DETAILED ACTION
Notice of AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Request for Continued Examination
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17© has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on May 11th, 2026 has been entered.
Response to Arguments
3. Applicant’s remarks received on 04/03/2026 with respect to the amended independent claims have been acknowledged and are moot in view of a new ground of rejected necessitated by the corresponding amendment. Currently claims 1-3, 5, 8, 9, 13, 17, 18, 21, 24, 25, 29, 33-35, 37, 41, 45, and 49 are rejected; and claims 4, 6, 7, 10-12, 14-16, 19, 20, 22, 23, 26-28, 30-32, 36, 38-40, 42-44, and 46-48 are cancelled.
Response to Amendments
Claim Rejections - 35 USC § 103
4. 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 of this title, 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.
51066.. Claims 1, 2, 5, 9, 13, 17, 18, 21, 25, 29, 33, 34, 37, 41, 45, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Birenbaum et al (US Pub: 2019/0239961) and in further view of Piorkowski et al (Nonfluoroscopic Sensor-Guided Navigation of Intracardiac Electrophysiology Catheters Within Prerecorded Cine Loops, 04/06/2011), Walker et al (US Pub: 2017/0151027) (Applicant disclosed reference), Ambrosini et al (Fully Automatic and Real-Time Catheter Segmentation in X-Ray Fluoroscopy , 07/17/2017) and Tran et al (3D Catheter Shape Reconstruction using Electromagnetic and Image Sensors, 01/25/2017).
Regarding claim 1 (currently amended), Birenbaum et al teaches: A method to visualize a three-dimensional pose of an instrument with respect to a two-dimensional image [abstract], the method comprising: obtaining two-dimensional image data generated by an imaging device of a medical system [p0010]; identifying a segment of the two-dimensional image data that corresponds to the instrument [p0010]; obtaining location sensor data indicating at least one position of the instrument [p0013-p0015]; generating a three-dimensional representation of the instrument based on the identified segment and the location sensor data [p0016]; and generating an augmented representation of the two-dimensional image data by overlaying the three-dimensional representation of the instrument on a planar representation of the two-dimensional image data [p0013, p0018].
Birenbaum et al fuses electromagnetic tracked catheter pose with fluoroscopic derived position and displays the position of the catheter on 3D rendering of soft tissue. In the same field of endeavor, Piorkowski et al explicitly overlays 3D catheter pose onto 2D fluoroscopy image: the augmented representation including a three-dimensional representation of the instrument in conjunction with a planar representation of the two-dimensional image data [page e36: Technology Description, p03, p04]. Piorkowski discloses the generation of a 3D representation of a catheter icon using electromagnetic sensors to compute the position of orientation of the catheter within a 3D tracking volume [fig. 2]. The rendered 3D icon representing how the catheter is angled and positioned in space is projected onto planar fluoroscopy images.
For a redundant teaching in the same field of endeavor, Walker et al further renders a three-dimensional representation of the instrument based on the identified segment and the location sensor data [p0073, p0074].
Therefore, given Birenbaum’s disclosure on reconstructing the 3D position of the tip/part of the catheter by finding the intersecting point of rays from 2D segments and registering that data with the EM sensor position and Piorkowski and Walker’s teaching on generating and overlapping a 3D representation of a catheter on a planner representation of 2D image data, it would have been obvious for an ordinary skilled in the art before the effective filing date of the claimed invention to combine Birenbaum’s tip segmentation accuracy with Piorkowski and Walker’s full body 3D representation of an instrument for improving visual experience.
Birenbaum et al in view of Piorkowski and Walker does not determine a shape of the instrument in a 2D space based on identified segment. In the same field of endeavor, Ambrosini et al teaches: determine a shape of the instrument in a 2D space based on identified segment [abstract]. And Tran et al teaches: generating a 3D representation of the instrument based at least in part on the shape of the instrument in the 2D space and the location sensor data [page 1: p01, page 2: p03]. Therefore, it would have been obvious for an ordinary skilled in the art before the effective filing date of the claimed invention to combine the teaching of all to generate more accurate 3D instrument representation using instrument extracted from fluoroscopic images with sensor based position information to improve medical instrument visualization for image guided navigation.
Regarding claim 2 (previously presented), the rationale applied to the rejection of claim 1 has been incorporated herein. Birenbaum et al further teaches: The method of Claim 1, further comprising: identifying a second segment of the two-dimensional image data that corresponds to a second instrument; and obtaining additional location sensor data indicating at least one position of the second instrument, wherein: generating the augmented representation of the two-dimensional image data is further based on second segment and the additional location sensor data, and the augmented representation further includes a three-dimensional representation of the second instrument overlaid on the planar representation of the two-dimensional image data [p0016 (There are multiple catheter tip candidates.)].
Regarding claim 5 (original), the rationale applied to the rejection of claim 1 has been incorporated herein. Birenbaum et al further teaches: The method of Claim 1, wherein the location sensor data includes sensor data generated by a location sensor located at least partially on a distal end of the instrument [p0034].
Regarding claim 9 (previously presented), the rationale applied to the rejection of claim 1 has been incorporated herein. Piorkowski et al further teaches: The method of Claim 1, wherein the two-dimensional image data lacks a third dimension, and generating the augmented representation further comprises: determining an angle of the two-dimensional image data relative to a coordinate frame of the location sensor data; and based on the angle and the location sensor data, adding data indicative of the instrument to the two-dimensional image data, the added data including positioning in the third dimension [page e36: Technology Description, p03, p04 (2D cine lacks depth. The system projects EM-tracked 3D pose onto 2D view.)].
Regarding 13 (previously presented), the rationale applied to the rejection of claim 1 has been incorporated herein. Tran et al teaches: The method of Claim 1, further comprising: generating first point cloud data based on the location sensor data, the first point cloud data including first point data in a first dimension, a second dimension, and a third dimension [abstract, page 2: 2. Probabilistic framework]; and generating second point cloud data based on the two-dimensional image data, the second point cloud data including second point data in the first dimension, the second dimension, and an unknown dimension [page 2: fig. 1 (2D set of points from fluoroscopic image are second point cloud. Fluoroscopic images miss depth.)], wherein generating the three-dimensional representation of the instrument further comprises using the first point cloud data to update the second point cloud data to include third point cloud data in the unknown dimension [pages 2 and 3: 2. Probabilistic framework; page 5: 2.2.3 (Using sensor based 3D points to supply/update unknown dimension.)].
Therefore, it would have been obvious for an ordinary skilled in the art before the effective filing date of the claimed invention to combine the teaching of all to update an image derived 2D point set with depth from a sensor derived 3D point cloud to produce an image-consistent 3D instrument layout for improved accuracy.
Claims 17, 18 (currently amended), 21 (original), and 25 (previously presented) have been analyzed and rejected with regard to claims 1, 2, 5, and 9 respectively.
Regarding claim 29 (previously presented), the rationale applied to the rejection of claim 17 has been incorporated herein. Claim 29 has been analyzed and rejected with regard to claim 13.
Claims 33 (currently amended), 34 (previously presented), 37 (original), and 41 (previously presented) have been analyzed and rejected with regard to claims 1, 2, 5, and 9 respectively; and in accordance with Birebaum et al’s further teaching on: A non-transitory computer readable storage medium having stored thereon instructions that, when executed, cause a processor of a device to [p0054].
Regarding claim 45 (previously presented), the rationale applied to the rejection of claim 33 has been incorporated herein. Claim 45 has been analyzed and rejected with regard to claim 13.
Regarding claim 49 (new), the rationale applied to the rejection of claim 1 has been incorporated herein. Walker et al further teaches: determining a pose of the instrument in a 3D space based on the location sensor data, wherein generating the 3D representation of the instrument is further based on the pose of the instrument in the 3D space [p0008, p0073]. Tran et al also combines EM sensor info with fluoroscopic image to reconstruct 3D catheter shape [abstract].
61066.. Claims 3 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Birenbaum et al (US Pub: 2019/0239961), Piorkowski et al (Nonfluoroscopic Sensor-Guided Navigation of Intracardiac Electrophysiology Catheters Within Prerecorded Cine Loops, 04/06/2011), Walker et al (US Pub: 2017/0151027) (Applicant disclosed reference), Ambrosini et al (Fully Automatic and Real-Time Catheter Segmentation in X-Ray Fluoroscopy , 07/17/2017), and Tran et al (3D Catheter Shape Reconstruction using Electromagnetic and Image Sensors, 01/25/2017); and in further view of Gilboa (US Pub: 2004/0249267).
Regarding claim 3 (previously presented), the rationale applied to the rejection of claim 2 has been incorporated herein. Birenbaum et al in view of Piorkowski et al, Walker et al, Ambrosini et al, and Tran et al does not specify a plane anchored at a position of the instrument. In the same field of endeavor, Gilboa teaches: The method of Claim 1, wherein the augmented representation further includes: a first indicator representing a plane anchored at a position of the instrument; and a second indicator representing a plane anchored at a position of the second instrument [p0172]. Therefore, given Gilboa’s prescription on a plane indicator anchored at a position of one instrument and Birenbaum et al’s disclosure on multiple catheter tips, it would have been obvious for an ordinary skilled in the art before the effective filing date of the claimed invention to combine the teaching of all to have multiple indicators representing planes anchored at positions of the multiple instruments on UI for improving navigating experience.
Regarding claim 35 (currently amended), the rationale applied to the rejection of claim 33 has been incorporated herein. Claim 35 has been analyzed and rejected with regard to claim 3.
71066.. Claims 8 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Birenbaum et al (US Pub: 2019/0239961), Piorkowski et al (Nonfluoroscopic Sensor-Guided Navigation of Intracardiac Electrophysiology Catheters Within Prerecorded Cine Loops, 04/06/2011), Walker et al (US Pub: 2017/0151027) (Applicant disclosed reference), Ambrosini et al (Fully Automatic and Real-Time Catheter Segmentation in X-Ray Fluoroscopy , 07/17/2017), and Tran et al (3D Catheter Shape Reconstruction using Electromagnetic and Image Sensors, 01/25/2017); and in further view of DeFonzo et al (US Pub: 20200085516).
Regarding claim 8 (original), the rationale applied to the rejection of claim 1 has been incorporated herein. Birenbaum et al in view of Piorkowski et al, Walker, Ambrosini et al, and Tran et al does not disclose a kinematic model for the instrument. In the same field of endeavor, DeFonzo et al teaches: the location sensor data includes data from a kinematic model of the instrument, the kinematic model being derived based on commanded movement of the instrument [p0117]. Therefore, given DeFonzo et al’s prescription on location data including data from a kinematic model derived from commanded movement, it would have been obvious for an ordinary skilled in the art before the effective filing date of the claimed invention to combine the teaching of all to include data from a kinematic model for improving robustness and latency of the augmented representation.
Regarding claim 24 (original), the rationale applied to the rejection of claim 17 has been incorporated herein. Claim 24 has been analyzed and rejected with regard to claim 8.
Conclusion
8. There is a new ground of rejection necessitated by the corresponding amendment 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 extension fee 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.
Contact
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FAN ZHANG whose telephone number is (571)270-3751. The examiner can normally be reached on Mon-Fri 9:00-5:00.
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/Fan Zhang/
Patent Examiner, Art Unit 2682
Prosecution Insights