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 .
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 21-40 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12011595 and claims 1-32 of US Patent No. 12064631. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims read on the application claims.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 21-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Single (US 10500399 B2) in view of Panken (US 2010/0010380 A1).
Regarding claims 21, 31, and 40, Single discloses A system comprising: sensing circuitry configured to sense an evoked compound action potential (ECAP) signal elicited by a first stimulation pulse (eg. Abstract, Col. 3, Ln. 30-45, Fig. 3, Col. 6, Ln. 35-47); and processing circuitry configured todetermine a characteristic value of the ECAP signal elicited from the first stimulation pulse (eg. Col. 7, Ln. 40-55, Fig, 6); compare the characteristic value of the ECAP signal to the threshold ECAP characteristic value (eg. Abstract, Col. 7, Ln. 40-47) and control, based on the comparison, delivery of a second stimulation pulse (eg. Col. 3, Ln. 30-60, claim 1-2). Single discloses detecting a posture signal from a change in the ECAP response (eg. Fig. 6, Col. 4, Ln. 5-20), but does not disclose receive from a sensor, a posture state signal representing a posture state of the patient, select, based on the posture state signal, a threshold ECAP characteristic value.
Panken teaches detecting posture changes using accelerometers/other sensors and classifying postures and movements and to modify therapy based on posture state (eg. Para. 9-10, 26-29, 57-58, 81-111, 260).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Single with the sensor and selection logic for therapy modification as taught by Panken to provide the predictable result of providing more accurate tracking of postures with an accelerometer and allowing automatic selection of appropriate therapy parameters.
Regarding claims 22 and 32, the combined invention of Single and Panken discloses the processing circuitry is configured to :control delivery of a first plurality of pulses at least partially defined by a first value of a stimulation parameter, the first plurality of pulses comprising the first stimulation pulse; determine, based on the comparison, that the characteristic value of the ECAP signal exceeds the threshold ECAP characteristic value; responsive to determining that the characteristic value of the ECAP signal exceeds the threshold ECAP characteristic value, control delivery of the second stimulation pulse by at least iteratively decreasing, from the first value, the stimulation parameter that defines respective pulses of a second plurality of pulses until a subsequent characteristic value of a subsequent ECAP signal no longer exceeds the threshold ECAP characteristic value at a second value of the stimulation parameter, wherein the second plurality of pulses comprises the second stimulation pulse (eg. Single Col. 6, Ln. 35-45, Col. 1, Ln. 25-45, multiple pulses, Col. 4, Ln. 28 – Col. 5, Ln. 21, Col. 7, Ln. 42 – Col. 8, Ln. 11).
Regarding claims 23 and 33, the combined invention of Single and Panken discloses the subsequent characteristic value is a first subsequent characteristic value and the subsequent ECAP signal is a first subsequent ECAP signal, and wherein the processing circuitry is configured to: responsive to determining that the first subsequent characteristic value of the first subsequent ECAP signal no longer exceeds the threshold ECAP characteristic value, increasing, from the second value, the stimulation parameter that defines respective pulses of a third plurality of pulses until one of: (1) a second subsequent characteristic value of a second subsequent ECAP signal exceeds the threshold ECAP characteristic value again, or (2) the stimulation parameter is increased back to the first value (eg. Single Col. 6, Ln. 35-45, Col. 1, Ln. 25-45, multiple pulses, Col. 4, Ln. 28 – Col. 5, Ln. 21, Col. 7, Ln. 42 – Col. 8, Ln. 11).
Regarding claims 24 and 34, the combined invention of Single and Panken discloses the stimulation parameter is one of an amplitude or a pulse width (eg. Single Col. 6, Ln. 35-45, Col. 1, Ln. 25-45, multiple pulses, Col. 4, Ln. 28 – Col. 5, Ln. 21, Col. 7, Ln. 42 – Col. 8, Ln. 11).
Regarding claims 25 and 35, the combined invention of Single and Panken discloses the processing circuitry is configured to: select, based on the posture state signal, the posture state from a plurality of posture states comprising a sleep state and an awake state; and select the threshold ECAP characteristic value according to the selected one of the sleep state or the awake state (Eg. Panken, Para. 19, 118, 122, 149, 176, 179, 223-244, Table 1, Fig. 12-17).
Regarding claims 26 and 36, the combined invention of Single and Panken discloses the processing circuitry is configured to control delivery of the second stimulation pulse by at least adjusting a parameter value that defines the second stimulation pulse (Eg. Single, Abstract, Col. 3, Ln. 10-55, Col. 4, Ln. 43 – Col. 5, Ln. 21, Col. 7, Ln. 14 – Col. 8, Ln. 22, Col. 12, Ln. 12 – Col. 13, Ln. 47).
Regarding claims 27 and 37, the combined invention of Single and Panken discloses is configured to adjust the parameter value by at least adjusting a first value of the first stimulation pulse to a second value of the second stimulation pulse based on both: (1) the comparison of the characteristic value of the ECAP signal to the threshold ECAP characteristic value and (2) a gain value (Eg. Single, Abstract, Col. 3, Ln. 10-55, Col. 4, Ln. 43 – Col. 5, Ln. 21, Col. 7, Ln. 14 – Col. 8, Ln. 22, Col. 12, Ln. 12 – Col. 13, Ln. 47).
Regarding claims 28 and 38, the combined invention of Single and Panken discloses the processing circuitry is configured to select the gain value according to the posture state (eg. Single, Col,. 3, Ln. 62 – Col. 4, Ln. 5, Col. 9, Ln. 55-60, Col. 12, Ln. 12-24, Claim 2).
Regarding claims 29 and 39, the combined invention of Single and Panken discloses determine, from at least the posture state signal representing the posture state of the patient, that the posture state of the patient has changed; and responsive to determining that the posture state has changed, change an ECAP sensing frequency (eg. Panken, Para. 29 57, 260 with Single, Para. Col. 7, Ln. 42-53 Col. 9, Ln. 15-56, sampling rate).
Regarding claim 30, the combined invention of Single and Panken discloses an implantable medical device comprising the sensing circuitry and the processing circuitry (eg. Single, Fig. 1-2, implanted spinal cord stimulator 100, Col. 6, Ln. 20-46).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796