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 .
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 50 - 73 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mishra et al. (US PGPUB 2019/0001139 – in IDS).
Regarding claim 50, Mishra discloses a method for providing stimulation to a patient, the method comprising: configuring a first pulse rate of stimulation pulses of a first stimulation waveform independently from a second pulse rate of stimulation pulses of a second stimulation waveform (e.g. ¶ 175 – 176), wherein the first and second pulse rates are different (e.g. ¶ 444); and delivering the first and second stimulation waveforms simultaneously to the patient over a periodic time interval such that the stimulation pulses of the first and second stimulation waveforms do not overlap over the periodic time interval (e.g. ¶ 450), wherein the first stimulation waveform is delivered via at least a first delivery element of an implantable device and the second stimulation waveform is delivered via at least a second delivery element of the implantable device (e.g. ¶ 23).
Regarding claim 51, Mishra discloses each of the first and second pulse rates comprise a number of stimulation pulses delivered over the periodic time interval, and wherein the periodic time interval is one second (e.g. ¶ 55).
Regarding claim 52, Mishra discloses the stimulation pulses of the first and second stimulation waveforms are separated to maintain a constant average load condition for the implantable device (e.g. e.g. ¶ 162 and 368).
Regarding claims 53 and 54, Mishra discloses configuring one or both of an on time and an off time for a first dose of the first stimulation waveform independently from one or both of an on time and an off time for a second dose of the second stimulation waveform, wherein the first and second doses are time-shifted and non- overlapping over the periodic time interval (e.g. ¶ 55 and 450).
Regarding claim 55, Mishra discloses the first stimulation waveform is delivered to a first anatomical location of the patient and the second stimulation waveform is delivered to a second, different anatomical location of the patient (e.g. ¶ 98).
Regarding claim 56, Mishra discloses each of the first and second stimulation waveforms is delivered from an independent current source (e.g. ¶ 48).
Regarding claim 57, Mishra discloses the first pulse rate is higher than the second pulse rate, and wherein delivering the first and second stimulation waveforms comprises: delivering the stimulation pulses of the first stimulation waveform with the first pulse rate over each of a plurality of periodic time intervals; and delivering a subset of stimulation pulses of the second stimulation waveform with the first pulse rate over each of the plurality of periodic time intervals such that the second pulse rate is achieved over the plurality of time intervals (e.g. ¶ 444).
Regarding claim 58, Mishra discloses the stimulation pulses of the first stimulation waveform are evenly spaced within each of the plurality of periodic time intervals (e.g. at least Figs 22, 24, 30A).
Regarding claims 59 – 61¸ Mishra discloses configuring a first form of charge recovery of the first stimulation waveform independently from a second form of charge recovery of the second stimulation waveform, wherein each of the first and second forms of charge recovery comprises a combination of active and passive charge recovery and wherein each of the first and second forms of charge recovery comprises normalized charge recovery based on one or more time periods each comprising a predetermined number of stimulation pulses (e.g. ¶ 16 and 100).
Regarding claim 62, Mishra discloses each of the first and second stimulation waveforms are configured to treat pain of the patient (e.g. ¶ 3).
Regarding claim 63, Mishra discloses a method for providing stimulation to a patient, the method comprising: configuring a first stimulation waveform for a first anatomical location of the patient independently from a second stimulation waveform configured for a second anatomical location of the patient (e.g. ¶ 175 – 176); and delivering the first and second stimulation waveforms simultaneously from independent current sources of an implantable device over a periodic time interval (e.g. ¶ 444), wherein the first stimulation waveform is delivered via at least a first delivery element of an implantable device to a first anatomical location of the patient and the second stimulation waveform is delivered via at least a second delivery element of the implantable device to a second anatomical location of the patient (e.g. ¶ 98), wherein the implantable device is configured to balance charge delivered and charge recovered from each of the independent current sources over a time period comprising a predetermined number of stimulation pulses (e.g. ¶ 16 and 100).
Regarding claim 64, Mishra discloses delivering the first and second stimulation waveforms comprises passively recovering charge during periods between stimulation pulses of each of the first and second stimulation waveforms (e.g. ¶ 16 and 100).
Regarding claim 65, Mishra discloses delivering the first and second stimulation waveforms comprises performing a combination of active and passive charge recovery for one or both of the first and second stimulation waveforms (e.g. ¶ 68).
Regarding claim 66, Mishra discloses the implantable device is configured to achieve a net zero charge over each of the first and second anatomical locations of the patient (e.g. ¶ 249).
Regarding claim 67, Mishra discloses configuring the first and second waveforms comprises configuring, for each of the first and second stimulation waveforms, one or more of a number of anatomical locations for stimulating, a pulse width of stimulation pulses, an amplitude of stimulation pulses, a pulse rate of stimulation pulses, a form of charge recovery, a stimulation dose on time, and a stimulation dose off time (e.g. ¶ 98 – 100).
Regarding claim 68, Mishra discloses the first and second stimulation waveforms are delivered in time-shifted doses that are non-overlapping over the periodic time interval (e.g. ¶ 55 and 450).
Regarding claims 69 and 70, Mishra discloses one or both of the first and second stimulation waveforms are delivered at a sub-threshold level and/or a supra threshold level (e.g. ¶ 60).
Regarding claim 71, Mishra discloses transferring power from an external system to the implantable device during the time period (e.g. ¶ 13).
Regarding claim 72, Mishra discloses the first and second anatomical locations are overlapping (e.g. 445).
Regarding claim 73, Mishra discloses the first and second stimulation waveforms are configured to treat pain of the patient (e.g. ¶ 3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cholette et al. (US PGPUB 2018/0369573) discloses a method for treating pain by applying a plurality of stimulation waveforms.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
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