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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/20/2026 has been entered.
In view of the amendments, an updated search was conducted resulting in a new 103 Rejection set forth below.
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.
Claim(s) 1, 2, and 4-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masaki et al. (2021/0369355).
With respect to claim 1, Masaki et al. teach of an apparatus comprising a shaft assembly or steerable catheter 100 with tubular sheath with a working channel 105 to receive a working element and spans from a proximal end to a distal end along the longitudinal axis [0046] and allows a working element or tool to pass through the channel to the opening at the distal end 101 [0049]. Masaki teaches of an image sensor or camera 180 having a field of view distal to the distal end such that the image sensor is configured to capture the image providing a field of view distal to the distal end [0047, 0049, 0064, 0065]. Masaki further teaches of a navigation sensor being configured to generate signals indicative of a position of the distal end in three-dimensional space [0099]. Masaki et al. further teach of a reference marker 190 or EM sensor 790 located at the distal end of the steerable catheter shaft [0049, 0099] or marker 191 and 192 attached at the distal tip of the catheter sheath [0068] or positioned within the field of view of the image sensor or camera 180 where the reference marker 190 can be imaged by the camera 180 such that a graphical representation can be observed in the field of view image of the camera regardless of the direction in which the distal end of the instrument is steered [0064, 0065]. Therefore, the reference marker 190 stays fixed against movement relative to the image sensor to ensure that the marker remains at a fixed location within the field of view of the image sensor or where markers 191/192 are arranged at a predetermined orientation with respect to each other where the orientation of the camera view can be tracked with respect to the orientation of the catheter [0074]. Masaki et al. thereby teach providing a reference point for determining an orientation of the distal end of the catheter shaft where regardless of the orientation of the distal end of the catheter, the reference marker can be observed in the field of view of the camera [0074].
With respect to claim 2, Masaki et al. teach the use of a single navigation sensor or use of electromagnetic sensor located at the tip of the instrument to obtain electromagnetic data for sensing the position and/or orientation of the instrument’s tip and controlling navigation of the instrument based on the EM data [0058].
With respect to claim 4, Masaki et al. teach of the reference marker 190 is positioned distally of the image sensor 180 (as seen in fig. 1, 2).
With respect to claim 5, Masaki et al. teach of the reference marker 190 to comprise protrusion 191, 192 (fig. 4, 0068).
With respect to claim 6, Masaki et al. teach of the reference marker 190 being optically recognizable by the image sensor or camera 180 or where the marker is imaged by the camera 180 such that a graphical representation or reference mark can be observed in the field of view image of the camera [0064].
With respect to claim 7, Masaki et al. teach of visible reference markers of different reflectivity/transparency/colors and shapes including radiopaque markers 892 [0087].
With respect to claims 8-10, Masaki et al. teach of the reference markers 190/192 being configured to define a visual obstruction in a first image at a first location with a first mark relative to a structure that is distal to the distal end [0049, 0064] and a second image in which the visual obstruction is at a second location with a second reference marker relative to the structure that is distal to the distal end with the second location [0072] being angularly displaced from the first location relative to a longitudinal axis of the shaft or the bending angle/direction ([0074], claim 13).
With respect to claims 11 and 12, Masaki et al. teach of a processor 410 being in operative communication with the image sensor for receiving an image and the navigation sensor for receiving signals from the navigation sensor [0067, claim 1]. Masaki et al. therefore teach of the processor being configured to determine a position and orientation [0058, 0064, 0065] of the distal end in three-dimensional space [0041, 0046] based on the image received from the image sensor and signals received from the navigation sensor [0049, 0075-0080]. With respect to claim 13, Masaki et al. teach of the processor being configured to determine the position of the distal end in three-dimensional space based on the signals received from the navigation sensor [0099, 0100]. With respect to claims 14 and 15, Masaki et al. teach of the processor being configured to determine the pitch angle, yaw angle, and roll angle of the distal end in three-dimensional space based on the signals received from the sensor and image received from the image sensor [0041, 0060]. With respect to claim 16, Masaki et al. teach of an actuation system being operable to rotate the shaft assembly of the catheter about the longitudinal axis to change the roll angle of the distal end [0048, 0060].
With respect to claims 17 and 18, Masaki et al. teach of the catheter shaft comprising a proximal portion defining a longitudinal axis with a steerable distal end 101 arranged along the longitudinal axis [0046] where the shaft is flexible [0052, 0054] and can therefore deflect the distal end laterally relative to the longitudinal axis or provide rotation or twisting or bending movement in a desirable direction [0056, 0064]. Masaki et al. teach of an actuation system being operable to rotate the shaft assembly of the catheter about the longitudinal axis to change the roll angle of the distal end [0048, 0060].
Masaki et al. do not explicitly teach of all the claimed limitations in a single embodiment. It would have therefore been obvious to one of ordinary skill in the art to combine the elements from the various embodiments to provide an improved endoscope system which can prevent negative effects on the user and/or patient due to mis-mapping between orientation of the camera view, orientation of the controller, and orientation of the catheter tip and more accurately navigate the tip of the endoscope through the patient’s anatomy [0008, 0009].
Claim(s) 3 rejected under 35 U.S.C. 103 as being unpatentable over Masaki et al. in view of Thompson et al. Masaki et al. do not explicitly teach of a single-axis sensor. In a related field of endeavor Thompson et al. teach of the use of single-axis sensor [0054]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Thompson et al. to modify the previous teachings to provide accurate, real time monitoring of the heart and ensure better alignment and orientation.
Conclusion
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BR
/BAISAKHI ROY/Primary Examiner, Art Unit 3797