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 Status: Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed on June 3, 2026 have been fully considered but they are not persuasive.
Applicant stated that anatomically-defined directions include anterior, posterior, superior, inferior, lateral, and medial and are defined by the body of the patient and that moving the stimulation up or down the lead (i.e., using lead-defined directions) is substantially different from moving the stimulation anteriorly or posteriorly (i.e., using anatomically-defined directions). Applicant further elaborated that a lead-defined direction uses the lead as a frame of reference and an anatomically-defined direction uses the body as a frame of reference. Applicant argued that Blum dos not teach or suggest using directional inputs for moving stimulation in the anatomically-defined directions.
This argument has been considered but is not persuasive.
Blum discloses displaying overlay of images of brain structures, a target VOA, leadwire, and initial stimulation field and adjusting the stimulation parameters based on whether the VOA meets the target VOA; therefore, the directional input Blum receives is in reference to anatomical structures. The following is the disclosure of Blum: Blum discloses “rotating the 3-D view of the leadwire and brain structure so the intended direction of stimulation is to the left or right of the leadwire and manually select the location to which to move the current field; touching/selecting the structure or the structure name towards which the current field is desired to be directed, and then, e.g., the system automatically, increasing or decreasing the overall amplitude or intensity in order to fill the intended stimulation target” (para. [0251], [0252]). Blum discloses the user setting various DBS parameter combinations and view the predicted VOAs (volume of activation) so that the user can use the information to decide which parameters to set during the brain stimulation (para. [0016]). Blum further discloses that the display may illustrate, for example, a VOA and anatomical structures, and their overlap, and the user may thereby determine whether an anatomical structure intended to be activated is activated in a displayed VOA and/or whether anatomical structures for which activation is detrimental is activated in the displayed VOA (para. [0016]). Para. [0255]-[0281] discloses registering a 3-D atlas to patient data, displaying a 3-D view of the atlas, a 3-D target VOA, a 3-D view of the leadwire, and an initial model stimulation field, and receiving directional inputs for moving the displayed stimulation field until the stimulation field is located approximately at the target stimulation field.
Therefore, the disclosure on the directional inputs in Blum reads on “a user input to move the stimulation in a selected anatomically-defined direction”.
Response to Amendment
With respect to 112(b) rejection, Applicant’s amendment has overcome each and every rejection.
With respect to 101 rejection, Applicant’s amendments have overcome each and every rejection.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blum et al. (US 2009/0287271A1).
Re Claim 1, Blum discloses a method for modifying stimulation by a stimulation system comprising a stimulation device (abstract, a processor that calculates a VOA for each of a plurality of sets of parameter settings of the leadwire) and a stimulation lead coupled to the stimulation device (para. [0146], fig. 3D, a stimulation leadwire 335) and comprising a distal end portion implanted in a patient and a plurality of electrodes, optical emitters, or any combination thereof disposed along the distal end portion (para. [0146], the stimulation leadwire 335 includes one or more electrical contacts or electrodes 336), wherein the distal end portion is not parallel to at least one of a sagittal plane or a coronal plane of the patient (fig. 3C and 3D shows that leadwire 335 is not parallel to at least one of a sagittal plane or a coronal plane), the method comprising:
providing stimulation to the patient by the stimulation device through at least one of the electrodes or optical emitters of the stimulation lead according to an initial set of stimulation parameters (para. [0141], fig. 6, a stimulation is applied and the location of the electrodes relative to the brain structures is confirmed axially and rotationally, e.g., based on one or more medical images or other sensor or observed data; para. [0142], fig. 7, That is, trial stimulations may be performed prior to closing of the patient's head to determine whether any benefits and/or side effects result from the stimulations with the leadwire at its present location; para. [0265], [0278]);
receiving, at a programming device, a user input to move the stimulation in a selected anatomically-defined direction (para. [0144], the clinician programmer system can suggest optimal program parameters, e.g., parameters that are predicted to result in an estimated VOA that closely corresponds to a target VOA manually input as described above or automatically determined, for example, based on a therapeutic goal; para. [0243], user input is up/down, side to side, clockwise/counterclockwise. In response to the user input, an algorithm controls the movement of the stimulation field by changing the amount of current delivered to a set of electrodes to either a different amount of current to some or each electrode or a different combination of electrodes; para. [0247], 26 basic linear directional inputs that can be used to steer a current field for a leadwire; para. [0250]-[0253], a directional input for redistributing current from one set of electrodes to another; para. [0266], [0280]);
determining, by the programming device or the stimulation device, a modified set of stimulation parameters that moves the stimulation in the selected anatomically-defined direction (para. [0144], [0145], the clinician programmer system can suggest optimal program parameters, e.g., parameters that are predicted to result in an estimated VOA that closely corresponds to a target VOA manually input as described above or automatically determined, for example, based on a therapeutic goal; para. [0267], [0281]); and
providing stimulation to the patient by the stimulation device through at least one of the electrodes or optical emitters of the stimulation lead according to the modified set of stimulation parameters (para. [0146], stimulation parameters are adjusted to optimal stimulation field orientation. In an example, the parameters can be adjusted to account for variation between the surgical plan and the actual leadwire or other component placement, direction, or location; para. [0267], [0281]).
Re Claim 2, Blum discloses that the anatomically-defined direction is selected from anterior, posterior, superior, inferior, lateral, medial, or any combination thereof (para. [0247], The stimulation leadwire is in the center of the cube shown in FIG. 22. The first set of inputs is directed toward the vertices (8), another set of inputs is directed perpendicular to each face (6), and additionally another set of inputs is directed toward the midpoint of each side or arête (12).).
Re Claim 3, Blum discloses obtaining a trajectory of the distal end portion of the stimulation lead (para. [0094], a lead insertion site and trajectory are planned; para. [0095], the clinician programmer system is configured to plan a surgical path for implantation of a stimulation leadwire using a head-frame (e.g., Lexcel), a frameless head mount (e.g., Nexframe), or other surgical tool; para. [0101], the microelectrode can be inserted into the brain, such as at a proposed or actual trajectory of a therapy delivery or other device or at another area, and can be configured to receive physiological information indicative of a location, structure, or substructure of the brain at which the microelectrode is located or with which the microelectrode is in contact).
Re Claim 4, Blum discloses that obtaining the trajectory comprises receiving, at the programming device, a user input of the trajectory (para. [0091], once imported, the scans can be analyzed, such as automatically by the clinician programmer system using image processing or other techniques or algorithms or manually by the user, to create a model of the patient's brain anatomy, or to fit a pre-loaded best-fit scan or preloaded model of the patient's brain anatomy, such as a brain atlas; para. [0092], the system may provide for receipt and processing of user input selecting a plurality of points within a 2-D or 3-D model to outline a 2-D or 3-D target location. The system may further provide for clicking and dragging upon one or more points of a displayed target location to change its shape; para. [0093], the target location can be identified or suggested by the clinician programmer system, for example, using clinician input, the patient's information (such as a patient disorder, patient history, etc.) population information (such as learned information from one or more other patients)).
Re Claim 5, Blum discloses that obtaining the trajectory comprises determining an actual or estimated trajectory from imaging (para. [0088], fig. 5, importing pre-surgical patient MR (or MRI) and CT scans, fitting patient scans to a pre-loaded best-fit atlas(es), identifying a target location within a graphical representation of a best-fit scan, and planning the lead insertion site and trajectory).
Re Claim 6, Blum discloses obtaining a rotational orientation of the stimulation lead (para. [0110], the post-operative or other CT data can be correlated, registered, co-registered, or otherwise morphed, changed, or altered, e.g., to the same or similar view, plane, or other orientation as the MRI data, to identify the location or placement of the identified lead or electrode on the pre-operative or other MRI data; para. [0125]-[0128], Different types of markers are disclosed. The angle at which these features are viewed under fluoro, CT, and/or MRI can tell the user the direction in which each electrode set is pointing; fig. 24, 25, and 26, para. [0129]-[0131] shows different rotational positions of the leadwire).
Re Claim 7, Blum discloses that obtaining the rotational orientation comprises observing an orientation marker of the stimulation lead or estimating the rotational orientation from responses to stimulation (para. [0125]-[0128], Different types of markers are disclosed. The angle at which these features are viewed under fluoro, CT, and/or MRI can tell the user the direction in which each electrode set is pointing; fig. 24, 25, and 26, para. [0129]-[0131] shows different rotational positions of the leadwire).
Re Claim 8, Blum discloses that obtaining the rotational orientation comprises determining the rotational orientation from imaging of the stimulation lead (para. [0129], [0130], [0131], [0132], Depending on the image the physician sees in the fluoroscopy image, the physician can tell in which direction the electrodes are pointing due to the asymmetry of the marker band. The physician would select, via the user interface, which pictures most closely relate to the image the physician is viewing in a fluoro machine, CT, or MRI.).
Re Claim 9, Blum discloses that determining the modified set of stimulation parameters comprises transforming the selected anatomically-defined direction into a lead coordinate system or at least one lead direction (para. [0243], user input is up/down, side to side, clockwise/counterclockwise. In response to the user input, an algorithm controls the movement of the stimulation field by changing the amount of current delivered to a set of electrodes to either a different amount of current to some or each electrode or a different combination of electrodes; para. [0247], 26 basic linear directional inputs that can be used to steer a current field for a leadwire; para. [0250]-[0253], a directional input for redistributing current from one set of electrodes to another).
Re Claim 10, Blum discloses that determining the modified set of stimulation parameters comprises determining the modified set of stimulation parameters using a predefined algorithm with the selected anatomically-defined direction being an input to the algorithm (para. [0243], user input is up/down, side to side, clockwise/counterclockwise. In response to the user input, an algorithm controls the movement of the stimulation field by changing the amount of current delivered to a set of electrodes to either a different amount of current to some or each electrode or a different combination of electrodes; para. [0247], 26 basic linear directional inputs that can be used to steer a current field for a leadwire; para. [0250]-[0253], a directional input for redistributing current from one set of electrodes to another). .
Re Claim 11, Blum discloses that the programming device comprises a control for switching between user input controls for moving stimulation along anatomically-defined directions and user input controls for moving stimulation along lead directions (para. [0243], there are several ways the field can be manipulated. Looking in two dimensions, the field can be moved either up or down the leadwire in the Z direction by hitting directional up or down arrow buttons 3013 and 3015 as shown in FIG. 23. The field can be moved side to side in the X direction by hitting directional side to side buttons 3012 and 3014 as shown in FIG. 23; para. [0247], The first set of inputs is directed toward the vertices (8), another set of inputs is directed perpendicular to each face (6), and additionally another set of inputs is directed toward the midpoint of each side or arête (12). In addition, two rotational directional inputs can be used (clockwise and counterclockwise) for rotational movement as shown in FIG. 21.).
Re Claims 12 and 20, Claims 12 and 20 are rejected under substantially the same basis as claim 1.
Re Claim 13, Claim 13 is rejected under substantially the same basis as claim 2.
Re Claim 14, Claim 14 is rejected under substantially the same basis as claim 3.
Re Claim 15, Claim 15 is rejected under substantially the same basis as claim 4.
Re Claim 16, Claim 16 is rejected under substantially the same basis as claim 6.
Re Claim 17, Claim 17 is rejected under substantially the same basis as claim 9.
Re Claim 18, Claim 18 is rejected under substantially the same basis as claim 10.
Re Claim 19, Claim 19 is rejected under substantially the same basis as claim 11.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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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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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, August 22, 2026Examiner, Art Unit 3792
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