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).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
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.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-27, and 30-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al. (US 2019/0365199 A1).
With respect to claim 21, Zhao discloses a system for determining divergence of an anatomic region from an anatomic model of the anatomic region, the system comprising (medical device #100 as seen on Figure 1): a medical device comprising a sensor (sensor #108), wherein the medical device is insertable within a patient (instrument #104 is insertable as further shown in Figure 6A where the environment #600 shows elongated device #610 inserted within patient P; see paragraphs 0042 and 0044 describing instrument #104 located within the surgical site where the surgical site is within the patient and hence inserted); and a computing device in communication with the medical device (controller #112 in communication with instrument #104 as described in paragraphs 0038 and 0043), 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 (see paragraphs 0008 and 0043): 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 (see Abstract and paragraphs 0036, 0061 and 0112), comparing the sensor data to a corresponding portion of the model anatomic passageway, based at least in part on the comparing (see Abstract and paragraphs 0041, 0060-0061 and 0071), 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 (see paragraphs 0095-0097 and 0127), 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 (see paragraphs 0086, 0093 and 0109).
With respect to claim 22, Zhao discloses comparing includes comparing the sensor data to a corresponding portion of a centerline of the model anatomic passageway (see paragraph 0060 and 0064-0067).
With respect to claim 23, Zhao discloses updating the virtual location of the target anatomic structure includes receiving an indication from a user to perform the update (see paragraphs 0086, 0093 and 0109).
With respect to claim 24, Zhao discloses displaying an update prompt and wherein the indication from the user is responsive to the update prompt (see paragraph 0042 and see Figure 1 showing user O to view the interventional site and to control teleoperational manipulator assembly #102).
With respect to claim 25, Zhao discloses 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 (see paragraphs 0035-0037).
With respect to claim 26, Zhao discloses 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 (see paragraphs 0086, 0093 and 0109).
With respect to claim 27, Zhao discloses the updating of the virtual location of the anatomic region occurs while the medical device is within the anatomic region (see paragraphs 0086, 0093 and 0109).
With respect to claim 30, Zhao discloses comparing includes: determining an offset between the corresponding portion of the model anatomic passageway and the medical device (see paragraph 0087).
With respect to claim 31, Zhao discloses analyzing the sensor data to determine a shape of the at least a portion of the medical device (see paragraphs 0049-0050).
With respect to claim 32, Zhao discloses 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 (see Abstract and paragraphs 0041, 0060-0061 and 0071).
With respect to claim 33, Zhao discloses 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 (see paragraphs 0049-0050).
With respect to claim 34, Zhao discloses 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 (see paragraphs 0070-0071 and 0110).
With respect to claim 35, Zhao discloses 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 (see paragraphs 0036, and 0049-0050).
With respect to claim 36, Zhao discloses 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 (see paragraphs 0055 and 0076).
With respect to claim 37, Zhao discloses a plurality of points associated with a shape of the medical device are determined from sampled points by the shape sensor (see Abstract and paragraphs 0041, 0060-0061 and 0071).
With respect to claim 38, Zhao discloses the medical device includes a catheter (see paragraphs 0055 and 0076), and wherein the sensor includes an electromagnetic (EM) sensor located at a distal end or tip of the catheter (paragraphs 0055 and 0076),
With respect to claim 39, Zhao discloses 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 (see Abstract and paragraphs 0041, 0060-0061 and 0071) of the catheter (see paragraphs 0055 and 0076) by the EM sensor as it is driven through an anatomic passageway (paragraphs 0055 and 0076).
With respect to claim 40, Zhao discloses 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 (instrument #104 is insertable as further shown in Figure 6A where the environment #600 shows elongated device #610 inserted within patient P; see paragraphs 0042 and 0044 describing instrument #104 located within the surgical site where the surgical site is within the patient and hence inserted), 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 (see Abstract and paragraphs 0036, 0061 and 0112), comparing the sensor data to a corresponding portion of the model anatomic passageway (see Abstract and paragraphs 0041, 0060-0061 and 0071), 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 (see paragraphs 0095-0097 and 0127), 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 (see paragraphs 0086, 0093 and 0109).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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.
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US 2019/0365199 A1) in view of Qiu et al. (US 2015/0320507 A1).
With respect to claim 28, Zhao discloses 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 (see paragraphs 0095-0097 and 0127). Furthermore, Zhao discloses the claimed invention as stated above except for 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. However. Qiu discloses the step of 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 (see paragraphs 0059-0061). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to perform 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 as taught by Qiu in combination with Zhao’s calculations for the purpose of accurately defining the path of insertion from selected points by providing passageway points for each of the locations with interpolation and/or smoothing (see paragraphs 0016 and 0059-0060).
With respect to claim 29, Zhao discloses 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 (see paragraph 0121).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional prior art cited in the PTO 892 not relied upon discloses insertable medical devices that can be track during operation in order to determine the progress of an illness.
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/DIXOMARA VARGAS/Primary Examiner, Art Unit 3798
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