DETAILED ACTION
Response to Amendment
This action is in response to the amendment after non-final filed 11 August 2026. Claims 1-19 are pending.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of claim(s) 1-19 based on the 35 USC 101 statutory type double patenting have been fully considered and are persuasive. The amendments to the claims provide additional limitations not previously recited by US Patent no. 11,135,431. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the doctrine of non-statutory double patenting as the present claims and the conflicting claims of the ‘431 patent are not identical but 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)
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,135,431.
For instance, claim 1 of the ‘431 substantially recites the limitations of present claim 1 as described below:
CLAIM 1 of Present Invention:
An implantable medical device (IMD), comprising: a battery;
a lead system comprising one or more leads configured to be positioned proximate to a patient's tissue, wherein each lead includes a plurality of electrodes;
a first voltage multiplier configured to generate an adjustable target voltage at an output node based on a voltage supplied by the battery; and
a plurality of stimulation engines, each respectively including:
a second voltage multiplier operative to drive an anodic node;
a current regulator powered by a floating voltage supply, the current regulator coupled to a cathodic node, wherein the second voltage multiplier, the current regulator and the floating voltage supply are commonly referenced to a floating reference node; and
a selector configured to selectively couple the anodic node and the cathodic node of a respective stimulation engine to a select portion of the electrodes for applying a select stimulation therapy to the patient's tissue according to a stimulation set,
wherein each anodic node of the plurality of stimulation engines is commonly coupled to the output node of the first voltage multiplier.
CLAIM 1 of the ‘431 Patent:
An implantable medical device (IMD), comprising:
a lead system comprising a plurality of leads configured to be positioned proximate to a patient's tissue, wherein respective leads of the plurality of leads include a plurality of electrodes;
a first voltage multiplier configured to generate an adjustable target voltage at an output node based on a voltage supplied by a battery; and
a plurality of stimulation engines, respectively including:
a second voltage multiplier operative to drive an anodic node;
a current regulator powered by a floating voltage supply, the current regulator coupled to a cathodic node, wherein the second voltage multiplier, the current regulator and the floating voltage supply are commonly referenced to a floating reference node; and
a selector configured to selectively couple the anodic node and the cathodic node of a respective stimulation engine to a select portion of the electrodes for applying a select stimulation therapy to the patient's tissue according to a stimulation set or a plurality of stimulation sets,
wherein anodic nodes of the plurality of stimulation engines are commonly coupled to the output node of the first voltage multiplier.
The changes made to the claims are considered to merely comprise broadening language to exclude the singular recitations of the lead and anodic nodes. However, as the ‘431 was drafted in the alternative using the narrower recitation of “one or more” to provide for plural groups of elements as well as singular groups of elements, the “or more” language is considered to anticipate the newly recited plurality.
Similar overlap is demonstrated between claim 8 of the present invention and claim 8 of the ‘431 patent, wherein claim 8 of the ‘431 substantially recites the limitations of present claim 8 as described below:
CLAIM 8 of Present Invention:
A stimulation therapy method using an implantable medical device (IMD), the IMD including a battery and a lead system of one or more leads configured to be positioned proximate to a patient's tissue, wherein each lead includes a plurality of electrodes, the method comprising: providing a first voltage multiplier configured to generate a range of target voltages at an output node based on a voltage supplied by the battery;
providing a plurality of stimulation engines (SE), each respectively powered by a corresponding floating power supply, wherein each SE is configured to support an anodic node and a cathodic node, the anodic node driven by a respective second voltage multiplier coupled to the output node of the first voltage multiplier and the cathodic node coupled to a respective current regulator powered by the corresponding floating power supply;
selectively coupling one or more sets of electrodes of the lead system to a corresponding number of SEs at respective anodic and cathodic nodes; and
independently applying multiple stimulation therapies to respective sets of the electrodes wherein at least one of stimulation delivery collisions and channel contention between the respective sets of electrodes of the lead system is avoided.
CLAIM 8 of the ‘431 Patent:
A stimulation therapy method using an implantable medical device (IMD), the IMD including a lead system of a plurality of leads configured to be positioned proximate to a patient's tissue, wherein respective leads of the plurality of leads include a plurality of electrodes, the method comprising: providing a first voltage multiplier configured to generate a range of target voltages at an output node based on a voltage supplied to the first voltage multiplier;
providing a plurality of stimulation engines (SE)s, each respectively powered by a corresponding floating power supply, wherein respective Ses are configured to support an anodic node and a cathodic node, the anodic node driven by a respective second voltage multiplier coupled to the output node of the first voltage multiplier and the cathodic node coupled to a respective current regulator powered by the corresponding floating power supply;
selectively coupling one or more sets of electrodes of the lead system to a corresponding number of SEs at respective anodic and cathodic nodes; and
applying multiple stimulation therapies to respective sets of the electrodes wherein at least one of stimulation delivery collisions or channel contention between the respective sets of electrodes of the lead system is avoided.
The changes made to the claims are considered to merely comprise broadening language to exclude the singular recitations of the lead. However, as the ‘431 was drafted in the alternative using the narrower recitation of “one or more” to provide for plural groups of elements as well as singular groups of elements, the “or more” language is considered to anticipate the newly recited plurality. Additionally, the battery recited in the ‘431 provides anticipation for a source of power to supply a voltage to the first voltage multiplier. Further, removing “each” from the stimulation engine limitation broadens the claim scope. The claim no longer requires an individual floating power supply for every stimulation engine, but now allows for a common source. Consequently, this broader scope is anticipated by the power sources in the ‘431 patent.
Similar overlap is demonstrated between claim 14 of the present invention and claim 14 of the ‘431 patent, wherein claim 14 of the ‘431 substantially recites the limitations of present claim 14 as described below:
CLAIM 14 of Present Invention:
A therapy system, comprising:
an implantable medical device (IMD) including:
a battery;
a lead system comprising one or more leads configured to be positioned proximate to a patient's tissue, wherein each lead includes a plurality of electrodes;
a first voltage multiplier configured to generate an adjustable target voltage at an output
node based on a voltage supplied by the battery; and
a plurality of stimulation engines, each respectively including:
a second voltage multiplier operative to drive an anodic node;
a current regulator powered by a floating voltage supply, the current regulator coupled to a cathodic node, wherein the second voltage multiplier, the current regulator and the floating voltage supply are commonly referenced to a floating reference node; and
a selector configured to selectively couple the anodic node and the cathodic node of a respective stimulation engine to a select portion of the electrodes, wherein each anodic node of the plurality of stimulation engines is commonly coupled to the output node of the first voltage multiplier; and
an external programmer device for independently applying multiple stimulation therapies in a concurrent manner to respective portions of the electrodes by actuating the selector of the IMD according to respective stimulation sets, wherein at least one of stimulation delivery collisions and channel contention between the respective portions of electrodes of the lead system is avoided during concurrent application of the multiple stimulation therapies.
CLAIM 14 of the ‘431 Patent:
A therapy system, comprising:
an implantable medical device (IMD) including:
;
a lead system comprising a plurality of leads configured to be positioned proximate to a patient's tissue, wherein respective leads of the plurality of leads include a plurality of electrodes;
a first voltage multiplier configured to generate an adjustable target voltage at an output node based on a voltage supplied by a battery; and
a plurality of stimulation engines, respectively including:
a second voltage multiplier operative to drive an anodic node;
a current regulator powered by a floating voltage supply, the current regulator coupled to a cathodic node, wherein the second voltage multiplier, the current regulator and the floating voltage supply are commonly referenced to a floating reference node; and
a selector configured to selectively couple the anodic node and the cathodic node of a respective stimulation engine to a select portion of the electrodes, wherein respective anodic nodes of the plurality of stimulation engines are commonly coupled to the output node of the first voltage multiplier; and
an external programmer device for applying multiple stimulation therapies in a concurrent manner to respective portions of the electrodes by actuating the selector of the IMD according to one or more stimulation sets, wherein at least one of stimulation delivery collisions and channel contention between the respective portions of electrodes of the lead system is avoided during concurrent application of the multiple stimulation therapies.
The changes made to the claims are considered to merely comprise broadening language to exclude the singular recitations of the lead and anodic nodes. However, as the ‘431 was drafted in the alternative using the narrower recitation of “one or more” to provide for plural groups of elements as well as singular groups of elements, the “or more” language is considered to anticipate the newly recited plurality.
The claims dependent from present claims 1, 8, and 14 are also verbatim to the dependent claims of claims 1, 8, and 14 of the ‘431 patent such that the inventions are the same.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 8 October 2026
