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 1-3, 5-14, and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-14, and 16-20 of U.S. Patent No. 11,523,348 B2 (hereinafter “the ‘348 patent”, each listed claim of the instant application corresponding respectively to the same claim number of the ’348 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘348 patent are directed to overlapping subject matter. For example, each independent claim of the instant application only require “obtaining a set of stimulation parameter values” while the independent claims of the ‘348 requires automatic generation of a proposed set of stimulation parameter values. The other features as recited in the dependent claims of the ‘348 patent are the same as those in the instant application. Therefore, the instant claims are considered to be more broad than the corresponding claims of the ‘348 patent and encompass the features of the above listed claims in the ‘348 patent.
Claim Rejections - 35 USC § 102
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 5, 7, 12, 13, 15, 16, 17, 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Burdick et al (US 2014/0180361 A1, hereinafter “Burdick”).
Regarding claim 1, Burdick discloses a system for facilitating programming settings of an implantable pulse generator associated with a patient (par 0012), the system comprising: a processor (par 0015, 0173); a memory (par 0174); and control logic, stored in the memory, and configured, when executed by the processor, to perform actions (pars 0173-0174) comprising: a) obtaining a set of stimulation parameter values (par 0201); b) receiving one or more clinical response values arising from testing of the set of stimulation parameter values by stimulating the patient using the set of stimulation parameter values (par 0201); c) predicting one or more therapeutic response values for each of a plurality of sets of untested stimulation parameter values using one or more machine learning engines and the one or more received clinical response values (par 0198-0199); d) selecting, based on at least the one or more predicted therapeutic response values, a revised set of stimulation parameter values from the plurality of sets of untested stimulation parameter values (par 0197, 0200); e) receiving one or more clinical response values arising from testing of the revised set of stimulation parameter values by stimulating the patient using the revised set of stimulation parameter values (par 0200); and f) repeating actions c) to e) until a one of at least one stop condition has been reached (par 0200).
Regarding claim 3, Burdick discloses at least one sensor, wherein each instance of receiving one or more clinical response values comprises automatically receiving at least one of the one or more clinical response values from the at least one sensor (pars 0192-0195).
Regarding claim 4, Burdick discloses at least one stop condition comprises at least one of the following: the one or more received clinical response values indicates a value that corresponds to a therapeutic response indication within a designated tolerance; a predefined number of iterations; a predefined time spent in a programming session; or a determination by a user to stop (par 0200).
Regarding claim 5, Burdick discloses the predicting comprises using multiple machine learning techniques to predict the one or more therapeutic response values (pars 0198-0199).
Regarding claim 7, Burdick discloses the selecting comprises selecting the revised set of stimulation parameter values based upon one or more rules (pars 0198-0199).
Regarding claim 12, Burdick discloses a computer-implemented (pars 0207-0208) method for automatically determining patient programming settings for an electrical stimulator (par 0083), comprising: a) obtaining a set of stimulation parameter values (par 0201); b) receiving one or more clinical response values arising from testing of the set of stimulation parameter values by stimulating a patient using the set of stimulation parameter values (par 0201); c) predicting one or more therapeutic response values for each of a plurality of sets of untested stimulation parameter values using one or more machine learning engines and the one or more received clinical response values (par 0198-0199); d) selecting, based on at least the one or more predicted therapeutic response values, a revised set of stimulation parameter values from the plurality of sets of untested stimulation parameter values (par 0197, 0200); e) receiving one or more clinical response values arising from testing of the revised set of stimulation parameter values by stimulating the patient using the revised set of stimulation parameter values (par 0200); and f) repeating steps c) to e) until a one of at least one stop condition has been reached (par 0200).
Regarding claim 13, Burdick discloses the predicting comprises predicting the one or more therapeutic response values using a training data set based upon prior data for one or more subjects (par 0199).
Regarding claim 15, Burdick discloses the at least one stop condition comprises at least one of the following: the one or more received clinical response values indicates a value that corresponds to a therapeutic response indication within a designated tolerance; a predefined number of iterations; a predefined time spent in a programming session; or a determination by a user to stop (par 0200).
Regarding claim 16, Burdick discloses the predicting comprises using multiple machine learning techniques to predict the one or more therapeutic response values (pars 0198-0199).
Regarding claim 17, Burdick discloses a computer-readable memory medium containing instructions that control a computer processor (par 0015, 0173, 0210-0212), when executed, to determine programming settings of an implantable pulse generator (IPG) associated with a patient (par 0012) by performing a method comprising: a) obtaining a set of stimulation parameter values (par 0201); b) receiving one or more clinical response values arising from testing of the set of stimulation parameter values by stimulating the patient using the set of stimulation parameter values (par 0201); c) predicting one or more therapeutic response values for each of a plurality of sets of untested stimulation parameter values using the one or more machine learning engines and the one or more received clinical response values (par 0198-0199); d) selecting, based on at least the one or more predicted therapeutic response values, a revised set of stimulation parameter values from the plurality of sets of untested stimulation parameter values (par 0197, 0200); e) receiving one or more clinical response values arising from testing of the revised set of stimulation parameter values by stimulating the patient using the revised set of stimulation parameter values (par 0200); and f) repeating actions c) to e) until a one of at least one stop condition has been reached (par 0200).
Regarding claim 20, Burdick discloses the predicting comprises using multiple machine learning techniques to predict the one or more therapeutic response values (pars 0198-0199).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lindsey G Wehrheim whose telephone number is (571)270-5181. The examiner can normally be reached Monday - Friday 9 a.m. - 5 p.m. EST.
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Lindsey G Wehrheim
Primary Examiner
Art Unit 3799
/LINDSEY G WEHRHEIM/Primary Examiner, Art Unit 3799