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.
Claims 1-4, 7-16, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dinsmoor (US 2019/0388692).
Regarding claims 1, 16, and 20, Dinsmoor discloses the claimed apparatus and related method including (e.g. [0053], [0054], [0060], [0061], [0074] - [0081], figures 2A, 3, 4B-7)
sensing circuitry (e.g. sensing circuitry 212);
a stimulation generator (e.g. stimulation generator 211); and
processing circuitry (e.g. processing circuitry 214), the processing circuitry configured to:
control the stimulation generator to deliver a pulse train to a patient, the pulse train comprising at least one first pulse at least partially interleaved with at least one second pulse (e.g. interleaved pulses as shown in Figures 4B-6);
deliver a pulse train to a patient, the pulse train comprising at least one first pulse at least partially interleaved with at least one second pulse, wherein the at least one first pulse includes a cathodic active first phase and a passive second phase, and wherein the at least one second pulse includes an anodic first phase and passive second phase, (e.g. interleaved pulses as shown in fig. 4B, [0108]-[0110] which shows that the 1st pulses (control pulses 412A-N) are biphasic with negative and positive phases, an interphase interval and a passive recharge portion (see [0053]). The 2nd pulses (informed pulses 424A- N) are interleaved with the 1st pulses and are biphasic with positive and negative phases and an interphase interval ([0110]). The negative (anodic) phase can be before or after the positive (cathodic) phase ([0108]));
sense, via the sensing circuitry, an electrical signal elicited by electrical stimulation delivered to the patient from the stimulation generator (e.g. sensing as disclosed in [0060]-[0061]);
Regarding claim 2, Dinsmoor additionally discloses wherein the at least one first pulse comprises a plurality of first pulses and the at least one second pulse comprises a plurality of second pulses (e.g. as shown in Figures 4B-6).
Regarding claim 3, Dinsmoor additionally discloses wherein respective first pulses of the plurality of first pulses are interleaved with respective second pulses of the plurality of second pulses on a one to one pulse basis (e.g. as shown in Figures 4B-6).
Regarding claim 4, Dinsmoor additionally discloses wherein the plurality of first pulses have the same amplitude as the plurality of second pulses (e.g. as shown in Figure 5).
Regarding claim 7, Dinsmoor additionally discloses wherein the at least one first pulse is delivered by a first combination of electrodes and the at least one second pulse is delivered by a second combination of electrodes (e.g. different electrode combinations as disclosed in [0053]).
Regarding claim 8, Dinsmoor additionally discloses wherein the first combination of electrodes and the second combination of electrodes have at least one common electrode (e.g. different electrode combinations as disclosed in [0053]).
Regarding claim 9, Dinsmoor additionally discloses wherein the first combination of electrodes is different than the second combination of electrodes (e.g. different electrode combinations as disclosed in [0053]).
Regarding claims 10 and 19, Dinsmoor additionally discloses wherein the processing circuitry is configured to: control the stimulation generator to deliver a pulse train at a frequency to a patient, the pulse train comprising a plurality of third pulses at least partially interleaved with a plurality of fourth pulses; and sense the electrical signal elicited by a respective third pulse of the plurality of third pulses, wherein the plurality of third pulses are configured to facilitate sensing elicited electrical signals, each pulse of the plurality of third pulses having an active first phase and active second phase, and wherein each pulse of the plurality of fourth pulses comprises an active first phase and a passive second phase (e.g. extra pulses that are interleaved as shown in Figures 5 and 6).
Regarding claim 11, Dinsmoor additionally discloses, wherein the processing circuitry is configured to control the stimulation generator to deliver the plurality of third pulses and the plurality of fourth pulses such that at least one pulse of the plurality of fourth pulses has an interphase interval that is longer than an interphase interval of at least one pulse of the plurality of third pulses (e.g. as shown in Figures 5 and 6).
Regarding claim 12, Dinsmoor additionally discloses wherein the processing circuitry is configured to control the stimulation generator to deliver the plurality of third pulses and the plurality of fourth pulses such that the active first phase of at least one pulse of the plurality of fourth pulses has a lower amplitude than the active first phases of at least one pulse of the plurality of third pulses (e.g. as shown in Figures 5 and 6).
Regarding claim 13, Dinsmoor additionally discloses wherein the processing circuitry is configured to sense an evoked compound action potential (ECAP) evoked by each pulse of the plurality of third pulses instead of sensing an ECAP evoked by each pulse of the plurality of fourth pulses (e.g. decrease frequency of ECAP sensing as shown in [0074]).
Regarding claim 14, Dinsmoor additionally discloses wherein the frequency of the pulse train comprises a first frequency, the method further comprising sensing an evoked compound action potential (ECAP) at a second frequency less than that of the first frequency (e.g. decrease frequency of ECAP sensing as shown in [0074]).
Regarding claim 15, Dinsmoor additionally discloses wherein the processing circuitry is configured to control the stimulation generator to deliver the plurality of third pulses and the plurality of fourth pulses such that the active first phase of the plurality of fourth pulses comprises a cathodic phase and the passive second phase comprises an anodic phase (e.g. the negative (anodic) phase can be before or after the positive (cathodic) phase as disclosed in [0108]).
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 5-6 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor in view of Hou et. al (US 2018/0126169)
Regarding claims 5-6 and 17-18, Dinsmoor discloses the claimed invention except the express mention of the use of a sensed trend or a trend line in determination of stimulation. Hou discloses that it was known in the art of measurement of ECAPs to include the use of sensed trends to determine stimulation protocol (e.g. use of trends as disclosed in [0005] – [0007] and [0057]). It would have been obvious to one having ordinary skill in the art to include the trends of Hou in the device of Dinsmoor since such a modification would provide the system with the predictable results of a reliable means of sensing and stimulating.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792
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