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 .
Claim Rejections - 35 USC § 102
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 1-9 and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kottenstette et al (US Pub 2020/0129740 -cited by applicant).
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); 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).
Re claims 2, 3, 17, 18: 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: 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: 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: 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: 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: 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 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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kottenstette, as applied to claim 1, in view of Thienphrapa et al (US Pub 2021/0085421 -cited by applicant).
Re claim 10: Kottenstette 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, 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 filed 5/12/26 have been fully considered but they are not persuasive. Applicant argues that Kottenstette does not reference the geometry of the distal portion of the guidewire and that movement and position of the guidewire is not determining a change in geometry because movement is stopped when the remaining path length is equal to zero. Respectfully, the Examiner disagrees. Kottenstette teaches that real time image 904 shows movement and position of the guidewire and this is a determination of change in geometry. While Applicant does refer to this correlation (while not necessarily agreeing with it), they state that such is not applicable because the movement is stopped with the remaining path length is zero. While this is true, the limitation as currently set forth is met. The geometric change is that of determining the position/movement of the guidewire tip and, based on that information (i.e. when no change in position/movement is determined), a guidewire extension completion is identified. Therefore, the limitation is met.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
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