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 .
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 11-17, in the reply filed on 3 February 2026 is acknowledged. Claims 1-10 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions/groups, there being no allowable generic or linking claim.
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 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.
(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 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chatuvedi et al. (US 2016/0067495; hereinafter “Chatuvedi”).
Regarding claim 11, Chatuvedi discloses a neurostimulation device for electrical connection to one or more implantable electrodes, the neurostimulation device comprising: a therapy circuit configured to deliver electrical neurostimulation energy to the one or more implantable electrodes (e.g. Fig. 2, #16 & 24/26); a port (e.g. ¶¶ 53 – “External medical device programmer 14 is configured to wirelessly communicate with IMD 16 as needed to provide or retrieve therapy information”; where the examiner considers the port to be a COMM port that communicates wirelessly that is equivalent to the disclosure at ¶¶ 64 of published application states which describes “port 718 may be connected to a communication circuit to receive information wirelessly”); a user interface (e.g. ¶¶ 84); and a control circuit (e.g. Fig. 3, #14) operatively coupled to the therapy circuit and the port (e.g. ¶¶ 53 – “External medical device programmer 14 is configured to wirelessly communicate with IMD 16 as needed to provide or retrieve therapy information”) and configured to: receive, via the port, a selection of a physiological search area of a subject for a therapy mapping operation, wherein the control circuit initiates delivery of neurostimulation to the selected search area during the therapy mapping operation in different combinations of stimulation location and stimulation energy (e.g. ¶¶ 32-34); receive an indication of a physiological search area for a therapy mapping operation, wherein the therapy mapping operation tests one or both of stimulation location and stimulation energy for the selected search area (e.g. ¶¶ 34 – “a patient with Parkinson's disease, one electrode combination may provide electrical stimulation in an area of the brain associated with more efficacy results for speech”); estimate one or more expected symptoms of the subject for the therapy mapping operation using symptom data for the one or both of stimulation location and stimulation energy untested during the therapy mapping operation (e.g. ¶¶ 35 – “efficacy map may include each region of tissue (e.g., specifically anatomical structures of the brain) associated with either positive or negative effects of electrical stimulation therapy for the particular disease, symptom, or function”); and present, using the user interface, an indication of the one or more expected symptoms for one or both of the untested stimulation location and the untested stimulation energy (e.g. ¶¶ 59 – “programmer 14 may compare therapy programs, and generate and display information regarding the VTAs for each therapy program. For example, programmer 14 may generate a display that lists each electrode 24, 26, or a subset of electrodes 24, 26, and, for each electrode or electrode combination, the therapy program(s) resulting in the highest score. In some examples, the estimated clinical rating scale score may be displayed.”; ¶¶ 93 – “processor 80 is configured to store determined efficacy maps in memory 82 as efficacy map information 98. A clinician may review the stored efficacy map information 98, e.g., during programming of IMD 16 to select one or more therapy programs with which IMD 16 may deliver efficacious electrical stimulation to patient 12. For example, the clinician may interact with user interface 86 to retrieve the stored efficacy map information 98”; ¶¶ 128 – “stimulation parameter sets that maximize each of a plurality of subscores may also be displayed. In other examples, the highest estimated clinical rating scale score for each electrode combination, or a subset of electrode combinations, may be displayed. In some examples, a plurality of estimated clinical rating subscores score/parameter set combinations are displayed for a patient, who may select between stimulation parameters sets based on which symptom the patient would like to control the most”; etc.).
Regarding claim 12, Chatuvedi discloses the control circuit is configured to: display a therapy map using the user interface, wherein the therapy map includes combinations of stimulation location and stimulation energy as tested points and untested points on the therapy map; and derive the one or more expected symptoms for untested points on the therapy map using proximity of the untested points to the tested points of the therapy map (e.g. ¶¶ 100 – “Efficacy map information 98 may store one or more efficacy maps. In some examples, each efficacy map stored in efficacy map 98 may be associated with a different patient condition or symptom. In some examples, the efficacy maps may be clinical rating scale score efficacy maps (CRSEM), each associated with a particular patient condition or symptom.”).
Regarding claim 13, Chatuvedi discloses the control circuit is configured to indicate one or more symptoms of other subjects for the selected search area for the combinations of stimulation location and stimulation energy (e.g. ¶¶ 30 – “selection of various therapy programs based on the symptoms a particular patient is most interested in alleviating”).
Regarding claim 14, Chatuvedi discloses a memory operatively coupled to, or integral to, the control circuit; wherein the control circuit is configured to: store a therapy map for the selected search area in the memory, the therapy map including points corresponding to the combinations of stimulation location and stimulation energy; and estimate the one or more expected symptoms by comparing the determined therapy map to another therapy map included in a database of therapy maps (e.g. ¶¶ 117-118).
Regarding claim 15, Chatuvedi discloses a memory operatively coupled to, or integral to, the control circuit; wherein the control circuit is configured to: store a therapy map for the selected search area in the memory, the therapy map including points corresponding to the combinations of stimulation location and stimulation energy; update the therapy map to include tested combinations of stimulation location and stimulation energy as tested points (e.g. ¶¶ 94 – “clinician may update efficacy map information 98 based on patient feedback”); and upload the therapy map to a database of therapy maps (e.g. ¶¶ 30 – “data may be in a database which allows clinicians or researchers to determine brain regions of efficacy and side effects based on a large patient population”).
Regarding claim 16, Chatuvedi discloses the control circuit is configured to: display a therapy map using the user interface, wherein the therapy map includes the combinations of stimulation location and stimulation energy as tested points and untested points on the therapy map, and the one or more expected symptoms displayed as one or more side effect volumes in the therapy map (e.g. ¶¶ 119 – “there is a therapy program that is untested”; initiate delivery of neurostimulation corresponding to a stimulation location and stimulation energy of an untested point of the therapy map; and update a side effect volume of the one or more side effect volumes in response to the neurostimulation (e.g. ¶¶ 121-122).
Regarding claim 17, Chatuvedi discloses the control circuit is configured to: display a confidence level of an estimation of an expected symptom of the one or more expected symptoms; test an untested combination of a stimulation location and stimulation energy; and update the confidence level of the estimation (e.g. ¶¶ 111 – “The efficacy map may include information regarding the regions of brain where stimulation is most efficacious at treating the symptom”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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