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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1066. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 (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 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.
Claims 1, 3-10, 13, 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gerber et al. (US Pre-Grant Publication 2011/0040547), hereinafter ‘Gerber’.
Regarding claim 1, Gerber teaches a neuromodulation system (therapy system 10, Fig. 1A), comprising:
an electrostimulator (IMD 14, Fig. 1A) configured to provide electrostimulation to a neural target in a patient ([0036], provides DBS to brain) via at least one lead (medical lead 16, Fig. 1A); and
a programmer device (programmer 20, Fig. 1A) operable by a user to program the electrostimulator ([0036], clinician interacts with user interface provided by programmer to program stimulation parameters), the programmer device including:
a graphical user interface (GUI) (GUI 130, Fig. 7); and
a controller circuit (processor 60, Fig. 3, [0074], processor may comprise digital logic circuitry) configured to:
display on the GUI a graphical representation of the neural target (target anatomical structures 116, Fig. 6C, [0143], processor displays anatomical structures on GUI);
receive, via the GUI, a user input to create or modify a graphical stimulation field representation (stimulation field 134, Fig. 7) with respect to the neural target ([0144], user creates stimulation field);
based on the received user input of the graphical stimulation field representation, estimate a stimulation setting ([0144], processor generates set of therapy parameter values that would match the stimulation field (e.g., a therapy program)) including one or more stimulation parameters or electrode configurations ([0152], processor selects electrodes and parameter values) using a computational model ([0154], algorithm for generating stimulation parameter values that fit user defined stimulation field), the estimation including determining a stimulation test volume, activated by an application of the estimated stimulation setting, that substantially matches the received graphical stimulation field representation ([0154], processor utilizes stimulation templates and selects the best fit to the stimulation field); and
generate a control signal to the electrostimulator to deliver electrostimulation energy to the neural target in accordance with the estimated stimulation setting (Fig. 2, processor 40 communicates with stimulation generator 44, [0069], deliver stimulation).
Regarding claim 13, see rejection of similarly worded claim 1 above. Gerber further teaches a method of operating a programmer device to program an electrostimulator (see Fig. 16, [0206]).
Regarding claims 3 and 15, Gerber teaches the system/method of claims 1 and 13, further comprising:
wherein the controller circuit is configured to display on the GUI a graphical representation of a base stimulation field model (reference field 149, Fig. 7),
wherein the user input to create or modify the graphical stimulation field representation is further with respect to the base stimulation field model ([0086], reference points for achieving functional outcome for therapy to patient, [0161]).
Regarding claim 4, Gerber teaches the system of claim 1, further comprising:
wherein the GUI includes one or more user interface control elements operable by the user to provide the user input to create or modify the graphical stimulation field representation ([0144], user can change size/shape/position of stimulation field with a cursor/stylus control).
Regarding claim 5, Gerber teaches the system of claim 4, further comprising:
wherein the user input to create or modify the graphical stimulation field representation includes, via the one or more user interface control elements:
creating an initial graphical stimulation field representation (stimulation field 134, Fig. 7); and
modifying the initial graphical stimulation field representation (scroll bars 136, 140, Fig. 7), including one or more of translating ([0150], user can move stimulation field up/down using scroll bar), rotating ([0151], user can rotate stimulation field using scroll bar), resizing, flipping, or cropping of the initial graphical stimulation field representation or a portion thereof.
Regarding claim 16, see above rejection of similarly worded claims 4 and 5.
Regarding claims 6 and 17, Gerber teaches the system/method of claims 1 and 13, further comprising:
wherein the user input to create or modify the graphical stimulation field representation is spatially relative to the at least one lead (lead 16, Fig. 7),
wherein the estimated stimulation setting includes an electrode configuration specifying a selection of one or more active electrodes from the at least one lead and a fractionalization of electrical current flowing through the selected one or more active electrodes ([0150], processor reduces/increases stimulation energy from electrodes and phases electrodes in/out as stimulation field moves).
Regarding claim 7, Gerber teaches the system of claim 1, further comprising:
wherein the estimated stimulation setting includes the stimulation parameters including one or more of an amplitude, a pulse width, or a frequency of electrostimulation pulses ([0190], processor selects amplitudes and pulse widths to best fit stimulation field created by user).
Regarding claims 8 and 18, Gerber teaches the system/method of claims 1 and 13, further comprising:
wherein to receive the user input to create or modify the graphical stimulation field representation, the controller circuit is configured to create an initial graphical stimulation field representation based on a user selection of one or more of a stimulation target volume or a stimulation avoidance volume within or proximate the neural target ([0039], target and non-target anatomical regions, isolating stimulation field around target anatomical region).
Regarding claims 9 and 19, Gerber teaches the system/method of claims 1 and 13, further comprising:
wherein to receive the user input to create or modify the graphical stimulation field representation, the controller circuit is configured to create an initial graphical stimulation field representation based on a user input of a base stimulation setting ([0148], stimulation field is defined by user provided stimulation parameter values).
Regarding claim 10, Gerber teaches the system of claim 1, further comprising:
wherein the controller circuit is further configured to:
determine a reference graphical stimulation field representation corresponding to the stimulation test volume (reference field 149, Fig. 7); and
display on the GUI the reference graphical stimulation field representation overlaid upon the graphical stimulation field representation received as the user input (Fig. 7).
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.
Claims 11-12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over by Gerber et al. (US Pre-Grant Publication 2011/0040547) in view of Mustakos et al. (US Pre-Grant Publication 2019/0184171), hereinafter ‘Mustakos’.
Regarding claim 11, Gerber teaches the system of claim 10, further comprising:
wherein the controller circuit is further configured to:
present on the GUI an indication of a difference between the reference graphical stimulation field representation and the graphical stimulation field representation received as the user input (Fig. 7, [0093], processor computes similarity between therapy program and reference field).
Gerber further teaches the user providing feedback to processor based on a comparison between displayed fields ([0094-0095]), and allowing the user to verify the therapy field ([0166]), but does not explicitly teach the user accepting/rejecting the stimulation field.
Mustakos teaches a system/method for delivering electrostimulation (abstract, Fig. 6), further comprising:
receive a user acceptance or rejection of the received graphical stimulation field representation ([0096], user accepts, rejects, modifies stimulation state).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Gerber to incorporate the teachings of Mustakos to include the user accepting/rejecting the stimulation field. Doing so would allow for the user to control/monitor the operation of the system, as recognized by Mustakos [0052].
Regarding claim 12, Gerber and Mustakos teach the system of claim 11. Mustakos teaches the system further comprising:
wherein the controller circuit is configured to:
in response to the user acceptance of the received graphical stimulation field representation, generate the control signal to the electrostimulator to deliver electrostimulation energy in accordance with the estimated stimulation setting; and
in response to the user rejection of the received graphical stimulation field representation, prompt the user to further modify the received stimulation field model on the GUI ([0123], stimulation configuration transmitted to IMD, 1352, or presented to user and adjusted, 1354, Fig. 13, [0089], user selects for modification and/or use in programming a stimulation device).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Gerber to incorporate the teachings of Mustakos to include generation of a control signal/prompting for further modification. Doing so would allow for the user to control/monitor the operation of the system, as recognized by Mustakos [0052].
Regarding claim 20, see above rejection of similarly worded claims 10-12.
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over by Gerber et al. (US Pre-Grant Publication 2011/0040547) in view of Mustakos et al. (US Pre-Grant Publication 2019/0329040), hereinafter ‘Mustakos B’.
Regarding claims 2 and 14, Gerber teaches the system/method of claims 1 and 13, further comprising selecting the best fitting stimulation template that substantially matches to desired stimulation field from the user ([0154]), but does not specifically teach an inverse modeling algorithm relating a stimulation volume to a stimulation setting.
Mustakos B teaches a system/method for adjusting neuromodulation parameters (abstract, Fig. 6), further comprising:
wherein the computational model includes an inverse modeling algorithm relating a stimulation volume to a stimulation setting ([0093], inverse modeling algorithm, relates a stimulation configuration to a volume of activation).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Gerber to incorporate the teachings of Mustakos B to include an inverse modeling algorithm relating a stimulation volume to a stimulation setting. Doing so would allow for the automatic generation of the stimulation configuration for activating the test volume, as recognized by Mustakos B [0093].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Steinke (US Pre-Grant Publication 2016/0375258) teaches methods/systems for selecting stimulation parameters. See [0076], [0088], Figs. 7-8.
Carcieri et al. (US Pre-Grant Publication 2016/0030749) teaches a system/method for refinement of target stimulation volumes. See [0102], Fig. 11.
Zhang (US Pre-Grant Publication 2017/0304633) teaches a system/method for producing a stimulation field that approximates the target stimulation field. See Fig. 4.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
July 23, 2026
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