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 .
Status of Claims
Claims 1-12 and 16-17 are currently pending and under examination. Claims 13-15 and 18-21 are canceled. As per the amendments filed on 08/18/2025, claims 1, 3-4, 12, and 16-17 are amended.
Response to Arguments
Applicant’s arguments, see Remarks page 1 (Claim Objections), filed 08/18/2025, with respect to the objection to claim 17 have been fully considered and are persuasive. The objection is withdrawn.
Applicant’s arguments, see Remarks page 1 (Claim Rejections-35 U.S.C 112(b)), filed 08/18/2025, with respect to the rejections of claims 1, 4, and 12 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Regarding claim 1, the antecedent bases for the terms are provided and the terms “the ablation zone produced by the ablation treatment” and “the achieved ablation zone of the subject” are reconciled. Regarding claim 4, the antecedent basis for the term is provided. Regarding claim 12, the change clarifies the limitation and removes the indefiniteness.
Applicant’s arguments, see Remarks page 1 (Claim Rejections-35 U.S.C 102), filed 08/18/2025, with respect to the 35 U.S.C. § 102 rejections of claims 1-3, 5-12, and 16 over Kruecker (US PG Pub 2011/0251607 A1) have been fully considered but they are not persuasive. Specifically, the applicant argues:
With regard to independent claim 1, Kruecker fails to disclose for example, "obtaining post-treatment ablation data generated after the ablation treatment is performed on the subject. Applicants respectfully submit that Kruecker never acquires imaging after the entire ablation procedure is finished; its CT/US/MR images are taken during the intervention to steer the next needle placement and that the predicted ablation zone is constructed prior to the generation of the post-treatment ablation data and thus Applicants respectfully submit that claim 1 is allowable over Kruecker. Claims 3, 5-12 and 16 depend either, directly or indirectly, from claim 1 and are thus allowable for the same reasons. (page 1, 08/18/2025 Remarks).
The full claim 1 limitations regarding post-treatment data are “obtaining post-treatment ablation data generated after the ablation treatment is performed on the subject, the post-treatment ablation data providing information on the achieved ablation zone of the subject; processing the post-treatment ablation data to construct the achieved ablation zone.” The post treatment data is presented as being used as a tool to assess the achieved ablation zone after an ablation treatment. The Examiner’s interpretation of these limitations is that each ablation cycle would constitute a treatment which needs to be assessed after the treatment to determine the extent of actual ablation. Kruecker discloses a feedback mechanism for evaluating actual ablation volume after a treatment:
The system further includes a feedback component for determining actual probe position and orientation using the navigation component or imaging component, and for determining actual ablation volume based on treatment images provided by the imaging component, and feeding the actual probe position/orientation and actual ablation volume during treatment to the planning component. The planning component calculates a treatment iteration based on the executed treatment plan, the actual probe position/orientation and actual ablation volume, the treatment iteration resulting in at least one of a desired next probe position/orientation and a desired next ablation volume. [0013]
The imaging of the actual ablation volume is achieved both during and after each treatment cycles ([0035] – “A three-dimensional (3D) medical image of the ablation area (e.g. CT, MRI, ultrasound) that provides adequate grayscale-contrast to allow delineation of the ablation zone can be obtained during or shortly after an ablation and the image transferred to the navigation component”).
An interpretation of “post-treatment” referring only to times after the total ablation session (after all ablation cycles) would similarly be anticipated by Kruecker ([0013]) - “The navigation component provides revised treatment instructions to the operator based on the treatment iteration until treatment is completed according to the desired planned target volume”). The final assessment of ablation volume, which halts additional treatment cycles once reaching a desired volume, would represent the final achieved ablation volume after all the treatment cycles are completed. Therefore, the rejections of claims 1-3, 5-12, and 16 are maintained.
Applicant’s arguments, see Remarks page 2 (Claim Rejections-35 U.S.C 103), filed 08/18/2025, with respect to the 35 U.S.C. § 103 rejections of claim 4 over Kruecker in view of Liu (US PG Pub 2014/02101669 A1) and claim 17 over Kruecker in view of Dalal (US PG Pub 2011/0015628 A1) have been fully considered but they are not persuasive. Specifically, the applicant argues the dependence of claims 4 and 17 on claim 1 make these claims allowable because “neither Kruecker nor Liu, whether taken alone or in combination, show or suggest obtaining post-treatment ablation data generated after the ablation treatment is performed on the subject” (page 2, 08/18/2025 Remarks) and “neither Kruecker nor Dalal, whether taken alone or in combination, show or suggest obtaining post-treatment ablation data generated after the ablation treatment is performed on the subject as discussed above with respect to claim 1” (page 2, 08/18/2025 Remarks). The rejection of claim 1 is maintained, thereby making the arguments regarding claims 4 and 17 moot. Therefore, the rejections of claims 4 and 17 are maintained.
Summary: The 35 U.S.C. § 102 rejections for claims 1-3, 5-12, and 16 and 35 U.S.C. § 103 rejections for claims 4 and 17 are maintained.
Claim Rejections - 35 USC § 102
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 1-3, 5-12, and 16 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Kruecker (US PG Pub 2011/0251607 A1, see previously cited).
Regarding Claim 1, Kruecker discloses a computer-implemented method ([0014] – ablation therapy planning method is disclosed) for providing an assessment of the accuracy of a predicted ablation zone obtained from intra-treatment data generated by an ablation system during an ablation treatment ([0016] – “By combining and integrating procedure planning and navigation, and by providing feedback from the navigation component back to the planning component about actual electrode position and ablation size/shape, complex procedures can be carried out more accurately, efficiently, and potentially with better clinical outcomes”) the computer-implemented method comprising:
• obtaining intra-treatment ablation data generated by an ablation system during an ablation
treatment, the intra-treatment ablation data providing information on an ablation treatment performed on a subject ([0021] – “which is capable of creating an initial treatment plan, and adjusting the treatment plan to take into account data received during a procedure”), and
• wherein the intra-treatment ablation data comprises applicator information identifying at least one of position, an orientation ([0014] – “a plurality of desired ablation probe placement positions and orientations”) and type of at least one ablation applicators during the ablation treatment (Different applicators are envisioned for use with the planning system: “treating the tissue of interest with at least one of RF ablation, cryo-ablation, microwave ablation, ultrasound ablation, and other thermal or non-thermal ablation” [0014]. However, applicator type is not specifically disclosed as part of applicator information data). Note that only one of position, orientation, or applicator type is necessary based on the examiner’s claim interpretation in Paragraph 6 of this action (see the Claim 4 obviousness rejection based on the inclusion of applicator type).
• processing the intra-treatment ablation data, including the applicator information, to construct a predicted ablation zone that predicts an achieved ablation zone produced by the ablation treatment ([0014] – “calculating a three-dimensional treatment plan for a tissue of interest including a plurality of desired ablation probe placement positions and orientations and a plurality of estimated ablation volumes to achieve a desired composite ablation volume that will treat the entire planned target volume (PTV) … Planning and treatment images of the tissue to be treated are obtained, and actual probe position/orientation and actual ablation volume based on the treatment images are determined”);
• obtaining post-treatment ablation data generated after the ablation treatment is performed on the subject, the post-treatment ablation data providing information on the achieved ablation zone of the subject ([0013] – actual ablation data collected after each treatment iteration: “The navigation component provides revised treatment instructions to the operator based on the treatment iteration until treatment is completed according to the desired planned target volume”; [0035] – imaging can occur both during and shortly after ablation);
• processing the post-treatment ablation data to construct the achieved ablation zone ([0013] –calculation of “actual ablation volume” after treatment for comparison with the planned ablation zone volume to determine next treatment; Note the final assessment of ablation volume, which halts additional treatment cycles once reaching a desired volume, would represent the final achieved ablation volume after all the treatment cycles are completed);
• registering the predicted ablation zone and the achieved ablation zone with respect to one another, and determining an error between the predicted ablation zone and the achieved ablation zone, to thereby provide an assessment of the accuracy of the predicted ablation zone ([0013] – actual and targeted ablation zones are compared to assess the extent of additional ablation necessary to achieve target ablation: “The planning component calculates a treatment iteration based on the executed treatment plan, the actual probe position/orientation and actual ablation volume, the treatment iteration resulting in at least one of a desired next probe position/orientation and a desired next ablation volume. The navigation component provides revised treatment instructions to the operator based on the treatment iteration until treatment is completed according to the desired planned target volume”); and
• using the assessment of the accuracy of the predicted ablation zone to calibrate the applicator information used to generate the predicted ablation zone ([0015-0016] – the accuracy of the planned ablation instructions is assessed and used to adjust subsequent iterations of the procedure until the desired ablation volume is accurately produced in the desired location. Additionally, the navigation system is calibrated, “By combining and integrating procedure planning and navigation, and by providing feedback from the navigation component back to the planning component about actual electrode position and ablation size/shape, complex procedures can be carried out more accurately, efficiently, and potentially with better clinical outcomes” [0016]).
Therefore, Claim 1 is anticipated by Kruecker.
Regarding Claim 2, Kruecker anticipates the computer-implemented method according to Claim 1, as indicated hereinabove. Kruecker further discloses a step of displaying the determined error ([0035] – The feedback with actual ablation information is sent back to the planning component to assess error between planned and actual ablations: “Ablation size/shape feedback to determine the actual ablation shape Sactual (step 30) can be obtained in the following way: A three-dimensional (3D) medical image of the ablation area (e.g. CT, MRI, ultrasound) that provides adequate grayscale-contrast to allow delineation of the ablation zone can be obtained during or shortly after an ablation, and the image transferred to the navigation component … The size/shape information is transferred to the planning component in order to update the plan for the remaining ablations with the measured ablation size/shape as the new ablation size/shape estimate”; [0022] – graphical user interface).
Therefore, Claim 2 is anticipated by Kruecker.
Regarding Claim 3, Kruecker anticipates the computer-implemented method according to Claim 1, as indicated hereinabove. Kruecker further discloses a step of adjusting at least one setting of the ablation system based on the determined error ([0013] – the difference between the planned and actual ablation is used to assess how the ablation system should be used for subsequent treatments to complete the planned ablation: “The planning component calculates a treatment iteration based on the executed treatment plan, the actual probe position/orientation and actual ablation volume, the treatment iteration resulting in at least one of a desired next probe position/orientation and a desired next ablation volume. The navigation component provides revised treatment instructions to the operator based on the treatment iteration until treatment is completed according to the desired planned target volume”).
Therefore, Claim 3 is anticipated by Kruecker.
Regarding Claim 5, Kruecker anticipates the computer-implemented method according to Claim 3, as indicated hereinabove. Kruecker further discloses a step of sharing the adjusted settings of the ablation system with one or more other ablation systems ([0029] – the treatment plan and revisions can be exported: “The navigation system component (2) has the ability to import an entire treatment plan from the planning component (1), consisting of multiple individual ablation locations, and potentially individual skin entry points for each of the ablation electrode placements” while “embodiments of the present disclosure can be applied to other types of ablative therapy” [0020]).
Therefore, Claim 5 is anticipated by Kruecker.
Regarding Claim 6, Kruecker anticipates the computer-implemented method according to Claim 1, as indicated hereinabove. Kruecker further discloses the step of registering the predicted ablation zone and the achieved ablation zone comprises registering the intra-treatment ablation data and the post-treatment ablation data with respect to one another, to thereby register the predicted ablation zone and the achieved ablation zone with respect to one another ([0013] – actual and targeted ablation zones are compared to assess the extent of additional ablation necessary to achieve the target: “The planning component calculates a treatment iteration based on the executed treatment plan, the actual probe position/orientation and actual ablation volume, the treatment iteration resulting in at least one of a desired next probe position/orientation and a desired next ablation volume. The navigation component provides revised treatment instructions to the operator based on the treatment iteration until treatment is completed according to the desired planned target volume”).
Therefore, Claim 6 is anticipated by Kruecker.
Regarding Claim 7, Kruecker anticipates the computer-implemented method according to Claim 6, as indicated hereinabove. Kruecker further discloses the step of registering the intra-treatment ablation data and the post-treatment ablation data with respect to one another comprises:
• obtaining reference ablation data ([0022] – “The planning system component (1) can allow computation of a composite ablation consisting of a plurality of optimal individual ablation positions/orientations based on input of a desired planned target volume (PTV) to be covered, and estimated or known individual ablation sizes”). Note that the broad term “reference data” appears to refer to “pre-treatment ablation data” (Instant Specification, Page 6, Lines 10-11), which could be considered planning data since planning data is acquired before treatment. Note that baseline segmented images, defining the target tissue before the planning phase, are also acquired and could be considered “reference data” ([0026] – “This component requires input and visualization of an image data set (the ‘baseline image’) and the ability to segment a tumor or PTV, or to import the segmentation from elsewhere”).
• registering the intra-treatment ablation data to the reference ablation data ([0015] – Comparing data during ablation to the reference: “An imaging component for obtaining treatment images of the tissue to be treated is also included, along with a feedback component for calculating actual probe position/orientation and actual ablation volume based on treatment images provided by the imaging component, and feeding the actual probe position/orientation and actual ablation volume during treatment to the planning component. The planning component maps the actual probe location and actual ablation volume to the three-dimensional plan and calculates a treatment iteration based on the treatment plan”); and
• registering the post-treatment ablation data to the reference ablation data, thereby indirectly registering the intra-treatment ablation data to the post-treatment ablation data ([0035] – Comparing data after treatment to the reference: “A three-dimensional (3D) medical image of the ablation area (e.g. CT, MRI, ultrasound) that provides adequate grayscale-contrast to allow delineation of the ablation zone can be obtained during or shortly after an ablation, and the image transferred to the navigation component …. The size/shape information is transferred to the planning component in order to update the plan for the remaining ablations with the measured ablation size/shape as the new ablation size/shape estimate”).
Therefore, Claim 7 is anticipated by Kruecker.
Regarding Claim 8, Kruecker anticipates the computer-implemented method according to Claim 1, as indicated hereinabove. Kruecker further discloses the step of registering the predicted ablation zone and the achieved ablation zone comprises directly processing the predicted ablation zone and the achieved ablation zone to register the two together ([0015] – direct comparison between predicted and actual ablation is a feature of the feedback system: “An imaging component for obtaining treatment images of the tissue to be treated is also included, along with a feedback component for calculating actual probe position/orientation and actual ablation volume based on treatment images provided by the imaging component, and feeding the actual probe position/orientation and actual ablation volume during treatment to the planning component. The planning component maps the actual probe location and actual ablation volume to the three-dimensional plan and calculates a treatment iteration based on the treatment plan, the actual probe position/orientation and actual ablation volume”).
Therefore, Claim 8 is anticipated by Kruecker.
Regarding Claim 9, Kruecker anticipates the computer-implemented method according to Claim 1, as indicated hereinabove. Kruecker further discloses the post-treatment ablation data comprises one or more medical images of the subject captured after the ablation treatment, the one or more medical images providing visual information on the achieved ablation zone ([0035] - Ablation size/shape feedback obtained via 3D medical images post-treatment: “A three-dimensional (3D) medical image of the ablation area (e.g. CT, MRI, ultrasound) that provides adequate grayscale-contrast to allow delineation of the ablation zone can be obtained during or shortly after an ablation”).
Therefore, Claim 9 is anticipated by Kruecker.
Regarding Claim 10, Kruecker anticipates the computer-implemented method according to Claim 1, as indicated hereinabove. Kruecker further discloses the intra-treatment ablation data comprises one or more medical images captured during the ablation treatment ([0035] - Ablation size/shape feedback obtained via 3D medical images during treatment: “A three-dimensional (3D) medical image of the ablation area (e.g. CT, MRI, ultrasound) that provides adequate grayscale-contrast to allow delineation of the ablation zone can be obtained during or shortly after an ablation”).
Therefore, Claim 10 is anticipated by Kruecker.
Regarding Claim 11, Kruecker anticipates the computer-implemented method according to Claim 10, as indicated hereinabove. Kruecker further discloses wherein:
• the post-treatment ablation data comprises one or more medical images of the subject captured after the ablation treatment, the one or more medical images providing visual information on the achieved ablation zone ([0035] – “Ablation size/shape feedback to determine the actual ablation shape Sactual (step 30) can be obtained in the following way: A three-dimensional (3D) medical image of the ablation area (e.g. CT, MRI, ultrasound) that provides adequate grayscale-contrast to allow delineation of the ablation zone can be obtained during or shortly after an ablation”); and
• the step of registering the predicted ablation zone and the achieved ablation zone with respect to one another comprises registering at least one of the medical images captured during the ablation treatment against at least one of the medical images captured after the ablation treatment, to thereby register the predicted ablation zone and the achieved ablation zone with respect to one another ([0015] – The images are compared between the planning and post-treatment components: “An imaging component for obtaining treatment images of the tissue to be treated is also included, along with a feedback component for calculating actual probe position/orientation and actual ablation volume based on treatment images provided by the imaging component, and feeding the actual probe position/orientation and actual ablation volume during treatment to the planning component. The planning component maps the actual probe location and actual ablation volume to the three-dimensional plan and calculates a treatment iteration based on the treatment plan, the actual probe position/orientation and actual ablation volume”).
Therefore, Claim 11 is anticipated by Kruecker.
Regarding Claim 12, Kruecker anticipates the computer-implemented method according to Claim 11, as indicated hereinabove. Kruecker further discloses the step of registering at least one of the medical images captured during the ablation treatment against at least one of the medical images captured after the ablation treatment comprises:
• obtaining a reference medical image ([0026] – The planning component uses baseline medical images: “This component requires input and visualization of an image data set (the "baseline image") and the ability to segment a tumor or PTV, or to import the segmentation from elsewhere. The planning system component segments the baseline PTV0 in the baseline image at step 12”). Note that the broad term “reference data” appears to refer to “pre-treatment ablation data” (Instant Specification, Page 6, Lines 10-11), which could be considered planning data since planning data is acquired before treatment.
• registering at least one of the medical images captured during the ablation treatment against the reference medical image ([0015] – “An imaging component for obtaining treatment images of the tissue to be treated is also included, along with a feedback component for calculating actual probe position/orientation and actual ablation volume based on treatment images provided by the imaging component, and feeding the actual probe position/orientation and actual ablation volume during treatment to the planning component. The planning component maps the actual probe location and actual ablation volume to the three-dimensional plan and calculates a treatment iteration based on the treatment plan”); and
• registering at least one of the medical images captured after the ablation treatment against the reference medical image, to thereby indirectly register at least one of the medical images captured during the ablation treatment against at least one of the medical images captured after the ablation treatment ([0035] – Medical images from before and after ablation treatment are compared: “A three-dimensional (3D) medical image of the ablation area (e.g. CT, MRI, ultrasound) that provides adequate grayscale-contrast to allow delineation of the ablation zone can be obtained during or shortly after an ablation, and the image transferred to the navigation component. A GUI can be provided for the user to measure the size/shape of the ablation in one or several dimensions, based on the visible ablation contrast in the image …. The size/shape information is transferred to the planning component in order to update the plan for the remaining ablations with the measured ablation size/shape as the new ablation size/shape estimate”).
Therefore, Claim 12 is anticipated by Kruecker.
Regarding Claim 16, Kruecker anticipates the computer-implemented method according to Claim 1, as indicated hereinabove. Kruecker further discloses the predicted ablation zone is constructed by combining a plurality of individual ablation zones ([0022] – “The planning system component (1) can allow computation of a composite ablation consisting of a plurality of optimal individual ablation positions/orientations based on input of a desired planned target volume (PTV) to be covered, and estimated or known individual ablation sizes. The desired composite ablation volume is comprised of a plurality of ablations that together will treat the entire PTV”) and wherein the applicator information further comprises at least one of a default size and dimension of each ablation zone, and wherein the using the assessment of the accuracy of the predicted ablation zone to calibrate the applicator information comprises: modifying the at least one of the default size and dimension of each individual ablation zone based on the determined error ([0037] – “The planning component (1) receives the feedback information and updates the plan for the remainder of the procedure if the measured position or ablation size/shape deviate from the planned/assumed position and size/shape. In particular, the planning component can subtract the measured ablation size/shape at the measured ablation position from the initially segmented PTVk, and compute a new plan for the remaining PTVk+1”).
Therefore, Claim 16 is anticipated by Kruecker.
Claim Rejections - 35 USC § 103
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim 4 is rejected under U.S.C. 103 as being unpatentable over Kruecker (US PG Pub 2011/0251607 A1, see previously cited) in view of Liu (US PG Pub 2014/02101669 A1, see previously cited).
Regarding Claim 4, Kruecker anticipates the computer-implemented method according to Claim 3, as indicated hereinabove. Kruecker further discloses:
• the intra-treatment ablation data comprises applicator information identifying at least a position ([0013] – “The system further includes a feedback component for determining actual probe position and orientation using the navigation component or imaging component”) and use of one or more ablation applicators during the ablation treatment ([0020] –“The use of the method and system of the exemplary embodiments of the present disclosure can be adapted for application to other types of applicators”);
• the step of constructing a predicted ablation zone comprises the applicator information to construct the predicted ablation zone, the one or more ablation applicator settings defining an anticipated ablation zone around an individual ablation performed by each ablation applicator based on the applicator information ([0022] – the planned ablation can be a series of individual ablations: “The planning system component (1) can allow computation of a composite ablation consisting of a plurality of optimal individual ablation positions/orientations based on input of a desired planned target volume (PTV) to be covered, and estimated or known individual ablation sizes. The desired composite ablation volume is comprised of a plurality of ablations that together will treat the entire PTV” and [0023] – the applicator information is supplied to the applicator in order to carry out the individual ablations: “The navigation system component (2) with monitoring and feedback capability, which provides visual guidance via a GUI (7) to assist in delivering an ablation probe (6) to any of the planned target locations can determine the actual ablation probe position (via the imaging component (4) or tracking sub-system (5)), the actual individual ablation size/shape (via the imaging component (4) when using e.g. ultrasound elastography), and the actual tumor location relative to the ablation probe (via imaging)”); and
• the step of adjusting at least one settings of the ablation system comprises adjusting at least one of the one or more applicator settings ([0021] – the ablation therapy treatment is adjusted based on feedback during the ablation procedure).
Although Kruecker explains that the system can be adapted for different applicators with potentially different ablation mechanisms, Kruecker does not specifically disclose applicator type as an input into the system interface.
Liu, in the same field of endeavor of ablation planning ([0002]), teaches inputs including the type of applicator and applicator settings ([0050] – “Other information may also be included in the input. In block 509, the set of inputs may include one or more of a type of ablation probe, a margin of error, ablation coverage, collateral damage, ablation time, etc.”). Kruecker discloses the treatment is adjusted via feedback, but does not explicitly disclose the applicator type (such as in Liu) as data for treatment adjustment.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Kruecker’s ablation treatment planning feedback system method with Liu’s applicator type setting for an ablation planning feedback system. This would have been obvious because both Kruecker and Liu discuss feedback mechanisms for planning ablation treatments and Liu provides a solution/improvement to accommodate applicator type as an input for enhanced ablation planning. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Kruecker by incorporating the applicator type settings from the ablation planning feedback system in Liu.
Therefore, Claim 4 is obvious over Kruecker in view of Liu.
Claim 17 is rejected under U.S.C. 103 as being unpatentable over Kruecker (US PG Pub 2011/0251607 A1, see previously cited) in view of Dalal (US PG Pub 2011/0015628 A1), see previously cited.
Regarding Claim 17, Kruecker anticipates the computer-implemented method according to Claim 2, as indicated hereinabove. Kruecker further discloses the one or more settings of the ablation system define an ablation size and the position of the probe ([0013] – “The system further includes a feedback component for determining actual probe position and orientation using the navigation component or imaging component, and for determining actual ablation volume based on treatment images provided by the imaging component, and feeding the actual probe position/orientation and actual ablation volume during treatment to the planning component”). While defining position and ablation size may necessarily inform on ablation shape and applicator position offset to some extent, Kruecker does not explicitly disclose control of a size of a major and/or minor axes for at least one of an elliptical ablation and an offset of an ablation zone with respect to the applicator.
Dalal, in the same field of endeavor of ablation planning ([0010]), teaches settings which include defining the major and minor axes of an ellipsoid ([0010] – “The method further includes scaling minor axes of the template ellipsoidal enclosing ablation volume and the initial PTV upward until they are equal in magnitude to a major axis of the template ellipsoidal enclosing ablation volume, to generate an enclosing sphere that encompasses the scaled PTV” where the method of using the ellipse planning tool during ablation is disclosed generally in [0070-0071]). Dalal also teaches ellipsoids, which by default are defined by a major and minor axis, are a common shape to generate with an ablation probe ([0003] – “A probe may be connected to power for a predetermined time period (e.g., approximately 15 minutes, or some other suitable time period), and ablates in a variety of shapes, but commonly a sphere or ellipsoid”). Dalal also teaches a setting for an offset between the ablation zone and the applicator ([0051] – “The selection of probe entry points (optional) and ablation points (e.g., placement of the probe tip with a given offset for the expected ablation shape) is performed by the optimization component 14”). Note that the offset in Dalal is a position offset between the applicator and ablation zone and would fall under the broad claim language of “an offset of an ablation zone with respect to the applicator.”
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Kruecker’s ablation treatment planning feedback system method with Dalal’s applicator input settings based on defining an ellipsoid ablation shape and a position offset between the applicator and ablation zone. This would have been obvious because both Kruecker and Dalal discuss settings and control in planning ablation treatments and Dalal provides a solution/improvement to specific settings for the applicator to define desired applicator shape and position. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Kruecker by incorporating the applicator input settings based on defining an ellipsoid ablation shape and a position offset between the applicator and ablation zone in Dalal.
Therefore, Claim 17 is obvious over Kruecker in view of Dalal.
Conclusion
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.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796
Prosecution Insights