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
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 15, 2026.
Applicant's election with traverse of Invention I, claims 1-13 in the reply filed on May 15, 2026 is acknowledged. The traversal is on the ground(s) that the process that the Restriction requirement suggests is not materially different from the process of Group I that requires the use of the machine recited by Group II that requires the inputs from the steps of the process of Group I. This is not found persuasive because there are differences between Group I and Group II as set forth in the mailed Restriction Requirement. Specifically, Applicant asserts that the machine of claim 14 describes the Probe-Select of claim 1 that is configured to select the optimum probe, but claim 1 sets forth that the Probe-Select is used to determine a working length of the probe that corresponds to specifically “ a distance from a deep end of a fixation device in the skull to a target within the skull”, and the machine of claim 14 fails to define the “working length” as such. Thus, this is one example of how the process of Group I is materially different from the machine of claim 14. With regards to the restriction of Group III from Group I, Applicant argues that the process the Restriction Requirement suggests is not materially different from the process of Group I that requires the use of the machine recited by Group III that requires the inputs from the steps of Group I. However, this is not persuasive as the restriction between Group I and Group III is between a process (Group I) and a machine/apparatus (Group III), wherein the apparatus of Group III can be used to practice another and materially different process, such as a process that does not require securing the probe at a top of the fixation device with a tip of the probe terminating at the target as required by the process of Group I. Further, undue burden does exists as the prior art applicable to Group I may not be applicable to Groups II and III and would require the use of different search terms. Further, as set forth in the restriction requirement, the different groups have different classifications which show undue burden for search. Group III, for example, is directed to a machine configured to design/manufacture an optimum probe, which would have a different classification than a process for inserting a probe into a brain as set forth in Group I.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 1-6, 8-11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cameron et al. (US Pub No. 2020/0297430) in view of Gill et al. (US Pub No. 2024/0207010).
With regards to claim 1, Cameron et al. disclose a process for selecting a probe for inserting into a brain, the process comprising:
receiving a real-time registration (i.e. 2103) of the brain from a neuronavigational system (paragraph [0092], referring to the processing unit accounting for brain shift intraoperatively in real time; paragraphs [0097]-[0099], referring to a surgeon capturing CT or MR images (2100, 2101, 2102), wherein the images are registered to one another to provide a merged image 2103; Figure 21);
co-registering the real-time registration (i.e. 2103) of the brain with an anatomical model (204) (paragraph [0099], referring to the merged image (2103) being registered to with atlas data (204) from the patient’s brain atlas; Figures 21-22);
co-registering the neuronavigational system between an anatomical model of the brain and the real-time registration of the brain (paragraph [0100], referring to the targeted image (2106) being used to create patient registration (2110) by combining actual visual cranial images that make up the reference array (2108) of patient (2107) who has now been readied for surgery in the operating room using tracking camera (2120), which patient registration (2110) is visible on said display; Figure 23);
determining, using the neuronavigational system, an entry point (i.e. 1162) for the probe into the brain (paragraphs [0067]-[0069], referring to planning trajectories for placement of implants such as electrodes through a guide tube held by a robot, wherein the trajectory includes an entry point into the skull for reaching a fixed target location; paragraph [0099], referring to plan trajectories (2106A, 2106B), which is defined by an entry point; Figures 10-11, 23)
identifying, using the neuronavigational system, a target point (i.e. 1058, 1164, 1166) for the probe (paragraphs [0067]-[0068], referring to the trajectory to the target location (1058) and/or referring to the target locations (1164, 1166) for placement of electrodes through a guide tube held by a robot; paragraph [0099], referring to the plan trajectories (2106A, 2106B), which is defined by a target point/location; Figures 10-11, 23).
However, though Cameron et al. disclose that an end-effector (112) may be coupled to a robot arm (104), wherein the end-effector (112) can comprise a guide tube (114), which is able to receive and orient an implant, such as an electrode, on a patient (paragraphs [0044], [0067], [0076]; Figures 1-2), Cameron et al. do not specifically disclose that the process further comprises receiving a measurement of a device configured to at least one of attach or secure a fixation device to a skull, determining, using a Probe-Select, in real time, a working length for the probe, wherein a distance from a deep end of a fixation device in the skull to a target within the skull defines the working length, selecting, using the Probe-Select and the working length, the probe for connecting to and extending through the fixation device to a distance that terminates at the target and securing the probe at a top of the fixation device with a tip of the probe terminating at the target.
Gill et al. disclose an implantable guide hub (i.e. “fixation device”) for use in neurosurgery, neurotherapeutic and neurodiagnostics, and a jig for setting the depth of insertion of a surgical tool, such as an electrode, into a patient during surgery, wherein the device and jig are particularly useful in image-guided stereotactic neurosurgery where accurate and reproducible targeting is required (Abstract; paragraphs [0001], [0018]). The surgical guide hub comprises a through-bore for delivering a device (i.e. electrode) therethrough and along the trajectory, wherein the guide hub is secured/fixed with an aperture in a skull (paragraph [0008]). An insertion tool (570) is attached to the guide hub (220) and is used to deliver the hub (220) into a profiled hole (561) of the skull (500) (paragraphs [0174]-[0175], note that the insertion tool corresponds to the claimed “device configured to at least one of attach or secure a fixation device [i.e. guide hub] to a skull; Figures 5, 7). The insertion tool (570) comprises a shank (571) and a threaded distal end (572), wherein the shank (571) is dimensioned to be operable with a stereotactic guide (paragraphs [0174]-[0175]). For example, insertion tool (570) comprises a shank of 150 mm length and 10 mm diameter which allows the insertion tool (570) to be used with existing stereotactic guides and provides a sufficiently long insertion tool (570) to deliver the hub (220) to the profiled hole (561) using the stereotactic guide (paragraphs [0174]-[0175], note that a measurement (i.e. shank dimensions of the insertion tool) configured to at least one of attach or secure a fixation device to a skull is received/identified). The insertion tool (570) may also comprises a depth stop (1806), wherein the depth stop (1806) is set at the correct position along the insertion tool (570) such that the depth stop will engage the stereoguide datum (503) when the guide hub 220 has been inserted to the correct depth in the aperture, wherein the setting of the position of the depth stop (1806) may be carried out using the jigs of the invention (paragraph [0180], note that the setting of the position of the depth stop (1806) inherently requires that a measurement (i.e. position setting) of the device (i.e. insertion tool) configured to attach/secure the fixation device (i.e. hub) to the skull is received in order to be carried out using the jigs; Figures 5, 19). The jig may be motor driven and may be computer controlled to set the baseline distance, wherein the setting of the jig may even be directly from surgical planning software (i.e “Probe-Select”) (paragraph [0080]). From the planning scan, information such as the target location relative to skull, the thickness and the skull and a trajectory from the skull to a target are obtained, wherein the jig therefore may be set by computer control using scan data as input, prior to the surgical procedure (paragraph [0080]). In the jigs of the invention, the reference guide may comprise at least one guide channel extending therethrough, for passage of a surgical tool or device, the guide channel extending from the datum surface and continuing in the direction set by the tool aligning device (paragraph [0081]). This allows the length of a device from the datum surface to be measured and adjusted or cut to a length as required, for example the required length (i.e. “working length) of a cannula that in use will extend below a guide hub (i.e. from a deep end of the hub) into the brain of a patient (paragraph [0081], note that a working length (i.e. distance from a deep end of the hub in the skull to a target within the skull defines the working length of the tool/cannula/electrode)). The jig allows setting of tools for creating a profiled hole in a skull and also the lengths of devices to be inserted into a skull, all determined from one setting of the baseline length and the scan data used when determining the trajectory and distances to target when planning surgery (paragraph [0082], note that the probe/cannula/electrode for connecting to and extending through the fixation device (i.e. hub) to a distance that terminates at the target is selected using the Probe-Select (i.e. planning software of jig) and the working length). The jig (600) is for setting the depth of insertion of multiple neurosurgical tools and devices into the skull or brain of a patient during neurosurgery (paragraphs [0196]-[0200], [0216], [0219]; Figure 9). A device/electrode (593) can be inserted through the hub (220) to a target point/location (paragraphs [0165]-[0166], [0183]-[0184], [0189]; Figures 5, 7, note that the probe/electrode is secured at a top of the fixation device (i.e. hub) with a tip of the probe/electrode terminating at the target).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the process of Cameron et al. further comprise receiving a measurement of a device configured to at least one of attach or secure a fixation device to a skull, determining, using a Probe-Select, in real time, a working length for the probe, wherein a distance from a deep end of a fixation device in the skull to a target within the skull defines the working length, selecting, using the Probe-Select and the working length, the probe for connecting to and extending through the fixation device to a distance that terminates at the target and securing the probe at a top of the fixation device with a tip of the probe terminating at the target, as taught by Gill et al., in order to provide accurate and reproducible targeting (Abstract; paragraphs [0001], [0018]).
With regards to claim 2, Gill et al. disclose that the process further comprises the working length comprising a length optimized for modulating sites (i.e. via Deep Brain Stimulation) in the brain, located along the probe optimized based on an anatomy, along a length of a planned trajectory of the probe; and the neuronavigational system determining a length from a top of an alignment mechanism of the neuronavigational system to the target (paragraphs [0018], [0103]-[0105], referring to the devices can include cannulas or catheters for the delivery or removal of fluid, electrodes for stimulating or blocking neural activity, etc, such as Deep Brain Stimulation (DBS) electrodes, which will modulate/stimulate sites in the brain; paragraph [0081], referring to the length of the device being measured and adjusted or cut to a length as required that in use will extend below a guide hub into the brain of a patient; paragraphs [0165]-[0166], referring to brain imaging being performed to determine the location of a target (501) and trajectory (502) with respect to a stereoguide (i.e. “alignment mechanism”) datum (503), wherein the known distance/length between the stereoguide datum (503) and the target (501) allows the surgeon to accurately plan surgery using instruments delivered using the stereotactic guidance system; Figures 5a, 7).
With regards to claim 3, Cameron et al. disclose that the process further comprises using the anatomical model of the brain for deriving or identifying sites in the brain for optimal electrode implantation for modulation; and determining, using the sites, the entry point and the target defining a planned trajectory for the probe (paragraphs [0011], [0095]-[0096], [0099], referring to using the atlas/”anatomical mode” to allow the surgeon to see a more defined location for each structure they may be targeting, allowing for the accurate mapping of plan trajectories (2106A, 2106B), which is defined by the entry point and target; paragraphs [0067], [0073], [0074], [0076], referring to the surgical tool being an electrode for Deep Brain Stimulation, etc.; Figures 22-23).
With regards to claim 4, Gill et al. disclose that the process further comprises selecting a length of the fixation device (i.e. hub) optimized for a thickness of an anatomical structure (paragraph [0057], referring to brain imaging providing the skill thickness which allows the surgeon to calculate the length of each piece of the apparatus to be introduced along the trajectory into the head of the patient; paragraph [0151], referring to the hub (220) being a length such that it can be fully implanted within the thickness of the skull).
With regards to claim 5, both Cameron et al. and Gill et al. disclose that the probe comprises an electrode (see Cameron et al., paragraphs [0067], [0073], [0074], [0076], referring to the surgical tool being an electrode for Deep Brain Stimulation, etc.; see Gill et al., paragraphs [0018], [0103]-[0105], referring to the devices can include electrodes for stimulating or blocking neural activity, etc, such as Deep Brain Stimulation (DBS) electrodes, which will modulate/stimulate sites in the brain). Gill et al. disclose selecting the probe using a location of an electrode located on the probe and a desired site in the brain along the probe (paragraph [0081], referring to the length of the device being measured and adjusted or cut to a length as required that in use will extend below a guide hub into the brain of a patient; paragraphs [0165]-[0166], referring to brain imaging being performed to determine the location of a target (501); paragraph [0183], referring to the guide tube (581), which can be viewed as corresponding to a “probe”).
With regards to claim 6, Gill et al. disclose that the process further comprises securing the fixation device onto an anatomical structure at the entry point (paragraphs [0008], [0027]-[0029], [0146], referring to at least one formation on an external surface for securing the hub (i.e. fixation device) within the aperture in a skull, which corresponds to an entry point; Figures 5A).
With regards to claim 8, Gill et al. disclose that the process further comprising the neuronavigational system comprising an alignment mechanism and driving, through the alignment mechanism, the fixation device through an opening in the skull.
With regards to claim 9, Gill et al. disclose that the process further comprises determining a distance from a surface of a scalp to a top of the fixation device implanted in the skull (paragraph [0057], referring to brain imaging providing the skill thickness which allows the surgeon to calculate the length of each piece of the apparatus to be introduced along the trajectory into the head of the patient; paragraph [0151], referring to the hub (220) being a length such that it can be fully implanted within the thickness of the skull, wherein such a length corresponds to a distance from a surface of a scalp to a top of the fixation device implanted in the skull; Figure 5).
With regards to claim 10, Gill et al. disclose that the process further comprises attaching a depth stop (1806) on a driver (i.e. insertion tool; 570) connected to the fixation device (i.e. guide hub; 220) implanted in the skull; and the Probe-Select receiving and using a distance from the depth stop to a tip of the driver for determining the working length (paragraphs [0174]-[0178], [0180]-[0181], referring to the insertion tool (570) comprising a depth stop (1806) which provides a visual and/or tactile indication of when the guide hub (220) has been inserted to the correct depth by engaging with the stereoguide datum (503), wherein before inserting the guide hub (220), the depth stop (1806) is set at the correct position along the insertion tool (570) such that the depth stop will engage the stereoguide datum (503) when the guide hub (220) has been inserted to the correct depth of the aperture, wherein the setting of the position of the depth stop (1806) is carried out using the jigs of the invention; paragraph [0081], referring to the length of the device being measured and adjusted or cut to a length as required that in use will extend below a guide hub into the brain of a patient; paragraphs [0165]-[0166], referring to brain imaging being performed to determine the location of a target (501) and trajectory (502) with respect to a stereoguide (i.e. “alignment mechanism”) datum (503), wherein the known distance/length between the stereoguide datum (503) and the target (501) allows the surgeon to accurately plan surgery using instruments delivered using the stereotactic guidance system; paragraph [0197], referring to the jig being used “for setting the tools and devices used in surgical procedures such as those shown in Figs. 5a to 5k”; Figures 5, 19).
With regards to claim 11, Gill et al. disclose that the process further comprises the neuronavigational system comprising an alignment mechanism; connecting a driver to the fixation device and driving the fixation device through the skull; attaching a depth stop on the driver; the Probe-Select (i.e. surgical planning software associated with the jig) receiving a distance from the depth stop to a tip of the driver; and using the distance for determining the working length, wherein the depth stop is set flush at a top of the alignment mechanism after the fixation device is secured in the skull (paragraph [0080], referring to the jib being motor drive and may be computer controlled to set the baseline distance, wherein the setting of the jig may even be directly from the surgical planning software, wherein from the planning scan, information such as the target location relative to the skull, the thickness and the skull and a trajectory from the skull to a target (i.e. working length) are obtained; paragraphs [0174]-[0178], [0180]-[0181], referring to the insertion tool (570) comprising a depth stop (1806) which provides a visual and/or tactile indication of when the guide hub (220) has been inserted to the correct depth by engaging with the stereoguide datum (503), wherein before inserting the guide hub (220), the depth stop (1806) is set at the correct position along the insertion tool (570) such that the depth stop will engage the stereoguide datum (503) (i.e. and thus the depth stop is set flush at a top of the alignment mechanism (i.e. stereoguide)) when the guide hub (220) has been inserted to the correct depth of the aperture; paragraph [0081], referring to the length of the device being measured and adjusted or cut to a length as required that in use will extend below a guide hub into the brain of a patient; paragraphs [0165]-[0166], referring to brain imaging being performed to determine the location of a target (501) and trajectory (502) with respect to a stereoguide (i.e. “alignment mechanism”) datum (503), wherein the known distance/length between the stereoguide datum (503) and the target (501) allows the surgeon to accurately plan surgery using instruments delivered using the stereotactic guidance system; paragraph [0197], referring to the jig being used “for setting the tools and devices used in surgical procedures such as those shown in Figs. 5a to 5k”; Figures 5, 19).
With regards to claim 13, Cameron et al. disclose that the process further comprises creating coordinates that define the entry point in a first data set in the anatomical model of the brain in communication with the neuronavigational system; and creating coordinates that define the target in a second data set from a real-time image (i.e. ultrasound image) of the brain co-registered to the first data set in the anatomical model of the brain in communication with the neuronavigational system (paragraphs [0066]- [0069], referring to planning trajectories to control a robot to place implants such as electrodes through a guide tube held by the robot, wherein coordinates are established using the target and trajectory (which will include the entry point) in the planning stage relative to the image space, etc.; paragraph [0095], referring to registered live images allowing for a clearer reference as to where structures should be seen; paragraph [0099], referring to the merged image with at least data (204) allowing the surgeon to see a more defined location for each structure they may be targetint, allowing for the accurate mapping of plan trajectories (2106A, 2106B), which would include the entry point determination; paragraphs [0100]-[0104], referring to ultrasound images (2110) being taken in the operating room and registered to the atlas image/anatomical model, wherein the registration allows for identification of the level of deformation or brain shift in a patient (2107) which provides feedback to target the positioning of cranial surgical equipment during the procedure (i.e. coordinates that define the target for the positioning of the equipment) Figures 10-11).
Claim(s) 7 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cameron et al. in view of Gill et al. as applied to claim 1 above, and further in view of Vetter et al. (US Pub No. 2009/0118806).
With regards to claims 7 and 12, as discussed above, the above combined references meet the limitations of claim 1. Further, Gill et al. disclose that the probe comprises a functional element/electrode and one of selecting or manufacturing the probe is based upon a distance between the functional element/electrode tip and end (i.e. length of electrode) which is used to reach a target (paragraphs [0018], [0103]-[0105], referring to the devices can include cannulas or catheters for the delivery or removal of fluid, electrodes for stimulating or blocking neural activity, etc, such as Deep Brain Stimulation (DBS) electrodes, which will modulate/stimulate sites in the brain; paragraph [0081], referring to the length of the device being measured and adjusted or cut to a length as required that in use will extend below a guide hub into the brain of a patient; paragraphs [0165]-[0166], referring to brain imaging being performed to determine the location of a target (501) and trajectory (502) with respect to a stereoguide (i.e. “alignment mechanism”) datum (503), wherein the known distance/length between the stereoguide datum (503) and the target (501) allows the surgeon to accurately plan surgery using instruments delivered using the stereotactic guidance system; Figures 5a, 7).
However, the above combined references do not specifically disclose that the probe comprises functional elements/electrodes (i.e. more than one electrode) and the distance corresponds to distances between the functional elements/electrodes located along the probe.
Vetter et al. disclose combining microelectrode and macroelectrode sites on a single device to allows for sites to be used in a customized mode of operation for Deep Brain Stimulation, wherein the positions of the sites selected for stimulation can be adjusted as needed to optimally interface with the neural region of interest (Abstract; paragraphs [0004], [0017]; Figures 1-2). The positions of the sites selected for stimulation can be adjusted as needed to optimally interface with the neural region of interest (paragraph [0017], note that each microelectrode of the plurality of microelectrodes (i.e. functional elements) is associated with a neural/target site, and therefore it would follow that distances between the microelectrodes corresponds to a distance of the device to a site associated with the targets).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the probe comprise functional elements/electrodes (i.e. more than one electrode) and the distance corresponds to distances between the functional elements/electrodes located along the probe, as taught by Vetter et al., in order to allow for sites to be used in a customized mode of operation for Deep Brain Stimulation, wherein the positions of the sites selected for stimulation can be adjusted as needed to optimally interface with the neural region of interest (Abstract; paragraphs [0004], [0017]; Figures 1-2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bova et al. (US Pub No. 2006/0212044) disclose that stereotactic biopsy has long relied upon phantom testing to ensure the accuracy and precision of biopsy frame setting. The steps in the phantom procedure are generally as follows: 1) analyze various 3D scan data and select the optimal target and entry coordinates; 2) calculate a trajectory and setting for a stereotactic frame; 3) adjust the stereotactic biopsy frame to the calculated settings; 4) set the phantom base with a ring that matches the ring applied to the patient to the target coordinates; 5) set the stereotactic biopsy frame onto the phantom base; 6) adjust the biopsy probe to the required length; 7) inset the biopsy probe into the stereotactic biopsy frame applied to the phantom base; and 8) ensure the tip of the biopsy needle touches the phantom target point (Abstract; paragraphs [0037]-[0045]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/ Primary Examiner, Art Unit 3798
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