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 .
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
Regarding the amendments to the claims, newly-found reference of Van Roosbroeck has been introduced. Van Roosbroeck teaches that the flexible elongate device and shape sensor together traverse the reference shape. Thus, 102 rejections have been withdrawn.
Claim Rejections - 35 USC § 102
Rejections under 35 USC 102 have been withdrawn in response to Applicant’s amendments filed 05/26/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8, 10-14, 16, 21, 23, 25, & 27 are rejected under 35 U.S.C. 103 as being unpatentable over Chopra (US 2014/0275997) in view of Van Roosbroeck (US 2022/0110508).
Regarding claim 1, Chopra in view of Van Roosbroeck teach a medical tracking system comprising:
a flexible elongate device (flexible catheter body 254, [0049], Figure 3);
a shape sensor (optical fiber shape sensor 253, [0049], Figure 3) extending at least partially along the flexible elongate device ([0049]), and configured to measure a shape of the flexible elongate device ([0049]); and
a controller (control system 112, [0030]) comprising at least one processor (processor, [0030]), the controller configured to:
register a reference shape (predetermined configuration, [0058]) of the flexible elongate device to an anatomical reference frame (image reference frame, [0058]);
identify, using the shape sensor, the reference shape at a first portion of the flexible elongate device (reference portion 251 of the shape sensor fiber 253, [0058]) while the reference shape is traversed by the shape sensor ([0058] & Figure 3);
determine, using the shape sensor, a spatial relationship between a second portion of the flexible elongate device (pose of the distal end (or any other portion) of the shape sensor fiber 253, [0058]) and the first portion ([0058]); and
determine a position of the second portion of the flexible elongate device in the anatomical reference frame based on the registration of the reference shape to the anatomical reference frame and the spatial relationship between the first portion and the second portion of the flexible elongate device ([0058]).
However, Chopra fails to disclose that the reference shape is traversed by the flexible elongate device with the shape sensor.
Van Roosbroeck teaches that the reference shape (known shape, [0089]) is traversed by the flexible elongate device (catheter, [0089]) with the shape sensor (multicore fiber, [0005]) ([0089] & Figure 4).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Chopra such that the reference shape is traversed by the flexible elongate device with the shape sensor, as taught by Van Roosbroeck. Feeding the shape sensor through the reference shape while it is in the flexible elongate device creates a more compact, manageable design during a procedure.
Regarding claim 2, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 1, and Chopra further teaches that the flexible elongate device includes an articulable portion (cables, linkages, or other steering controls, [0047]; Figure 2) configured to be manually articulated by an operator ([0047]).
Regarding claim 3, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 1, and Chopra further teaches that registering the reference shape comprises measuring the shape of a second elongate device (elongated flexible instrument, Claim 11) with a second shape sensor (second shape sensor, [0007] & Claims 10-11 or optical fiber shape sensor 470, [0066], Figure 8).
Regarding claim 4, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 1, and Chopra further teaches that the reference shape is a lumen shape of a lumen of a reference object (interventional instrument 252, [0049]), wherein the flexible elongate device is configured to conform to the lumen shape when disposed in the lumen ([0049] & [0058], Figure 3).
Regarding claim 5, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 4, and Chopra further teaches that the reference object is an adapter (reference fixture 462, [0065]) having a known shape and pose in the anatomical reference frame (“The reference fixture holds the proximal ends of the sensor fibers 470, 451 in fixed positions and orientations relative to each other and to the reference fixture”, [0070]).
Regarding claim 6, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 5, and Chopra further teaches that the adapter comprises a first straight portion and a second straight portion angled relative to the first straight portion ([0070] & Figure 8).
Regarding claim 7, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 4, and Chopra further teaches that the reference object is an endotracheal tube ([0048]).
Paragraph [0048] states that the interventional instrument system 202 may be a bronchial catheter. This comprises a tube that passes through the trachea. Nevertheless, one having ordinary skill in the art would understand that the teachings of Chopra, which pertain to inserting a shape sensor into a catheter, can be applied to an endotracheal tube.
Regarding claim 8, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 1, and Chopra further teaches that identifying the reference shape at the first portion comprises:
identifying a plurality of reference points in the reference shape ([0056]);
Paragraph [0056] teaches determining the pose and shape of the shape sensor fiber 253 (and, thus, the catheter body 254) in both the reference portion 251 and the distal tip. In order to determine the shape of the entire fiber, the relative positions of a plurality of points throughout the fiber must be known.
identifying a plurality of measured points at the first portion ([0056]); and
comparing the relative positions of the plurality of reference points and the plurality of measured points ([0056]).
Regarding claim 10, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 1, and Chopra further teaches that identifying the reference shape at the first portion comprises:
identifying a plurality of reference vectors in the reference shape ([0056]);
identifying a plurality of measured vectors at the first portion ([0056]); and
comparing the relative directions of the plurality of reference vectors and the plurality of measured vectors ([0056]).
Per the instant application, “vectors” refer to the direction of the shape sensor/reference object. By connecting any amount of consecutive points of the tracked points of the shape sensor, a vector can be deduced at any point of the sensor.
Regarding claim 11, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 1, and Chopra further teaches that the anatomical reference frame includes a reference landmark located at a proximal portion of an internal cavity of a patient (“the fiduciary apparatus may be attached to the internal patient anatomy, e.g., trans-nasal, trans-rectal, trans-vaginal, trans-esophageal”, [0049]).
Regarding claim 12, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 1, and Chopra further teaches that the controller is further configured to determine the position of the flexible elongate device relative to a system base reference frame different from the anatomical reference frame ([0045]).
Regarding claim 13, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 1, and Chopra further teaches that the second portion is disposed distal relative to the first portion ([0058] & Figure 3).
Claim 14 is rejected for similar reasons to claim 1. Chopra further teaches a non-transitory computer-readable medium storing instructions ([0030]).
Claim 16 is rejected for similar reasons to claim 3.
Claim 21 is rejected for similar reasons to claim 8.
Claim 23 is rejected for similar reasons to claim 10.
Claim 25 is rejected for similar reasons to claim 12.
Claim 27 is rejected for similar reasons to claim 1.
Claims 9 & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Chopra in view of Van Roosbroeck, as applied to claims 8 & 21, above, in view of Donhowe (US 11,202,680).
Regarding claim 9, Chopra in view of Van Roosbroeck teach the medical tracking system of claim 8.
However, Chopra in view of Van Roosbroeck fail to disclose that identifying the reference shape at the first portion comprises matching the plurality of measured points to the plurality of reference points within a similarity threshold.
Donhowe teaches that identifying the reference shape at the first portion comprises matching the plurality of measured points to the plurality of reference points (Column 21, Lines 22-24) within a similarity threshold (maximum distance threshold, Column 21, Line 36).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Chopra and Van Roosbroeck such that identifying the reference shape at the first portion comprises matching the plurality of measured points to the plurality of reference points within a similarity threshold, as taught by Donhowe. This results in a more accurate tracking of the device, as the measured points can only be associated with the reference points if they are substantially close.
Claim 22 is rejected for similar reasons to claim 9.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection 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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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