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 I in the reply filed on June 09, 2026 is acknowledged. Claims 11-15 are pending under examination. Claims 16-30 are canceled.
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 11-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, and 13 of U.S. Patent No. 11,129,983. Although the claims at issue are not identical, they are not patentably distinct from each other because the current pending claims are merely broader in scope than the patented claims of U.S. 11,129,983 by eliminating features from the patented claims. Broadening a patented claim is obvious to one of ordinary skill in the art.
Instant Application: 18/668,799
Reference Patent: 11,129,983
In re claim 1, an implantable stimulator system, comprising:
(a) at least one implantable neural stimulator circuit configured to be disposed beneath the skin of a subject:
(b) an external circuit configured for placement sufficiently proximal said implantable stimulator circuit for communicating
power to said implantable stimulator circuit, and
data to and/or from said implantable stimulator circuit;
(c) wherein said at least one implantable stimulator circuit comprises:
(i) a first inductive coil configured for receiving power from the external circuit as a power coupling;
(ii) a second inductive coil configured for communicating data with the external circuit as a data coupling;
(iii) a data link circuit configured for communicating data through said data coupling;
(iv) at least one electrode;
(v) an output stage configured for driving said at least one electrode;
(vi) a bio-impedance characterization circuit configured for determining bio-impedance at said at least one electrode;
(vii) a stimulation recording circuit; and
(viii) a controller circuit and memory configured
for storing stimulation parameters and recorded stimulation data, and
for controlling stimulation of the at least one electrode and communication with the external circuit in which said bio-impedance characteristics are utilized for controlling the stimulation applied at said at least one electrode according to one or more stimulation parameters that may be adjusted in real time.
In re claim 1, an implantable stimulator system, comprising:
(a) an implantable stimulator circuit configured for implanting within an organism:
(b) an external circuit configured for retention sufficiently proximal said implantable stimulator circuit for communicating power to said implantable stimulator circuit, and data to and/or from said implantable stimulator circuit;
(c) wherein said implantable stimulator circuit comprises:
(i) a first inductive coil configured for receiving power from the external circuit as a power coupling;
(ii) a second inductive coil configured for communicating data with the external circuit as a data coupling;
(iii) a data link circuit configured for communicating data through said data coupling;
(iv) a flexible epidural electrode array comprising a plurality of electrodes;
(v) a multi-channel stimulation circuit having a high voltage output stage configured for multiplexed driving of the plurality of electrodes in said epidural electrode array;
(vi) a bio-impedance characterization circuit configured for determining bio-impedance at the plurality of electrodes;
(vii) a multi-channel stimulation recording circuit; and
(viii) a controller circuit and memory configured
for storing stimulation parameters and recorded stimulation data, and
for controlling stimulation of the plurality of electrodes and communication with the external circuit in which said bio-impedance characteristics are utilized for controlling the stimulation applied at said electrode array according to one or more stimulation parameters that may be adjusted in real time.
In re claim 12, wherein said external circuit comprises:
at least one inductive coil configured
for transmitting power as a power coupling to said implantable stimulator circuit and
for communicating data as a data coupling with said implantable stimulator circuit; and
a data link circuit configured for communicating data through said data coupling.
In re claim 2, wherein said external circuit comprises:
at least one inductive coil configured
for transmitting power as a power coupling to said implantable stimulator circuit and
for communicating data as a data coupling with said implantable stimulator circuit;
a data link circuit configured for communicating data through said data coupling; and
a controller circuit and memory configured for controlling stimulation in said implantable stimulator circuit and for receiving information transmitted by said implantable stimulator circuit.
In re claim 13, wherein said implantable stimulator circuit is configured for performing real time adjustment of stimulation parameters used for providing stimulation of a target treatment region.
In re claim 4, wherein said implantable stimulator circuit is configured for performing real time adjustment of stimulation parameters used for providing stimulation of a target treatment region.
In re claim 14, wherein the implantable stimulator circuit is configured for placement in the body for vagus nerve stimulation or cortical neuromodulation.
In re claim 13, wherein the implantable stimulator circuit is configured for placement in the body for vagus nerve stimulation or cortical neuromodulation.
In re claim 15, wherein said controller circuit, bio-impedance characterization circuit, multi-channel stimulation circuit, data link circuit, and multi-channel stimulation recording circuit of said implantable stimulator circuit are integrated as a system on chip (SoC).
In re claim 5, wherein said controller circuit, bio- impedance characterization circuit, multi-channel stimulation circuit, data link circuit, and multi-channel stimulation recording circuit of said implantable stimulator circuit are integrated as a system on chip (SoC).
Claim Rejections - 35 USC § 103
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 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al. (US 2015/0157862) in view of Ranu et al (US 2015/0005846).
In re claim 11, Greenberg discloses an implantable stimulator system [0011], comprising:
(a) at least one implantable neural stimulator circuit configured to be disposed beneath the skin of a subject [0011]:
(b) an external circuit configured for placement sufficiently proximal said implantable stimulator circuit ([0011]: “external system”) for communicating
power to said implantable stimulator circuit ([0217]: “coil may receive power and data signals from the external apparatus”), and
data to and/or from said implantable stimulator circuit ([0217]: “may send information about the implant… out to the external apparatus”);
(c) wherein said at least one implantable stimulator circuit comprises:
(i) a first inductive coil configured for receiving power from the external circuit as a power coupling ([0167]: “secondary inductive coil… receive both power and data”);
(ii) a second inductive coil configured for communicating data with the external circuit as a data coupling ([0158]: “transmits data with a coil to an external coil”);
(iii) a data link circuit configured for communicating data through said data coupling ([0139]: “bidirectional wireless link”; [0154]: forward and back telemetry communicate data);
(iv) at least one electrode [0011];
(v) an output stage configured for driving said at least one electrode ([0139]: “any electrode, or electrodes, within the array may be connected to any… stimulation driver”; [0158]: “stimulation electronic circuit 14, which drives stimulation electrode array”);
(vi) a impedance characterization circuit configured for determining impedance at said at least one electrode ([0218]: “measure electrical properties of the entire system (i.e. impedance…)”);
(vii) a stimulation recording circuit [0158]: “recording electronics package receives signals from electrodes on a recording electrode array”); and
(viii) a controller circuit [0158] and memory ([0155]: “system also has the ability to store the history of chronic neural sense data”) configured
for storing stimulation parameters ([0158]: “determines the proper stimulation patterns”) and recorded stimulation data ([0155]: “store the history of chronic neural sense data”; Note: Under broadest reasonable interpretation, recorded stimulation data could include neural sense data that is recorded during stimulation), and
for controlling stimulation of the at least one electrode and communication with the external circuit [0158] in which said impedance characteristics are utilized for controlling the stimulation applied at said at least one electrode according to one or more stimulation parameters that may be adjusted in real time [0157, 0218].
Greenberg lacks
a bio-impedance characterization circuit configured for determining bio-impedance at said at least one electrode
a controller circuit… for controlling… in which said bio-impedance characteristics…
Ranu teaches a system comprising a medical lead that can be implanted near a tissue region of the patient that has monitoring circuitry for measuring different parameters, such as impedance [0017], that could be used with a cortical stimulator or a stimulator to produce coordinated limb movement [0031]. The system can measure tissue impedance based on the applied electrical signals [0050] at each electrode [0051]. Then, depending on the determined tissue impedance value, a stimulation parameter can be automatically adjusted [0013].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Greenberg with being able to measure the tissue impedance and adjust stimulation parameters as taught by Ranu, as tissue impedance values can change overtime so determining tissue impedance and then adjusting stimulation parameters can be used to ensure a safe and efficacious level of therapy is applied to a user.
In re claim 12, the proposed combination, all mapping directed to Greenberg, yields wherein said external circuit comprises:
at least one inductive coil configured
for transmitting power as a power coupling to said implantable stimulator circuit [0217] and
for communicating data as a data coupling with said implantable stimulator circuit [0158]; and
a data link circuit configured for communicating data through said data coupling [0154].
In re claim 13, the proposed combination, all mapping directed to Greenberg, yields wherein said implantable stimulator circuit is configured for performing real time adjustment of stimulation parameters used for providing stimulation of a target treatment region [0157, 0158, 0218].
In re claim 14, the proposed combination, all mapping directed to Greenberg, yields wherein the implantable stimulator circuit is configured for placement in the body for vagus nerve stimulation or cortical neuromodulation [0011].
In re claim 15, the proposed combination, all mapping directed to Greenberg, yields wherein said controller circuit, bio-impedance characterization circuit, multi-channel stimulation circuit, data link circuit, and multi-channel stimulation recording circuit of said implantable stimulator circuit are integrated as a system on chip (SoC) ([0228]: “the present invention includes the addition of one or more integrated circuits or chips”; Note: a system on a chip is an integrated circuit that combines key components onto one chip; [0230]: “place all of the required electrical circuitry on a single coated chip”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gerber et al. (US 2011/0040546) teaches a therapy program that can be modified based on information that indicates a change in the therapy field, which can represent a region of the patient’s tissue (abstract). Tissue impedance characteristics can be used to determine an efficacious therapy program [0056]. Stimulation signals can be adjusted based on impedance values, as impedance values can change at the electrode site due to tissue ingrowth or leads shifting [0086].
Burdick et al. (US 2014/0180361) teaches a neurostimulator that can communicate data and instructions from an external device which can determine stimulation parameters by using information collected by a sensor (abstract).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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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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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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