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 .
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kornet et al. (US PGPUB 2011/0105926).
Regarding claims 1 and 11, Kornet discloses a data processing system and method for planning neurostimulation programming of a patient, comprising: at least one memory device (e.g. 82) configured to store patient data corresponding to multiple characteristics of an autonomic condition of the patient (e.g. ¶ 48, 55); at least one processor configured to: identify neural targets of the patient corresponding to respective leads and electrodes of a neurostimulation system (e.g. ¶ 31 – 34); generate, neurostimulation programming settings for use at the neural targets (e.g. ¶ 37); and output programming data, based on the neurostimulation programming settings, for controlling neurostimulation with the neurostimulation system (e.g. ¶ 34), but fails to explicitly recite determining, based on the patient data, respective severity scores corresponding to the multiple characteristics of the autonomic condition. However, using “severity scores” are well known in the art. As described in the specification of the present application, severity scores could be determined from a symptom questionnaire given to the patient. User input/feedback would read on such a questionnaire. Kornet teaches in ¶ 34 that the user may interact with the programmer including adjusting operational parameters to adjust therapy. This would be a form of user feedback that could be considered to indicate a severity score.
Regarding claims 2 and 12, Kornet discloses the neural targets of the patient include spinal neural targets, and wherein the neurostimulation includes spinal cord stimulation (SCS) to be provided via the respective leads and electrodes to the spinal neural targets (e.g. ¶ 29).
Regarding claims 3 – 8 and 13 – 18, Kornet teaches the severity scores are well known as described above in claim 1. Furthermore, Kornet discloses interacting with a programmer to input data of multiple characteristics (e.g. ¶ 34). Displaying the inputs on the programmer would require only routine skill in the art.
Regarding claims 9 and 19, Kornet discloses the neurostimulation programming settings includes information for: one or more spatial targets, one or more frequencies, and one or more pulse-widths used for the neurostimulation; and wherein the neurostimulation programming settings are generated based on a configuration of the respective leads and electrodes of the neurostimulation system used for the patient, wherein the configuration provides specifications for: a type of implantable pulse generator, a type of lead, a number of leads, and a number of electrodes on respective leads (e.g. ¶ 31-40).
Regarding claims 10 and 20, Kornet discloses communication circuitry configured to provide programming instructions for an electrostimulator of the neurostimulation system, the programming instructions corresponding to the neurostimulation programming settings to control stimulation of at respective neural targets of the patient via the respective leads and electrodes; wherein the programming instructions includes one or more stimulation parameters including: an electrode configuration; one or more stimulation pulse parameters including a pulse amplitude, a pulse width, or a stimulation frequency; a stimulation pulse waveform; an ON-OFF cycling scheme comprising an ON period for delivering stimulation pulses and a subsequent stimulation-free OFF period; or a charge per second (CPS) or a charge per hour (CPH) delivered to a respective neural target (e.g. ¶ 31-40).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
Prosecution Insights