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 .
Specification
The disclosure is objected to because of the following informalities: paragraph 0001 needs to be updated to reflect the status of US Patent Application Number 18/482,657 which is now issued as US Patent No. 12,168,131.
Appropriate correction is required.
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, 3-8, 10-11, 13-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 and 20 of U.S. Patent No. 12,168,131. Although the claims at issue are not identical, they are not patentably distinct from each other as shown below and illustrated by the underlined portions of the claims. There are minor claim wording changes between the two cases, however a terminal disclaimer is necessary to expedite prosecution.
Current Application No. 18/982,307
US Patent No. 12,168,131
Claim 1
A system comprising: memory configured to store evoked compound action potential (ECAP) information associated with a plurality of postures; and processing circuitry configured to: determine, based on information from one or more sensors, a posture of the plurality of postures of a patient; identify, from the ECAP information stored in the memory, a subset of ECAP information associated with the determined posture; select, based on the detected posture and the subset of ECAP information, a value of a target ECAP characteristic; compare the value of the target ECAP characteristic to a value of a characteristic of an ECAP signal elicited by a first stimulation pulse delivered to the patient of a plurality of first stimulation pulses, the plurality of first stimulation pulses being at least partially interleaved with a plurality of second stimulation pulses, wherein at least one parameter value defining the plurality of first stimulation pulses is different than parameter values defining the plurality of second stimulation pulses, and wherein sensing circuitry is configured to detect the ECAP signal elicited by at least some of the plurality of first stimulation pulses instead of any ECAP signals elicited by the plurality of second stimulation pulses; select, based on the comparison, a value of a parameter at least partially defining delivery of one or more subsequent first stimulation pulses of the plurality of first stimulation pulses to the patient; and control delivery of the one or more subsequent first stimulation pulses according to the value of the parameter.
Claim 9
A system comprising: memory configured to store evoked compound action potential (ECAP) information associated with a plurality of postures; and processing circuitry configured to: determine, based on information from one or more sensors, a posture of the plurality of postures of a patient; identify, from the ECAP information stored in the memory, a subset of ECAP information associated with the determined posture; select, based on the detected posture and the subset of ECAP information, a value of a target ECAP characteristic; compare the value of the target ECAP characteristic to a value of a characteristic of an ECAP signal elicited by a first stimulation pulse delivered to the patient,
the first stimulation pulse being interleaved with a plurality of second stimulation pulses, wherein at least one parameter value defining the first stimulation pulse is different than parameter values defining the plurality of second stimulation pulses, and wherein sensing circuitry is configured to detect the ECAP signal elicited by the first stimulation pulse instead of any ECAP signals elicited by the plurality of second stimulation pulses; select adjust, based on the comparison, a value of a parameter at least partially defining delivery of one or more subsequent second stimulation pulses of the plurality of second stimulation pulses to the patient; and control delivery of the one or more subsequent second stimulation pulses according to the value of the parameter.
Claim 3
The system of claim 1, further comprising: one or more sensors configured to generate the information that is representative of the posture of the plurality of postures of the patient; and sensing circuitry configured to sense the ECAP signal elicited by the first stimulation pulse delivered to the patient, wherein the processing circuitry is configured to receive the ECAP signal from the sensing circuitry.
Claim 10
The system of claim 9, further comprising one or more sensors configured to generate the information that is representative of the posture of the plurality of postures of the patient.
Claim 11
The system of claim 9, further comprising sensing circuitry configured to sense the ECAP signal elicited by the first stimulation pulse delivered to the patient, wherein the processing circuitry is configured to receive the ECAP signal from the sensing circuitry.
Claim 4
The system of claim 1, wherein the processing circuitry is configured to compare the value of the target ECAP characteristic to the value of the characteristic of the ECAP signal elicited by the first stimulation pulse by at least determining that the value of the target ECAP characteristic is greater than the value of the characteristic of the ECAP signal elicited by the first stimulation pulse, and
wherein the processing circuitry is configured to select, based on the comparison, the value for the parameter defining delivery of the one or more subsequent second stimulation pulses to the patient by at least increasing the value for the parameter defining delivery of the one or more subsequent first stimulation pulses to the patient.
Claim 12
The system of claim 9, wherein comparing the value of the target ECAP characteristic to the value of the characteristic of the ECAP signal elicited by the first stimulation pulse comprises determining that the value of the target ECAP characteristic is greater than the value of the characteristic of the ECAP signal elicited by the first stimulation pulse, and
wherein selecting, based on the comparison, the value for the parameter defining delivery of the one or more subsequent second stimulation pulses to the patient comprises increasing the value for the parameter defining delivery of the one or more subsequent second stimulation pulses to the patient.
Claim 5
The system of claim 1, wherein the processing circuitry is configured to: compare the value of the target ECAP characteristic to the value of the characteristic of the ECAP signal elicited by the first stimulation pulse by at least determining that the value of the target ECAP characteristic is less than the value of the characteristic of the ECAP signal elicited by the first stimulation pulse, and select, based on the comparison, the value for the parameter defining delivery of the one or more subsequent first stimulation pulses to the patient by at least decreasing the value for the parameter defining delivery of the one or more subsequent first stimulation pulses to the patient.
Claim 13
The system of claim 9, wherein the processing circuitry is configured to: compare the value of the target ECAP characteristic to the value of the characteristic of the ECAP signal elicited by the first stimulation pulse by at least determining that the value of the target ECAP characteristic is less than the value of the characteristic of the ECAP signal elicited by the first stimulation pulse, and select, based on the comparison, the value for the parameter defining delivery of the one or more subsequent second stimulation pulses to the patient by at least decreasing the value for the parameter defining delivery of the one or more subsequent second stimulation pulses to the patient.
Claim 6
The system of claim 1, wherein the parameter at least partially defining the delivery of the one or more subsequent first stimulation pulses comprises one of a current amplitude, pulse width, a voltage amplitude, or a frequency of the one or more stimulation pulses.
Claim 14
The system of claim 9, wherein the parameter at least partially defining the delivery of the one or more subsequent second stimulation pulses comprises one of a current amplitude, pulse width, a voltage amplitude, or a frequency of the one or more stimulation pulses.
Claim 7
The system of claim 1, wherein the characteristic of the ECAP signal elicited by the second stimulation pulse comprises an amplitude of at least a portion of the ECAP signal elicited by the first stimulation pulse.
Claim 15
The system of claim 9, wherein the characteristic of the ECAP signal elicited by the first stimulation pulse comprises an amplitude of at least a portion of the ECAP signal elicited by the first stimulation pulse.
Claim 8
The system of claim 1, wherein the processing circuitry is configured to select the value of the target ECAP characteristic by at least: selecting, based on the detected posture, an ECAP growth curve of a plurality of ECAP growth curves, wherein each ECAP growth curve of the plurality of ECAP growth curves is associated with at least one posture of the plurality of postures, and wherein each ECAP growth curve of the plurality of ECAP growth curves defines a relationship between the parameter defining delivery of one or more subsequent second stimulation pulses to the patient and a characteristic of an ECAP signal elicited by the first stimulation pulse; selecting, based on the selected ECAP growth curve, the value of the target ECAP characteristic.
Claim 16
The system of claim 9, wherein the processing circuitry is configured to select the value of the target ECAP characteristic by at least: selecting, based on the detected posture, an ECAP growth curve of a plurality of ECAP growth curves, wherein each ECAP growth curve of the plurality of ECAP growth curves is associated with at least one posture of the plurality of postures, and wherein each ECAP growth curve of the plurality of ECAP growth curves defines a relationship between the parameter defining delivery of one or more subsequent second stimulation pulses to the patient and a characteristic of an ECAP signal elicited by the first stimulation pulse; selecting, based on the selected ECAP growth curve, the value of the target ECAP characteristic.
Claim 10
The system of claim 1, further comprising an implantable medical device comprising the processing circuitry and therapy delivery circuitry configured to deliver therapy to the patient, wherein the therapy comprises at least one of the plurality of first stimulation pulses or the plurality of second stimulation pulses.
Claim 17
The system of claim 9, further comprising an implantable medical device comprising the processing circuitry and therapy delivery circuitry configured to deliver therapy to the patient, wherein the therapy comprises the plurality of second stimulation pulses.
Claim 11
A method comprising: determining, by processing circuitry and based on information from one or more sensors, a posture of a plurality of postures of a patient; identifying, by the processing circuitry, stored evoked compound action potential (ECAP) information associated with the determined posture; selecting, by the processing circuitry and based on the detected posture and the identified ECAP information, a value of a target ECAP characteristic; comparing, by the processing circuitry, the value of the target ECAP characteristic to a value of a characteristic of an ECAP signal elicited by a first stimulation pulse delivered to the patient of a plurality of first stimulation pulses, the plurality of first stimulation pulses being at least partially interleaved with a plurality of second stimulation pulses, wherein at least one parameter value defining the plurality of first stimulation pulses is different than parameter values defining the plurality of second stimulation pulses, and wherein sensing circuitry is configured to detect the ECAP signal elicited by at least some of the plurality of first stimulation pulses instead of any ECAP signals elicited by the plurality of second stimulation pulses; selecting, by the processing circuitry and based on the comparison, a value of a parameter at least partially defining delivery of one or more subsequent first stimulation pulses of the plurality of first stimulation pulses to the patient; and controlling, by the processing circuitry, delivery of the one or more subsequent first stimulation pulses according to the value of the parameter.
Claim 1
A method comprising: determining, by processing circuitry and based on information from one or more sensors, a posture of a plurality of postures of a patient; identifying, by the processing circuitry, stored evoked compound action potential (ECAP) information associated with the determined posture; selecting, by the processing circuitry and based on the detected posture and the identified ECAP information, a value of a target ECAP characteristic; comparing, by the processing circuitry, the value of the target ECAP characteristic to a value of a characteristic of an ECAP signal elicited by a first stimulation pulse delivered to the patient, the first stimulation pulse being interleaved with a plurality of second stimulation pulses, wherein at least one parameter value defining the first stimulation pulse is different than parameter values defining the plurality of second stimulation pulses, and wherein sensing circuitry is configured to detect the ECAP signal elicited by the first stimulation pulse instead of any ECAP signals elicited by the plurality of second stimulation pulses; adjusting, by the processing circuitry and based on the comparison, a value of a parameter at least partially defining delivery of one or more subsequent second stimulation pulses of the plurality of second stimulation pulses to the patient; and controlling, by the processing circuitry, delivery of the one or more subsequent second stimulation pulses according to the value of the parameter.
Claim 13
The method of claim 11, further comprising: generating, by one or more sensors, the information that is representative of the posture of the plurality of postures of the patient; and sensing, by sensing circuitry, the ECAP signal elicited by the first stimulation pulse delivered to the patient, wherein the processing circuitry is configured to receive the ECAP signal from the sensing circuitry.
Claim 2
The method of claim 1, further comprising generating, by the one or more sensors, the information that is representative of the posture of the plurality of postures of the patient.
Claim 3
The method of claim 1, further comprising: sensing, by sensing circuitry, the ECAP signal elicited by the first stimulation pulse delivered to the patient; and receiving, by the processing circuitry, the ECAP signal.
Claim 14
The method of claim 11, wherein comparing the value of the target ECAP characteristic to the value of the characteristic of the ECAP signal elicited by the first stimulation pulse comprises determining that the value of the target ECAP characteristic is greater than the value of the characteristic of the ECAP signal elicited by the first stimulation pulse, and wherein selecting, based on the comparison, the value for the parameter defining delivery of the one or more subsequent second stimulation pulses to the patient comprises increasing the value for the parameter defining delivery of the one or more subsequent first stimulation pulses to the patient.
Claim 4
The method of claim 1, wherein comparing the value of the target ECAP characteristic to the value of the characteristic of the ECAP signal elicited by the first stimulation pulse comprises determining that the value of the target ECAP characteristic is greater than the value of the characteristic of the ECAP signal elicited by the first stimulation pulse, and wherein selecting, based on the comparison, the value for the parameter defining delivery of the one or more subsequent second stimulation pulses to the patient comprises increasing the value for the parameter defining delivery of the one or more subsequent second stimulation pulses to the patient.
Claim 15
The method of claim 11, further comprising: comparing the value of the target ECAP characteristic to the value of the characteristic of the ECAP signal elicited by the first stimulation pulse by at least determining that the value of the target ECAP characteristic is less than the value of the characteristic of the ECAP signal elicited by the first stimulation pulse, and selecting, based on the comparison, the value for the parameter defining delivery of the one or more subsequent first stimulation pulses to the patient by at least decreasing the value for the parameter defining delivery of the one or more subsequent first stimulation pulses to the patient.
Claim 5
The method of claim 1, wherein comparing the value of the target ECAP characteristic to the value of the characteristic of the ECAP signal elicited by the first stimulation pulse comprises determining that the value of the target ECAP characteristic is less than the value of the characteristic of the ECAP signal elicited by the first stimulation pulse, and wherein selecting, based on the comparison, the value for the parameter defining delivery of the one or more subsequent second stimulation pulses to the patient comprises decreasing the value for the parameter defining delivery of the one or more subsequent second stimulation pulses to the patient.
Claim 16
The method of claim 11, wherein the parameter at least partially defining the delivery of the one or more subsequent first stimulation pulses comprises one of a current amplitude, pulse width, a voltage amplitude, or a frequency of the one or more stimulation pulses.
Claim 6
The method of claim 1, wherein the parameter at least partially defining the delivery of the one or more subsequent second stimulation pulses comprises one of a current amplitude, pulse width, a voltage amplitude, or a frequency of the one or more second stimulation pulses.
Claim 17
The method of claim 11, wherein the characteristic of the ECAP signal elicited by the second stimulation pulse comprises an amplitude of at least a portion of the ECAP signal elicited by the first stimulation pulse.
Claim 7
The method of claim 1, wherein the characteristic of the ECAP signal elicited by the first stimulation pulse comprises an amplitude of at least a portion of the ECAP signal elicited by the first stimulation pulse.
Claim 18
The system of claim 1, wherein selecting the value of the target ECAP characteristic comprises: selecting, based on the detected posture, an ECAP growth curve of a plurality of ECAP growth curves, wherein each ECAP growth curve of the plurality of ECAP growth curves is associated with at least one posture of the plurality of postures, and wherein each ECAP growth curve of the plurality of ECAP growth curves defines a relationship between the parameter defining delivery of one or more subsequent second stimulation pulses to the patient and a characteristic of an ECAP signal elicited by the first stimulation pulse; selecting, based on the selected ECAP growth curve, the value of the target ECAP characteristic.
Claim 8
The method of claim 1, wherein selecting the value of the target ECAP characteristic comprises: selecting, based on the detected posture, an ECAP growth curve of a plurality of ECAP growth curves, wherein each ECAP growth curve of the plurality of ECAP growth curves is associated with at least one posture of the plurality of postures, and wherein each ECAP growth curve of the plurality of ECAP growth curves defines a relationship between the parameter defining delivery of the one or more subsequent second stimulation pulses to the patient and a characteristic of an ECAP signal elicited by the first stimulation pulse; selecting, based on the selected ECAP growth curve, the value of the target ECAP characteristic.
Claim 20: A non-transitory computer-readable medium comprising instructions that, when executed, cause processing circuitry of a medical device to: determine, based on information from one or more sensors, a posture of the plurality of postures of a patient; identify, from ECAP information stored in a memory, a subset of ECAP information associated with the determined posture; select, based on the detected posture and the subset of ECAP information, a value of a target ECAP characteristic; compare the value of the target ECAP characteristic to a value of a characteristic of an ECAP signal elicited by a first stimulation pulse delivered to the patient of a plurality of first stimulation pulses, the plurality of first stimulation pulses being at least partially interleaved with a plurality of second stimulation pulses, wherein at least one parameter value defining the plurality of first stimulation pulses is different than parameter values defining the plurality of second stimulation pulses, and wherein sensing circuitry is configured to detect the ECAP signal elicited by at least some of the plurality of first stimulation pulses instead of any ECAP signals elicited by the plurality of second stimulation pulses; select, based on the comparison, a value of a parameter at least partially defining delivery of one or more subsequent first stimulation pulses of the plurality of first stimulation pulses to the patient; and control delivery of the one or more subsequent first stimulation pulses according to the value of the parameter.
Claim 18. A non-transitory, computer-readable medium comprising instructions that, when executed, cause processing circuitry of a medical device to: determine, based on information from one or more sensors, a posture of a plurality of postures of a patient; identify stored evoked compound action potential (ECAP) information associated with the determined posture; select, based on the detected posture and the identified ECAP information, a value of a target ECAP characteristic; compare the value of the target ECAP characteristic to a value of a characteristic of an ECAP signal elicited by a first stimulation pulse delivered to the patient, the first stimulation pulse being interleaved with a plurality of second stimulation pulses, wherein at least one parameter value defining the first stimulation pulse is different than parameter values defining the plurality of second stimulation pulses, and wherein sensing circuitry is configured to detect the ECAP signal elicited by the first stimulation pulse instead of any ECAP signals elicited by the plurality of second stimulation pulses; select adjust, based on the comparison, a value of a parameter at least partially defining delivery of one or more subsequent second stimulation pulses of the plurality of second stimulation pulses to the patient; and control delivery of the one or more subsequent second stimulation pulses according to the value of the parameter.
Allowable Subject Matter
Claims 2, 9, 12 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The invention is directed towards a method, system and non-transitory computer readable medium. The invention includes sensors to determine posture positions of a patient, identifying ECAP information associated with each posture and selecting a target ECAP characteristic. The prior art fails to disclose or render obvious all of the limitations of the independent claims in combination with interleaving a stimulation pulse(s), and the sensing circuitry detecting the ECAP elicited by the certain pulses but not all stimulation pulse(s).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paula J. Stice whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
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