a pulse generator configured to supply stimulation to a patent's tissue (e.g. par. 4,12: EMI mitigation for SCS implant), the method comprising:
monitoring an interference voltage sensed at a Kelvin connection node associated with an implantable lead system of the IMD [e.g. par. 33: “An EMI antenna can be utilized to sense and mitigate interference voltages induced by EMI. By way of example, the EMI antenna may include one or more Kelvin connect electrodes or unused electrodes in a NS Lead that are not being used to deliver stimulation therapy to the patient.”; par. 57: “the EMI antenna may include one or more Kelvin connect electrodes or unused electrodes (e.g., any one or more of the electrodes 332-335) that are not being used to deliver stimulation therapy to the patient”]; and
Allowable Subject Matter
Claims 2-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art does not reasonably teach, suggest or render obvious, either alone or in combination, claim 2 taken as a whole. The closest prior art of record is Boor, yet it fails to teach Claim 2, as a whole. Claims 3-9 depend on Claim 2, and are thus also allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
It is also noted here that this application is a divisional of 16931030, “with consonance”, thus obviating the potential requirement for relevant terminal disclaimers with the issued patent of the parent case.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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