Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 96-101 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In claim 96, line 14, the implanted sensor combines the patient’s body, encompassing a human organism. It is suggested to replace “implanted” with “implantable”.
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 86-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,883,670. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are directed to obvious variations of stimulating a spinal cord with electrodes and detecting an evoked compound action potential induced by the stimulation, and adjusting parameter values of the stimulation to different values based on the detected evoked action potential and iteratively perform these operations until a target neural response which is an obvious equivalent to a smoother and/or more pleasant sensation is achieved as claimed in claims 1-24 of U.S. Patent No. 11,883,670.
Claims 86-101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,918,867. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are directed to obvious variations of stimulating a spinal cord with electrodes and detecting an evoked compound action potential induced by the stimulation, and adjusting parameter values of the stimulation to different values based on the detected evoked action potential in addition to iteratively performing these operations until a target neural response is measured. It would have been obvious to eliminate performing these operations until a target neural response is measured. Without performing these operations until a target neural response is measured, the present claims 86-101 are essentially claiming the same features as claims 1-11 of U.S. Patent No. 10,918,867.
Claims 86-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,179,241. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are directed to obvious variations of stimulating a spinal cord with electrodes and detecting an evoked compound action potential induced by the stimulation, and adjusting parameter values of the stimulation to different values based on the detected evoked action potential and iteratively perform these operations until a target neural response which is an obvious equivalent to a smoother and/or more pleasant sensation is achieved as claimed in claims 1-22 of U.S. Patent No. 10,179,241.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 86, 94, 95, 96, 101 and 102are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Inman et al (US 2007/0255320).
Regarding claims 86, 96 and 102, Inman teaches delivering closed loop spinal cord stimulation to treat pain in a patient is well known, see paragraph [0009].
Inman discloses applying an electrical signal to a spinal cord of the patient that induces a neural response in the form of an evoked compound action potential. Inman provides a stimulating nerve electrode assembly 125 where a substantially complete insulation around the electrodes 900 increases the ability to sense evoked compound action potentials in the nerve 220, in part by reducing ingress of intercellular body fluids from outside the nerve to the electrodes 900.
Inman meets the limitation of detecting, via an implanted sensor comprising electrodes 900, the evoked compound action potential induced by the applied electrical signal from electrode assembly 125.
One of ordinary skill in the art would have found it obvious to automatically adjust a first parameter value of the electrical signal to a second parameter value based at least in part on the detected evoked compound action potential because Inman teaches providing an external user interface 670 with a programming device 670a that is capable of programming various modules and stimulation parameters of the implantable device 600, see paragraph [0044].
The skilled artisan would have been motivated to adjust a first parameter value of the electrical signal to a second parameter value because Inman teaches the electrical neurostimulation involves performing a detection, with the electrical signal being delivered in response to a detected physiologic parameter. The skilled artisan would have found it likewise logical that adjusting a first parameter value of the electrical signal to a second parameter value would change the response to another value which could be a desired outcome.
Inman teaches delivering neurostimulation as a pulsed electrical signal in discrete stimulation periods known as pulse bursts, which constitute a series of controlled electrical pulses defined by a plurality of parameters, see paragraph [0061].
One of ordinary skill in the art would have found it obvious to provide the series of controlled electrical pulses defined by the parameters iteratively by automatically adjusting the parameters until a target neural response is measured because the skilled artisan would have found it desirable to select parameters which bring the stimulation closer to the desired evoked response,
Inman teaches providing the external user interface 670 with a programming device 670a that is capable of programming stimulation parameters for implantable device 600. It would have been a simple programming adjustment that would not require undue experimentation to automatically adjust the stimulation until a target neural response is measured, see paragraph [0070].
Regarding claim 94 and 101, Inman meets all of the claim limitations as discussed above except for the electrical signal is applied or sensed to the neural population within the spinal cord via one or more electrodes implanted in an epidural space of the spinal cord.
The epidural space of the spinal cord is well known for treating pain associated with lower body pain.
One of ordinary skill in the art would have found it obvious to apply the neural population within the spinal cord via one or more electrodes 125 implanted in an epidural space of the spinal cord to treat lower body pain.
Regarding claim 95, Inman meets all of the claim limitations as discussed above except for generating the electrical signal using a pulse generator implanted in the patient.
Inman teaches using a pulse generator 600 implanted in the patient.
Claims 87-93, 97-100, 104 and 105 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Inman et al (US 2007/0255320) as applied to claims 86, 96 and 102 above, and further in view of Litvak et al (US 7,283,877).
Regarding claim 87, Inman meets all of the claim limitations as discussed above except for the evoked compound action potential includes measuring an amplitude of the evoked compound action potentials.
Litvak teaches current amplitude is used to characterize the response characteristic of a nerve to various applied stimulus levels, see col. 4, lines 66-58.
One of ordinary skill in the art would have found it obvious to measure an amplitude of the evoked compound action potentials because, as Litvak points out, the amplitude is commonly used to characterize the response.
Regarding claims 88-93, 97-100, 104 and 105, Inman meets all of the claim limitations as discussed above except for the claimed first parameter value compared to the second parameter value.
Litvak teaches current amplitude and pulse width are used to characterize the response characteristic of a nerve to various applied stimulus levels, see col. 4, lines 66-58.
One of ordinary skill in the art would have found it obvious to adjust the parameters of the first and second values to maximize the desired response characteristics.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Maschino et al (US 2007/0179557) discloses multiple evoking signal pulse paradigms can be interleaved, synchronous or asynchronous, and various external and internal therapeutic and/or evoking signals may be synchronized and coordinated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Manuel whose telephone number is (571) 272-4952.
The examiner can normally be reached on regular business days.
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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
1/24/2026