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 Invention II (claims 8-12), and Species A (claims 8-9) in the reply filed on March 13, 2026 is acknowledged.
Claims 1-7, 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 13, 2026.
Response to Amendment
Claims 1-7, 10-12 are withdrawn due to a restriction requirement. Currently, claims 8-9 are pending for examination.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 8-9 are directed toward the invention elected in the parent application (U.S. Application No. 16/917,199, now U.S. Patent No. 11,771,904), and not directed toward the restricted non-elected claim set of the parent application. Therefore, claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,771,904. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader in scope than the patented claims. For example, application claim 8 requires a power supply module, a processing unit, pulse generator, an implantable lead system including electrodes as claimed, switching circuitry operative to selectively couple one or more terminals associated with each electrode to an analog-to-digital converter (ADC) having a sense input and a reference input, the switching circuitry including switching for each electrode corresponding to the terminals similar to the patented claim 1.
The application claim 8 further requires diagnostic circuitry comprising the ADC operative for selectively actuating the switching circuitry based on a Kelvin connection mode with respect to an active electrode and a Kelvin electrode, wherein the switching circuitry couples a terminal of the active electrode and a terminal of the Kelvin electrode, respectively, to sense input and the reference input of the ADC for obtaining a voltage measurement indicative of a charge state associated with the active electrode. This is disclosed in the patented claim 1 as it requires utilizing a direct current (DC) blocking stimulation capacitor CDC2 terminal coupled to a (second) active electrode to sense input of the ADC and a direct current (DC) blocking stimulation capacitor CDC1 terminal coupled to a Kelvin electrode (regarded as a first inactive electrode, see claim 3) to reference input of the ADC; and obtaining the voltage measurement across the first and second Kelvin connection terminals as a voltage indicative of a charge state associated with an electrode/tissue interface of the (second) active electrode.
Application claim 9 further limits claim 8 to require a direct current (DC) blocking stimulation capacitor (CDC) terminal of the active electrode is coupled to the sense input of the ADC and a DC blocking stimulation capacitor (CDC) terminal of the Kelvin electrode is coupled to the reference input of the ADC. As explained above, patented claim 1 discloses these limitations.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baru et al. (US PG Pub 2019/0255333) in view of Wilson (US Pat 5,540,235), Keith (Jim Keith. “Kelvin Connection”. https://www.electroschematics.com/kelvin-connection/, posted at least as of 9/19/2014 per the comment, viewed on 11/3/2022), Armstrong et al. (US PG Pub 2008/0015641).
Regarding claims 8-9, Baru et al. discloses an implantable medical device and method, comprising: a power supply module ([0003], [0059]); a processing unit (abstract, [0066], [0075]); a pulse generator ([0003], [0059]); an implantable lead system including at least one lead having a plurality of electrodes 100 ([0059], [0062]) adapted to stimulate a patient’s tissue responsive to instructions generated by the processing unit in association with the pulse generator ([0066-0067]); and switching circuitry ([0066-0067]) to selectively couple one or more terminals associated with each electrode, the switching circuitry including one or more switches for each electrode corresponding to the one or more terminals associated therewith ([0069]); and diagnostic circuitry ([0013], [0031-0034]), wherein the switching circuitry couples a terminal of an active electrode and a terminal of an inactive electrode, respectively, to sense input and reference inputs for obtaining a voltage measurement ([0003-0004], [0009], [0015-0018], [0031-0034]).
Baru et al. does not expressly disclose the diagnostic circuitry comprises an analog-to-digital converter (ADC) having a sense input and a reference input; where the one or more terminals associated with each electrode is coupled to the ADC either via the sense input and reference input. Wilson teaches it is known in the art to determine electrical discharges of an electrode/tissue interface by measuring changes in the voltage of the active electrode relative to an inactive electrode, which is amplified and passed to an analog-to-digital converter that produces a signal corresponding to the voltage difference between the two electrodes (col. 1, lines 42-64). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baru et al. to include the ADC as diagnostic circuitry as taught by Wilson as it is a known method of measuring the electrical activity at the electrode/tissue interface and the combination/substitution of elements of Baru et al. with those of Wilson is merely the combining of prior art elements according to known methods to yield predictable results, and/or the simple substitution of one known element for another to obtain predictable results.
Baru et al. does not expressly disclose a Kelvin connection mode with respect to an active electrode and a Kelvin electrode. Keith however, teaches the use of a Kelvin connection path (“A Kelvin connection is a means of making electrical potential contact with a current carrying component in such a way that eliminates or greatly reduces the effect of contact resistance (p. 1). This is especially important when dealing with low millivolt measurements as in shunt resistors where contact resistance is a significant and unknown variable”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baru et al. to include the elements of Keith as a way of providing a voltage measurement while eliminating or greatly reducing the effect of contact resistance.
Baru et al. does not expressly disclose obtaining the voltage measurement is indicative of a charge state associated with the active electrode. Armstrong et al. teaches an analogous invention where a voltage measurement associated with the electrode/tissue interface of an active electrode ([0006-0007], [0024-0026], [0038]) is obtained as a voltage measurement across a first and second connection terminal as a voltage indicative of a charge state associated with an electrode/tissue interface (ETI) of an active electrode ([0006], [0024-0026], [0038]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baru et al. to include the elements of Armstrong et al. to better allow for the determination of the presence of undesirable charges and balancing those charges for the safety of the patient ([0009-0011]). Additionally, the combination/substitution of elements of Baru et al. with those of Armstrong et al. is merely the combining of prior art elements according to known methods to yield predictable results, and/or the simple substitution of one known element for another to obtain predictable results; using sensing as particular terminal in order to determine residual voltage so that it can be countered/removed/discharged.
Regarding claim 9, Baru et al. discloses wherein the switching circuitry is selectively actuated responsive to the Kelvin connection mode such that a direct current (DC) blocking stimulation capacitor (CDC) terminal ([0004], [0063-0064]) of the active electrode is coupled to the sense input of the ADC and a DC blocking stimulation capacitor (CDC) terminal ([0004], [0063-0064]) of the Kelvin electrode is coupled to the reference input of the ADC ([0003-0004], [0009], [0015-0018], [0031-0034]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (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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/ERICA S LEE/Primary Examiner, Art Unit 3796
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