Prosecution Insights
Last updated: April 18, 2026
Application No. 18/566,178

APPARATUS FOR THE EMISSION OF TUMOR CELL DESTRUCTIVE RADIATION

Final Rejection §103
Filed
Dec 01, 2023
Examiner
BRUCE, FAROUK A
Art Unit
3797
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Elesta S P A
OA Round
2 (Final)
46%
Grant Probability
Moderate
3-4
OA Rounds
4y 7m
To Grant
84%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allow Rate
93 granted / 200 resolved
-23.5% vs TC avg
Strong +37% interview lift
Without
With
+37.2%
Interview Lift
resolved cases with interview
Typical timeline
4y 7m
Avg Prosecution
58 currently pending
Career history
258
Total Applications
across all art units

Statute-Specific Performance

§101
6.7%
-33.3% vs TC avg
§103
47.3%
+7.3% vs TC avg
§102
15.7%
-24.3% vs TC avg
§112
21.3%
-18.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 200 resolved cases

Office Action

§103
CTFR 18/566,178 CTFR 93337 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Withdrawn Objections The objection made to the drawings has been withdrawn pursuant of Applicant’s amendments filed 03/20/2026. Pursuant of Applicant’s amendments filed 03/20/2026, the objections made to claims 6 and 21 have been withdrawn. Withdrawn Rejections Pursuant of Applicant’s amendments filed 03/20/2026, the rejections made to claims 1-15 and 17-21 under 35 U.S.C. 112(b) have been withdrawn. Pursuant of Applicant’s amendments filed 03/20/2026, the rejection made to claim 17 under 35 U.S.C. 112(d) has been withdrawn. Response to Arguments 07-37 AIA Applicant's arguments filed 03/20/2026 with respect to the rejections of claims 1-15 and 17-21 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant remarks on pages 13 to 14 that the rejection in view of modified Zvuloni, et al., US 20130090554 A1 appears to draw on isolated features of the document so that the disclosed simulator ([0240]) relied upon in the rejection does not include the recited “spatial definition of the intervention area on a combined image;…and display of a simulated irradiated volume generated by the virtually positioned emission head. Examiner respectfully disagrees. The simulator in [0240] is introduced as such in [0240]: “Additionally, some embodiments comprise means for adjusting a probe delivery apparatus as a function of detected differences between first and second images. Attention is drawn to FIGS. 18A-18C, which are samples of output of a simulator running an algorithm appropriate for detecting angle .theta. based on first and second image inputs shown in the Figures , the algorithm outputting instructions to a surgeon detailing how to position a stereotactic probe placement template so that probe positioning information based on first images will be usable on a prostate positioned as shown in second images”. The abstract states that “Systems and methods for locating lesions in a prostate or other organ during a first intervention session, and for using that lesion location information during a second intervention session are presented”. Hence Examiner notes that the simulator is not limited in scope as argued but rather, the simulator embodies the features of the of the invention as indicated in the abstract. Furthermore, [0254]-[0255] indicate combination of the different features of the disclosed invention, stipulating that “It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention”. By this, the simulator, as presented in the rejection, does not lack any of the features relied upon to reject the claimed invention. Applicant’s assertion of impermissible hindsight reasoning on page 14 is not persuasive because "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." In re McLaughlin , 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). Applicant further remarks on pages 14-15 that the stored models of prior art Zuvloni are neither results of previous simulations nor generated based on treatment parameters such as the number of emission heads,… However, [0156] states “Alignment (registration) methods disclosed herein enable a user to align a 3D model (and its associated intervention information) created during a first session with a new 3D model based on ultrasound images (optionally real-time images) created during a second session, making it possible to present historical information (e.g. biopsy locations) in the context of an organ's current orientation and position ”. Meaning that Zuvloni discloses database of stored simulation results based on treatment parameters as required by the claims. Applicant’s remarks regarding prior art Betrouni are moot as Zuvloni teaches the limitation directed to the recalling information from the database. Applicant’s remarks regarding prior arts Kumar, et al., US 20140074078 A1 and Bolorforosh, et al., US 20050124884 A1 on pages 16-17 are moot as Zvuloni has been demonstrated as teaching the recited simulation module . Claim Objections 07-29-01 AIA Claim 5 is objected to because of the following informalities: Claim 5 should be amended to recite -- an Arrhenius damage value --. Appropriate correction is required. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim s 1-5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zvuloni, et al., US 20130090554 A1 in view of Glossop, N., US 20170020623 A1 (disclosed in the IDS filed 12/01/2023) and Betrouni, et al., US 20130289963 A1 . Regarding claim 1, Zvuloni teaches an apparatus for the emission of tumor cell destructive radiation ( the abstract discloses systems and methods for locating lesions in a prostate or other organ during a first intervention session, and for using that lesion location information during a second intervention session ), the apparatus comprising: an ultrasonic probe ( [0036] discloses a transrectal ultrasound probe ) configured to acquire at least a first image ( [0140] discloses using the transrectal ultrasound (TRUS) to collect images by stating that “A medical procedure according to some embodiments starts with physician's free hand insertion of a trans-rectal ultrasound (TRUS) into the rectum of a patient and his use of the TRUS to create and collect in a computer memory a series of two-dimensional ultrasound segment images, typically in transverse mode. At the time of creation of each of the ultrasound images measurements are taken and recorded showing the spatial location and orientation of the transducer with respect to the patient” ) relating to a spatial volume where the tumor cells to be destroyed are present ( the images are of lesion locations in the body according to [0136] which states that “the present invention can be used to diagnose locations of lesions within a body organ during a first diagnostic phase of medical activity” ); at least one radiation emission head configured to emit destructive radiation being destructive for tumor cell ( [0168] states that “At 84, sites requiring treatment, and whose real-time positions within the target organ are now known, are treated. Treatment may consist additional diagnostic steps, of ablative therapy by insertion and operation of ablative probes such as cryoprobes, RF probes, or others, or by focusing of intense radiation towards an identified locus (for example using HIFU), or other treatment methods may be used”, and [0169] describes directing the probes or energy discharges of the probe at the treatment site under algorithmic control, meaning that the ablative probe or radiation emission head are configured for irradiating the identified treatment site ); a second support system ( treatment needle guide 106c of [0189] ), configured to support and guide said at least one emission head, along a given trajectory ( expected or predicted trajectory 171 of reproduced fig. 12A below and [0199] which states “The position of needle cannula 106c with respect to transducer 106b is known, or can be determined by one-time calibration to observe the geometrical relation between the position of sensor 117 and the expected trajectory of a needle 171 passing through cannula 106C” ), in or in a vicinity of an area with the tumor cells to be destroyed ( [0179] states that “control module 112b includes a servomechanism control 115b for operating a servomechanism 199b to move a therapeutic tool 146 into and within patient 102”, where the site requiring treatment or intervention ([0167]-[0168]), reside within an organ 104 of the patient 102 [0179] ), PNG media_image1.png 522 672 media_image1.png Greyscale whereby the position of said trajectory defined by said second guide system with respect to said ultrasonic probe and with respect to the spatial volume investigated by said ultrasonic probe is known ( [0190] states that “An additional sensor 117a is firmly connected to transducer 106b and detects the spatial location of both the ultrasound imaging plane and the trajectory of any needle inserted through needle guide 106c (since their geometrical relations are known with reference to transducer 106b)” ); and an electronic device ( control module 112a of the imaging modality 106a of [0173] ) for managing the apparatus ( [0173] discloses control of components of the system 100 under the auspices of the control module and [0175] disclose image acquisition and processing by the control module ), comprising a screen and an electronic program ( [0038] discloses “a computing workstation comprising a CPU, memory, display, and software or firmware” ) adapted to combine at least one said first image deriving from the acquisition of said ultrasonic probe, with at least one second diagnostic image different from images acquired by said ultrasonic probe and relating to the same area where the tumor cells to be destroyed are present, to obtain at least a third combined image ( [0182] discloses a first-image and second-image pair that are aligned and superimposed on each other to attain a combined image 128 of [0181], the combined image depicting the treatment/intervention location [0187]. The first and second images are acquired by the probe and distinct from each other [0140] ), and wherein the at least one third combined image is adapted to be displayed on said screen ( [0181] states that “locations of sites of biopsy samples taken by diagnostic tool 145, optionally reported by sensor 117a and recorded in memory 116a of control module 112a, and identified and recorded in terms of coordinate system 92a of 3-D model 90a, may be mapped into model 90b and displayed on display 114b in form of a combined (composite) image 128, also referred to herein as common image 128, which combines information from model 90a with information from model 90b, and/or which combines information from first images 89a with information from second images 89b” ), wherein said electronic program ( [0038] discloses “a computing workstation comprising a CPU, memory, display, and software or firmware” ) comprises a simulation module ( [0240] discloses a simulator ) for simulating destruction of tumor cells which provides for the operations of spatial definition, on at least said third combined image displayed on the screen, of the intervention area where to perform the destructive treatment of tumor cells ( [0240] states that “Attention is drawn to FIGS. 18A-18C, which are samples of output of a simulator running an algorithm appropriate for detecting angle .theta. based on first and second image inputs shown in the Figures, the algorithm outputting instructions to a surgeon detailing how to position a stereotactic probe placement template so that probe positioning information based on first images will be usable on a prostate positioned as shown in second images”, that is, the output of the simulator identifies the areas to be treated in the images ), displaying, on said at least a third combined image displayed on the screen, of a simulation of the position of at least part of said given trajectory defined by said second support system, so that it is possible to virtually position at least one said emission head in said intervention area ( [0150] states that “with a 3D model of the prostate on the user's screen, the user can manipulate the TRUS transducer in order to observe a predicted trajectory of a biopsy needle or treatment needle on screen in real time”. According to [0181], the combined/composite image 128 is a displayed form of the 3D model, meaning that when [0150] mentions the 3D model, it is referring to the combined image. Reproduced fig. 12A displays the predicted/expected trajectory 171 along which the treatment needle travels toward the model of the prostate 90a ), virtual positioning of at least one said emission head in said intervention area displayed on the screen in said at least one third combined image ( [0152] states that “Given the known and calibrated geometrical relations between the TRUS transducer, the needle cannula, the needle sensor, and the needle tip, positions of the ultrasound, of the needle trajectory, and of the needle distal tip can be displayed in the context of the 3D model in real time”. As indicated above, the 3D model is the combined image displayed on the screen according to [0181] ), displaying, on said at least a third combined image displayed on the screen ( [0181] discloses displaying the three-dimensional model including the organ 104 on the display ), of a simulation of the volume that can be irradiated by said at least one emission head virtually positioned in said intervention area ( [0214] states that “FIG. 15D presents results of procedures described at 78 and 79 of FIG. 2, wherein sites which are sources for biopsy samples found to contain pathological tissues are marked for treatment in model 90a. In exemplary FIG. 15D, biopsy sites 240b and 240c are labeled as treatment targets 250”. The target sites 250 are the intervention areas to be irradiated. Fig. 15D has been reproduced below to show the locations 240b,250 and 240c,250 ), PNG media_image2.png 256 482 media_image2.png Greyscale wherein said simulation module provides a database containing the results of previous simulations ( [0147] discloses a system memory in which the models are stored, stating that “a 3D model is created using a method referred to herein as the "Fast 3D" method, and which may be described as follows: The system comprises a set of canonic models. These are 3D surface rendered models of the prostate with typical sizes and shapes. These models are stored in the system memory and can be displayed to the user, who selects the pre-defined model which in his opinion most closely resembles the displayed shape of the patient's prostate as displayed to him as described above”, and [0156] states “Alignment (registration) methods disclosed herein enable a user to align a 3D model (and its associated intervention information) created during a first session with a new 3D model based on ultrasound images (optionally real-time images) created during a second session, making it possible to present historical information (e.g. biopsy locations) in the context of an organ's current orientation and position” ), wherein the results of a previous simulation carried out on the basis of the same parameters are retrievable from said database by the surgeon ( [0187] states “Common image 128, displayed to a surgeon or other user, provides real-time guidance for a surgeon, by creating an image which directly shows whether a currently inserted ablation probe or other treatment tool 146 is correctly positioned with respect to a previously diagnosed treatment target site ”, [0156] states “Alignment (registration) methods disclosed herein enable a user to align a 3D model (and its associated intervention information) created during a first session with a new 3D model based on ultrasound images (optionally real-time images) created during a second session, making it possible to present historical information (e.g. biopsy locations) in the context of an organ's current orientation and position ”, and [0147] states “a 3D model is created using a method referred to herein as the "Fast 3D" method, and which may be described as follows: The system comprises a set of canonic models . These are 3D surface rendered models of the prostate with typical sizes and shapes. These models are stored in the system memory and can be displayed to the user , who selects the pre-defined model which in his opinion most closely resembles the displayed shape of the patient's prostate as displayed to him as described above”. By the above, models indicative of parameters such as position and orientation information, are created and stored in the system memory, and then the stored models are retrieved as historical models and treatment target site, to guide the current/intraprocedural treatment ), and wherein the electronic program ( [0038] discloses “a computing workstation comprising a CPU, memory, display, and software or firmware” ) comprises a module ( data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage in [0111] ) for the destructive treatment of the area with the tumor cells configured to set treatment parameters corresponding to the virtual treatment parameters set on the apparatus during operation of simulation module ( [0223] states that “Common image 128 can show an organ 104 as positioned within a patient on an operating table ready for a surgical intervention, can show positions of treatment probes or other surgical tools used during the intervention, and can also graphically show locations of sites determined during diagnostic phase activities to be targets of the intervention. A surgeon is thus provided with a graphic presentation of a virtual space in which his patient, his tools, and his surgical targets are together visible”, and [0224] states that “FIG. 15J portrays a surgical intervention in progress, with intervention probes 146 and target loci 250 both visible on common image 128”. Fig. 15J has been reproduced below to show the graphical positioning of the probe with respect to the target 250 in the combined image 128 ). PNG media_image3.png 408 672 media_image3.png Greyscale Zvuloni fails to teach a first support system, configured to support said ultrasonic probe in the area to be investigated, the position of said probe in said first support system being known; said second support system being in spatial relationship with said first support system. However, within the same field of endeavor, Glossop teaches systems, methods, and devices for assisting or performing guided interventional procedures using custom templates. The system uses pre- procedure scans of a patient's anatomy to identify targets and critical structures. A template is then manufactured containing guide elements. During a procedure, the template may be aligned to the patient and instruments passed though the guide elements and into various targets ( see abstract ). The targets include prostate gland according to [0136] . For the system, a first support system is provided ( [0163] discloses a support mechanism 922 ), the first support system configured to support said ultrasonic probe in the area to be investigated ( [0163] states that “TRUS probe 906 (or other ultrasound probe) may be affixed to a support mechanism 922”. In reproduced fig. 9 below, the support mechanism 922 ), the position of said probe in said first support system being known ( [0164] states that “The position and orientation of TRUS probe 906 may be tracked using encoders on support mechanism 922” ); said second support system being in spatial relationship with said first support system ( [0164] states that the “support mechanism 922 may also hold template 900 (or a frame assembly that surrounds (or encompasses) all or a portion of template 900… Encoders on support mechanism 922 may report the relative location of the template 900” ). PNG media_image4.png 524 668 media_image4.png Greyscale Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Zvuloni with a first support system, configured to support said ultrasonic probe in the area to be investigated, the position of said probe in said first support system being known; said second support system being in spatial relationship with said first support system, as taught by Glossop, as such modification would increase the accuracy and speed of placement of the therapeutic device at the region of interest [0058]-[0060] , with a reasonable expectation of success, as Zvuloni is also tasked with enabling accurate placement of surgical and/or diagnostic tools in a region of interest [0010]-[0011] . Zvuloni in view of Glossop fails to teach that the database includes previous simulations carried out on the basis of the following treatment parameters: number of the emission heads, the mutual positions of the emission heads and the energy dose applied by each emission head, and said treatment parameters comprising said number of the emission heads, said mutual positions of the emission heads, and said energy dose applied by each emission head. However, within the same field of endeavor, Betrouni teaches a method (200) for planning of a treatment with photodynamic therapy for a patient includes performing a measurement (230) of the volume of the treatment area by volume reconstruction from digital processing of contours inputted directly into a series of digital images of the area being treated, then determining (250) by calculating the number of optical fibers used, their position relative to the brachytherapy grid and their insertion length which optimizes the correspondence of a total theoretical action volume calculated with the measured volume of the treatment area ( see abstract ). [0021] states that “The digital images are for instance magnetic resonance or ultrasound images”. [0014] provides further explanation of the modeling/simulation of the treatment plan, implemented on a computer, wherein said simulation module ( computer of [0014] ) provides a database containing the results of previous simulations carried out on the basis of the following treatment parameters: number of the emission heads, the mutual positions of the emission heads and the energy dose applied by each emission head ( [0056]-[0059] describe a database of previous clinical trials employing the same parameters being modeled, the parameters comprising dosage/energy from an optical fiber [0056] , at least the number of optical fibers used, their position on the brachytherapy grid, and the introduction length of each of the fibers in the treatment area [0059] ), said treatment parameters comprising said number of the emission heads, said mutual positions of the emission heads, and said energy dose applied by each emission head ( [0056] discloses that the parameters comprise dosage/energy from an optical fiber and [0059] discloses that the parameters include at least the number of optical fibers used, their position on the brachytherapy grid, and the introduction length of each of the fibers in the treatment area). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Zvuloni, as modified by Glossop, such that the database includes previous simulations carried out on the basis of the following treatment parameters: number of the emission heads, the mutual positions of the emission heads and the energy dose applied by each emission head, and said treatment parameters comprising said number of the emission heads, said mutual positions of the emission heads, and said energy dose applied by each emission head, as taught by Betrouni, as such modification would optimize precise positioning of a treatment apparatus at a treatment site [0007], [0013], and [0080], with a reasonable expectation of success, as modified Zvuloni is also tasked with enabling accurate placement of surgical and/or diagnostic tools in a region of interest [0010]-[0011] . Regarding claim 2, Zvuloni in view of Glossop and Betrouni teaches all the limitations of claim 1. Zvuloni further teaches wherein said at least one second diagnostic image is of a different type from images deriving from ultrasonic probes and more preferably is an image deriving from a magnetic resonance ( [0173] states that “In FIG. 4, organ 104 of patient 102 is shown, with optional fiducial markers 130 inserted therein. An imaging modality 106a may be an ultrasound probe, an x-ray device, an MRI system, or any other imaging modality or combination of imaging modalities”, hence while not explicitly stated that the second image is an MRI image, the statement of a combination of imaging modalities, at the least, suggests that the second image is an MRI. Fig. 4 has been reproduced below ). PNG media_image5.png 696 538 media_image5.png Greyscale Regarding claim 3, Zvuloni in view of Glossop and Betrouni teaches all the limitations of claim 1. Zvuloni further teaches wherein said ultrasonic probe is an endocavitary ultrasonic probe ( [0140] states that “A medical procedure according to some embodiments starts with physician's free hand insertion of a trans-rectal ultrasound (TRUS) into the rectum of a patient and his use of the TRUS to create and collect in a computer memory a series of two-dimensional ultrasound segment images”). Regarding claim 4, Zvuloni in view of Glossop and Betrouni teaches all the limitations of claim 1. Zvuloni further teaches wherein said processing program provides that, before combining said at least one first and at least one second image, said diagnostic second image shows a circumscription of the area occupied by the tumor cells ( [0215] states that “Treatment-phase activity comprises using imaging modalities 106b to create a set of second images 89b of target organ 104, as well as their contours 160 as shown in FIG. 15E and described at 81 in FIG. 3”. The circumscription is hereby equivocated to the circular labeling 250, overlaying the treatment site 240b,240c, and hence effectively circumscribing the treatment site 240b,240c ), whereby said circumscription of the area with the tumor cells is also found in said at least a third combined image ( [0214] states that “FIG. 15D presents results of procedures described at 78 and 79 of FIG. 2, wherein sites which are sources for biopsy samples found to contain pathological tissues are marked for treatment in model 90a. In exemplary FIG. 15D, biopsy sites 240b and 240c are labeled as treatment targets 250”. Meaning that the circular label 250 used to label positions 240b,240c within the combined image as shown in fig. 15D below ). PNG media_image6.png 254 480 media_image6.png Greyscale Regarding claim 5, Zvuloni in view of Glossop and Betrouni teaches all the limitations of claim 1. Zvuloni in view of Glossop fails to teach wherein the size of the volume that can be irradiated by said at least one emission head virtually positioned in said intervention area is a function of one or more of the following parameters: power of the emitted radiation, the quantity or dose of energy of the emitted radiation, a possible movement of the at least one emission head during the emission step, a length of said possible movement, a Arrhenius damage value. However, Betrouni further teaches wherein the size of the volume that can be irradiated by said at least one emission head virtually positioned in said intervention area is a function of one or more of the following parameters: power of the emitted radiation, the quantity or dose of energy of the emitted radiation ( [0056] states that “In reference to FIG. 2, the modeling method 100 thus includes a preliminary step 110 of constructing a database of results from clinical trials conducted previously on a plurality of patients using the same photosensitive material at the same dosage, such as 4 mg/kg of WST11, associated with at least one optical fiber that we seek to model” and [0067] states that “The modeling method 100 described above has been validated on a database compiled from results from 28 clinical trials performed with a dosage of 4 mg per kilogram of patients involved, each time using a number of fibers with insertion lengths ranging from 15 to 40 mm by increments of 5 mm” ), the possible movement of the at least one emission head during the emission step, the length of said possible movement , the Arrhenius damage value ( [0026] discloses a method of assistance in the planning of patient treatment by photodynamic therapy including: [0027] Loading and displaying of a digital file corresponding to a series of digital images of the treatment area on a graphical user interface displayed on a computer screen; [0028] Contouring of the treatment area by direct input on each image of the series displayed on the computer screen; [0029] Measuring the volume of the treatment area by volume reconstruction from digital processing of the contours inputted; [0031] determination by calculation of the number of optical fibers used, their positions relative to the brachytherapy grid and their insertion length, which optimizes the correspondence of a total theoretical action volume calculated with the measured volume of the treatment area, said total theoretical action volume being calculated based on the position of each fiber ). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Zvuloni, as modified by Glossop, wherein the size of the volume that can be irradiated by said at least one emission head virtually positioned in said intervention area is a function of one or more of the following parameters: power of the emitted radiation, the quantity or dose of energy of the emitted radiation, the possible movement of the at least one emission head during the emission step, the length of said possible movement, the Arrhenius damage value, as taught by Betrouni, as such modification would optimize precise positioning of a treatment apparatus at a treatment site [0007], [0013], and [0080], with a reasonable expectation of success, as modified Zvuloni is also tasked with enabling accurate placement of surgical and/or diagnostic tools in a region of interest [0010]-[0011] . Regarding claim 17, Zvuloni in view of Glossop and Betrouni teaches all the limitations of claim 4. Zvuloni in view of Glossop fail to teach wherein the said processing program provides for a circumscription operation of the area with the tumor cells before combining said at least one first and at least one second image. However, Betrouni further teaches wherein the said processing program provides for a circumscription operation of the area with the tumor cells before combining said at least one first and at least one second image ( [0215] states that “Treatment-phase activity comprises using imaging modalities 106b to create a set of second images 89b of target organ 104, as well as their contours 160 as shown in FIG. 15E and described at 81 in FIG. 3”. The circumscription is hereby equivocated to the circular labeling 250, overlaying the treatment site 240b,240c, and hence effectively circumscribing the treatment site 240b,240c ). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Zvuloni, as modified by Glossop, wherein the said processing program provides for a circumscription operation of the area with the tumor cells before combining said at least one first and at least one second image, as taught by Betrouni, as such modification would optimize precise positioning of a treatment apparatus at a treatment site [0007], [0013], and [0080], with a reasonable expectation of success, Zvuloni is also tasked with enabling accurate placement of surgical and/or diagnostic tools in a region of interest [0010]-[0011] . 07-22-aia AIA Claim 6-8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zvuloni, et al., US 20130090554 A1 in view of Glossop, N., US 20170020623 A1 (disclosed in the IDS filed 12/01/2023) and Betrouni, et al., US 20130289963 A1 , as applied to claim 1 above, and further in view of Kumar, et al., US 20140074078 A1 . Regarding claim 6, Zvuloni in view of Glossop and Betrouni teaches all the limitations of claim 1. Zvuloni in view of Glossop and Betrouni fail to teach wherein said module for the destructive treatment is configured to set also the following parameters: power of the radiation emitted by the at least an emission head, the possible movement of the at least one emission head during the emission step, the length of said possible movement. However, within the same field of endeavor, Kumar teaches a method for minimally invasive laser ablation of a target tissue within a patient while sparing tissue within a safety zone proximate to the target tissue, comprising: guiding a laser fiber within a patient with a guidance tool; measuring a temperature within the target tissue and the safety zone based on an invasive and a non-invasive thermal sensor; computing a thermal profile in conjunction with a real-time tissue image adapted for guidance of the laser fiber with the guidance tool within the patient; and controlling a laser to deliver energy through the laser fiber, to deliver a minimally therapeutic ablation therapy to the target tissue ( see abstract ), wherein said module ( computer and software of [0019] ) for the destructive treatment is configured to set also the following parameters: power of the radiation emitted by the at least an emission head ( [0019] further states that “a controller configured to control energy from the laser source, a duration of its application, and dosage of energy from the laser source, and at least one automated processor, e.g., a computer with software that can compute thermometry based on precise location and duration of application or dosage of the laser source” ), the possible movement of the at least one emission head during the emission step, the length of said possible movement ( [0035] states that “the target region and laser fiber placements are planned using a planning image acquired before a procedure. The planning image may be through a different modality, such as CT scan, PET, MRI, MSRI, or the like. The software loads this plan and maps it to a frame of reference of the live ultrasound image, which may involve a coordinate transformation and/or a deformation of the tissues to account for deviations from linear geometry, especially for ultrasound images. The needle for laser guidance is then placed according to the plan through the transperineal grid. The plan for each needle is represented by {(i,j).sub.k, D.sub.k, t.sub.k} where (i,j).sub.k represents the grid location, D.sub.k and t.sub.k represent the depth of insertion and duration of laser application respectively” ). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Zvuloni, as modified by Glossop and Betrouni, wherein said module for the destructive treatment is configured to set also the following parameters: power of the radiation emitted by the at least an emission head, the possible movement of the at least one emission head during the emission step, the length of said possible movement, as taught by Kumar, to provide improved systems and methods for performing for image-guided laser ablation procedures [0017], as modified Zvuloni is also tasked with enabling accurate placement of surgical and/or diagnostic tools in a region of interest [0010]-[0011] . Regarding claim 7, Zvuloni in view of Glossop and Betrouni teaches all the limitations of claim 1. Zvuloni in view of Glossop and Betrouni wherein at least one emission head for emitting destructive radiation of tumor cells is capable of emitting a laser beam. However, Kumar further teaches wherein at least one emission head for emitting destructive radiation of tumor cells is an organ capable of emitting a laser beam ( [0039] discloses “a controller configured to control a laser to deliver energy through the laser fiber; and at least one automated processor configured to at least measure a temperature within the target tissue and the safety zone, for example based on both an invasive thermal sensor and a non-invasive thermal sensor, to control the controller to deliver a minimally therapeutic ablation therapy to the target tissue based on at least a treatment plan, while ensuring that the safety zone is maintained in a non-ablation condition”. The delivery of laser energy to the target tissue from the laser fiber comprises emitting a therapeutic laser beam ). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Zvuloni, as modified by Glossop and Betrouni, wherein at least one emission head for emitting destructive radiation of tumor cells is an organ capable of emitting a laser beam, as taught by Kumar, to provide improved systems and methods for performing for image-guided laser ablation procedures [0017], as modified Zvuloni is also tasked with enabling accurate placement of surgical and/or diagnostic tools in a region of interest [0010]-[0011] . Regarding claim 8, Zvuloni in view of Glossop and Betrouni teaches all the limitations of claim 1. Zvuloni in view of Glossop and Betrouni fails to teach wherein at least one tumor cell destructive radiation emission head is arranged within a guide needle movable along said given trajectory defined by said second support system. However, Kumar further teaches wherein at least one tumor cell destructive radiation emission head is arranged within a guide needle movable along said given trajectory defined by said second support system by discloses in [0064] that “FIG. 2 shows an overall scheme for a localized targeted laser ablation. The laser source(s) 1 and temperature sensors 2 are placed at the planned locations using a fixed grid 3, which may be attached to an ultrasound transducer or to a guidance tool. The needles may also be directly placed using a guidance tool under live ultrasound guidance. The laser placement is done in two stages: first, a hollow needle, which acts as a guide or sleeve for the laser fiber 1 to be inserted through, is placed to desired location; and then, the laser fiber 1 is inserted along the needle such that the laser source(s) 1 reaches the tip of the needle sleeve” . Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Zvuloni, as modified by Glossop and Betrouni, wherein at least one tumor cell destructive radiation emission head is arranged within a guide needle movable along said given trajectory defined by said second support system, as taught by Kumar, to provide improved systems and methods for performing for image-guided laser ablation procedures [0017], as modified Zvuloni is also tasked with enabling accurate placement of surgical and/or diagnostic tools in a region of interest [0010]-[0011] . Regarding claim 12, Zvuloni in view of Glossop and Betrouni teaches all the limitations of claim 1. Zvuloni in view of Glossop and Betrouni fail to teach wherein said database of previous simulations is carried out also on the basis of one or more of the following parameters: power of a source of an ablation radiation, possible presence of pullback actions, with a possible definition of a pullback length/distance. However, Kumar further teaches wherein said database of previous simulations is carried out also on the basis of one or more of the following parameters: power of the source of the ablation radiation, possible presence of pullback actions, with the possible definition of the pullback length/distance ( [0019] further states that “a controller configured to control energy from the laser source, a duration of its application, and dosage of energy from the laser source, and at least one automated processor, e.g., a computer with software that can compute thermometry based on precise location and duration of application or dosage of the laser source” Of note, [0063] discloses that A planning image from a previous patient visit may be used for planning the laser ablation ) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Zvuloni, as modified by Glossop and Betrouni, wherein said database of previous simulations is carried out also on the basis of one or more of the following parameters: power of the source of the ablation radiation, possible presence of pullback actions, with the possible definition of the pullback length/distance, as taught by Kumar, to provide improved systems and methods for performing for image-guided laser ablation procedures [0017], as modified Zvuloni is also tasked with enabling accurate placement of surgical and/or diagnostic tools in a region of interest [0010]-[0011] . 07-22-aia AIA Claim 9-11 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Zvuloni, et al., US 20130090554 A1 in view of Glossop, N., US 20170020623 A1 (disclosed in the IDS filed 12/01/2023) and Betrouni, et al., US 20130289963 A1 , as applied to claim 1 above, and further in view of Bolorforosh, et al., US 20050124884 A1 (disclosed in the IDS filed 12/01/2023) . Regarding claim 9, Zvuloni in view of Glossop and Betrouni teaches all the limitations of claim 1. Zvuloni in view of Glossop and Betrouni fails to teach wherein said ultrasonic probe comprises an oblong body, with a convex curved outer surface, extending along a longitudinal development of said body, wherein a plurality of ultrasonic sensors facing the curved surface are provided on the body to emit and receive ultrasonic waves; preferably said curved surface of said ultrasonic probe is substantially cylindrical and has a longitudinal axis parallel to the longitudinal development of the oblong body. However, within the same field of endeavor, Bolorforosh teaches an intra-patient probe/endocavity and invasive catheter transducers for four-dimensional or other imaging ( [0006] ), wherein said ultrasonic probe comprises an oblong body, with a convex curved outer surface, extending along a longitudinal development of said body ( reproduced fig. 1 below shows the cylindrical/oblong shape of a distal end of the endocavity probe, with a convex curved outer surface, with [0029] stating that “As shown in FIG. 1, the array 16 is concave from the perspective of within the catheter and convex from the perspective of the exterior of the catheter or other housing 12 for conforming to the cylindrical outer surface of the housing 12” ), wherein a plurality of ultrasonic sensors ( elements 20 of the array 16 in [0024] ) facing the curved surface are provided on the body to emit and receive ultrasonic waves ( see reproduced fig. 1 below which shows the array 16 arranged on a surface of the housing 12 of the probe and [0029] denotes that the array is arranged on the cylindrical surface of the housing 12 ) ; preferably said curved surface of said ultrasonic probe is substantially cylindrical and has a longitudinal axis parallel to the longitudinal development of the oblong body ( see fig. 1 for the cylindrical shape of the probe and an azimuth/longitudinal development of the oblong/cylindrical shape/body of the probe ). PNG media_image7.png 316 468 media_image7.png Greyscale PNG media_image8.png 364 516 media_image8.png Greyscale Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Zvuloni as modified by Glossop and Betrouni, wherein said ultrasonic probe comprises an oblong body, with a convex curved outer surface, extending along a longitudinal development of said body, wherein a plurality of ultrasonic sensors facing the curved surface are provided on the body to emit and receive ultrasonic waves; preferably said curved surface of said ultrasonic probe is substantially cylindrical and has a longitudinal axis parallel to the longitudinal development of the oblong body, as taught by Bolorforosh, to provide better contextual information, planar information may be used to generate a three-dimensional image with improved accuracy of identifying locations within the volume of interest being examined [0005] , with a reasonable expectation of success, as modified Zvuloni is also tasked with enabling accurate placement of surgical and/or diagnostic tools in a region of interest [0010]-[0011] . Regarding claim 10, Zvuloni in view of Glossop, Betrouni and Bolorforosh teaches all the limitations of claim 9. Zvuloni in view of Glossop and Betrouni fail to teach wherein said ultrasonic sensors are arranged according to a two-dimensional matrix. However, Bolorforosh further teaches wherein said ultrasonic sensors are arranged according to a two-dimensional matrix ( fig. 2 shows a six-by-six matrix 16 of ultrasound transducers, with [0027] stating that “As shown in FIG. 2, the multi-dimensional array 16 is an N.times.M array of elements 20. N and M are either equal or different, such as a 32.times.32, 64.times.12 or a 40.times.20 array” ). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Zvuloni as modified by Glossop and Betrouni, wherein said ultrasonic sensors are arranged according to a two-dimensional matrix, as taught by Bolorforosh, to provide better contextual information, planar information may be used to generate a three-dimensional image with improved accuracy of identifying locations within the volume of interest being examined [0005] , with a reasonable expectation of success, as modified Zvuloni is also tasked with enabling accurate placement of surgical and/or diagnostic tools in a region of interest [0010]-[0011] . Regarding claim 11, Zvuloni in view of Glossop, Betrouni and Bolorforosh teaches all the limitations of claim 10. Zvuloni in view of Glossop and Betrouni fail to teach a device for controlling the switching of the ultrasonic sensors of said ultrasonic probe. However, Bolorforosh further teaches a device for controlling the switching of the ultrasonic sensors of said ultrasonic probe ( [0041] discloses that the probe includes switches 28 which activate the elements 20 ). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Zvuloni as modified by Glossop and Betrouni, a device for controlling the switching of the ultrasonic sensors of said ultrasonic probe, as taught by Bolorforosh, to provide better contextual information, planar information may be used to generate a three-dimensional image with improved accuracy of identifying locations within the volume of interest being examined [0005] , with a reasonable expectation of success, as modified Zvuloni is also tasked with enabling accurate placement of surgical and/or diagnostic tools in a region of interest [0010]-[0011] . Regarding claim 18, Zvuloni in view of Glossop, Betrouni and Bolorforosh teaches all the limitations of claim 9. Zvuloni in view of Glossop and Betrouni fail to teach wherein the ultrasonic sensors of the probe are arranged according to at least one rectilinear curtain, parallel to the axis of the probe and at least one curvilinear curtain, lying on a circumference on a plane orthogonal to the axis of the probe. However, Bolorforosh further teaches wherein the ultrasonic sensors of the probe are arranged according to at least one rectilinear curtain, parallel to the axis of the probe and at least one curvilinear curtain, lying on a circumference on a plane orthogonal to the axis of the probe ( In reproduced figs. 1 and 2 above, the elements 20 of the array 16 are arranged in both, an azimuth axis, which is along a longitudinal axis of the cylindrical probe, and an elevation direction which is along a circumference of the cylindrical probe ). Therefore, it would have been obvious to one of ordinary skill in the art before the ef
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Prosecution Timeline

Dec 01, 2023
Application Filed
Dec 20, 2025
Non-Final Rejection — §103
Mar 20, 2026
Response Filed
Mar 30, 2026
Final Rejection — §103 (current)

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Expected OA Rounds
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4y 7m
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