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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/11/26 has been entered.
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.
Claims 1-9 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kottenstette et al (US Pub 2020/0129740 -cited by applicant) in view of Albers et al (US Pub 2022/0054153 with priority to August 2020).
Re claims 1, 15, 19, 20: Kottenstette discloses a thrombectomy device and a corresponding vascular therapy method [0003, Abstract; see the mechanical thrombectomy], comprising:
a retrieval device configured to deploy and subsequently retrieve an associated tethered self-expanding stent, the retrieval device including a guidewire having a tip that is radiopaque [0050; see the working catheter that is a stent delivery system and see that the distal tip of the guidewire is radiopaque]; and
at least one electronic processor (see fig 8) programmed to:
receive a time sequence of images of extension of the guidewire through a clot during a thrombectomy procedure being performed using the thrombectomy device [0050, fig 8; step 804: tracking of guidewire executed by imaging system];
perform image analysis on the images of the time sequence of images to determine a geometric change of the tip of the guidewire [0051, fig 9; real time image 904 showing movement and position of guidewire requires the determination of change in geometric shape of the guidewire];
identify a completion of the extension of the guidewire through the clot based on the geometric change of the tip of the guidewire (fig 8, step 810; completion when remaining path length equals zero, wherein the position change identification is a geometric change); and
respond to the identification of the completion of the extension of the guidewire through the clot by:
outputting an indication that the guidewire is extended completely through the clot [0056, fig 8; navigation is ended, thus providing indication that the target has been reached]; and
controlling a robot to stop the extension of the guidewire through the clot [0050, 0056; step 812, movement of guidewire is stopped, which can be either by the operator or automatically].
Kottenstette further discloses a therapy method including receiving the time sequence of images, performing image analysis, identifying a completion, and responding to the identification (see the above citations and descriptions for the corresponding steps).
Kottenstette discloses all features except that the geometric change is a change in shape of the tip. However, Albers teaches of a device and method for treatment of thrombosis, wherein a wire tip includes expandable mesh web that is compressed as it passes through a thrombus and expands after passing through, which permits identification that the guidewire has extended through the clot [0063, figure 1; see the guidewire with mesh expandable tip that is expanded upon passing through the clot]. It would have been obvious to the skilled artisan to modify Kottenstette, to incorporate the mesh tip as taught by Albers, in order to facilitate device localization and removal of the clot.
Re claims 2, 3, 17, 18: Kottenstette discloses the image analysis determines the geometric change of the tip of the guidewire comprising a loop at the tip of the guidewire expanding after completion of the extension of the guidewire through the clot, and wherein the loop at the tip that is compressed during the extension of the guidewire through the clot and is expanded after completion of the extension of the guidewire through the clot [0056, fig 10; see the types of wire prolapses detected of the guidewire tip, which includes the loop that is compressed during extension and expanded after completion in combination with the navigation of the guidewire and subsequent correction actions].
Re claim 4: Kottenstette discloses the processor is programmed to respond to the identification by outputting an indication that the guidewire is extended completely through the clot (fig 8, 0003; the guidewire extends through the entire clot in a thrombectomy procedure such that the indication is provided by ending navigation when the target is reached).
Re claim 5: Kottenstette discloses a robot is controlled by the at least one electronic processor to automatically perform the extension of the guidewire through the clot [0003; see the robotic catheter procedure].
Re claims 6, 7: Kottenstette discloses an imaging device with X-ray source and detector is configured to acquire the time sequence of images of the guidewire acquired during the thrombectomy procedure; wherein the imaging device is in communication with the processor [0050; see the imaging system that communicates with the processor, where fluoroscopic images are obtained with an X-ray source/detector].
Re claims 8, 9: Kottenstette discloses the tip that is radiopaque comprises one or more radiopaque markers disposed on the tip [0050; see the radiopaque distal tip of the guidewire which is a radiopaque marker or radiopaque wire].
Re claim 16: Kottenstette discloses after identifying the completion of the extension of the guidewire through the clot, deploying a self-expanding stent along the guidewire and subsequently retrieving the self-expanding stent [0041; see the driving of the stent in and out of a patient as part of the stent delivery system after the guidewire reaches the target].
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kottenstette/Albers, as applied to claim 1, in view of Thienphrapa et al (US Pub 2021/0085421 -cited by applicant).
Re claim 10: Kottenstette/Albers discloses all features except for a sensor attached to the tip of the guidewire and configured to measure a contraction or an expansion of the tip. However, Thienphrapa teaches a sensor attached to the tip of the guidewire and configured to measure a contraction or an expansion of the tip [0132; see the optical shape sensor that can measure contraction or expansion]. It would have been obvious to the skilled artisan to modify Kottenstette/Albers, to incorporate a sensor as taught by Thienphrapa, in order to provide addition information of the distal end of the instrument for improved navigation.
Response to Arguments
Applicant’s arguments with respect to claims 1-10 and 15-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
