DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. Claims 1-24 are pending in this application.
Claims 1, 10 and 13 are currently amended.
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/30/2026, with respect to the 35 U.S.C. 101 Rejection of Claims 1-24 have been fully considered and are persuasive. The 35 U.S.C. 101 Statutory Double Patenting Rejection of Claims 1-24 has been withdrawn.
Applicant’s arguments, see Remarks, filed 03/30/2026, with respect to the rejection(s) of claim(s) 1-24 under Camps (US PAT. No. 12,156,760 B2) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Robinson (US PG. Pub. 2021/0137384 A1).
Applicant’s argues on pages 10-11 of the Remarks that the prior art of Camps fails to teach the amended limitation “wherein the supplemental boundary is in addition to a previously-determined planning target volume for the particular patient.”
The examiner respectfully agrees, however the newly added prior art of Robinson (US PG. Pub. 2021/0137384 A1) teaches “wherein the supplemental boundary is in addition to a previously-determined planning target volume for the particular patient (See Robinson, Sect. [0101], the image mapping can be a volume for use in treatment planning (e.g., in a treatment planning system/software). The target segments or 3D contours may be used to identify a planning target volume within treatment planning software. In some examples, the planning target volume and/or the segments/contours can be used to simulate treatment for internal quality assurance. The image mapping can be used as an input to a treatment planning system (e.g., that can carry out the ablation). The image mapping can provide for patient customized treatment planning.). Thus, the amended limitations are now taught by the added prior art of Robinson as required.
Claim Rejections - 35 USC § 103
7. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
8. 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.
9. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
10. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
11. Claims 1-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Camps (US PAT. No. 12,156,760 B2) in view of Robinson (US PG. Pub. 2021/0137384 A1).
Referring to Claim 1, Camps teaches a method (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206) to facilitate compensating for motion during a cardiac radioablation session for a heart of a particular patient (See Camps, Figs. 1 and 6, col. 10 lines 28-34 and Col. 11 lines 28-43, The ablation treatment plan 186 is a comprehensive plan that forms the basis of control execution and performance verification of the non-invasive cardiac ablation system 100 including heartbeat sensing system 172 that generates cardiac cycle data 174, such as an ECG measuring the electrical activity generated by the heart and to acquire and send the cardiac cycle data 174 to the target motion management system 110 during cardiac heart treatment of specific patient for motion control and irradiation of target motion area and landmark positions, personalized parameters for cardiac phase identification and respiratory phase identification and beam irradiation control during the ablation and judgment stages S204 and S205 (FIG. 6).), the method comprising:
by a control circuit (See Camps, Fig. 3, The non-invasive cardiac ablation system 100):
accessing multi-dimensional information for the particular patient (See Camps, Fig. 12, Neural Network 400, Col. 22 lines 36-53, The neural network 400 accepts as input an image sequence 402 as a plurality of the real-time images 142 (e.g., a video) as two-dimensional B-mode ultrasonic frames with a gray value range of 8 bits (between 0 and 255 inclusive) that are normalized between 0 and 1. The image sequence 402 has a dimension of NxHxWx1, where N is the number of real-time images 142, each real-time image 142 being an H×W array of pixels. The image sequence 402 is processed by a three-dimensional convolutional neural network (3D CNN) 406 to output a spatial feature layer 408.);
automatically determining a supplemental boundary for at least one portion of the particular patient as a function (See Camps, Col. 11 lines 32-37, The ablation treatment plan 186 includes a patient-specific list of treatment properties in order to irradiate the appropriate volume in the patient body with the required therapeutic radiation dose. The treatment properties may include treatment target volume, treatment target motion boundaries), at least in part, of the multi-dimensional information (See Camps, Col. 11 lines 55-62, The ablation treatment plan 186 may include determining, for each of the chosen motion phases, boundaries for the target region and determining the beam properties for each of the chosen motion phases based on the target region and surrounding healthy tissues).
Camps fails to explicitly teach
wherein the supplemental boundary is in addition to a previously-determined planning target volume for the particular patient.
However, Robinson teaches
wherein the supplemental boundary is in addition to a previously-determined planning target volume for the particular patient (See Robinson, Sect. [0101], the image mapping can be a volume for use in treatment planning (e.g., in a treatment planning system/software). In some examples, the image mapping can be used as an input to a treatment planning system (e.g., that can carry out the ablation). The image mapping can provide for patient customized treatment planning (e.g., not all patients will require or present with all known multi-modal data). The target segments or 3D contours may be used to identify a planning target volume within treatment planning software. In some examples, the planning target volume and/or the segments/contours can be used to simulate treatment for internal quality assurance.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Camps to incorporate the teachings of Robinson to provide wherein the supplemental boundary is in addition to a previously-determined planning target volume for the particular patient. Doing so would provide in determining a cardiac arrhythmia target for ablation and more specifically to multimodal image mappings and risk profiles for determining atrial or ventricle segments for ablation, as recognized by Robinson.
Referring to Claim 2, the combination of Camps in view Robinson teaches method of claim 2 (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206), wherein the supplemental boundary comprises a margin that is added to a boundary of the at least one portion of the particular patient (See Camps, Col. 11 lines 43-54, margins are added around the clinical target that consider the possible errors related to patient positioning and motion during the delivery based on off-line image scans (static or time-resolved), where the medical staff has defined the clinical target which should receive a given dose, the critical healthy tissues that should be irradiated in the least possible fashion and the gating windows within which irradiation is allowed (beam-gating) or motion phases for which the treatment plan applies (beam-tracking).).
Referring to Claim 3, the combination of Camps in view Robinson teaches the method of claim 1 (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206), wherein the at least one portion of the particular patient comprises at least one of (See Camps, Fig. 4, Col. 16 lines 7-8, The beam-gating step s227 involves determining the position of the target region 128.):
a treatment target portion of the heart (See Camps, Col. 16 lines 12-15, the particle beam 118 is emitted by the particle emitting system 102 at a prescribed angle and directed to the prescribed target region 128 of the heart (as determined during treatment planning).);
an organ-at-risk (See Camps, Col. 1 lines 51-65, Ablation therapies for patient with heart issues and are at risk of serious complications like tissue perforation, vein stenosis, or blood clot creation.).
Referring to Claim 4, the combination of Camps in view Robinson teaches the method of claim 1 (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206), further comprising: determining a planning treatment volume as a function, at least in part, of the
supplemental boundary (See Camps, Col. 14 lines 49-54, The ablation treatment planning step s216 of the simulation stage S201 involves developing the ablation treatment plan 186 to be performed for one or more respiratory and cardiac cycles with the target volume ranging from approximately 2 to 200 cubic centimeters (cc) inclusive.).
Referring to Claim 5, the combination of Camps in view Robinson teaches the method of claim 1 (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206), wherein the multi-dimensional information includes motion-based imagery comprising cardiac-based imagery for the particular patient and at least one of respiratory-based imagery for the particular patient and cyclic gastric motion-based imagery for the particular patient (See Camps, Col. 6 lines 42-54, treatment planning relies on performing 3Dimensional+time system scans using a combination of respiratory and cardiac sensors for motion phases or combination of motion phases including determining an ablation target for one or more phases of respiratory and cardiac cycles and the required beam properties (angle, energy, position, intensity) to effectively ablate the target while sparing sensitive surrounding healthy tissues during each of these motion phases.)
Referring to Claim 6, the combination of Camps in view Robinson teaches the method of claim 5 (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206),
presenting the motion-based imagery to a user (See Camps, Col. 13 lines 24-26, The real-time images 142 may be acquired and updated to the target motion management system 110 continuously, providing the operator (user) with a live stream of data.);
providing the user, via a user interface, with an opportunity to selectively modify movement of one motion-based imagery separately from another motion-based imagery (See Camps, Col. 9 lines 63-67 and Col. 10 lines 1-4, The target motion management system 110 includes hardware control and signal capabilities that are coupled to a central target motion controller 162 and includes a control console 164 for user interface with the central target motion controller 162 operatively coupled to receive input from and/or send output to the charged particle emitting system 102, the patient positioning system 104, the real-time imaging system 106.).
Referring to Claim 7, the combination of Camps in view Robinson teaches the method of claim 1 (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206), further comprising:
generating a motion model for the particular patient as a function, at least in part, of the multi-dimensional information for the particular patient (See Camps, Col. 24 lines 29-37, the neural network 400 is trained for multiple epochs for generating a motion model. A 4-fold cross-validation strategy may be implemented to assess network performances. In the 4-fold approach, 75% of samples (data from patients) are used as a training set and 25% of the samples (patients) as a validation set, every sample is used only once in the validation set. The model having the best correlation is selected for as the motion model.).
Referring to Claim 8, the combination of Camps in view Robinson teaches the method of claim 7 (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206), further comprising:
assessing efficacy for each of a plurality of different therapeutic treatment modalities for the particular patient as a function, at least in part, of the motion model (See Camps, Col. 11 lines 55-58, the treatment efficacy of the Invasive catheter ablation procedures are surgical interventions performed manually and varies largely from 50% to 80% depending on the motion model.).
Referring to Claim 9, the combination of Camps in view Robinson teaches the method of claim 7 (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206), further comprising:
accessing supplemental multi-dimensional information for the particular patient at a time of treatment (See Camps, Col. 15 lines 42-50, The target ablation stage S204 includes a start treatment step s225. The target ablation stage S204 commences upon verification of satisfactory patient positioning. The start treatment step s225 involves readying the non-invasive cardiac ablation system 100 for particle beam emission. Activities may include arming the charged particle emitting system 102, for example by powering up the accelerator 112, and starting the streaming of data from the respiratory and cardiac motion subsystems 108 and 188.);
updating the motion model as a function, at least in part, of the supplemental multi-dimensional information (See Camps, Col. 21 lines 51-60, In the beam-tracking mode (s386(b)), the updated cardiac phase P.sub.k is passed on to the processor μ of the central target motion controller 162 as the cardiac motion signal 196. The processor μ may also receive the respiratory motion signal 184 from the respiratory control module 182. As described attendant to FIG. 5, the processor μ processes the respiratory and cardiac phase signals 184 and 196 and relays information via the digital communication signal 198 for utilization by the charged particle emitting system 102 to configure the properties of the particle beam 118.).
Referring to Claim 10, the combination of Camps in view Robinson teaches the method of claim 7 (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206), further comprising:
accessing supplemental multi-dimensional information for the particular patient at a time of treatment (See Camps, Col. 15 lines 42-50, The target ablation stage S204 includes a start treatment step s225. The target ablation stage S204 commences upon verification of satisfactory patient positioning. The start treatment step s225 involves readying the non-invasive cardiac ablation system 100 for particle beam emission. Activities may include arming the charged particle emitting system 102, for example by powering up the accelerator 112, and starting the streaming of data from the respiratory and cardiac motion subsystems 108 and 188.);
validating the motion model as a function, at least in part, of the supplemental multi-dimensional information (See Camps, Col. 24 lines 30-35, A 4-fold cross-validation strategy may be implemented to assess network performances. In the 4-fold approach, 75% of samples (data from patients) are used as a training set and 25% of the samples (patients) as a validation set every sample is used only once in the validation set.).
Referring to Claim 11, the combination of Camps in view Robinson teaches the method of claim 1 (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206), further comprising:
reconstructing an absorbed dose administered during the cardiac radioablation session as a function (See Camps, Col. 14 lines 49-57, The therapeutic dose may vary or otherwise be in a range from approximately 20 to 60 Gray (Gy) inclusive. The ablation treatment planning step s216 of the simulation stage S201 involves developing the ablation treatment plan 186, for example as described above. The simulation stage S201 may be performed for one or more respiratory and cardiac cycles. The target volume may range from approximately 2 to 200 cubic centimeters (cc) inclusive.), at least in part, of at least one of:
the multi-dimensional information for the particular patient (See Camps, Col. 15 lines 24-28, After completion of the patient positioning stage S202, the patient position verification stage S203 is carried out. At a position verification step s224, 3D position verification of the patient 124 relative to the propagation axis 132 of the particle beam 118.); and
a motion model for the particular patient that was generated as a function, at least in part, of the multi-dimensional information for the particular patient (See Camps, Col. 15 lines 28-41, The 3D position verification may involve the placement of the patient 124 on the patient support 122, as well as manipulation of the patient support 122 with the positioner system 126. The patient positioning and verification stages S202 and S203 may be iteratively performed until the position of the patient 124 is the same as for the off-line imaging of the simulation stage S201, as determined by the patient position verification system 166. Also, for cases where the ablation treatment plan 186 calls for multiple angles, when irradiation is completed at one configuration of the gantry 140, irradiation is stopped and the beam controller 116 orients the gantry 140 to the new pre-determined angle. If necessary, the patient positioning and position verification stages S202 and S203 are repeated.).
Referring to Claim 12, the combination of Camps in view Robinson teaches the method of claim 1 (See Camps, Fig. 6, The Ablation Treatment Plan 186, Steps S201-S206), further comprising:
optimizing a cardiac radioablation treatment plan for the particular patient as a function of at least two different dimensions of movement as derived (See Camps, Col. 13 lines 66-67 and Col. 14 lines 1-4, To optimize the performance for the specific patient, the phase identification aspect of the cardiac gating module 192 may be used in the simulation stage S201 to customize algorithm parameters and the patient position may also be recorded, for example using the patient position verification system 166), at least in part, from the multi-dimensional information (See Camps, Col. 24 lines 38-49, the neural network 400 may be trained with an ADAMAX optimizer for multiple epochs for each phase of every real-time image 142 of the image sequence 402 with implementations of the neural network 400 include PYTHON® 3 with the KERAS framework using TENSORFLOW® as a backend.).
Referring to Claim 13, arguments analogous to claim 1 are applicable herein. “A method” in claim 1 perform all of the functions of “An apparatus” in claim 13. Thus, “An apparatus” in claim 13 is rejected for the same reasons as discussed in the rejection of claim 1.
Referring to Claim 14, arguments analogous to claim 2 are applicable herein. “The method” in claim 2 perform all of the functions of “The apparatus” in claim 14. Thus, “The apparatus” in claim 14 is rejected for the same reasons as discussed in the rejection of claim 2.
Referring to Claim 15, arguments analogous to claim 3 are applicable herein. “The method” in claim 3 perform all of the functions of “The apparatus” in claim 15. Thus, “The apparatus” in claim 15 is rejected for the same reasons as discussed in the rejection of claim 3.
Referring to Claim 16, arguments analogous to claim 4 are applicable herein. “The method” in claim 4 perform all of the functions of “The apparatus” in claim 16. Thus, “The apparatus” in claim 16 is rejected for the same reasons as discussed in the rejection of claim 4.
Referring to Claim 17, arguments analogous to claim 5 are applicable herein. “The method” in claim 5 perform all of the functions of “The apparatus” in claim 15. Thus, “The apparatus” in claim 17 is rejected for the same reasons as discussed in the rejection of claim 5.
Referring to Claim 18, arguments analogous to claim 6 are applicable herein. “The method” in claim 6 perform all of the functions of “The apparatus” in claim 18. Thus, “The apparatus” in claim 18 is rejected for the same reasons as discussed in the rejection of claim 6.
Referring to Claim 19, arguments analogous to claim 7 are applicable herein. “The method” in claim 7 perform all of the functions of “The apparatus” in claim 19. Thus, “The apparatus” in claim 19 is rejected for the same reasons as discussed in the rejection of claim 7.
Referring to Claim 20, arguments analogous to claim 8 are applicable herein. “The method” in claim 8 perform all of the functions of “The apparatus” in claim 20. Thus, “The apparatus” in claim 20 is rejected for the same reasons as discussed in the rejection of claim 8.
Referring to Claim 21, arguments analogous to claim 9 are applicable herein. “The method” in claim 9 perform all of the functions of “The apparatus” in claim 21. Thus, “The apparatus” in claim 21 is rejected for the same reasons as discussed in the rejection of claim 9.
Referring to Claim 22, arguments analogous to claim 10 are applicable herein. “The method” in claim 10 perform all of the functions of “The apparatus” in claim 22. Thus, “The apparatus” in claim 22 is rejected for the same reasons as discussed in the rejection of claim 10.
Referring to Claim 23, arguments analogous to claim 11 are applicable herein. “The method” in claim 11 perform all of the functions of “The apparatus” in claim 23. Thus, “The apparatus” in claim 23 is rejected for the same reasons as discussed in the rejection of claim 11.
Referring to Claim 24, arguments analogous to claim 12 are applicable herein. “The method” in claim 12 perform all of the functions of “The apparatus” in claim 24. Thus, “The apparatus” in claim 24 is rejected for the same reasons as discussed in the rejection of claim 12.
Cited Art
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Bydlon et al. et al. (US PAT. No. 12,229,950 B2) discloses A controller for assisting navigation in an interventional procedure includes a memory that stores instructions and a processor (310) that executes the instructions. When executed by the processor (310), the instructions cause the controller to implement a process that includes obtaining (S410) a three-dimensional model generated prior to an interventional procedure based on segmenting pathways with a plurality of branches in a subject of the interventional procedure. The process also includes determining (S470), during the interventional procedure, whether a current position of a tracked device (250) is outside of the pathways in the three-dimensional model. When the current position of the tracked device (250) is outside of the pathways in the three-dimensional model, the process includes deforming (S480) the three-dimensional model to the current position of the tracked device (250).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DARRYL V DOTTIN whose telephone number is (571)270-5471. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abderrahim Merouan can be reached on 571-270-5254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DARRYL V DOTTIN/Primary Examiner, Art Unit 2683
/DARRYL V DOTTIN/Primary Examiner, Art Unit 2683
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