DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The requirement for restriction of claims 19-23 filed 08/20/2025 is withdrawn for now being dependent on and requiring all of the limitations of presented elected claim 7.
Priority
Acknowledgement is made to Applicant’s claims to priority to U.S. Provisional App. No. 63/323,457 filed 03/24/2022; U.S. Provisional App. No. 63/394,871 filed 08/03/2022; and U.S. Provisional App. No. 63/394,873 filed 08/03/2022.
Status of Claims
This Office Action is responsive to the claims filed on 01/22/2026. Claims 14-15 and 18 were previously cancelled in a preliminary amendment. Claims 1-6 have been canceled. Claim 19 has been amended. Claims 24-29 have been newly presented. The restriction requirements over claims 19-23 have been withdrawn as noted above. Claims 7-13, 16, 17, and 19-29 are presently pending in this application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 7-13, 16, 17, and 24-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Subject matter eligibility pursuant to 35 U.S.C. § 101 requires first (“Eligibility Step 1”) that the claimed invention fall within one of the four statutorily authorized categories, and second (“Eligibility Step 2”) that the claim not be improperly directed to a judicial exception. MPEP 2106(III).
Determination as to whether a claim is improperly directed to a judicial exception is a two-part inquiry. Part one (“Eligibility Step 2A”) depends first (“Eligibility Step 2A, Prong One”) on whether the claim recites a judicial exception, and second (“Eligibility Step 2A, Prong Two”) whether the claim contains additional elements sufficient to integrate the judicial exception into a practical application. MPEP 2106(III). If the claim at issue does recite a judicial exception but does contain said such sufficient additional elements, then the claim is not improperly directed to a judicial exception and is not directed to patent ineligible subject matter. See MPEP 2106.04(d).
If the claim at issue does recite a judicial exception and does not contain sufficient additional elements to integrate the judicial exception into a practical application, then assessment must be made as to whether the claim sufficiently furnishes an inventive concept. MPEP 2106.04(d). Part two of the two-part inquiry (“Eligibility Step 2B”) thus looks at any additional claim elements to determine whether “the claim as a whole amounts to significantly more than the judicial exception itself.” MPEP 2106.05(d), (citing Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 227-218 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, at 71-72 (1966))). Claims that do amount to “significantly more” are not directed to patent ineligible subject matter under 35 U.S.C. 101; claims that do not amount to “significantly more” are directed to patent ineligible subject matter. MPEP 2106(III).
Independent claim 7:
With regard to Step 1, the claim 7 is directed to one of the four statutory categories of invention. Specifically claim 7 is directed to a system.
With regard to Step 2A: Prong 1, claim 7 recites limitations directed towards:
identifying a plurality of passageways in an anatomic region
identifying at least one area of anatomic constraint in the plurality of passageways
determining an ablation treatment plan based on the at least one area of anatomic constraint
Each of the recited steps, as drafted, amount to nothing more than a limitation that can practically be performed in the human mind and/or with the aid of pen/paper. For example:
One could identify a plurality of passages in an anatomic region by looking at a CT image or other medical image of a patient displaying groups of blood vessels and identifying a plurality of blood vessels
One could identify an area of anatomic constraint by identifying a portion of the blood vessels which shows a clot or other form of restriction
One can determine an ablation plan by selecting a route for a medical instrument to take and selecting an appropriate ablation tool and settings.
Therefore, the limitations recite mental-process type abstract ideas. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, claim 7 further recites additional elements directed towards a processor, a memory, and the ablation treatment plan including a treatment order for the passageways and a plurality of sequential treatment locations. The limitation, however, directed towards the processor, memory, and the treatment plan are recited at a high level of generality. The limitations of the processor and memory are interpreted as merely elements to implement the abstract ideas on the processors to perform the abstract idea. Such instructions are not sufficient to integrate a judicial exception into a practical application. See MPEP 2106.05(f). The limitation directed towards the ablation treatment plan including a treatment order for the passageways and a plurality of sequential treatment locations is considered to be limitations indicating a field of use or technological environment in which to apply the judicial exception. Such instructions are not sufficient to integrate a judicial exception into a practical application. See MPEP 2106.05(h). Consequently, the additional elements do not appear, either individually or as a whole, to integrate the judicial exceptions into a practical application.
With regard to Step 2B, as explained above, the additional limitations of the claims comprise no more than elements to implement the judicial exceptions on a computer, or merely use a computer as a tool to perform the judicial exceptions and indicating a field of use or technological environment in which to apply the judicial exception. Therefore, when considered separately and in combination, the additional limitations do not result in the claim, as a whole, amounting to significantly more than the judicial exceptions.
Dependent claim 8 adds further limitations to the plurality of sequential treatment locations. These limitations are:
a start treatment location at which a first ablation treatment of the ablation treatment plan is delivered and a stop treatment location at which a final ablation treatment of the ablation treatment plan is delivered
These additional limitations comprise no more than limitations indicating a field of use or technological environment in which to apply the judicial exception. Therefore, the additional limitations, when considered separately and in combination, do not integrate the judicial exceptions into a practical application, or result in the claims amounting to significantly more than the judicial exceptions.
Dependent claims 9, 10, and 11 add further limitations to the anatomic constraint. These limitations are:
the area of anatomic constraint includes an obstruction in a passageway of the plurality of passageways
the area of anatomic constraint includes a passageway diameter size for a passageway of the plurality of passageways that is smaller than a diameter of an instrument used in the ablation treatment plan
the area of anatomic constraint includes a shape of a passageway of the plurality of passageways that exceeds a bend radius of an instrument used in the ablation treatment plan
These additional limitations comprise no more than limitations indicating a field of use or technological environment in which to apply the judicial exception. Therefore, the additional limitations, when considered separately and in combination, do not integrate the judicial exceptions into a practical application, or result in the claims amounting to significantly more than the judicial exceptions.
Dependent claims 12, 13, 16, and 17 add further limitations to the ablation treatment plan. These limitations are:
the ablation treatment plan includes one or more treatment modes or includes a drive mode for an instrument used in the ablation treatment plan
the ablation treatment plan includes a duration of treatment or a treatment dosage
the ablation treatment plan includes a stay-out zone through which an instrument used in the ablation treatment plan is not to traverse
the ablation treatment plan includes a distance that an instrument used in the ablation treatment plan is moved or a spacing distance between the sequential treatment locations
These additional limitations comprise no more than limitations indicating a field of use or technological environment in which to apply the judicial exception. Therefore, the additional limitations, when considered separately and in combination, do not integrate the judicial exceptions into a practical application, or result in the claims amounting to significantly more than the judicial exceptions.
Dependent claims 24-29 add further limitations to the treatment order. These limitations are:
the treatment order is based on accessibility.
the treatment order is based on an available surface area for ablation
the treatment order is based on a volume for ablation
the treatment plan is based on characterization of one or more passageways
the characterization of the passageways comprises a straightness
the characterization of the passageways comprise a variation in lumen diameter of the passageways.
These additional limitations comprise no more than limitations indicating a field of use or technological environment in which to apply the judicial exception and further well-Understood, routine, conventional activity in planning an ablation. Therefore, the additional limitations, when considered separately and in combination, do not integrate the judicial exceptions into a practical application, or result in the claims amounting to significantly more than the judicial exceptions.
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.
Claims 7-9, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Coates (US 20200320706) in view of Barry (WO-2021007255-A1).
Regarding claim 7, Coates teaches a system (Paragraph [0005]; The system is configured to model the structure and blood flow of the coronary vasculature of a patient according to obtained physiological data, Fig. 1) comprising:
a processor (Paragraph [0034]; computer system 310 includes one or more processors 301, Fig. 3); and
a memory (Paragraph [0034]; storage device(s) 302, Fig. 3) having computer readable instructions stored thereon, the computer readable instructions, when executed by the processor (Paragraph [0034]; processor 301 is programmed by one or more computer program instructions stored on the storage device 302), cause the system to:
identify a plurality of passageways (Paragraph [0049]; the modeling module 312 is configured to generate a blood flow network… stores information about an arterial tree 605, including each vessel branch 601 in the network and the vessel branch nodes 602. The network model 600 also stores a blood flow field, including information about the blood pressures and blood flow rates at one or more locations within the vessel branches; Paragraph [0053]; Image capture and interpretation is employed to digitally define the arterial lumens of the coronary vascular network; Fig. 6 and 7) in an anatomic region (Paragraph [0005]; within the coronary vasculature, Fig. 7);
identify at least one area of anatomic constraint in the plurality of passageways (Paragraph [0030]; the effects of the bifurcation 215 and lesion 201 combine to create a reduced FFR score for the lesion 201 in the arterial tree 220, Fig. 2; Paragraph [0039]; The lesion identification module 314 is configured to identify lesions within the patient coronary vasculature according to the patient physiologic data, including both the angiographic images and the blood flow measurements).
Coates does not explicitly teach determining an ablation treatment plan based on the at least one area of anatomic constraint, the ablation treatment plan including a treatment order for the passageways and a plurality of sequential treatment locations.
Barry, however, teaches a system (Paragraph [0040]; elongated medical instrument system 100 extending within branched anatomic passageways or airways 102 of an anatomical structure; Paragraph [0104]; a robot-assisted medical system as described in further detail below. As shown in FIG. 23) comprising:
a processor (Paragraph [0107]; Control system 512 includes… at least one computer processor 514, Fig. 23); and
a memory (Paragraph [0107]; Control system 512 includes at least one memory 516, Fig. 23) having computer readable instructions stored thereon (Paragraph [0107]; includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement a plurality of operating modes), the computer readable instructions, when executed by the processor (Paragraph [0110]; one or more of the processes may be performed by a control system or may be implemented, at least in part, in the form of executable code stored on non-transitory, tangible, machine-readable media that when run by one or more processors may cause the one or more processors to perform one or more of the processes), cause the system to:
determine an ablation treatment plan (Paragraph [0108]; the control system 512 may use a pre-operative image to locate the target tissue and create a pre-operative plan, including an optimal first location for performing bronchial passageway and vasculature occlusion. The pre-operative plan may include, for example, a planned size to expand the expandable device, a treatment time, and/or multiple deployment locations; Paragraph [0055]; target tissue 127 may be directly ablated) based on the at least one area of anatomic constraint (Paragraph [0056]; the target tissue may be emphysematous lung tissue or other tissue afflicted with other diseases. Emphysematous segments of the lung may conduct gas exchange poorly and may be hyperinflated such that the diseased segments encroach on healthier lung segments), the ablation treatment plan including a treatment order for the passageways (Paragraph [0066]; treatment device may be moved from the first location to a second sequential location; Paragraph [0108]; a pre-operative plan including an optimal first location for performing bronchial passageway and vasculature occlusion. The pre-operative plan may include, for example, a planned size to expand the expandable device, a treatment time, and/or multiple deployment locations) and a plurality of sequential treatment locations (Paragraph [0067]; the expandable device 288 may be placed in a plurality of airway regions, such as in fourth to fifteenth generation airways, to create sequential heat delivery to various locations of the targeted anatomy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Coates to have included performing the steps of determining an ablation treatment plan based on the at least one area of anatomic constraint, the ablation treatment plan including a treatment order for the passageways and a plurality of sequential treatment locations as taught by Barry because it would have allowed targeted treatment of the detected points of flow restriction within the passageways and treated a number of disease that results from obstructions and poor gas exchange (Paragraph [0043]).
Regarding claim 8, together Coates and Barry teach all of the limitations of claim 7 as noted above.
Together Coates does not explicitly teach the plurality of sequential treatment locations includes a start treatment location at which a first ablation treatment of the ablation treatment plan is delivered and a stop treatment location at which a final ablation treatment of the ablation treatment plan is delivered.
Barry, however, teaches the plurality of sequential treatment locations includes a start treatment location at which a first ablation treatment of the ablation treatment plan is delivered (Paragraph [0108]; the control system 512 may use a pre-operative image to locate the target tissue and create a pre-operative plan, including an optimal first location for performing bronchial passageway and vasculature occlusion; Paragraph [0060]-[0062]; process 252, a treatment device is positioned in an anatomic lumen at a first location; cause ablation of the target tissue 284 in the anatomic passageway 102) and a stop treatment location at which a final ablation treatment of the ablation treatment plan is delivered (Paragraph [0066]-[0067]; treatment device may be moved from the first location to a second sequential location… treatment device is expanded at the second location… to cause ablation of the airway 102 at the second location 292; The second location in method 250 is considered to read on the claimed limitation of a stop treatment location as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the plurality of sequential treatment locations of Coates in view of Barry to have further included a start treatment location at which a first ablation treatment of the ablation treatment plan is delivered and a stop treatment location at which a final ablation treatment of the ablation treatment plan is delivered as further taught by Barry because it would have allowed automatically applying a thermal energy treatment to ablate a passageway by performing the process at the planned locations (Barry, Paragraph [0059) and further allow ablating target tissue while avoiding ablation of the adjacent vasculature or providing only minor ablation to the adjacent vasculature. Any of these methods, either alone or in combination, may be used to effectively treat a variety of disease states (Paragraph [0068]).
Regarding claim 9, together Coates and Barry teach all of the limitations of claim 7 as noted above.
Coates further teaches the area of anatomic constraint includes an obstruction in a passageway of the plurality of passageways (Paragraph [0067]; FFR values of less than 1, i.e., any FFR value indicating an obstruction of flow, may be used to identify a vascular lesion; FFR values used to identify lesions and lesions of interest may be arterial tree specific, vessel branch specific).
Regarding claim 12, together Coates and Barry teach all of the limitations of claim 7 as noted above.
Coates does not explicitly teach the ablation treatment plan includes one or more treatment modes or includes a drive mode for an instrument used in the ablation treatment plan
Barry, however, further teaches the ablation treatment plan includes one or more treatment modes or includes a drive mode for an instrument used in the ablation treatment plan (Paragraph [0104]; As shown in FIG. 23, a robot-assisted medical system 500 may include a manipulator assembly 502… and may optionally include a plurality of actuators or motors that drive inputs on medical instrument 504 in response to commands from a control system 512. The actuators may optionally include drive systems that when coupled to medical instrument 504 may advance medical instrument 504 into a naturally or surgically created anatomic orifice.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Coates in view of Barry to have further included a drive mode for an instrument used in the ablation treatment plan because it would have allowed the control system to advance the surgical instrument into the treatment positions (Barry, Paragraph [0104]).
Regarding claim 13, together Coates in view of Barry teach all of the limitations of claim 7 as noted above.
Coates does not explicitly teach the ablation treatment plan includes a duration of treatment or a treatment dosage.
Barry, however, further teaches the ablation treatment plan includes a duration of treatment (Paragraph [0062]; occluded by the ablation may be controlled based on the duration of application; Paragraph [0108]; pre-operative plan may include, for example,… a treatment time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the ablation treatment plan of Coates in view of Barry to have included a duration of treatment as taught by Barry because it would have allowed the target location receives proper treatment while ensuring adjacent tissue and vasculature receive minor damage (Paragraph [0068]).
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Coates in view of Barry as applied to claim 7 above, and further in view of Duindam (US 20200078103).
Regarding claim 10, together Coates and Barry teach all of the limitations of claim 7 as noted above.
Together Coates and Barry does not explicitly teach the area of anatomic constraint includes a passageway diameter size for a passageway of the plurality of passageways that is smaller than a diameter of an instrument used in the ablation treatment plan.
Duindam, however, teaches the area of anatomic constraint includes a passageway diameter size for a passageway of the plurality of passageways that is smaller than a diameter of an instrument (Paragraph [0079]; For example, roadblock indicator 530 may mark an anatomical passageway that is too narrow to fit the elongate device) used in the ablation treatment plan (Paragraph [0078]; virtual roadmap 520 displayed in window 500 indicates a predetermined route leading to a target location… indicate which branches in the anatomical passageways to steer the elongate device towards and/or away from; Paragraph [0049]; used for procedures such as surgery, biopsy, ablation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the area of anatomic constraint of Coates and Barry to have further included a passageway diameter size for a passageway of the plurality of passageways that is smaller than a diameter of an instrument used in the ablation treatment plan because it would have ensured the instrument does not enter an anatomical passageway that is too narrow to fit the elongate device and thus reduce the chance of entering a an anatomical passageway in which it would be dangerous and/or impossible to steer the elongate device (Duindam, Paragraph [0079])
Regarding claim 16, together Coates and Barry teach all of the limitations of claim 7 as noted above.
Together Coates and Barry do not explicitly teach the ablation treatment plan includes a stay-out zone through which an instrument used in the ablation treatment plan is not to traverse.
Duindam, however, teaches the ablation treatment plan (Paragraph [0078]; virtual roadmap 520 displayed in window 500 indicates a predetermined route leading to a target location… indicate which branches in the anatomical passageways to steer the elongate device towards and/or away from; Paragraph [0049]; used for procedures such as surgery, biopsy, ablation) includes a stay-out zone (Paragraph [0079]; As depicted in FIG. 5, roadblock indicator 530 includes an icon placed over to the anatomical passageway) through which an instrument used in the ablation treatment plan is not to traverse (Paragraph [0079]; A roadblock indicator 530 displayed in window 500 indicates an undesirable anatomic feature or an anatomical passageway and/or direction in which the elongate device should not or cannot be steered).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the ablation treatment plan of Coates in view of Barry to have included a stay-out zone through which an instrument used in the ablation treatment plan is not to traverse as taught by Duindam because it would have ensured the instrument does not enter an anatomical passageway where the bend of the anatomical passageway may be too tight and thus reduce the chance of entering an anatomical passageway in which it would be dangerous and/or impossible to steer the elongate device (Duindam, Paragraph [0079]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Coates in view of Barry as applied to claim 7 above, and further in view of Wang (US 20200030044).
Regarding claim 11, together Coates and Barry teach all of the limitations of claim 7 as noted above.
Together Coates and Barry do not explicitly teach the area of anatomic constraint includes a shape of a passageway of the plurality of passageways that exceeds a bend radius of an instrument used in the ablation treatment plan.
Wang, however, teaches the area of anatomic constraint includes a shape of a passageway of the plurality of passageways that exceeds a bend radius of an instrument used (Paragraph [0098]; Automatic, manual, and/or semi-automatic techniques may be used to determine whether a planned route includes any bends that are too tight. For example, given the known physical characteristics of various medical instruments to be used in the medical procedure, a bend radius that is too tight may be automatically identified) in the ablation treatment plan (Paragraph [0043]; one or more processors associated with a planning workstation are adapted to cause the one or more processors to perform a method including… identifying a hazard within the displayed image data… where the hazard includes an excessive bend within the plurality of connected anatomical passageways; Paragraph [0068]; medical instrument 226 may be used for procedures such as surgery, biopsy, ablation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Coates in view of Barry such that the area of anatomic constraint further included a shape of a passageway of the plurality of passageways that exceeds a bend radius of an instrument used in the ablation treatment plan as taught by Wang because it would have allowed planning a different route to the target that avoids the bend thereby preventing the medical instrument from entering a hazardous location (Paragraph [0098]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Coates in view of Barry as applied to claim 7 above, and further in view of Wong (US 20190298451).
Regarding claim 17, together Coates and Barry teach all of the limitations of claim 7 as noted above.
Together Coates and Barry do not explicitly teach the ablation treatment plan includes a distance that an instrument used in the ablation treatment plan is moved or a spacing distance between the sequential treatment locations.
Wong, however, teaches the ablation treatment plan (Paragraph [0042]-[0043]; At process 350, the updated model may be used to plan a medical procedure including determining a navigational path to an anatomic or ablation target and/or creating a treatment plan) includes a distance that an instrument used in the ablation treatment plan is moved or a spacing distance between the sequential treatment locations (Paragraph [0043]; Treatment plans can include determining treatment parameters such as treatment location… number of treatments, and spacing of treatments).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the ablation treatment plan of Coates in view of Barry to have included a distance that an instrument used in the ablation treatment plan is moved or a spacing distance between the sequential treatment locations as taught by Wong because it would have allowed fully automated entry into patient anatomy, navigation of the ablation probe to target tissue, and ablation according to the navigation and treatment plans (Wong, Paragraph [0065]).
Claims 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Coates in view of Barry as applied to claim 7 above, and further in view of Kruecker (US 20140058387 A1).
Regarding claim 19, together Coates and Barry teaches all of the limitations of claim 7 as noted above.
Together Coates and Barry do not explicitly teach the computer readable instructions, when executed by the processor, further cause the system to:
provide navigation guidance to perform an ablation treatment according to the ablation treatment plan; and
generate a treatment report after performance of the ablation treatment according to the ablation treatment plan.
Kruecker, however, teaches the computer readable instructions, when executed by the processor, further cause the system to:
provide navigation guidance (Paragraph [0041]; Conventional image guidance methods may be employed to execute the procedure according to the plan, or the plan geometry can be sent to a guidance system (e.g., (electromagnetic or other) to provide needle guidance for each individual ablation) to perform an ablation treatment according to the ablation treatment plan (Paragraph [0062]; In block 614, an ablation probe is guided to the target volume to perform ablation according to the plan);
and generate a treatment report after performance of the ablation treatment (Paragraph [0062]; In block 618, the treatment plan may be updated in accordance with recomputed probabilities to determine a more accurate probability map. This may include displaying a visual effect to reflect the probabilities in a display image) according to the ablation treatment plan (Paragraph [0062]; the target volume is ablated in accordance with the plan. In block 618, the treatment plan may be updated in accordance with recomputed probabilities).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Coates in view of Barry to have further included provide navigation guidance to perform an ablation treatment according to the ablation treatment plan; and
generate a treatment report after performance of the ablation treatment according to the ablation treatment plan as taught by Kruecker because it would have been well known and understood methods of using an ablation plan to perform an ablation (Paragraph [0005] and [0041]) and further would have allowed visualizing the progression of the actual procedure and to update the plan as needed (Paragraph [0005]).
Regarding claim 20, together Coates, Barry, and Kruecker teaches all of the limitations of claim 19 as noted above.
Coates does not explicitly teach the treatment report includes an image of an anatomic model with a treatment marker indicating an ablation location generated during the ablation treatment.
Kruecker, however, further teaches the treatment report includes an image of an anatomic model (Paragraph [0058]; In the visualization, regions may be displayed as treated, untreated and transitional, where transitions are between the treated and untreated probability regions. In block 536, the treatment status may be displayed on a display relative to an image of the targets, Fig. 4) with a treatment marker (Paragraph [0050]; One advantageous implementation is a color-coded overlay 402 of the values of qn calculated for each voxel, superimposed on a medical image of the treatment area as depicted in FIG. 4) indicating an ablation location generated during the ablation treatment (Paragraph [0062]; ablation probe is guided to the target volume to perform ablation according to the plan… treatment plan may be updated in accordance with recomputed probabilities to determine a more accurate probability map. This may include displaying a visual effect to reflect the probabilities in a display image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Coates in view of Barry and Kruecker such that the treatment report includes an image of an anatomic model with a treatment marker indicating an ablation location generated during the ablation treatment because it would have allowed the user to see locations where ablation has already taken place so the user can move to a next ablation without unnecessarily ablating areas that have already been treated, or, due to the accumulated effects in nearby areas, have a high probability of being treated already (Paragraph [0063]).
Regarding claim 21, together Coates, Barry, and Kruecker teach all of the limitations of claim 10 as noted above.
Coates does not explicitly teach the treatment marker includes a duration or a power level of the ablation treatment at the ablation location.
Kruecker, however, teaches the treatment marker includes a duration or a power level of the ablation treatment at the ablation location (Paragraph [0028]; module 122 is capable of computing an achieved composite ablation shape or treatment region based on probability of treatment of each of discrete volumes (e.g., voxels) in individual ablations contributing to the composite ablation shape. The probability may include such factors as ablation duration; Paragraph [0024]; the module 122 collects data such as a position, treatment time, perfusion, etc. to be able to estimate the probability of treatment of this and surrounding areas… treatment region 134 may be displayed and may be overlaid on an imaging scan).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the treatment marker of Coates in view of Barry and Kruecker to have included a duration or a power level of the ablation treatment at the ablation location as further taught by Kruecker because it would have allowed determining whether surrounding regions have been treated and thereby inform a user where ablation has already taken place so the user can an move to a next ablation without unnecessarily ablating areas that, due to the accumulated effects in nearby areas, have a high probability of being treated already (Paragraph [0063]).
Regarding claim 22, together Coates, Barry, and Kruecker teach all of the limitations of claim 20 as noted above.
Coates does not explicitly teach the computer readable instructions, when executed by the processor, cause the system to: generate a second ablation treatment plan based on the image of the anatomic model with the treatment marker.
Kruecker, however, further teaches generating a second ablation treatment plan (Paragraph [0044]; another embodiment, execution of the ablation plan is performed with feedback and iterative plan updates) based on the image of the anatomic model with the treatment marker (Paragraph [0044]; After each executed ablation and update of the executed joint probability map 142, that map 142 can be employed to update (manually or automatically) the procedure plan).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Coates in view of Barry and Kruecker to have included generate a second ablation treatment plan based on the image of the anatomic model with the treatment marker as further taught by Kruecker because it would have ensured that an improved or an optimal plan is provided for the remainder of the procedure after each actual ablation in the event of a deviation has occurred between a planned ablation and the corresponding executed ablation (Paragraph [0044]).
Regarding claim 23, together Coates, Barry, and Kruecker teach all of the limitations of claim 19 as noted above.
Coates does not explicitly teach the treatment report includes a measure of an actual treatment area for the performed ablation treatment compared to a predicted treatment area from the ablation treatment plan.
Kruecker, however, further teaches the treatment report includes a measure of an actual treatment area for the performed ablation treatment (Paragraph [0043]; In addition to the feedback described above, medical imaging or other means can be used to determine or estimate an actual size or a probability map (140) of actual, individual, executed ablations) compared to a predicted treatment area from the ablation treatment plan (Paragraph [0044]; each executed ablation and update of the executed joint probability map 142… update (manually or automatically) the procedure plan, in the event that a deviation has occurred between a planned individual ablation probability map 140 and the corresponding executed ablation probability map 142).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Coates in view of Barry and Kruecker to have included a measure of an actual treatment area for the performed ablation treatment compared to a predicted treatment area from the ablation treatment plan because it would have allowed determining a deviation between the planned ablation and an actual ablation, thereby allowing one to update the plan ensure optimal plan is provided for the remainder of the procedure after each actual ablation (Paragraph [0044]).
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Coates in view of Barry as applied to claim 7 above, and further in view of Schwartz (US 20180325597 A1).
Regarding claim 24, together Coates and Barry teaches all of the limitations of claim 7 as noted above.
Together Coates and Barry do not explicitly teach the treatment order for the passageways is based at least in part on accessibility.
Schwartz, however, teaches a treatment order for the passageways (Paragraph [0099]; indication comprises showing a line of planned ablation together with a 3-D representation of the target anatomical structure. Optionally, the indication also comprises display of targeted ablation positions along the line, and/or the order and/or timing in which the ablation positions are to be targeted; Paragraph [0101]; preliminary target form is provided automatically… the indication may be “surrounding a root of a pulmonary vein”, additionally or alternatively, the root of a plurality of veins) is based at least in part on accessibility (Paragraph [0150]; an optimal path is generated, based on the preliminary ablation line, and on one or more of the data… describing access constraints and conditions (block 114), Fig. 1B; Paragraph [0165]; the access constraints of block 114 establish zones of preferable exclusion for the line of planned ablation. For example, if an ablation probe cannot mechanically reach a surface region from an assumed base position such as a transseptal entry point, then the line of planned ablation is optionally adjusted to avoid it).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the treatment order for the passageways of Coates in view of Barry to have been based at least in part on accessibility as taught by Schwartz because it would allow the plan to avoid areas where the ablation probe cannot mechanically reach, and further allow the plan to be adjusted for use of an ablation probe with different mechanical characteristics, different electrode positions, and/or a different base position, thereby ensuring the lesion is can be properly treated (Paragraph [0165]).
Regarding claim 25, together Coates and Barry teaches all of the limitations of claim 7 as noted above.
Together Coates and Barry do not explicitly teach the treatment order for the passageways is based at least in part on available surface area for ablation.
Schwartz, however, teaches a treatment order for the passageways (Paragraph [0099]; indication comprises showing a line of planned ablation together with a 3-D representation of the target anatomical structure. Optionally, the indication also comprises display of targeted ablation positions along the line, and/or the order and/or timing in which the ablation positions are to be targeted; Paragraph [0101]; preliminary target form is provided automatically… the indication may be “surrounding a root of a pulmonary vein”, additionally or alternatively, the root of a plurality of veins) is based at least in part on available surface area for ablation (Paragraph [0164]; line of planned ablation to avoid zones of preferable ablation exclusion. For example, if a preferred set of ablation parameters (e.g., a set which is optimal for speed and transmurality as a function of tissue wall thickness) happens to violate protective constraints, then the line of planned ablation is optionally moved to an area where the protective constraints are satisfied; Paragraph [0165] if an ablation probe cannot mechanically reach a surface region from an assumed base position such as a transseptal entry point, then the line of planned ablation is optionally adjusted to avoid it.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the treatment order for the passageways of Coates in view of Barry to have further been based on available surface area for ablation as taught by Schwartz because it would have would allow the plan to avoid areas where the ablation probe cannot mechanically reach, and further allow the plan to be adjusted for use of an ablation probe with different mechanical characteristics, different electrode positions, and/or a different base position, thereby ensuring the lesion is can be properly treated (Paragraph [0165]).
Regarding claim 26, together Coates and Barry teaches all of the limitations of claim 7 as noted above.
Together Coates and Barry do not explicitly teach the treatment order for the passageways is based at least in part on a volume for ablation.
Schwartz, however, teaches the treatment order for the passageways (Paragraph [0099]; indication comprises showing a line of planned ablation together with a 3-D representation of the target anatomical structure. Optionally, the indication also comprises display of targeted ablation positions along the line, and/or the order and/or timing in which the ablation positions are to be targeted; Paragraph [0101]; preliminary target form is provided automatically… the indication may be “surrounding a root of a pulmonary vein”, additionally or alternatively, the root of a plurality of veins) is based at least in part on a volume for ablation (Paragraph [0223]; The pre-planning phase simulates different parameters for the planned procedure, to help select one or more different parameters for the actual procedure, according to, for example,… and/or selection of ablation parameters and/or ablation lines according to a simulation of the ablation; Paragraph [0234]; the simulation includes coordinates in space which represent a simulation of electrodes and/or sensors that provide measurements of values of the electrical and/or thermal properties; Paragraph [0252]-[0258]; exemplary ablation region may be modeled as an approximately elliptical shape, and the ablated volume as an approximate half-ellipsoid… The temperature pattern may be used in the generated simulation described herein, Fig. 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the treatment order for the passageways in the system of Coates in view of Barry to have been based at least in part on a volume for ablation because it would have allowed simulating the effect of the ablation procedure on actual tissue (Paragraph [0193]) and thereby provide the optimal position to place the catheter for ablation (Paragraph [0235]).
Claims 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Coates in view of Barry as applied to claim 7 above, and further in view of Lavi (US 20160247279 A1).
Regarding claim 27, together Coates and Barry teaches all of the limitations of claim 7 as noted above.
Together Coates and Barry do not explicitly teach the ablation treatment plan is further based on a characterization of one or more passageways of the plurality of passageways.
Lavi, however, teaches a treatment plan (Paragraph [0398]; At block 1016, in some embodiments, treatment planning occurs) is further based on a characterization of one or more passageways of the plurality of passageways (Paragraph [0398]; An aspect of generating a Syntax Score assessment is the evaluation of stenotic lesion severity. Other parameters relevant to a vascular state score vascular state score include the presence of thrombosis, vascular tortuosity, and/or relative vascular branch diameters).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the ablation treatment plan of Coates in view of Barry to have further been based on a characterization of one or more passageways of the plurality of passageways as taught by Lavi because it would have allowed informing the user whether the vessel is suitability for safe/stable intervention, thereby ensuring a safer treatment (Paragraph [0480]).
Regarding claim 28, together Coates, Barry, and Lavi teaches all of the limitations of claim 27 as noted above.
Coates does not explicitly teach the characterization of the one or more passageways comprises a straightness of the one or more passageways.
Lavi, however, further teaches the characterization of the one or more passageways comprises a straightness of the one or more passageways (Paragraph [0398]; Other parameters relevant to a vascular state score vascular state score include… vascular tortuosity; Paragraph [0480]; for example according to tortuosity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the characterization of the one or more passageways in the system of Coates in view of Barry and Lavi to have further included a straightness of the one or more passageways as further taught by Lavi because it would have been a well-known parameter to determine the safety of an intervention, thus including the straightness would improve the safety, stability, prognosis, and/or effectiveness of a medical procedure (Paragraph [0480]-[0481]).
Regarding claim 29, together Coates, Barry, and Lavi teach all of the limitations of claim 27 as noted above.
Coates does not explicitly teach the characterization of the one or more passageways comprises a variation in lumen diameter of the one or more passageways.
Lavi, however, further teaches the characterization of the one or more passageways comprises a variation in lumen diameter of the one or more passageways (Paragraph [0398]; Other parameters relevant to a vascular state score vascular state score include… relative vascular branch diameters; Paragraph [0480]; suitability of stenotic region for safe/stable intervention… vascular size; paragraph [0313]; an initial reference diameter is chosen to comprise a statistical fit… Optionally, the point weightings are adjusted so that best-fit deviations from wider (potentially less-diseased) points along the segment are weighted as more important than deviations from narrower points).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the characterization of the one or more passageways in the system of Coates, Barry, and Lavi to have further included a variation in lumen diameter of the one or more passageways as further taught by Lavi because it would have been a well-known parameter to determine the safety of an intervention, thus including the straightness would improve the safety, stability, prognosis, and/or effectiveness of a medical procedure (Paragraph [0480]-[0481]). Furthermore, it would have allowed less-diseased regions of the vessel to dominate the determination of the virtually revascularized vessel width (Paragraph [0313]), thereby improving the tree model used for vascularization.
Response to Arguments
Claim Rejections under – 35 U.S.C. § 101
Applicant's arguments filed 01/22/2026 regarding arguments to rejections of claims 7-13, 16, and 17 under 35 USC 101 have been fully considered but they are not persuasive.
Applicant argues the ablation plan including a treatment order for the passageways and a plurality of sequential treatment locations are more than merely indicating a field of use or technological environment and thereby is sufficient to integrate the judicial exception of determining an ablation treatment plan. Examiner respectfully disagrees. Examiner would like entire step of determining a plan can be understood as a mental step. For example one can look at an image of blood vessels with an anatomic constraint and determining plan by selecting locations in the image of where to perform the ablation. The specific limitation of including the order and the sequence is understood to be limitations which are executed in a computer to perform the process of determining an ablation plan. Such limitations are understood to only limit the technological environment of the judicial exception and thereby fails to integrate the judicial exception into a practical application. Furthermore, one could further perform steps of determining a treatment order for a plurality of passageways and a plurality of sequential treatment locations by selecting a passageway way and choosing a set of ablation treatment operations to perform in a chosen order. For these reasons, claims 7-13, 16, and 17 remain rejected under 35 USC 101.
Claim Rejections under – 35 U.S.C. § 103
Applicant's arguments filed 01/22/2026 regarding arguments to rejections of claims 7-13, 16, and 17 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues the references of Coates and Barry fail to teach “identify at least one area of anatomic constraint in the plurality of passageways; and determine an ablation treatment plan based on the at least one area of anatomic constraints”. Examiner respectfully disagrees. Examiner would like to point out the reference of Coates is relied upon to teach methods of determining plurality of passageways, for example as described in at least paragraphs [0049] and [0053] and further a define a treatment plan based on a constriction within the plurality of pathways, as described in at least paragraph [0025]. Furthermore, the plan of Coates is directed toward removal of a lesion, as described in Coates in paragraph [0085]. The reference of Barry is relied upon to teach an ablation plan and further determining the ablation plan including an order for the passageways, as described in paragraphs [0108]. Applicant further argues that it would not have been obvious to modify Coates to include an ablation plan including the order for the passageways. Examiner respectfully disagrees. The reference of Coates already teaches planning a removal of a lesion but does not describe the treatment or method used. One of ordinary skill in the art, however, would understand an ablation treatment can be used to remove a lesion and thus would have been motivated to look for solutions to planning an ablation, for example as described by Barry. Furthermore, while the description of Coates is primarily directed toward the coronary arteries, the reference of Coates is useful for measurements in the context of planning treatment any blood vessel, as described in paragraph [0019], including for example the pulmonary blood vessels of Barry. One of ordinary skill in the art would have incorporated the planning and treatment method of Barry in the system of Coates because it would have expanded the functionality for treating lesions in pulmonary arteries and allowed targeted treatment for pulmonary diseases that result in poor gas exchange. For these reasons, rejections of claim 7 are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
4/6/26