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 .
Response to Arguments
I. Drawing Objections
Applicant’s newly submitted replacement FIGS. 6-7 have successfully overcome the previous objections.
II. Claim Objection
Applicant’s amendment to claim 1 has successfully overcome the previous claim objection.
III. Claim Rejections under 35 U.S.C. § 103
Applicant’s remarks concerning the previous § 103 rejections have been fully considered but are not persuasive. Applicant argues that neither Case nor Dalal “shows or renders a three-dimensional model of a remaining portion.” The Examiner respectfully disagrees because while neither reference teaches this limitation alone, they render it obvious in combination. Case demonstrates how to acquire and display three-dimensional models of patient tissue, whereas Dalal provides the teaching of displaying a remaining portion of untreated tissue. The rejection proposes combining these references such that Case is modified to display a remaining portion (as taught in Dalal) in a panel as a three-dimensional model using one or more of the three-dimensional modalities (as taught in Case). As such, the limitation is rendered obvious by the combination of the two references.
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.
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.
Claims 1-2 and 4-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0374646 A1 to Case et al. (hereinafter “Case”) in view of US 2011/0208055 A1 to Dalal et al. (hereinafter “Dalal”).
Regarding Claims 1, 2, 13-15, Case teaches a medical instrument (see e.g. “ablation planning and navigation system” in the abstract) comprising:
a user interface comprising a display (see e.g. “graphical user interfaces (GUIs) that may be displayed on display 110” in Para. 73);
a memory storing machine executable instructions (see e.g. “memory” in Paras. 20 and 22);
a computational system configured for controlling the medical instrument (see e.g. Paras. 20-22; see e.g. controller 106), wherein execution of the machine executable instructions causes the computational system to:
receive an anatomical segmentation identifying a location of an anatomical structure (see e.g. “image segmentation is performed to demarcate specific areas of interest and calculate volumetrics of the areas of interest” in Para. 72 and “planning system 100 may also segment organs and other vital structures in addition to targets” in Para. 88 and “after targets, tissues, organs, and other structures are segmented …” in Para. 91);
receive a target zone segmentation identifying a location of a volume at least partially within the anatomical segmentation (see e.g. “image segmentation is performed to demarcate specific areas of interest and calculate volumetrics of the areas of interest” in Para. 72 and “planning system 100 may also segment organs and other vital structures in addition to targets” in Para. 88 and “after targets, tissues, organs, and other structures are segmented …” in Para. 91); and
display a planning graphical user interface using the display (see example GUIs in e.g. FIGS. 6-7 and 26-28); wherein the planning graphical user interface comprises a first panel configured for rendering a cross sectional view of the anatomical segmentation and the target zone segmentation (see e.g. Para. 73: “each GUI is divided into a number of regions (e.g., regions 132, 134, and 136) for displaying the rendered DICOM images. For example, region 132 shows an image of patient “P” along a transverse cross-section and region 134 shows an image of patient “P” along a coronal cross-section. Region 136 depicts a 3D rendering of patient “P”. In other embodiments, a sagittal cross-section may also be displayed on the GUI.”); wherein the planning graphical user interface further comprises a second panel configured for displaying a rendering of a first three-dimensional model of the anatomical segmentation and the target zone segmentation (see e.g. Para. 73: “Region 136 depicts a 3D rendering of patient “P”.”); wherein the planning graphical user interface further comprises a third panel (see e.g. FIGS. 6-7 and 26-28 and Para. 73);
wherein the planning graphical user interface further comprises an ablation selector configured for providing a user-selectable ablation zone (see e.g. Para. 71: “select a seed point on the selected image” and Para. 73: “The GUI also allows a user to adjust the power and time settings in regions 133 and 135, respectively. Additionally, the GUI has a number of additional tools in region 137 that include, but are not limited to, a planning tool that initiates the selection of a seed point …” and Para. 67: “a user determines the treatment zone settings using planning system 100 and utilizes the treatment zone settings in effecting treatment using navigation system 200”) descriptive of a volume at least partially within a remaining portion (see e.g. Para. 89: “By segmenting the organ, controller 106 can calculate the organ volume 160 and subtract the determined ablation zone 162 to determine the volume of organ being spared 164 as shown in FIG. 12A.” – i.e., the volume of spared tissue is the “remaining portion”);
Case fails to explicitly teach:
the third panel is configured for rendering a second three- dimensional model of a remaining portion of the target zone segmentation;
wherein execution of the machine executable instructions further causes the computational system to repeatedly:
receive the ablation zone from the ablation selector; and
update the remaining portion by removing the ablation zone from the remaining portion.
Another reference, Dalal, teaches an analogous ablation planning system including a multi-panel GUI (see e.g. FIGS. 3-4) and in which the actual ablation performed is analyzed and then new zone(s) from within a remaining (untreated) portion are selected to treat any remaining (untreated) portion of tissue of interest, with the remaining portion being continually updated by removing the ablation zone (see e.g. Para. 23: “an intra-procedural system to monitor ablation volumes (e.g., through imaging means such as MRI or ultrasound elastography); a feedback module that communicates the observed ablation shapes to the planning module; and/or a re-calculation module for recalculating and updating the set of ablation locations and shapes for ablating the remaining (e.g., untreated) portion of the treatment volume. For instance, the re-calculation module can be implemented as part of a planning module as a specific mode of operation” and Para. 43: “The imaging feedback can provide a spatial map of what has been ablated so far during the procedure. Method 500 can determine if the ablation therapy has been completed in step 514 and if not then it can proceed to step 516 where the processor 75 can compare the actual ablated shapes and volumes with the pre-treatment estimates”; also see Paras. 44-45). Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Case to analyze and display the remaining portion and repeatedly receive a selection of ablation zone(s) to update the remaining portion, as taught in Dalal, because these additional steps would predictably help ensure that the entire intended ablation zone is actually ablated (as compared to only performing a single ablation without any follow-up analysis).
Regarding Claim 4, as noted in Paras. 43-45 of Dalal, the subsequent zone determinations can be automatic. It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Case to allow subsequent ablation zone generations to be automatic because this would provide the predictable advantages of automation, e.g. convenience and speed.
Regarding Claim 5, see e.g. Para. 89-90, 94, 115, of Case discussing various instructions and guidance provided to the user/clinician.
Regarding Claim 6, see e.g. the abstract and Paras. 30, 66, 93, 94, 96-97 of Case discussing how the ablation probe is tracked.
Regarding Claim 7, see e.g. Para. 15 of Case describing how this invention is applicable to any known ablation energy type, such as RF, microwave, etc.
Regarding Claims 8-9, see e.g. Para. 92 of Case discussing how real-time ultrasound guidance medical image data is gathered and displayed.
Regarding Claim 10, see e.g. Paras. 25 and 64 of Case describing the collection of MRI data.
Regarding Claim 11, as discussed above, Case teaches that segmentation can be automated in e.g. Paras. 30 and 72.
Regarding Claim 12, it is very well known to control a MRI system with pulse sequence commands to acquire k-space data. Given that Case utilizes traditional MRI systems as seen in e.g. Paras. 25 and 64, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Case (if Case doesn’t already teach this) to control the MRI with pulse sequence commands to acquire k-space data as this is a standard MRI procedure known in the art.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Case in view of Dalal as applied to claim 1 above, and further in view of US 2020/0008875 A1 to Lu (hereinafter “Lu”).
Regarding Claim 3, Case further teaches that a trajectory can be calculated and displayed (see e.g. Para. 94) but fails to specifically teach that the ablation selector is configured to receive a selection of a trajectory. Another reference, Lu, teaches an analogous ablation planning system including a GUI which allows a clinician to determine or set trajectories (among many other functions) (see e.g. Para. 69: “For example, the clinicians may set an optical view, may pick one or more spots in the image(s) from the slice(s) to determine one or more target points, to pick one or more entry points, to determine or set one or more trajectories (e.g., between a target point and an entry point), to drag and drop needles on the image(s), to determine or set how long to perform ablation, to determine or set a power level for ablation, to determine or set the size and shape of the ablation (e.g., iceball, balloon, etc.), etc.”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Case to allow the ablation selector to receive a selection of a trajectory, as taught by Lu, because it would advantageously help allow a user to consider multiple options for the trajectories to help determine an optimal selection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
THIS ACTION IS MADE FINAL. 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 JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792