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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 21, and 23-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6, 8-10, 13-15, 17, and 20 of U.S. Patent No. 12,349,980 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application cover the same subject matter as the U.S. Patent No. 12,349,980 B2 as shown below.
Current application
U.S. Patent No. 12,349,980 B2
21. (New) A system for determining divergence of an anatomic region from an anatomic model of the anatomic region, the system comprising: a medical device comprising a sensor, wherein the medical device is insertable within a patient; and a computing device in communication with the medical device, the computing device comprising a processor, and a memory coupled to the processor and storing instructions that, when executed by the processor, cause the system to perform operations comprising: receiving sensor data acquired by the sensor of the medical device while the medical device is inserted within an anatomic region of the patient and after the medical device has been registered to an anatomic model of the anatomic region, wherein the anatomic model is based on previously-obtained image data of the anatomic region and includes a model anatomic passageway and a target anatomic structure, and wherein the sensor data indicates a location of at least a portion of the medical device, comparing the sensor data to a corresponding portion of the model anatomic passageway, based at least in part on the comparing, producing a divergence classifier indicative of a divergence of the anatomic region from the anatomic model, wherein the divergence classifier is produced based on one or more weighted divergence vectors, and updating a virtual location of the target anatomic structure when the divergence classifier exceeds a predetermined threshold, wherein the updated virtual location of the target anatomic structure is based on the sensor data corresponding to a distal portion of the medical device.
1. A system for determining divergence of an anatomic region from an anatomic model of the anatomic region, the system comprising: a medical device comprising a sensor, wherein the medical device is insertable within a patient; and a computing device in communication with the medical device, the computing device comprising a processor, and a memory coupled to the processor and storing instructions that, when executed by the processor, cause the system to perform operations comprising: receiving sensor data acquired by the sensor of the medical device while the medical device is inserted within an anatomic region of the patient and after the medical device has been registered to an anatomic model of the anatomic region, wherein the anatomic model is based on previously-obtained image data of the anatomic region and includes a virtual path extending throughout the anatomic model to an anatomic structure of interest, and wherein the sensor data indicates a location of at least a portion of the medical device, comparing the sensor data to a corresponding portion of the virtual path, based at least in part on the comparing, producing a divergence classifier indicative of a divergence of the anatomic region from the anatomic model, wherein the divergence classifier is produced based on one or more weighted divergence vectors, and generating an alert when the divergence classifier exceeds a predetermined threshold.
6. The system of claim 5 wherein the updating the virtual location of the anatomic structure includes: calculating one or more divergence vectors between the corresponding portion of the virtual path and the at least a portion of the medical device, selecting one or more of the divergence vectors associated with one or more positional points located along the at least a portion of the medical device that are nearest to the anatomic structure, fitting a curve to the selected one or more divergence vectors, and extrapolating the curve to estimate a new target position of the anatomic structure in x, y, z coordinate points.
23. (New) The system of claim 21, wherein updating the virtual location of the target anatomic structure includes receiving an indication from a user to perform the update.
4. The system of claim 1 wherein the operations further comprise updating a virtual location of the anatomic region with respect to the anatomic model while the medical device is within the anatomic region.
24. (New) The system of claim 23, further comprising displaying an update prompt and wherein the indication from the user is responsive to the update prompt.
2. The system of claim 1 wherein the generating the alert includes displaying a graphical user interface on a display in communication with the computing device, wherein the graphical user interface includes one or both of graphical and text information indicative of a determination of the divergence of the anatomic region from the anatomic model.
25. (New) The system of claim 21, wherein the updated virtual location of the target anatomic structure is further based on the sensor data corresponding to a portion of the medical device between a proximal end of the medical device and the distal portion of the medical device.
4. The system of claim 1 wherein the operations further comprise updating a virtual location of the anatomic region with respect to the anatomic model while the medical device is within the anatomic region.
26. (New) The system of claim 21 wherein the operations further comprise updating a virtual location of the anatomic region, including at least a portion of the model anatomic passageway and the target anatomic structure.
4. The system of claim 1 wherein the operations further comprise updating a virtual location of the anatomic region with respect to the anatomic model while the medical device is within the anatomic region.
27. (New) The system of claim 26, wherein the updating of the virtual location of the anatomic region occurs while the medical device is within the anatomic region.
4. The system of claim 1 wherein the operations further comprise updating a virtual location of the anatomic region with respect to the anatomic model while the medical device is within the anatomic region.
28. (New) The system of claim 21 wherein the updating the virtual location of the target anatomic structure includes: calculating one or more divergence vectors between the corresponding portion of the model anatomic passageway and the at least a portion of the medical device, selecting one or more of the divergence vectors associated with one or more positional points located along the at least a portion of the medical device that are nearest to the target anatomic structure, fitting a curve to the selected one or more divergence vectors, and extrapolating the curve to estimate a new target position of the target anatomic structure in x, y ,z coordinate points.
6. The system of claim 5 wherein the updating the virtual location of the anatomic structure includes: calculating one or more divergence vectors between the corresponding portion of the virtual path and the at least a portion of the medical device, selecting one or more of the divergence vectors associated with one or more positional points located along the at least a portion of the medical device that are nearest to the anatomic structure, fitting a curve to the selected one or more divergence vectors, and extrapolating the curve to estimate a new target position of the anatomic structure in x, y, z coordinate points.
29. (New) The system of claim 28 wherein the updating the virtual location of the target anatomic structure further includes applying a weighting value to at least one of the one or more divergence vectors to produce the one or more weighted divergence vectors.
4. The system of claim 1 wherein the operations further comprise updating a virtual location of the anatomic region with respect to the anatomic model while the medical device is within the anatomic region.
30. (New) The system of claim 21 wherein comparing includes: determining an offset between the corresponding portion of the model anatomic passageway and the medical device.
8. The system of claim 1 wherein comparing includes: determining an offset between the corresponding portion of the virtual path and the medical device.
31. (New) The system of claim 21 wherein the operations further comprise analyzing the sensor data to determine a shape of the at least a portion of the medical device.
10. The system of claim 1 wherein the operations further comprise analyzing the sensor data to determine a shape of the at least a portion of the medical device.
32. (New) The system of claim 31, wherein comparing the sensor data to the corresponding portion of the model anatomic passageway includes comparing the shape of the at least a portion of the medical device with a portion of the model anatomic passageway.
10. The system of claim 1 wherein the operations further comprise analyzing the sensor data to determine a shape of the at least a portion of the medical device.
33. (New) The system of claim 31 wherein updating the virtual location of the target anatomic structure includes translating a portion of the model anatomic passageway based on the determined shape of the distal portion of the medical device.
10. The system of claim 1 wherein the operations further comprise analyzing the sensor data to determine a shape of the at least a portion of the medical device.
13. The system of claim 1 wherein the divergence classifier includes a device-to-path distance parameter that includes a mean distance between a last region of the portion of the virtual path to a distal end portion of the medical device.
34. (New) The system of claim 21 wherein the divergence classifier includes a distance parameter that includes a mean distance between a last region of the portion of the model anatomic passageway to a distal end portion of the medical device.
9. The system of claim 8 wherein determining the offset includes generating one or more divergence vectors pointing from the corresponding portion of the virtual path to the medical device, and wherein the one or more divergence vectors are point matched.
13. The system of claim 1 wherein the divergence classifier includes a device-to-path distance parameter that includes a mean distance between a last region of the portion of the virtual path to a distal end portion of the medical device.
35. (New) The system of claim 21 wherein the sensor data acquired by the sensor of the medical device are associated with one or more of a position, orientation, speed, pose, and/or shape of the medical device.
14. The system of claim 1 wherein the sensor data acquired by the sensor of the medical device are associated with one or more of a position, orientation, speed, pose, and/or shape of the medical device.
36. (New) The system of claim 21 wherein the medical device includes a catheter, and wherein the sensor includes a shape sensor comprising an optical fiber extending within and aligned with an elongate portion of the catheter.
15. The system of claim 1 wherein the medical device includes a catheter, and wherein the sensor includes a shape sensor comprising an optical fiber extending within and aligned with an elongate portion of the catheter.
37. (New) The system of claim 36 wherein a plurality of points associated with a shape of the medical device are determined from sampled points by the shape sensor.
10. The system of claim 1 wherein the operations further comprise analyzing the sensor data to determine a shape of the at least a portion of the medical device.
38. (New) The system of claim 21 wherein the medical device includes a catheter, and wherein the sensor includes an electromagnetic (EM) sensor located at a distal end or tip of the catheter.
17. The system of claim 1 wherein the medical device includes a catheter, and wherein the sensor includes an electromagnetic (EM) sensor located at a distal end or tip of the catheter.
39. (New) The system of claim 38 wherein a plurality of points associated with a shape of the medical device are determined from a plurality of individual points measured at the distal end or tip of the catheter by the EM sensor as it is driven through an anatomic passageway.
18. The system of claim 17 wherein a plurality of points associated with a shape of the medical device are determined from a plurality of individual points measured at the distal end or tip of the catheter by the EM sensor as it is driven through an anatomic passageway.
40. (New) A non-transitory, computer-readable medium storing instructions thereon that, when executed by one or more processors of a computing system, cause the computing system to perform operations comprising: receiving sensor data acquired by a sensor of a medical device while the medical device is inserted within an anatomic region of a patient and after the medical device has been registered to an anatomic model of the anatomic region, wherein the anatomic model is based on previously- obtained image data of the anatomic region and includes a model anatomic passageway and a target anatomic structure, and wherein the sensor data indicates a location of at least a portion of the medical device, comparing the sensor data to a corresponding portion of the model anatomic passageway, based at least in part on the comparing, producing a divergence classifier indicative of a divergence of the anatomic region from the anatomic model, wherein the divergence classifier is produced based on one or more weighted divergence vectors, and updating a virtual location of the target anatomic structure when the divergence classifier exceeds a predetermined threshold, wherein the updated virtual location of the target anatomic structure is based on the sensor data corresponding to a distal portion of the medical device.
20. A non-transitory, computer-readable medium storing instructions thereon that, when executed by one or more processors of a computing system, cause the computing system to perform operations comprising: receiving sensor data acquired by a sensor of a medical device while the medical device is inserted within an anatomic region of a patient and after the medical device has been registered to an anatomic model of the anatomic region, wherein the anatomic model is based on previously-obtained image data of the anatomic region and includes a virtual path extending throughout the anatomic model to an anatomic structure of interest, and wherein the sensor data indicates a location of at least a portion of the medical device, comparing the sensor data to a corresponding portion of the virtual path, based at least in part on the comparing, producing a divergence classifier indicative of a divergence of the anatomic region from the anatomic model, wherein the divergence classifier is produced based on one or more weighted divergence vectors, and generating an alert when the divergence classifier exceeds a predetermined threshold.
Allowable Subject Matter
Claim 22 is 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.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 07/15/26, with respect to claims 21-40, regarding the 35 U.S.C 102 and 35 U.S.C 103 rejections have been fully considered and are persuasive. The 35 U.S.C 102 and 35 U.S.C 103 rejections of claims 21-40 has been withdrawn. The claims would be in condition for allowance except for the Double patenting rejection above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DIXOMARA VARGAS/Primary Examiner, Art Unit 3798
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