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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 & 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "the value" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the value" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 & 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Howard et al. (US 20230414275 A1-effectively filed 06/22/2022), hereinafter “Howard”.
Regarding claim 1, Howard discloses a system for visualization of pulsed field ablation tags, comprising: a device, comprising a processor ([0051]; Figure 1—element 19) in communication with one or more sensors ([0054]; Figure 1—element 13) and a catheter comprising a plurality of electrodes ([0053]; Figure 1—elements 12 & 24); and wherein the processor is configured to: receive, via the one or more sensors, a position of each of the plurality of electrodes within a three-dimensional environment during a plurality of ablation sessions ([0054]; Figure 1—element 13; the tracking system 12 measures a position of the plurality of electrodes 24 prior to, during, and after delivery of PEF energy to target tissue), calculate, for each ablation session, a first implicit function representing an energy field of the corresponding ablation session from the received positions of each of the plurality of electrodes for the corresponding ablation session ([0055]-[0058]; Figures 2A-2C—elements 28; the PEF delivery points 28 can cause ablation or effect with defined field established by the electrodes so the area of effects can be inferred, estimated, and/or calculated by predefined models or even empirical measurements; the processing circuitry is configured to measure the aggregation of the intensity of the fields from applications of PEF energy to the delivery points 28 to determine if the geometric positions on the predetermined map of the target tissue region have been sufficiently affected to cause at least one metric of therapeutic effect; the examiner is considering the first implicit function to be the calculation of the intensity of the fields to the delivery points 28), identify an intersection of the calculated energy fields for the plurality of ablation sessions corresponding to regions having a number of ablation applications exceeding a threshold ([0057]-[0058]; Figures 2C & 2D—elements 28; the aggregated treatment of a PEF delivery point 28 may be displayed on the map, from the aggregated field effects of each application of PEF energy from delivery points 28 a measure of completeness of a particular energy application may be imposed on the previously generated map; for example one region may correspond to a measure of completeness of greater than 90% if the region experiences multiple irreversible field exposures; the examiner is considering the measure of completeness exceeding 90% to be the intersection exceeding a threshold); and present, via a display, a first volumetric representation of the identified intersection of the calculated energy fields ([0058] & [0066]; the measure of completeness may may be associated for any point within the volume being monitored and may be imposed on the generated anatomical-map; although Howard is silent to the map being a volumetric map, Howard discloses in [0066] that “some embodiments may benefit from at least some features disclosed in U.S. Patent Application Publication No. 2022/0273353, which is incorporated herein by reference in its entirety”; Howard et al. (US 20220273353 A1), which is incorporated by reference, discloses in [0069] the map being a volumetric).
Regarding method claim 12, The claim is rejected by the same or substantially the same rationale as applied to the rejection of system claim 1, since the operation of the prior art uses the same or substantially the same system and method.
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 4-6, 9, 15-17, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Adawi et al. (US 20210137588 A1), hereinafter “Adawi”.
Regarding claim 4, Howard discloses all of the limitations of claim 1, as described above.
Howard does not disclose wherein each electrode of the plurality of electrodes is associated with a unique identifier; and wherein the processor is further configured to determine, for each voxel of a plurality of voxels of the three dimensional environment, one or more identifiers of electrodes that provided energy to a position corresponding to the voxel during each ablation session.
Adawi teaches a system for visualization of catheter ablation tags ([0011] & [0013]), the system comprising a processor ([0037]; Figure 1—element 52) and a plurality of electrodes ([0045]; Figure 1—elements 74), wherein each electrode of the plurality of electrodes is associated with a unique identifier; and wherein the processor is further configured to determine, for each voxel of a plurality of voxels of the three dimensional environment, one or more identifiers of electrodes that provided energy to a position corresponding to the voxel during each ablation session ([0011], [0013], [0062]-[0066], [0071]-[0073], & [0075], [0078], [0082], & [0086]; Figures 6-7—elements 74 & 150; the voxels 150, that are used to generate the 3D model, correspond to data points within the electrodes 74, the 3D model comprises an electrodes definition and coordination records 162 having a one-to-one correspondence with voxels, and the visual markers (ablation tags) that correspond to location coordinates of where the electrodes engage an inner surface can be displayed; the examiner is considering the unique identifier to be the electrode definition 160 and coordinate records 160 that correspond to the ablation tags/visual markers).
A person of ordinary skill in the art, before the effective filing date of the claimed invention would have been motivated to modify the 3-dimensional displaying of ablation tags, as disclosed by Howard, to include wherein each electrode of the plurality of electrodes is associated with a unique identifier and wherein the processor is further configured to determine, for each voxel of a plurality of voxels of the three dimensional environment, one or more identifiers of electrodes that provided energy to a position corresponding to the voxel during each ablation session, as taught by Adawi, as both references and the claimed invention are directed toward 3-dimensional displaying of ablation tags. As disclosed by Howard, the system can indicate in tissue where the PEF was delivered by the electrodes ([0054]). As disclosed by Adawi, the system can accurately present the ablation tags that indicate locations in the tissue where the ablation energy is delivered by each electrodes during ablation procedures by generating a 3D model that comprises electrode definitions and coordinate records having a one-to-one correspondence with voxels ([0032], [0033], & [0064]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the 3-dimensional displaying of ablation tags, as disclosed by Howard, to include wherein each electrode of the plurality of electrodes is associated with a unique identifier and wherein the processor is further configured to determine, for each voxel of a plurality of voxels of the three dimensional environment, one or more identifiers of electrodes that provided energy to a position corresponding to the voxel during each ablation session, as taught by Adawi, as such a modification would provide for a known system for generating a 3D model of ablation tags and also would provide for a 3D model that accurately presents the ablation tags that indicate locations in the tissue where the ablation energy is delivered by each electrode during ablation procedures.
Regarding claims 5 & 6, Howard discloses all of the limitations of claim 1, as described above.
Howard does not disclose wherein the processor is further configured to, for each of a plurality of voxels of the three-dimensional environment, calculate a distance from the voxel to a position of an electrode of the plurality of electrodes (claim 5); wherein the processor is further configured to, for each of the plurality of voxels of the three-dimensional environment, determine whether the corresponding calculated distance is less than a threshold (claim 6).
Adawi teaches a system for visualization of catheter ablation tags ([0011] & [0013]), the system comprising a processor ([0037]; Figure 1—element 52) and a plurality of electrodes ([0045]; Figure 1—elements 74), wherein the processor is further configured to, for each of a plurality of voxels of the three-dimensional environment, calculate a distance from the voxel to a position of an electrode of the plurality of electrodes (claim 5); wherein the processor is further configured to, for each of the plurality of voxels of the three-dimensional environment, determine whether the corresponding calculated distance is less than a threshold (claim 6) ([0075] & [0076]; Figures 4, 6, & 9—elements 130, 150, & 194; the processor can detect engagement areas of the electrodes with target tissue using a collision detection algorithm to identify which voxels 150 are within a minimum distance threshold to any voxel 130, the identified voxels correspond to the location coordinates for engagement areas 194).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the 3-dimensional displaying of ablation tags, as disclosed by Howard, to include wherein the processor is further configured to, for each of a plurality of voxels of the three-dimensional environment, calculate a distance from the voxel to a position of an electrode of the plurality of electrodes and for each of the plurality of voxels of the three-dimensional environment, determine whether the corresponding calculated distance is less than a threshold, as taught by Adawi, as both references and the claimed invention are directed toward 3-dimensional displaying of ablation tags. As disclosed by Howard, the system can indicate in tissue where the PEF was delivered by the electrodes ([0054]). As disclosed by Adawi, the system can accurately present the ablation tags that indicate locations in the tissue where the ablation energy is delivered by each electrodes during ablation procedures by generating a 3D model that is configured to identify engagement areas between the electrodes and target tissue via a collision detection algorithm to identify which voxels are within a minimum distance threshold to another voxel wherein the identified voxels correspond to the location coordinates for the engagement areas ([0033] & [0076]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the 3-dimensional displaying of ablation tags, as disclosed by Howard, to include wherein the processor is further configured to, for each of a plurality of voxels of the three-dimensional environment, calculate a distance from the voxel to a position of an electrode of the plurality of electrodes and for each of the plurality of voxels of the three-dimensional environment, determine whether the corresponding calculated distance is less than a threshold, as taught by Adawi, as such a modification provide for a known system for generating a 3D model of ablation tags and also would provide for a 3D model that accurately presents the ablation tags that indicate locations in the tissue where the ablation energy is delivered by each electrode during ablation procedures.
Regarding claim 9, as best understood in view of the 112(b) rejection above, Howard in view of Adawi disclose all of the limitations of claim 6, as described above.
Howard further discloses wherein the processor is further configured to present the first volumetric representation in the three-dimensional environment, each volumetric element shaded based on the value ([0056], [0058], & [0066]; the measure of completeness may may be associated for any point within the volume being monitored and may be imposed on the generated anatomical-map; the zones may be visually coded (e.g. color, shading transparency, or pattern); although Howard is silent to the map being a volumetric map, Howard discloses in [0066] that “some embodiments may benefit from at least some features disclosed in U.S. Patent Application Publication No. 2022/0273353, which is incorporated herein by reference in its entirety”; Howard et al. (US 20220273353 A1), which is incorporated by reference, discloses in [0069] the map being a volumetric in the three-dimensional environment).
Howard does not disclose wherein the processor is further configured present the first volumetric representation as one or more voxels.
Adawi further teaches wherein the processor is further configured present the first volumetric representation as one or more voxels ([0033], [0059], & [0062]; the 3D model is generated as one or more voxels).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the 3-dimensional displaying of ablation tags, as disclosed by Howard, to include wherein the processor is further configured present the first volumetric representation as one or more voxels, as further taught by Adawi, as both references and the claimed invention are directed toward 3-dimensional displaying of ablation tags. As disclosed by Howard, the system can indicate in tissue where the PEF was delivered by the electrodes by generating a 3D model ([0056], [0058], & [0066]). As disclosed by Adawi, the system can accurately present the ablation tags that indicate locations in the tissue where the ablation energy is delivered by each electrodes during ablation procedures by generating a 3D model, wherein the 3D model comprises one or more voxels ([0033], [0059], & [0062]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the 3-dimensional displaying of ablation tags, as disclosed by Howard, to include wherein the processor is further configured present the first volumetric representation as one or more voxels, as further taught by Adawi, as such a modification provide for a known mechanism for generating a 3D model to produce the predictable result of displaying ablation tags.
Regarding method claim 15, The claim is rejected by the same or substantially the same rationale as applied to the rejection of system claim 4, since the operation of the prior art uses the same or substantially the same system and method.
Regarding method claim 16, The claim is rejected by the same or substantially the same rationale as applied to the rejection of system claim 5, since the operation of the prior art uses the same or substantially the same system and method.
Regarding method claim 17, The claim is rejected by the same or substantially the same rationale as applied to the rejection of system claim 6, since the operation of the prior art uses the same or substantially the same system and method.
Regarding method claim 20, as best understood in view of the 112(b) rejection above, the claim is rejected by the same or substantially the same rationale as applied to the rejection of system claim 9, since the operation of the prior art uses the same or substantially the same system and method.
Claim 10 are rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Garrott et al. (US 20240180616 A1; effectively filed 12/01/2022), hereinafter “Garrott”.
Regarding claim 10, Howard discloses all of the limitations of claim 1, as described above.
Howard does not disclose wherein the processor is further configured to: determine a centroid of the received positions for each ablation sessions; and construct a central path around the determined centroid for each ablation session.
Garrott teaches a system configured to generate a three-dimensional map of ablation tags and electric fields that are produced by the catheter ([0058], [0065], & [0070]); wherein the processor is further configured to: determine a centroid of the received positions for each ablation sessions; and construct a central path around the determined centroid for each ablation session ([0079], & [0105]-[0108]; Figure 6B—elements 652, 654, & 680; the processors is configured to automatically identify and annotate a contiguous strings 652 & 654 of two or more overlap zones of intersecting irreversible electroporation fields in tissue; the identification of the contiguous strings provides feedback to the clinician whether a lesion line includes a gap 680 between contiguous strings, and the processor can highlight the gap by determining whether a centroid distance between overlap zones proximate the gap is within a threshold amount).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the 3-dimensional displaying of ablation tags, as disclosed by Howard, to include wherein the processor is further configured to: determine a centroid of the received positions for each ablation sessions and construct a central path around the determined centroid for each ablation session, as taught by Garrott, as both references and the claimed invention are directed toward 3-dimensional displaying of ablation tags. As disclosed by Garrot, the processors may determine if there is a gap or an area of ablation that does not include an overlap zone of intersecting irreversible electroporation fields in tissue and highlight the gap by determining if a centroid distance between overlap zones proximate the gap are within a threshold amount ([0079] & [0105]-[0108]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the 3-dimensional displaying of ablation tags, as disclosed by Howard, to include wherein the processor is further configured to: determine a centroid of the received positions for each ablation sessions and construct a central path around the determined centroid for each ablation session, as taught by Garrott, as such a modification would allow for a user to visualize if there is a gap between adjacent ablation markers, in which the gap represents an area of the ablation that does not include an overlap zone.
Allowable Subject Matter
Claim 2-3, 7-8, 11, 13-14, & 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 2 recites “wherein the processor is further configured to calculate the first implicit function via a signed distance function based on positions of a pair of adjacent electrodes of the plurality of electrodes during the corresponding ablation session”; The Voth reference (US 20150366481 A1) provides a teaching for generating a three-dimensional model and determining for each electrode position a signed distance from the corresponding closest point on the boundary surface ([0032]); however, Voth does not provide a teaching for “calculate, for each ablation session, a first implicit function representing an energy field of the corresponding ablation session from the received positions of each of the plurality of electrodes for the corresponding ablation session” (as required by independent claim 1) and “calculate the first implicit function via a signed distance function based on positions of a pair of adjacent electrodes of the plurality of electrodes during the corresponding ablation session” (as required by dependent claim 2); the examiner notes that no other reference or combination of references have been found to disclose fairly suggest, or make obvious each and every limitation set forth in dependent claim 2. Claim 3, 11, 13, & 14 are indicated as comprising allowable subject matter for substantially the same rationale as claim 2.
Claim 7 recites “wherein the processor is further configured to, for one or more voxels of the plurality of voxels of the three-dimensional environment, modify a value associated with the voxel responsive to the corresponding calculated distance being less than the threshold”; The Adawi reference provides a teaching for: for each of the plurality of voxels of the three-dimensional environment, determine whether the corresponding calculated distance is less than a threshold ([0075] & [0076]); however the Adawi reference does not provide a teaching for “modify a value associated with the voxel responsive to the corresponding calculated distance being less than the threshold”; the examiner notes that no other reference or combination of references have been found to disclose, fairly suggest, or make obvious each and every limitation set forth in dependent claim 7. Claims 8, & 18-19 are indicated as comprising allowable subject matter for substantially the same rationale as claim 7.
Conclusion
Accordingly, claims 1, 4-6, 9-10, 12, 15-17, & 20 are rejected; claim 2-3, 7-8, 11, 13-14, & 18-19 are objected to as being dependent upon a rejected base claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794