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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/28/2026 has been entered.
Status of Claims
Claims 1-2, 4-12, 16-17, and 22-24 are currently pending and under examination. Claims 3, 13-15, and 18-21 are canceled. As per the amendments filed on 01/28/2026, claims 1, 4, and 16-17 are amended and claims 22-24 are newly added.
Priority
The instant application (filed on 09/30/2022) is a national stage of PCT/EP2021/057862 (filed on 03/26/2021), filed under 35 USC 371. Acknowledgment is made of Applicant's claim for foreign priority based on EP 20167655.8 (filed on 04/02/2020). Instant claims 1-2, 4-12, 16-17, and 22-24 are sufficiently supported in EP 20167655.8 to receive an effective filing date of 04/02/2020 for the instant application. Therefore, all prior art will be evaluated with respect to this date.
Response to Arguments
Applicant’s arguments, see Remarks pages 7-9 (Claim Rejections - 35 U.S.C. § 102), filed 01/28/2026, with respect to the 35 U.S.C. § 102 rejections of claims 1-3, 5-12, and 16 have been fully considered. Claim 3 is canceled. Regarding Claim 1, Applicant argues:
Independent claim 1, as amended, comprises "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, and wherein the intratreatment ablation data comprises applicator information identifying at least a position and a type of at least one ablation applicator used for the ablation treatment" (emphasis added). The Patent Office acknowledges that Kruecker fails to disclose "intra-treatment ablation data compris[ing] applicator information identifying at least a position and a type of at least one ablation applicator used for the ablation treatment," stating that: “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.” (page 9, 01/28/2026 Remarks)
This argument is persuasive. Kruecker does not disclose the integration of ablation probe type into the planning process data beyond an implied compensation for different types of probes ([0014] – “at least one of RF ablation, cryo-ablation, microwave ablation, ultrasound ablation, and other thermal or non-thermal ablation”). Therefore, the rejections of claims 1-2, 5-12 and 16 are withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Liu (US 2014/0201669 A1).
Applicant further argues:
Kruecker also fails to disclose "automatically adjusting, by the ablation system, one or more settings of the ablation system based on the determined error, wherein automatically adjusting one or more settings of the ablation system based on the determined error comprises a multi-dimensional optimization approach configured to minimize a difference between the predicted ablation zone and the achieved ablation zone." When Applicant proposed the limitation "adjusting, by the ablation system, one or more settings of the ablation system based on the determined error," the Patent Office asserted in the Advisory Action that:
The method claimed is described as "a computer-implemented method 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" which includes the step "adjusting one or more settings of the ablation system based on the determined error." There is no indication in the claim language that this adjustment must occur automatically by the computer apparatus. A review of the instant specification suggests Step 209 is associated with the settings adjustment limitation above (Page 19, Lines 16-34 and Page 20, Lines 1-19). The instant specification discloses that Step 209 can be either automatically performed or a response to manual input: [quote from the specification omitted].
Given that the limitation "adjusting one or more settings of the ablation system based on the determined error" lacks the specificity to claim only an automated method and the specification promotes a generic interpretation of the limitation as either an automated or manual process, the manual process of adjusting settings for the ablation probe (e.g. probe position, orientation, and energy output to produce a specific ablation volume) guided by a responsive and iterative planning feedback in Kruecker [0013] is interpreted as teaching on the limitation.
Applicant has amended the claims to recite "automatically adjusting, by the ablation system, one or more settings of the ablation system based on the determined error, wherein automatically adjusting one or more settings of the ablation system based on the determined error comprises a multi-dimensional optimization approach configured to minimize a difference between the predicted ablation zone and the achieved ablation zone." Applicant maintains that Kruecker fails to teach or disclose this automatic adjustment.
Accordingly, Kruecker fails to teach or disclose each and every limitation of the pending claims. It is respectfully requested that the rejections under 35 U.S.C. § 102 be withdrawn, and respectfully submitted that the claims are in condition for allowance. (pages 8-9, 01/28/2026 Remarks)
This argument is persuasive. Kruecker does not address an automatic adjustment of ablation system settings to minimize the difference between the predicted and achieved ablation zones. Therefore, the rejections of claims 1-2, 5-12 and 16 are withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Rodriguez (US 2020/0022649 A1).
Applicant’s arguments, see Remarks pages 9-10 (Claim Rejections - 35 U.S.C. § 103), filed 01/28/2026, with respect to the 35 U.S.C. § 103 rejections of claims 4 and 17 have been fully considered. Regarding claims 4 and 17, Applicant argues:
As described in detail above, Kruecker fails to disclose "automatically adjusting, by the ablation system, one or more settings of the ablation system based on the determined error, wherein automatically adjusting one or more settings of the ablation system based on the determined error comprises a multi-dimensional optimization approach configured to minimize a difference between the predicted ablation zone and the achieved ablation zone." The addition of the Liu and/or Dalal references fails to remedy this deficiency. Accordingly, it is respectfully requested that the rejections under 35 U.S.C. § 103 be withdrawn, and respectfully submitted that the claims are in condition for allowance. (pages 9-10, 01/28/2026 Remarks)
This argument is persuasive. Claims 4 and 17 are dependent on independent claim 1, where the arguments for claim 1 were previously found persuasive. However, upon further consideration, new grounds of rejection are made in view of Liu (US 2014/0201669 A1) and Rodriguez (US 2020/0022649 A1).
Newly added claims 22-24 are evaluated in light of the above arguments and rejected under 35 U.S.C. § 103.
Summary: The prior art rejections of claims 1-2 and 4-17 are withdrawn. 35 U.S.C. § 103 rejections for claims 1-2 and 4-17, newly in view of Liu and Rodriguez, are added. 35 U.S.C. § 103 rejections are inserted for newly added claims 22-24.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 is dependent on canceled claim 3. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 4-12, 16, and 22 are rejected under U.S.C. 103 as being unpatentable over Kruecker (US 2011/0251607 A1) in view of Liu (US 2014/02101669 A1) and Rodriguez (US 2020/0022649 A1).
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] – the planning, navigation, and feedback (about electrode position and actual ablation size/shape) can improve the accuracy of a procedure by providing an assessment of achieved vs. planned ablation volumes) 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 ([0013-0015] – the probe position and ablation volumes during an ablation treatment can be tracked in order to determine what volume still needs to be ablated in subsequent ablation iterations until a planned total ablation volume is achieved, [0035] – imaging can occur both during and shortly after ablation);
- wherein the intra-treatment ablation data comprises applicator information identifying at least a position of at least one ablation applicator used for the ablation treatment ([0013-0014] – the position of the probe is determined in the planned ablation procedure and tracked as a variable as the ablation procedure is carried out). Note different types of applicators are envisioned for use with the planning system ([0014]), but applicator type is not specifically disclosed as part of applicator information data.
• 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 ([0013-0015], [0035-0037] – the ablation zone is predicted as part of a treatment plan, where actual probe position and ablation volumes are measured to revise the next planned ablation treatment based on the extent planned ablation volumes were achieved; [0022] – multiple individual ablations are planned to treat the entire planned target volume), wherein the predicted ablation zone is based at least in part on the position of the at least one ablation applicator used for the ablation treatment ([0013-0014] – the position of the probe is determined in the planned ablation procedure and measured as the actual ablation procedure is carried out);
• 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 ([0013-0015] – actual ablation data, such as the achieved actual ablation volume, is 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” [0013]; [0035] – imaging can occur both during and shortly after ablation);
Note the final assessment of ablation volume, which halts additional treatment cycles once reaching a desired volume, represents the final achieved ablation volume after all the treatment cycles are completed).
• processing the post-treatment ablation data to construct the achieved ablation zone ([0013-0015], [0035-0037] – calculation of “actual ablation volume” after treatment for comparison with the planned ablation volume to revise subsequent treatment iterations or stop once a total planned volume is achieved);
• registering the predicted ablation zone and the achieved ablation zone with respect to one another (Claims 5 and 17 – “wherein the feedback component (3) registers treatment images with planning images to calculate at least one of the actual probe position and orientation and tumor position and orientation, and uses the information to update the three-dimensional treatment plan”; [0023] – registers baseline image used in planning with the treatment images), 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], [0035-0037] – planned and actual ablation zones are compared to assess the extent of additional ablation necessary, due to deviation of the actual result from the plan, to achieve the target ablation volume).
However, Kruecker does not disclose:
• identifying at least a type of at least one ablation applicator used for the ablation treatment
• wherein the predicted ablation zone is based at least in part on the type of the at least one ablation applicator used for the ablation treatment
• automatically adjusting, by the ablation system, one or more settings of the ablation system based on the determined error, wherein automatically adjusting one or more settings of the ablation system based on the determined error comprises a multi-dimensional optimization approach configured to minimize a difference between the predicted ablation zone and the achieved ablation zone.
Liu, in the same field of endeavor of an ablation planning system ([0002]), teaches inputs into the planning method steps include the type of applicator and applicator settings ([0050-0051] –
block 504 involves a selection of ablation probes used during the procedure;
block 508 inputs information about the ablation probes being used to determine the power and time needed to produce a desired ablation size and shape into the planning optimization engine;
block 509 describes “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.”;
block 510 describes how these variables are used to arrive at an optimized therapy plan to maximize ablation coverage and reduce collateral damage).
The applicator type information can be manually entered or automatically detected once the probes are connected to the system ([0045]). Liu emphasizes the reduction in manual tasks during ablation treatment planning as reducing the chances of mental errors by the user given the complexity of the procedure, which results in more accurate treatments ([0004]).
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 method by incorporating applicator type as an input for planning ablation treatments within a planning module in Liu. This would have been obvious because both Kruecker and Liu discuss computer-assisted planning of ablation treatments and Liu provides a solution/improvement of using applicator type as an input to plan an ablation treatment in light of the power and timing capabilities of the particular applicator in use (this information leading in part to reduced collateral tissue damage and more efficient/optimized ablation treatments). Therefore, a person of ordinary skill in the art would be motivated to improve the method of Kruecker by incorporating applicator type as an input for planning ablation treatments within a planning module as discussed in Liu.
Rodriguez, in the same field of endeavor of ablation planning (Abstract), teaches the adjustment of an ablation plan during the treatment, based on the differences between a planned and actual ablation as it occurs, either automatically or manually (via suggestions to the user) ([0150], [0471-0472]). An ablation effectiveness estimator is used to automatically generate an ablation adjustment plan by assessing/scoring multiple combinations of potential settings and incorporating the most optimized combination or allowing the user to select an ablation adjustment plan from a list of optimal combinations ([0482-0484]). Ablation segment effectiveness parameters and lesion effectiveness parameters include “lesion placement, ablation tool settings governing lesion formation (such as ablation power, dielectric quality of contact, angle of contact, force of contact, and timing of ablation), and/or tissue conditions within which the lesion is situated” and “indications of structure of an ablation segment (e.g., depth, size, volume of tissue etc.), indications of structure of one or more sub-lesions forming the segment and/or interaction between sub-lesions” ([0211], [0378]).
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 method by incorporating the automatic adjustment of ablation settings based on actual ablation feedback and taking into account the interaction of combinations of ablation parameters as described in Rodriguez. This would have been obvious because both Kruecker and Rodriguez discuss feedback mechanisms for adjusting ablation during a procedure and Rodriguez provides a solution/improvement to automatically calculate an applicator’s optimal settings via accounting for interaction effects between parameters on the treatment, which improves the accuracy of ablation predictions and reduces the mental load on the user using automatic calculations. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Kruecker by incorporating the automatic adjustment of ablation settings based on actual ablation feedback and taking into account the interaction of combinations of ablation parameters as described in Rodriguez, such as being applied to Kruecker’s assessment of planned ablation volumes compared to achieved ablation volume feedback.
Regarding Claim 2, the computer-implemented method according to Claim 1 is obvious over Kruecker in view of Liu and Rodriguez, as indicated hereinabove. Kruecker further discloses a step of displaying the determined error ([0035], [0037] – the feedback with actual ablation information is sent back to the planning component to assess deviations between planned and actual ablations and what additional ablation is necessary to achieve the planned total ablation volume; [0021-0023] – discloses a graphical user interface displaying the planned ablation relative to the actual ablation volume).
Regarding Claim 4, the computer-implemented method according to Claim 1 is obvious over Kruecker in view of Liu and Rodriguez, as indicated hereinabove. Kruecker further discloses:
• 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 ([0014-0015] – ablation volumes given a particular probe position are calculated; [0022] – the planned ablation can be a series of individual ablations);
• 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).
However, Kruecker does not disclose:
• the applicator information includes both applicator position and type
• specific ablation system settings which are changed based on feedback
As stated in claim 1, the proposed combination with Liu yields inputs into the planning method steps including the type of applicator and applicator settings ([0050-0051]) where the applicator type information can be manually entered or automatically detected once the probes are connected to the system ([0045]).
As stated in claim 1, the proposed combination with Rodriguez yields the adjustment of an ablation plan during the treatment, based on the differences between a planned and actual ablation as it occurs, either automatically or manually, via suggestions to the user ([0150], [0471-0472]). An ablation effectiveness estimator is used to automatically generate an ablation adjustment plan by assessing/scoring multiple combinations of potential settings and incorporating the most optimized combination or allowing the user to select an ablation adjustment plan from a list of optimal combinations ([0482-0484]). Ablation segment effectiveness parameters and lesion effectiveness parameters are listed ([0211], [0378]).
Regarding Claim 5, the computer-implemented method according to Claim 3 (see 112(d) rejection) is obvious over Kruecker in view of Liu and Rodriguez, 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]).
Regarding Claim 6, the computer-implemented method according to Claim 1 is obvious over Kruecker in view of Liu and Rodriguez, 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 ([0013-0015], [0035-0037] – actual post-ablation data is compared to the planned ablation data to assess the extent of additional ablation necessary to achieve the target ablation volume), to thereby register the predicted ablation zone and the achieved ablation zone with respect to one another (Claims 5 and 17 – registering planning and treatment images).
Regarding Claim 7, the computer-implemented method according to Claim 6 is obvious over Kruecker in view of Liu and Rodriguez, 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 ([0013-0015], [0035-0037]) 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 to determine how to achieve the total target volume. Baseline segmented images, defining the target tissue during 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 ([0026] – the initial plan is determined via the baseline image as a planning image, [0035-0037] – actual ablation data during the procedure is compared to the planning image to determine whether the plan needs to be adjusted to achieve the original total target volume); and
• registering the post-treatment ablation data to the reference ablation data ([0026] – the initial plan is determined via the baseline image as a planning image, [0035-0037] – actual ablation data after the procedure is compared to the planning image to determine whether the plan needs to be adjusted to achieve the original total target volume), thereby indirectly registering the intra-treatment ablation data to the post-treatment ablation data ([0035-0038] – data is iteratively compared to update the planned ablation).
Regarding Claim 8, the computer-implemented method according to Claim 1 is obvious over Kruecker in view of Liu and Rodriguez, as indicated hereinabove. Kruecker further discloses the step of registering the predicted ablation zone and the achieved ablation zone ([0013-0015], [0035-0037] – direct comparison between predicted and actual ablation is a feature of the feedback system to recalculate the ablation necessary in future treatment iterations) comprises directly processing the predicted ablation zone and the achieved ablation zone to register the two together (Claims 5 and 17 – registering planning and treatment images; [0023] – registers baseline image used in planning with the treatment images).
Regarding Claim 9, the computer-implemented method according to Claim 1 is obvious over Kruecker in view of Liu and Rodriguez, 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 of the ablation shortly after treatment).
Regarding Claim 10, the computer-implemented method according to Claim 1 is obvious over Kruecker in view of Liu and Rodriguez, 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 or after treatment).
Regarding Claim 11, the computer-implemented method according to Claim 10 is obvious over Kruecker in view of Liu and Rodriguez, 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 (Claims 5 and 17 – registering planning and treatment ablation images, which show the actual ablation), to thereby register the predicted ablation zone and the achieved ablation zone with respect to one another ([0014-0015] – The images are compared between the planning and post-treatment components to compute the ablation needed in future iterations).
Regarding Claim 12, the computer-implemented method according to Claim 11 is obvious over Kruecker in view of Liu and Rodriguez, 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 (Claims 5 and 17 – registering planning and treatment images; [0014-0015] – The images are compared between the planning and post-treatment components to compute the ablation needed in future iterations) comprises:
• obtaining a reference medical image ([0026] – the planning component uses a 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”);
• registering at least one of the medical images captured during the ablation treatment against the reference medical image (Claims 5 and 17 – registering planning and treatment images; [0026] – the initial plan is determined via the baseline image as a planning image, [0035-0037] – actual ablation data during the procedure is compared to the planning image to determine whether the plan needs to be adjusted to achieve the original total target volume); and
• registering at least one of the medical images captured after the ablation treatment against the reference medical image (Claims 5 and 17 – registering planning and treatment images; [0026] – the initial plan is determined via the baseline image as a planning image, [0035-0037] – actual ablation data after the procedure is compared to the planning image to determine whether the plan needs to be adjusted to achieve the original total target volume), 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 ([0035-0038] – data is iteratively compared to update the planned ablation).
Regarding Claim 16, the computer-implemented method according to Claim 1 is obvious over Kruecker in view of Liu and Rodriguez, 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 method further comprises using the determined error to modify at least one of a default size and dimension of each individual ablation zone used in constructing the predicted ablation zone ([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”).
Regarding Claim 22, the computer-implemented method according to Claim 1 is obvious over Kruecker in view of Liu and Rodriguez, as indicated hereinabove. Kruecker does not disclose comprising: displaying, via a user interface of the ablation system, the automatic adjustment of the one or more settings of the ablation system; and receiving, from a user via the user interface, a manual adjustment of the displayed automatic adjustment.
As stated in claim 1, the proposed combination with Rodriguez yields the adjustment of an ablation plan during the treatment, based on the differences between a planned and actual ablation as it occurs, either automatically or manually, via suggestions to the user ([0150], [0471-0472]). Pre-planned ablation parameters are automatically selected when the probe approaches an ablation target, but a user interface can be provided where the user is able to modify or override these settings ([0471]).
Additionally, Rodriguez teaches estimator-driven adjustments to the ablation plan can generally be manually guided (where the estimator result is shown to an operator, but the operator determines how to proceed with the next ablation) or automatic ([0359]). In the case of manual supervision, the ablation effectiveness estimator can automatically generate ablation adjustment plans (by assessing/scoring multiple combinations of potential settings) and displaying the best scoring combinations to the user to select one of the recommended therapies ([0482-0484]). Specific ablation segment effectiveness parameters and lesion effectiveness parameters are described ([0211], [0378]).
Claim 17 is rejected under U.S.C. 103 as being unpatentable over Kruecker (US 2011/0251607 A1) in view of Liu (US 2014/02101669 A1), Rodriguez (US 2020/0022649 A1), and Dalal (US 2011/0015628 A1).
Regarding Claim 17, the computer-implemented method according to Claim 1 is obvious over Kruecker in view of Liu and Rodriguez, 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]). 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 method by incorporating 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 of enhanced control over an ablation volume shape via applicator placement and ablation dimensions, where an ellipsoid capable of being produced in Dalal is noted to be a commonly desired ablation shape. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Kruecker by incorporating Dalal’s applicator input settings based on defining an ellipsoid ablation shape and a position offset between the applicator and ablation zone.
Claims 23-24 are rejected under U.S.C. 103 as being unpatentable over Kruecker (US 2011/0251607 A1) in view of Liu (US 2014/02101669 A1), Rodriguez (US 2020/0022649 A1), and Fialkov (US 2016/0058424 A1).
Regarding Claim 23, the computer-implemented method according to Claim 1 is obvious over Kruecker in view of Liu and Rodriguez, as indicated hereinabove. Kruecker discloses registering the predicted ablation zone and the achieved ablation zone with respect to one another (Claims 5 and 17 – registering planned and treatment images; [0035-0038] – post-ablation image data is compared to the planning image data to assess deviations between the planned and actual ablation volumes and the extent of additional ablations necessary to achieve the total target ablation volume). Note CT, MRI, and ultrasound can be used as imaging to plan an ablation treatment or assess actual ablation size ([0035]). However, Kruecker does not disclose the registering comprises manual registration by a user.
The image registration feature in Fialkov would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the claimed invention because Fialkov teaches the manual registration of images, specifically registering CT scan images or MRI with corresponding ultrasound images ([0016], [0029]). In this case, real-time ultrasound images are acquired where the user can manually select ultrasound images (as the probe is moved) which match up best with previously acquired CT or MRI images ([0031-0040]). Fialkov teaches the manual registration process is simplified relative to an automated image registration process ([0035]). The manual registration procedure can be used to facilitate imaging an ablation procedure ([0043]).
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 automated registration between a planning image and treatment image by incorporating the manual registration process between images in Fialkov. This would have been obvious because both Kruecker and Fialkov discuss registration between planning and treatment images during an ablation procedure and Fialkov provides a solution/improvement of allowing a user to manually refine the relative alignment of planning and treatment ablation images when the initial automated registration is not adequately aligned (which would lead to inaccuracies in ablation volume calculations). Therefore, a person of ordinary skill in the art would be motivated to improve the method of Kruecker by incorporating the manual registration process between images in Fialkov.
Regarding Claim 24, the computer-implemented method according to Claim 23 is obvious over Kruecker in view of Liu, Rodriguez, and Fialkov, as indicated hereinabove. Kruecker discloses registering planning and treatment images (Claims 5 and 17) where post-ablation image data is compared to the planning image data to assess deviations between the planned and actual ablation volumes and the extent of additional ablations necessary to achieve the total target ablation volume ([0035-0038]). Note CT, MRI, and ultrasound can be used as imaging to plan an ablation treatment or assess actual ablation size ([0035]). Kruecker does not disclose wherein manual registration by a user comprises:
• displaying, to the user via a user interface, a visual representation comprising the predicted ablation zone and the achieved ablation zone;
• receiving, from the user via the user interface, a manipulation of the displayed visual representation, comprising the manual registration of the predicted ablation zone and the achieved ablation zone with respect to one another.
As stated in claim 23, the proposed combination with Fialkov yields the manual registration of images, specifically registering CT scan images or MRI with corresponding ultrasound images during treatment ([0016-0017]). In this case, real-time ultrasound images are acquired where the user can manually select ultrasound images (as the probe is moved) which match up best with previously acquired CT or MRI images ([0031-0040]). Figure 6 shows a real-time display of ultrasound and pre-treatment CT scan imagery used to register the two images ([0035]). Therefore, the manual registration of Fialkov allows a user to refine the relative alignment of planning and treatment ablation images when the initial automated registration (such as in Kruecker) is not adequately aligned (which would lead to inaccuracies in ablation volume calculations).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights