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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 March 2026 has been entered. Claims 1, 6, 10-12, and 15 are currently amended. Claims 18-20 were previously canceled. Claims 1-17 and 21-23 are pending in the application. Applicant’s amendments to the claims have overcome the rejections under 35 U.S.C. 112(b) previously set forth in the Final Office Action mailed 16 December 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, the limitation “with a predetermined distance beyond the target tissue of error” is unclear in its meaning and therefore renders the scope of the claim unclear. Is the minimum electric field threshold set to produce a lesion extending a distance beyond the edge of the target tissue so as to include a margin of error, or is the predetermined distance a margin beyond the minimum electric field threshold (that is, a third boundary between the minimum and maximum thresholds)? For examination purposes, the claim will be read as wherein the target electric field threshold is a zone allowing for a margin of error, defined by a minimum electric field threshold that is lethal to the target tissue and a maximum electric field threshold. Dependent claims 2-9 are necessarily rejected by virtue of depending upon a rejected base claim.
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:
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sahay et al. (US PGPub No. 2017/0209218), hereinafter Sahay, in view of Borsic (WO 2021/216750), and further in view of Gutbrod et al. (US PGPub No. 2021/0369341), hereinafter Gutbrod.
Regarding claim 1, Sahay teaches a system for planning or preparing an ablation procedure (par. 0030: “cryosurgical system 10 includes a computer device 38 that is programmed with software configured to run an ablation planning, guidance and treatment system”), the system comprising:
a generator configured to generate electrical energy for delivery to a target tissue (par. 0033: “an ablation energy device, such as, for example, a cryoengine 16, in order to deliver energy/cryogen to the treatment region. Additional ablation energy devices include, and are not limited to, radio frequency generators, laser energy generators, microwave generators and high-intensity focused ultrasound generators”);
a plurality of probes operably connected to the generator, the plurality of probes configured to deliver the electrical energy to the target tissue (Fig. 5: two cryoprobes 122, 124; note that the disclosure teaches an embodiment using cryoprobes, but the teachings are interchangeable with other ablation devices such as radio frequency probes, as described in par. 0033 quoted above);
a display device (Fig. 1: display 40);
a processor operably connected to the display device and one or more input devices (par. 0030: “the computer device 38 also includes at least one user interface 39, a display 40 and a processor”);
and a non-transitory, computer-readable medium storing instructions (par. 0030: “a computer device 38 that is programmed with software”) that, when executed, cause the processor to:
receive an image of a patient comprising a target tissue (Fig. 3 and par. 0034: “the clinician begins by uploading patient image data of the treatment region”);
obtain an ablation plan comprising a planned probe arrangement including a planned position for each of a plurality of probes (Fig. 5 and par. 0040: “As can be seen in FIG. 5, based on all of the anatomy identified on the CT scan, including the treatment region, all of the information entered into the system by the clinician including the identification of surrounding anatomy and tissue type, and any thermal modeling performed by the system based on the information in the tissue property database, the planning system has developed a treatment plan that includes two cryoprobes 122, 124 with the specific locations and orientations (insertion angles) in the treatment region”),
identify, based on the image and the planned probe arrangement, a projected position for an origin probe of the plurality of probes (Fig. 5: probe 122 relative to target zone 114; par. 0040: “based on all of the anatomy identified on the CT scan, including the treatment region, all of the information entered into the system by the clinician including the identification of surrounding anatomy and tissue type, and any thermal modeling performed by the system based on the information in the tissue property database, the planning system has developed a treatment plan that includes two cryoprobes 122, 124 with the specific locations and orientations (insertion angles) in the treatment region”),
determine, based on one or more signals from a sensor, a real-time position of the origin probe, and
display, on the display device, the projected position and the real-time position for the origin probe superimposed over the image (Fig. 9 and par. 0048: “the clinician partially inserts the actual cryoprobe 138 and then obtains additional CT-fluoro image data (3 or more CT-slices) using the imaging device 36. After the additional CT-fluoro image data is received by the guidance system, the system performs the CT fusion process discussed above by registering the newly-received CT-fluoro image data with/to the baseline CT image data. At this juncture of the process, if needed, the system may also use cryoprobe positioning from the CT-fluoro image data as part of its fusion process. This newly registered CT-fluoro image data is now displayed as the three-view image depicted in FIG. 9, which shows that the actual cryoprobe 138 was not placed according to the calculated cryoprobe placement 122 of the treatment plan;” examiner interprets the CT-fluoro system in this instance as comprising at least one sensor).
Sahay teaches manual determination of the real-time position and a placed position of the origin probe based on the real-time position (par. 0049: “the clinician can see that the actual cryoprobe 138 placement is not in accordance with the planned cryoprobe 122 placement”) and does not explicitly teach (f) wherein the processor is configured to perform these steps. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the processor to determine the real-time position and placed position of the first probe, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Sahay further teaches wherein, when the placed position is determined to differ from the projected position, the processor presents an option to a user to update the ablation plan based on the placed position or modify the placed position (par. 0049: “Now that the clinician can see that the actual cryoprobe 138 placement is not in accordance with the planned cryoprobe 122 placement, the clinician can attempt to correct this misalignment as the actual cryoprobe 138 is inserted further into the treatment region (target 114) by altering the cryoprobe's 138 orientation/insertion angle during insertion […] at this point, the clinician can again revise the treatment plan by repositioning the planned cryoprobe 122 placement so that it coincides exactly with the actual cryoprobe 138 placement as depicted in FIG. 11” and par. 0051: “the planned cryoprobe 122 placement position has been updated to correspond to the actual cryoprobe 138 placement position. As a result of this updated cryoprobe placement position, the composite isotherms 134, 136 have been updated by the system to reflect the actual cryoprobe 138 placement thereby giving the clinician accurate visual information about the isotherms 134, 136 and ice ball formation. Based on the “revised treatment plan” that resulted from updating the planned cryoprobe 122 placement to correspond with the actual cryoprobe 138 placement, the clinician can again adjust the target 114 size or the planned placement of the other cryoprobe 124;” examiner notes that the processor presents an option to a user to update the ablation plan based on the placed position, while the option to modify the placed position is always available to the clinician via physical repositioning);
repeat (c) through (f) until all probes of the plurality of probes are placed (Figs. 11-12 and par. 0052: “Once the two actual cryoprobes 138, 140 are inserted to their final position in the target 114;” examiner interprets inserting second actual cryoprobe 140 to its final position as repeating the previous method steps for placement until all probes are placed);
and (h) generate a final ablation plan to satisfy the target ablation threshold after all of the probes of the plurality of probes are placed (par. 0052: “Once the two actual cryoprobes 138, 140 are inserted to their final position in the target 114, the system can be set to treatment mode as depicted FIG. 12. In treatment mode, the system runs the cryoprobes 138, 140 according to the pre-determined ablation protocols and provides the clinician with information about the cryoprobes 138, 140”).
Sahay is silent with respect to the details of the electrical delivery in the non-cryogenic embodiments of the disclosed ablation system and does not explicitly teach wherein the generator is configured to generate at least one electrical pulse, and the plurality of probes are configured to deliver the at least one electrical pulse to the target tissue, or wherein the planned probe arrangement is configured to satisfy a target electric field threshold of the target tissue. However, in an analogous art, Borsic teaches a multi-probe ablation system with a generator configured to generate at least one electrical pulse to be delivered by a plurality of probes for irreversible electroporation (par. 0112: “In IRE, tissue damage is not cause by thermal effects as in RFA, MWA, and CRA, but instead stems from bursting of cell membranes caused by high intensity, short duration, electric pulses. The probes inserted in the tissues apply voltage pulses that diffuse in the tissues”), which Borsic teaches as an explicit alternative to cryogenic, radiofrequency, and microwave ablation (par. 0044: “Ablation systems deliver energy and obtain the necrotization of tissues by heating (radiofrequency, microwave ablation), by freezing (cryoablation), and by causing irreversible cell damage (electroporation ablation) through one or more probes which necrotize a certain volume of targeted tissue”).
Borsic further teaches wherein the planned probe arrangement is configured to satisfy a target electric field threshold of the target tissue in order to improve treatment time and effectiveness (par. 0014: “treatment time and effectiveness can be improved by simulating ablation volume in real-time based on known probe positioning, by displaying the simulated ablation volume, and by continuing to update in real-time the simulated ablation volume to reflect any adjustments in the probe positioning. This allows a clinician to interactively adjust the probe positioning to ensure that a predicted and displayed treatment volume matches with the identified target volume” and par. 0114: “Equation (0.11) allows computing the electric potential in the tissues u and from the electric field E = ∇u. The intensity of the electric field determines whether a tissue would be subject to irreversible electroporation, the volume of the ablation can be therefore determined by the iso-surface |E|= k where k is the threshold above which electroporation occurs in the specific tissue”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Sahay by substituting the cryogenic, radiofrequency, or microwave ablation generator probes for the irreversible electroporation generator and probes taught by Borsic, since Borsic teaches that these forms of ablation are obvious alternatives of one another, and one of ordinary skill in the art could have performed the substitution by known means and the results would have been predictable, i.e., a system for non-thermal ablation. It would further have been obvious to one of ordinary skill in the art to modify the system of Sahay such that the planned probe arrangement is configured to satisfy a target electric field threshold of the target tissue, as taught by Borsic, in order to improve treatment time and effectiveness, as taught by Borsic.
Sahay teaches using the imaging device for indicating and determining positions of the probes and does not explicitly teach one or more sensors configured to indicate a position of each probe of the plurality of probes, separate from the imaging device itself, or wherein the one or more sensors include a respective sensor operatively coupled to each probe of the plurality of probes. However, Borsic further teaches that electromagnetic location tracking is known in the art as an obvious alternative to using an imaging device for determining positions of probes (par. 0056: “the positioning of the probes in the tissue and their orientation relative to each other are determined using known techniques. For example, the position of the probes can be identified with an optical or electromagnetic surgical tool tracking system. Alternatively, the probe positioning can be identified by acquiring an image of the tissue comprising the probes, and retrieving and processing the image with a computing device. For example, in accordance with known techniques, probes can be placed in a patient, and the positions of the probes can be verified using a CT scan”), wherein an electromagnetic location tracking system includes a respective sensor operatively coupled to each probe of the plurality of probes (par. 0066: “Electromagnetic tracking is instead based on setting up an array of electromagnetic coils, for example on the surface of the operating table, and in equipping the surgical tools with multiple miniaturized receiving coils. Analysis of the received signals at the coils allows to determine with precision the position/orientation of the surgical tool. In the present system, a surgical tool-tracking system continuously tracks the spatial position of the ablation probes and communicate this position via network to the computing device / guidance software”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the system of Sahay by substituting electromagnetic location tracking taught by Borsic for the CT-based location tracking taught by Sahay, since Borsic teaches that electromagnetic location tracking is a known and obvious alternative to other forms of location tracking, and one of ordinary skill in the art could have performed such a substitution by known means, and the results would have been predictable, i.e., a system that can continuously track the location of each respective probe rather than taking discrete images to track probe location.
The combination does not explicitly teach wherein the target electric field threshold is a zone allowing for a margin of error, defined by a minimum electric field threshold that is lethal to the target tissue and a maximum electric field threshold. However, in a related electroporation art, Gutbrod teaches using minimum and maximum electric field thresholds to define a target ablation zone, in order to differentiate between reversible and irreversible electroporation and to avoid killing other types of non-target tissue (Fig. 4A: electric field lines 400; pars. 0095-0096: “By viewing the electric field strength threshold line 402 on the anatomical map of the heart, and the increased density of the electric field lines 400 closer to the electrodes 314 and 316, the user can determine that cardiac tissue 302 between the electric field threshold line 402 and the electrodes 314 and 316 will or can be ablated by irreversible electroporation […] since electric field strengths of 1600 V/cm or more will ablate or kill tissue, such as red blood cells, vascular smooth muscle, endothelium tissue, and nerve tissue, by irreversible electroporation, a maximum or extreme electric field strength threshold line is provided on the display 92 to alert the user to excessive electric field strengths”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of the combined reference by providing both minimum and maximum electric field thresholds, as taught by Gutbrod, in order to differentiate between reversible and irreversible electroporation and to avoid killing non-target tissue, as taught by Gutbrod.
Regarding claim 2, the combination teaches the system of claim 1 as described previously. Sahay further teaches wherein the processor is operably connected to an imaging device (Figs. 1-2: imaging device 36; par. 0045: “current CT-fluoro image data (3 or more CT-slices) is obtained. In some embodiments, the imaging device 36 is connected to the primary ablation computer 38, which is programmed with software configured to run the guidance system, such that the CT-fluoro image data can be directly uploaded into the guidance system”) and wherein the instructions to receive an image of the target tissue comprise instructions that, when executed, cause the processor to receive the image of the target tissue from the imaging device (Fig. 3 and par. 0045: “the imaging device 36 is connected to the primary ablation computer 38, which is programmed with software configured to run the guidance system, such that the CT-fluoro image data can be directly uploaded into the guidance system”).
Regarding claim 3, the combination teaches the system of claim 1 as described previously. Sahay further teaches wherein a clinician compares the placed position of the first probe to the projected position of the first probe (Fig. 10 and par. 0049: “This newly-registered CT-fluoro image data of the final placement of the first cryoprobe 138 can be seen in FIG. 10, which shows that the actual final position of the cryoprobe 138 is closer to the planned cryoprobe 122 placement position but was still not placed exactly according to the treatment plan”), and modifies an ablation plan based on the comparison (Fig. 11 and par. 0049: “Therefore, at this point, the clinician can again revise the treatment plan by repositioning the planned cryoprobe 122 placement so that it coincides exactly with the actual cryoprobe 138 placement as depicted in FIG. 11”), wherein the modified ablation plan is configured to satisfy a target ablation threshold of the target tissue (par. 0051: “Based on the “revised treatment plan” that resulted from updating the planned cryoprobe 122 placement to correspond with the actual cryoprobe 138 placement, the clinician can again adjust the target 114 size or the planned placement of the other cryoprobe 124 in order to change the size and shape of the composite isotherms 134, 136 and hence, the size and shape of the resulting ice ball, to compensate for the misplacement of the first cryoprobe 138. Additional adjustments that can be made to the treatment plan to compensate for any misplacement of a cryoprobe include, but are not limited to, adjusting the energy power levels and/or cryoprobe freeze times or cycle times for certain cryoprobes or all cryoprobes;” examiner notes that the ablation parameters taught in Sahay correspond to a target electric field threshold in the combined reference).
Sahay teaches these steps as manual activities and does not explicitly teach wherein the processor is configured via the instructions to perform these steps. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the processor to compare the placed position with the projected position of the probe and modify a treatment plan based on the comparison, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Regarding claims 4-5, the combination teaches the system of claim 3 as described previously. Sahay further teaches wherein the modification of the treatment plan includes updating the planned position for one or more additional probes of the plurality of probes, or one or more treatment parameters of the treatment plan, based on the comparison (par. 0051: “Based on the “revised treatment plan” that resulted from updating the planned cryoprobe 122 placement to correspond with the actual cryoprobe 138 placement, the clinician can again adjust the target 114 size or the planned placement of the other cryoprobe 124 in order to change the size and shape of the composite isotherms 134, 136 and hence, the size and shape of the resulting ice ball, to compensate for the misplacement of the first cryoprobe 138. Additional adjustments that can be made to the treatment plan to compensate for any misplacement of a cryoprobe include, but are not limited to, adjusting the energy power levels and/or cryoprobe freeze times or cycle times for certain cryoprobes or all cryoprobes”).
Regarding claim 6, the combination teaches the system of claim 1 as described previously. Sahay further teaches further comprising one or more input devices (par. 0049: “a user interface such as, for example, an electronic pen, a mouse or any other user interface known in the art. Other manipulation methods and devices will be readily understood and known by those of skill in the art”),
wherein the instructions to obtain an ablation plan comprise instructions that, when executed, cause the processor to: identify, based on the image, a proposed target zone comprising at least a portion of the target tissue (Fig. 3: proposed target zone 114; par. 0036: “the clinician can now identify the treatment region with a target 114 […] The target 114 can be any size or geometric shape so that it completely covers/identifies the treatment region. Other embodiments of fast/intuitive methods for target definition include atlas shapes from a library of shapes that are automatically morphed using image density information to the shape of the lesion/target region”),
and the processor is configured to display, on the display device, the proposed target zone superimposed over the image (Fig. 3: target region 114 superimposed over image of kidney 115),
receive, by the one or more input devices, target feedback related to the proposed target zone, wherein the target feedback includes one or more of an indication 1) of the proposed target zone to be retained or removed, 2) to accept the proposed target zone, 3) to clear an entirety of the proposed target zone, and 4) to select a new zone for the proposed target zone, and modify the proposed target zone based on the target feedback to define a selected target zone (Fig. 3: target 114; par. 0036: “The target 114 is identified and delineated by the clinician using any of a number of fast/intuitive methods;” examiner interprets the delineation of the proposed target zone as an indication of the proposed target zone to be retained or removed),
and generate the ablation plan, wherein the ablation plan comprises the selected target zone and satisfies the target electric field threshold of the target tissue (par. 0041: “based on the clinician's identification of the treatment region with a target 114 and the clinician's identification of the target tissue and any surrounding anatomy of interest, the system calculates/generates a treatment plan (number of cryoprobes to use, location of cryoprobe insertion, and orientation of the cryoprobes) based on the treatment parameters recommended by the system;” examiner notes that the ablation parameters taught in Sahay correspond to a target electric field threshold in the combined reference).
Regarding claim 7, the combination teaches the system of claim 6 as described previously. Sahay further teaches wherein the instructions, when executed, further cause the processor to: measure one or more distances in the selected target zone based on the image, and define a location of the selected target zone based on the image, wherein the ablation plan is based on the one or more distances and the location of the selected target zone (Fig. 5: selected target zone 114, isotherms 126, 128, cryoprobes 122, 124; par. 0042: “the planning system has identified an individual isotherm 126, 128 for each cryoprobe 122, 124, respectively, as well as calculated the distances of each cryoprobe 122, 124 from its closest boney structure;” par. 0043: “The system also calculates and displays the boundary of the lethal ice zone (−20° C.) 134 and the margin of the lethal ice zone (0° C.) 136”).
Regarding claim 8, the combination teaches the system of claim 6 as described previously. Sahay further teaches wherein the instructions to generate the ablation plan comprise instructions that, when executed, further cause the processor to: identify, based on the selected target zone, a proposed probe arrangement comprising a proposed position for each of the plurality of probes (par. 0041: “based on the clinician's identification of the treatment region with a target 114 and the clinician's identification of the target tissue and any surrounding anatomy of interest, the system calculates/generates a treatment plan (number of cryoprobes to use, location of cryoprobe insertion, and orientation of the cryoprobes)”),
display, on the display device, the proposed probe arrangement superimposed over the image (Fig. 5: probes 122 and 124 superimposed over image),
receive, by the one or more input devices, probe feedback related to the proposed probe arrangement, modify the proposed probe arrangement based on the probe feedback to define a selected probe arrangement, and update the ablation plan based on the selected probe arrangement, wherein the planned probe arrangement of the ablation plan comprises the selected probe arrangement (par. 0044: “the clinician can make manual adjustments to the treatment plan based on the clinician's experience or preferences. For example, the clinician can change the location of the cryoprobes 122, 124, the orientation of the cryoprobes 122, 124 […] As a result of any clinician changes, the planning system will reflect these changes”).
Regarding claim 9, the combination teaches the system of claim 8 as described previously. Sahay teaches wherein the probe feedback comprises one or more of: an indication of one or more of the plurality of probes to be removed from the proposed probe arrangement; an indication to add one or more additional probes to the plurality of probes in the proposed probe arrangement; an indication to adjust the proposed position of one or more of the plurality of probes; and an indication of approval of the proposed probe arrangement (par. “0044: the clinician can make manual adjustments to the treatment plan based on the clinician's experience or preferences. For example, the clinician can change the location of the cryoprobes 122, 124, the orientation of the cryoprobes 122, 124”). Examiner notes that as these limitations are stated in the alternative, the claim is considered to be met when any one limitation is found in the prior art.
Regarding claim 10, the combination teaches the system of claim 8 as described previously. Sahay further teaches wherein updating the ablation plan comprises updating the power settings for the probes (par. 0041: “Any such changes to the treatment parameters results in the system recalculating a new treatment plan that may result in a change in the number of cryoprobes used, a change in the location of cryoprobe insertion, a change in cryoprobe orientation, a change in cryoprobe power settings, etc” and par. 0051: “Additional adjustments that can be made to the treatment plan to compensate for any misplacement of a cryoprobe include, but are not limited to, adjusting the energy power levels and/or cryoprobe freeze times or cycle times for certain cryoprobes or all cryoprobes”), and Borsic teaches providing a series of pulses for ablation (par. 0112: “In IRE, tissue damage […] stems from bursting of cell membranes caused by high intensity, short duration, electric pulses. The probes inserted in the tissues apply voltage pulses that diffuse in the tissues”), but the combination does not explicitly teach wherein the ablation plan further comprises a planned series of pulses to be emitted between the plurality of probes to satisfy the target electric field threshold of the target tissue, or wherein the instructions to update the ablation plan cause the processor to update the planned series of pulses.
However, given that Sahay teaches adjusting ablation power levels to compensate for a change in probe position, and Borsic teaches a providing a series of pulses for ablation, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the processor of the combined reference to update the planned series of pulses based on the selected probe arrangement, in order to compensate for a change in probe position, as taught by Sahay.
Claims 11-17 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sahay in view of Borsic.
Regarding claims 11 and 15, as described previously in the rejection for claim 1, Sahay teaches an ablation system and system for planning an ablation procedure, comprising a display device; a processor operably connected to the display device and one or more input devices; non-transitory, computer-readable medium storing instructions that, when executed by a processor, cause the processor to: receive an image of a target tissue; obtain a planned probe arrangement including a planned position for each of a plurality of probes; receive, by one or more input devices, target feedback related to the identification of a target zone; identify a planned probe arrangement, including a planned position for a first probe of a plurality of probes relative to the target zone; determine, based on one or more signals from a sensor, a real-time position of the first probe; display, on the display device, the planned position and the real-time position for the first probe superimposed over the image of the target tissue and the target zone; and determine a placed position of the first probe based on the real-time position; and repeat the placement steps for all probes in the plurality of probes.
Sahay in view of Borsic further teaches wherein the planned probe arrangement is configured to satisfy a desired electric field threshold of the target tissue, for the same reasons set forth previously in the rejection of claim 1.
Sahay further teaches wherein the processor is configured to provide an indicator on the display device indicating whether the placed position of the first probe differs from the projected position for the first probe based on at least one of a placed orientation and/or placed depth of the first probe (Fig. 10: placed position of cryoprobe 138 differing from projected position 122 based on placed orientation; examiner notes that the visual overlay of placed position and projected position serves as an indicator that indicates whether the two positions differ).
Regarding claim 12, the combination teaches the system of claim 11 as described previously. Sahay further teaches the limitations of claim 12 for the same reasons set forth previously in the rejection of claim 3.
Regarding claims 13-14, the combination teaches the system of claim 12 as described previously. Sahay further teaches the limitations of claims 13-14 for the same reasons set forth previously in the rejection of claims 4-5.
Regarding claim 16, the combination teaches the system of claim 15 as described previously. Sahay further teaches a generator (Fig. 1: cryoengine 16; par. 0033: “an ablation energy device, such as, for example, a cryoengine 16, in order to deliver energy/cryogen to the treatment region. Additional ablation energy devices include, and are not limited to, radio frequency generators, laser energy generators, microwave generators and high-intensity focused ultrasound generators”) with the plurality of probes operably connected to the generator (Fig. 2: probes 32 operably connected to generator 16), but does not explicitly teach wherein the generator is configured to generate at least one electrical pulse for delivery to a target tissue, or wherein the plurality of probes are configured to deliver the at least one electrical pulse to the target tissue to irreversibly electroporate substantially all of the target tissue in the target zone. However, these limitations are taught by Borsic for the same reasons set forth in the rejection of claim 1.
Regarding claim 17, the combination teaches the system of claim 15 as described previously. Borsic further teaches wherein the sensor comprises an electromagnetic sensor, and further comprising: an electromagnetic generator operably connected to the processor (par. 0066: “Electromagnetic tracking is instead based on setting up an array of electromagnetic coils, for example on the surface of the operating table, and in equipping the surgical tools with multiple miniaturized receiving coils. Analysis of the received signals at the coils allows to determine with precision the position/orientation of the surgical tool. In the present system, a surgical tool-tracking system continuously tracks the spatial position of the ablation probes and communicate this position via network to the computing device / guidance software”).
Regarding claim 21, the combination teaches the system of claim 13 as described previously. Sahay further teaches wherein the instructions to modify the ablation plan comprise instructions that, when executed, cause the processor to update one or more treatment parameters of the ablation plan based on the updated planned position for the one or more additional probes of the plurality of probes (par. 0051: “Additional adjustments that can be made to the treatment plan to compensate for any misplacement of a cryoprobe include, but are not limited to, adjusting the energy power levels and/or cryoprobe freeze times or cycle times for certain cryoprobes or all cryoprobes”).
Regarding claim 22, the combination teaches the system of claim 11 as described previously. Borsic further teaches wherein the instructions, when executed, further cause the processor to: determine a placed position of each probe of the plurality of probes; and determine a location and/or distance of each probe relative to other probes of the plurality of probes based on the determined placed positions (par. 0056: “the positioning of the probes in the tissue and their orientation relative to each other are determined using known techniques”), which facilitates simulating ablation volume based on the relative locations of the probes (Abstract: “the relative locations of a plurality of ablation probes capable of providing ablation energy are determined, and the effect of energy provided by the probes based on the determined locations is predicted to identify a simulated ablation volume”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of the combined reference by determining the relative locations of the plurality of probes, as taught by Borsic, in order to simulate ablation volume based on the relative locations, as taught by Borsic.
Regarding claim 23, the combination teaches the system of claim 11 as described previously. Sahay further teaches wherein a clinician may compare the placed position of the first probe to the projected position of the first probe and determine whether the placed position of the first probe is within a predetermined threshold distance of the projected position of the first probe (Fig. 9 and par. 0049: “the clinician can see that the actual cryoprobe 138 placement is not in accordance with the planned cryoprobe 122 placement”); and wherein, upon a determination that the placed position of the first probe is not within the predetermined threshold distance of the projected position of the first probe, the system provides feedback related to repositioning of the first probe so that the placed position of the first probe is within the predetermined threshold distance of the projected position of the first probe (Figs. 9-10: actual cryoprobe placement 138, planned cryoprobe 122 placement; examiner interprets visual display of misaligned placement as feedback related to repositioning and notes that the threshold distance is determined by the clinician in this case, where the placement in Fig. 9 is outside the threshold, but the placement in Fig. 10 is within the threshold). Sahay teaches these steps as a manual process and does not explicitly teach wherein the instructions cause a processor to perform the steps. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the instructions and processor to compare the placed and projected positions of the first probe and determine whether the placed position is within a threshold distance of the projected position, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Response to Arguments
Applicant’s arguments, filed 16 March 2026, with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claim, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gutbrod. As described previously, Gutbrod teaches minimum and maximum electric field thresholds defining a target ablation zone.
Applicant's arguments with respect to the rejections of claims 11 and 15 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant appears to implicitly rely (i.e., the display indicator indicating a value or assessment related to a degree of difference between the projected position and the placed position) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the absence of such recited limitations, Sahay’s visual overlay is still considered to read on the claim because it provides a clear indicator that the placed position and projected position differ from one another.
Regarding the new limitation in claims 1 and 15 of repeating placement steps for each probe in the plurality of probes, Sahay teaches placing two probes in a final position before generating a final treatment plan and is therefore considered to still read on this limitation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Desai et al. (US PGPub No. 2019/0008591) teaches providing a user with an option to update an ablation plan based on an actual probe position or modify the actual position (Fig. 9: step 915), repeating placement steps for all probes in a plurality of probes (Figs. 3 and 9: steps 920 and steps 312-316), and generating a final ablation plan after all of the probes of the plurality of probes are placed (Fig. 3: step 318).
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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